A QUALITY IMPROVEMENT PROJECT USING EVIDENCE-BASED INTERVENTIONS FOR SMOKING CESSATION IN ADULTS WITH BEHAVIORAL HEALTH CONDITIONS by Ileana Olga Asanache ________________________ Copyright © Ileana Olga Asanache 2022 A DNP Project Submitted to the Faculty of the BLOOMSBURG UNIVERSITY In Partial Fulfillment of the Requirements For the Degree of DOCTOR OF NURSING PRACTICE In the Graduate Nursing Program BLOOMSBURG UNIVERSITY 2022 2 THE UNIVERSITY OF BLOOMSBURG GRADUATE COLLEGE As members of the DNP Project Committee, we certify that we have read the DNP project prepared by Ileana Olga Asanache, titled A quality improvement project using evidence-based interventions for smoking cessation in adults with behavioral health conditions, and recommend that it be accepted as fulfilling the DNP project requirement for the Degree of Doctor of Nursing Practice. _________________________________________________________________ Date: ____________ _________________________________________________________________ Date: ____________ _________________________________________________________________ Date: ____________ [Instructor of Record Name] [Faculty Committee Member Name] [Department Chair Member Name] Final approval and acceptance of this DNP project is contingent upon the candidate’s submission of the final copies of the DNP project to the Graduate College. I hereby certify that I have read this DNP project prepared under my direction and recommend that it be accepted as fulfilling the DNP project requirement. _________________________________________________________________ [Committee Chair Name] DNP Project Committee Chair [Academic Department] Date: ____________ 3 ACKNOWLEDGMENTS Many thanks to my advisor and faculty mentor, Dr. Cheryl Jackson, under whose constant guidance I have completed this evidence-based clinical project. She not only enlightened me with the academic knowledge but also gave me valuable advice whenever I needed it the most. I would like to express my gratitude and appreciation for my clinical expert, Samantha Maccarone, whose support and encouragement have been invaluable throughout this journey. This project would not have been possible without your contribution. 4 DEDICATION I dedicate this thesis work to my husband, Florin Asanache, who has been a constant source of support and encouragement during the challenging time of graduate school and life. I am truly thankful and blessed for having you in my life. I also dedicated this work to my wonderful children, Dennis and Jennifer Asanache, who put up with my busy days and sleepless nights. Both of you were the reason for keeping me going. A special thank you goes to the smoking cessation group coordinator, Christa Carey, whose enthusiasm and overall insight made this project implementation a memorable experience. My thanks go to my friend Barbara Sitoski, who believed in me and shared her personal experience of tobacco use and the smoking cessation struggle. Thank you all for being there for me throughout the entire doctorate program. And last but not least, I am thankful to God, who gave me strength and wisdom, and has been there every step of the way throughout this amazing journey. 5 TABLE OF CONTENTS LIST OF FIGURES……………………………………………………………………………….7 ABSTRACT.....................................................................................................................................8 INTRODUCTION..........................................................................................................................9 Background Knowledge/Significance.........................................................................................11 Local Problem ..............................................................................................................................13 Intended Improvement ................................................................................................................16 Project Purpose ................................................................................................................17 Project Question ...............................................................................................................17 Project Objectives ............................................................................................................18 Theoretical Framework ...............................................................................................................19 Literature Synthesis .....................................................................................................................20 Evidence Search ...............................................................................................................20 Comprehensive Appraisal of Evidence ..........................................................................22 Strengths of Evidence ......................................................................................................30 Weaknesses of Evidence ..................................................................................................30 Gaps and Limitations ......................................................................................................31 METHODS ...................................................................................................................................32 Project Design...............................................................................................................................33 Model for Implementation ..........................................................................................................35 Setting and Stakeholders .............................................................................................................36 Planning the Intervention ...........................................................................................................37 Participants and Recruitment.....................................................................................................40 Consent and Ethical Considerations ..........................................................................................42 Data Collection .............................................................................................................................43 Data Analysis ................................................................................................................................45 RESULTS .....................................................................................................................................45 Outcomes ......................................................................................................................................51 6 TABLE OF CONTENTS - Continued DISCUSSION ..............................................................................................................................52 Summary.......................................................................................................................................53 Interpretation ...............................................................................................................................55 Implications (Practice, Education, Research and Policy) ........................................................56 Limitations ....................................................................................................................................57 DNP Essentials Addressed .........................................................................................................58 Conclusions ...................................................................................................................................59 Plan for Sustainability .....................................................................................................60 Plan for Dissemination ....................................................................................................61 APPENDIX A: SITE APPROVAL/AUTHORIZATION LETTER .........................................62 APPENDIX B: CONSENT DOCUMENT- CONSENT FORM ..............................................71 APPENDIX C: RECRUITMENT MATERIAL – PARTICIPANT SCREENING/ENROLMENT LOG ...............................................................78 APPENDIX D: PARTICIPANT MATERIAL - WRITTEN GUIDELINES, EDUCATIONAL MATERIALS ..................................................................................................80 APPENDIX E: CHART AUDIT FORMS ................................................................................89 APPENDIX F: PROJECT TIMELINE .....................................................................................93 APPENDIX G: OTHER DOCUMENTS AS APPLICABLE TO THE PROJECT – FISHBONE DIAGRAM……………………………………………………. 95 REFERENCES ..........................................................................................................................97 7 LIST OF FIGURES Figure 1. Study participants flow chart ………………………………………………………………41 Figure 2. Total patients screened………………………………………………………………………46 Figure 3. Daily tobacco use ……………………………………………………………………………46 Figure 4. Primary diagnosis ……………………………………………………………………………47 Figure 5. Two weeks phone call follow up…………………………………………………………….47 8 ABSTRACT Purpose: The purpose of this project was to implement a brief evidence-based smoking cessation intervention for smoking cessation in adults with behavioral health conditions. Background: Over 40% of adults who smoke do not receive advice to quit from a healthcare professional, fewer than one in three adults who smoke use cessation counseling or FDAapproved medications when trying to quit, and fewer than one in 10 U.S. adults successfully quit smoking each year. People with behavioral health conditions are not only more likely to smoke, but they also smoke more often than people with no mental illness and have an increased rate of relapse and cessation failure. Methods: The Transtheoretical Model of Health Behavioral Change was used to educate about the effects of smoking, recommend changes in behavior, offer options for achieving behavioral change, help develop a plan and select smoking cessation strategies, and follow up to monitor and reinforce the behavioral change. Results: The measurable outcomes showed 11% quit attempts in patients who benefit from nicotine replacement therapy and brief clinical intervention. Conclusions: The quality improvement project integrated the brief smoking cessation intervention as an essential part of patient care. The 5A’s brief clinical intervention was an effective way to identify smokers, start treatment, and provide resources for support. 9 INTRODUCTION Tobacco dependence is the leading cause of illness, disability, and death in the United States. Smoking tobacco is a harmful habit associated with high morbidity and mortality, including chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD), cancers in every human organ system, and decreased reproductive health (Adams & Morris, 2020). The Center for Disease Control and Prevention (CDC, 2020) reports that 480,000 people die each year because of cigarette smoking, 58 million nonsmokers are exposed to secondhand smoke, and $170 billion is spent each year to treat smoking-related diseases. When narrowed to a specific population, cigarette use is more common among adults with any mental illness (27.2%) than among adults with no mental illness (15.8%) (CDC, 2020). Tobacco use disorder is a behavioral health condition in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and a high percentage of individuals diagnosed with a mental illness have tobacco use as co-occurring disorder (American Psychiatric Association, 2013). People with mental illness or a substance use disorder account for 25 percent of the adult population, but they consumed 40 percent of cigarettes sold in the United States (Lipari & Van Horn, 2017). The association between current cigarette use among lifetime daily smokers and mental illness was found regardless of age group and gender (Lipari & Van Horn, 2017). Quitting smoking is more challenging for people with mental illness because of stressful living conditions, low income, lack of access to health insurance, and shortfall of resources (Prochaska et al., 2017). On average, persons with behavioral health conditions who smoke cigarettes are four times more likely to die prematurely than those who do not smoke (CDC, 10 2020). Smoking is a chronic illness that involves a physical, emotional, and behavioral addiction. To quit, each type of addiction, as well as barriers to quitting, needs to be addressed. Cigarette smoking in adults remains among the leading health indicators of top priority Healthy People 2030 objectives selected to drive action toward improving health and well-being (Office of Disease Prevention and Health Promotion [ODPHP], n.d.). Healthy People 2030 focuses on preventing people from using tobacco products and helping them quit through several evidence-based strategies that can help prevent and reduce tobacco use and exposure to secondhand smoke including smoke-free policies, price increases, and health education campaigns that target large audiences (Mager & Moore, 2020). Helping a patient stop smoking is one of the most beneficial preventive medicine interventions (Adams & Morris, 2021). Current tobacco cessation efforts in adults with psychiatric illnesses are insufficient. Clinicians must use the information and tools to better understand and address the needs of people with mental illness and to make progress in lowering the rates of smoking among them. This quality improvement (QI) initiative addressed the inconsistency and incompleteness of the usual care in tobacco cessation interventions offered to adult smokers with a behavioral health condition. When tobacco users are treated with comprehensive, targeted programs using evidence-based combinations of behavioral therapy and pharmacotherapy, long-term quit rates significantly increase and can reach 40–50% (Kendra et al., 2020). Quitting smoking increases overall life expectancy and quality of life and reduces the risk of various chronic diseases and premature death (CDC, 2020). Quitting smoking before the age of 40 has been shown to reduce smoking-related death by about 90% (Adams & Morris, 2021). 11 Background Knowledge/Significance Tobacco use has been termed as the habitual process that elicits not only a psychological but also a physiologic addictive mood notable amongst the users. The highly addictive ingredient in tobacco is nicotine, which contributes to sustained tobacco use. Smoking as an act has been a major problem owing to its various detrimental effects and the significant epidemiologic impact that affects human health (Sealock & Sharma, 2020). Tobacco causes adverse health outcomes via a series of steps, including the release of free radicals that contribute to effects such as oxidative stress and DNA damage, besides inflammation (Haddad & Davis, 2016). Also, the chemical toxins that are present in tobacco smoke are transported to most parts of the human body from the lungs through the bloodstream. The primary health concern for smokers is lung cancer caused by carcinogenic chemicals in tobacco (Al-Bashaireh et al., 2018). Smoking affects not only the lungs but contributes to cancers of the larynx, pharynx, stomach, and mouth. A relationship has been established between cigarette smoking and cancers of the liver, head, neck, cervix, colon, and even cancers of the bladder. These effects not only occur in active smokers but also in passive smokers. Thus, everyone is at risk of the effects of tobacco smoke, making it an issue of major concern globally. In causing cancer, the carcinogens that are present in tobacco smoke have been noted to bind to the human DNA causing mutations and DNA damage that contribute to abnormal cell growth and spread causing cancer (Haddad & Davis, 2016). The impact of tobacco use depends on both the exposure to cigarette smoking and the duration of smoking. Smoking has been associated with diverse systemic diseases, with various mechanisms contributing to this relationship. For instance, tobacco smoking has been linked to diseases such 12 as endothelial dysfunction, prothrombotic effects, inflammation, defects in lipid metabolism, and increased demand for myocardial oxygen (Haddad & Davis, 2016). Bronchitis, emphysema, and asthma are additional lung diseases that are triggered by smoking. These instances have been linked to such mechanisms as losing the cilia in the lungs, hyperplasia of the mucous glands, and overall inflammation. These mechanisms result in abnormal functioning of the lungs and injuries in the lungs. Females who smoke tobacco suffer various reproductive abnormalities (Haddad & Davis, 2016). Carbon monoxide, a compound found in tobacco, deprives oxygen supply to the fetus. This results in low birth weights. Other substances found in tobacco such as cadmium, mercury, lead, and polycyclic aromatic hydrocarbons have been noted to result in unexpected infant death syndrome, besides premature births, as well as decreased female fertility. Maternal cigarette smoking has also been related to orofacial clefts and ectopic pregnancies. In men, it has been linked to erectile dysfunction (Haddad & Davis, 2016). Research data has shown that people with mental illness are not only more likely to smoke, but they also smoke more often than people with no mental illness and have an increased rate of relapse and cessation failure (CDC, 2021b). The most prevalent smoking rates are among patients with anxiety disorders, mood disorders, psychoses, developmental disorders, and substance use disorders. Nicotine has mood-altering effects that can temporarily mask the negative symptoms of mental health disorders, putting people with such disorders at higher risk for cigarette use and nicotine addiction (CDC, 2020). Further, tobacco smoke can interact with and inhibit the effectiveness of certain medications taken by patients with behavioral health 13 conditions, often resulting in a need for higher medication doses to achieve the same therapeutic benefit. The U.S. Public Health Service Guideline Treating Tobacco Use and Dependence: 2008 Update (US Department of Health and Human Services [USDHHS], 2008) provides recommendations for clinical interventions and system changes to promote the treatment of tobacco dependence. The guideline’s objectives are to provide specific recommendations regarding brief and intensive tobacco cessation interventions and system-level changes designed to promote the assessment and treatment of tobacco use with new guideline recommendations for clinical practice. The U.S. Preventive Service Task Force (USPSTF, 2021) recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and approved pharmacotherapy for cessation. Despite effective and readily available interventions, disparities in tobacco use remain across groups defined by race, ethnicity, educational level, and socioeconomic status, contributing to difficulties with updating the guideline (CDC, 2020). The targeted audience for the implementation of the recommended guideline are clinicians, healthcare administrators, insurers, and purchasers. At the local level, the problem underlying the implementation of a smoking cessation program in a behavioral health unit is the lack of effective brief clinical interventions, evidence-based treatment, and affordable resources. Local Problem Many individuals with behavioral health conditions want to quit smoking, but they face extra challenges in successfully quitting and may need more intensive or longer-term treatment and support. Treatment for nicotine dependence requires screening, assessment for readiness to 14 change tobacco use behavior, and interventions to motivate and support the change. The QI project followed the current U.S. Public Health Service Guideline Treating Tobacco Use and Dependence: 2008 Update which provides specific recommendations regarding brief and intensive tobacco cessation interventions and system-level changes designed to promote the assessment and treatment of tobacco use (USDHHS, 2008). Studies have shown that smoking can exacerbate mental health symptoms and complicate treatment (CDC, 2020). Implementing smoking cessation clinical guidelines-based interventions has multiple benefits, such as improving physical and mental health, increasing life expectancy, lowering the risk of smoking-related diseases, and reducing financial stress. Current evidence concluded that (1) tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit; (2) brief tobacco dependence treatment, including practical counseling and social support, is effective; and (3) the combination of counseling and medication treatment is more effective than either alone (Fiore, 2008). Research studies identified that smoking cessation works best when nicotine replacement therapy (NRT) is used in combination with behavioral therapy (Agency for Healthcare Research and Quality [AHRQ], 2018). Giving up tobacco is a long-term, challenging process. Repeated tobacco screening and counseling are one of the three most important and cost-effective preventive services that can be provided in medical practice (Martínez et al., 2017). The gap analysis found that there was a discontinuity between the new smoking cessation research findings, recommending a combination of counseling and medication treatment, and the current practice which offered only nicotine replacement therapy. A proper message of information has been used to draw attention to this issue and provide evidence-based 15 information, treatment, and support for adult tobacco users with mental health disorders. Healthcare providers are at the front line in fighting against tobacco smoking among adults with behavioral disorders. The project’s team members determined which processes needed to be altered to implement the change based on the chosen guideline, agreed to be involved in the planning and implementation process, and collaborated to decide on specific interventions to promote change, identify the barriers to change, and devise methods to overcome them. The unique role of the health care team members in addressing tobacco dependence and delivering brief tobacco interventions was used as part of the current standard of care practice by implementing the utilization of 5 A’s brief intervention model (i.e., Ask, Advise, Assess, Assist, and Arrange) for smoking cessation with each patient’s encounter to promote patient behavior change (AHRQ, 2012a). The proposed policy aligned with the organizational mission to heal, comfort, and care for the people of the local community. Lehigh Valley Health Network conducted and published the results of the local community health needs assessment health profile in 2019 (Lehigh Valley Health Network [LVHN], 2019). The results showed that there were 146,360 people who lived in Schuylkill County with a median family income of $58,441. The leading cause of death in Schuylkill County was heart disease and coronary heart disease, followed by cancer. Survey results concluded that 17.13 percent of the population was living with disability and 33.72 percent of the Schuylkill County population was living at or below 200 percent of the Federal Poverty. Poor health behaviors are consistently mentioned as a challenge in Schuylkill County by participants in focus groups and interviews (LVHN, 2019). The statistics showed that 7.91 percent of the population was uninsured, 19.91 percent were receiving Medicaid, and 49.36 16 percent of adults reported ever smoking 100 or more cigarettes. Individuals within Schuylkill County reported an average of 4.1 poor mental health days per month. Schuylkill County provided mental health services for 7,392 individuals and provided drug and alcohol services for 2,273 individuals in the county in 2017 (LVHN, 2019). The report concluded that the stigma of mental health still existed and must change in order to make a difference. Smokers with psychiatric disorders, including substance use disorder, have higher tobacco-use prevalence rates and have extra challenges in successfully quitting, such as stressful living conditions, low income, and lack of access to health insurance, health care, and help in quitting. According to the CDC (2020), fewer than half of mental health and substance use disorder treatment facilities in the United States offer evidence-based tobacco cessation treatments. Implementing the smoking cessation program facilitated the option for tobaccodependence treatments (both NRT and Counseling) identified as effective by the guideline. Intended Improvement The brief clinical intervention for smoking cessation among individuals with mental health disorders was intended to enhance care for all tobacco users with a comorbid mental health disease by making improvements in tobacco use assessment and treatment and increasing the quit attempt rate by 10% after brief interventions during a short hospital stay (e.g., 5-10 days). The project adopted, implemented, and evaluated the effectiveness of an evidence-based tobacco cessation program, including 5A’s framework, NRT, and brief counseling intervention. The Model for Improvement tool recommended by the Institute of Healthcare Improvement (IHI, n.d.) was used to measure the healthcare processes and outcomes in two steps. The first step addressed three root questions: (1) “What are we trying to accomplish?”, (2) 17 “How will we know that a change is an improvement?”, and (3) “What change can we make that will result in improvement?” The second step used the Plan-Do-Study-Act (PDSA) cycle to test the change in a real-world setting and see if the change generated improvement. PDSA cycle is a scientific method adapted for action-oriented learning by planning it, trying it, observing the results, and acting on what is learned (IHI, n.d.). The project intended to improve quitting attempt rates for adults with a mental health disorder by increasing participants’ knowledge, attitudes, and beliefs about tobacco use. Project Purpose The purpose of this quality improvement project was to address the lack of systematic smoking cessation interventions and outpatient follow-up offered for hospitalized adult tobacco users with behavioral health disorders. The brief clinical intervention was used as an active effort to identify smokers and encourage smoking cessation through a combination of nicotine replacement therapy and counseling therapy. The significance of introducing smoking cessation programs among individuals with behavioral health conditions was important because the problem of smoking is more prevalent in this population. Adding psychological support (e.g., cognitive behavioral therapy) to the current NRT (e.g., Nicoderm C-Q, Nicorette gum, and Nicorette lozenge) was planned to enhance treatment effectiveness and improve patient outcomes of sustained smoking cessation. Project Question The PICO framework (i.e., population, intervention, comparison, and outcome) was used to structure the development of the intervention question: “Does the addition of evidence-based behavioral therapy interventions to current nicotine replacement therapy result in increased 18 smoking cessation attempts and sustained smoking cessation among hospitalized adult tobacco users with a mental health disorder?” (Melnyk & Fineout-Overholt, 2019). The most important characteristics of the population were male and female adult smokers, aged 21 to 55, with a psychiatric disorder. The main intervention was to use a combination treatment of nicotine replacement therapy and psychotherapy (e.g., individual behavioral counseling, motivational interviewing, cognitive-behavioral therapy [CBT]). The comparison was standard therapy of nicotine replacement therapy. The intended outcome was to address the inconsistency and incompleteness of the usual care in tobacco cessation interventions offered to adult smokers. Project Objectives The main objectives of this QI project were to implement a brief evidence-based smoking cessation intervention for smoking cessation in adults with behavioral health conditions, address the inconsistency and incompleteness of the usual care in tobacco cessation interventions offered to adult smokers, and increase awareness and the intention to quit. First, the project reviewed the risks that tobacco smoking poses to various groups of individuals including adult smokers with behavioral health conditions, and outlined the available strategies for smoking cessation. Second, the project summarized the resources available for assisting patients in discontinuing tobacco use and explored the implementation of a tobacco smoking cessation program. Third, the project integrated clinical guideline recommendations and evidence-based interventions for smoking cessation an integral part of patient care throughout inpatient hospitalization. Finally, the project used a brief clinical intervention to identify smokers, initiate treatment, and provide resources for support. 19 Theoretical Framework The Transtheoretical Model of Health Behavior Change was the theoretical framework used in developing the intervention for this project (Prochaska & Velicer, 1997). The transtheoretical model is a commonly applied theoretical and clinical framework in mental health that is effective across a broad spectrum of problems, including smoking, alcohol abuse, and addiction. The model has six stages: pre-contemplation, contemplation, preparation, action, and maintenance. The theory involved the initiation of the behavior change as well as sustenance of the health behavior change. The Transtheoretical Model of Health Behavioral Change was used to (1) educate the patient about the effects of smoking, (2) recommend changes in behavior, (3) offer options for achieving behavioral change, (4) help the patient develop a plan and select smoking cessation strategies, and (5) follow up to monitor and reinforce the behavioral change. Upon admission, all patients were screened about their current tobacco use and offered NRT during their hospitalization. The 5 A’s intervention tool was used to ask each patient about current tobacco use, advise quitting, and assess the willingness to make a quit attempt (AHRQ, 2012a). The patients that expressed their willingness to quit were provided with brief counseling and were referred to additional resources post-hospitalization. Before discharge, a two-week post-discharge phone call follow-up was scheduled to monitor treatment adherence, provide support, and continued help. The patients not ready to make a quit attempt were provided with a brief motivational message. The 5 R’s motivational intervention tool (i.e., Relevance, Risks, Rewards, Roadblocks, and Repetition), was used to increase readiness for smoking cessation (AHRQ, 2012b). The clinician encouraged the patient to indicate why quitting is personally relevant, asked the patient to identify potential negative consequences of tobacco use and 20 potential benefits of stopping tobacco use, and asked the patient to identify barriers or impediments to quitting. The motivational intervention was repeated every time an unmotivated patient had an interaction with the clinician. Literature Synthesis Evidence Search Tobacco use affects various significant indices, such as morbidity and mortality rates. Although smoking is dangerous for everyone, it is an even more severe problem for individuals with mental health disorders. People with a mental health diagnosis have high rates of tobacco use and face limited availability of tobacco treatment targeted to their needs. Smoking cessation has been associated with temporary mental health benefits, but smoking prevalence remains high in populations with mental health problems (Simonavicius et al., 2017). Studies have shown that when pharmacotherapy and behavioral interventions are used in combination, the smoking cessation results have higher success rates. This literature synthesis will appraise some of those studies, including several scholarly articles and tobacco cessation guidelines. A review of the literature focused on studies of smoking cessation program implementations among patients with psychiatric illnesses. The specific literature touched on high tobacco use rates and limited quitting attempts, successful methods, sustaining cessation effects, and barriers for practitioners and patients. In addition, the synthesis and evaluation included the strengths and weaknesses of the evidence presented in the literature while identifying gaps and limitations. The structure of the literature review followed a thematic approach focused on how tobacco delivers its effects, the physical health consequences of tobacco use, the increased use of 21 tobacco in people with mental illness, the treatment options for tobacco dependence, and the recommendations for evidence-based interventions for smoking cessation in adults with a mental health disorder. A systematic review of three types of literature (e.g., guidelines from public health agencies, peer-reviewed literature, and state and federal’s health department websites) was conducted to find relevant, good quality published articles for key topic areas pertinent to the research question. The following electronic databases were searched to identify eligible articles: PubMed, Cochrane, CINAHL, Medline, EBSCO, and ScienceDirect. Relevant keywords, phrases, and synonyms (e.g., tobacco use, smoking cessation, counseling, nicotine replacement therapy, mental health disorder) were used and combined by applying Boolean operators to find suitable articles. The search was limited to the language of publication (i.e., English only), publication types (i.e., primary sources, peer-reviewed, academic journals), year of publication (i.e., 2016 onward), and subject age group (i.e., age 21 and older). The articles were eligible for inclusion if they targeted a specific population (i.e., adult smokers with a mental health condition), supplied recommendations for the treatment of tobacco use dependence (i.e., a combination of nicotine replacement therapy and counseling), and followed specific clinical practice guidelines (i.e., treating tobacco use and dependence: 2008 update) for tobacco cessation for the vulnerable population. Articles were excluded if they were non-English, non-peerreviewed, and more than five years old. Comprehensive Appraisal of Evidence Health Issues Related to Smoking Tobacco Smoking combusts gases into the lungs while burning tobacco in cigarettes. The National Institute on Drug Abuse (National Institute on Drug Abuse [NIDA], 2020) acknowledges that 22 there are over 7000 potentially detrimental chemicals in tobacco itself or other combustible tobacco. Cigarettes create an effective system of drug delivery to the human organism. When inhaling the smoke, up to one to two milligrams of nicotine go into a smoker’s system (NIDA, 2020). It quickly flows in the bloodstream and reaches the brain, where it stimulates the adrenal glands and causes a discharge of adrenaline. Adrenaline release activates the feelings of pleasure and reinforcement through reward pathways in the human brain (NIDA, 2020). Nicotine is the primary component of tobacco that drives smokers to seek and use tobacco compulsively. Regular and prolonged use leads to neuroadaptive changes and addiction. The reason for the addiction lies in the effect nicotine has on the brain (NIDA, 2020). The release of endorphins in reward circuits brings a brief euphoric feeling after the nicotine is delivered. Another neurotransmitter, dopamine, is also increased because of nicotine and reinforces the behavior of tobacco intake. Thus, tobacco's repeated use leads to decreased sensitivity toward dopamine and affects other brain parts responsible for stress and learning (NIDA, 2020). The dependence on endorphins and dopamine results in long-term brain changes that makes it increasingly hard for the regular smoker to quit. The lack of nicotine can cause depression, anxiety, and increased irritability from the time of withdrawal. Nicotine has a powerful influence on the human body on all levels, including neurons. Tobacco use produces a cumulative impact on neurotransmission, which is believed to establish dependence on it. Neurotransmission itself is the act of the brain, responding to various experiences (Flores-González et al., 2017). When a new situation occurs, the information passes from neuron to neuron to send the signal to other organs and determine what a person does and feels. The neurotransmitter responsible for transporting and delivering nicotine to the cholinergic 23 system is acetylcholine (Flores-González et al., 2017). Furthermore, nicotine, like all drugs, dramatically increases dopamine, leading to pleasure and a desire to repeat through increased dopamine. The nicotine reaches the brain within a few seconds and sends impulses to several parts of the brain. The prefrontal cortex is responsible for impulses and emotions and is extensively affected while smoking because of its vulnerability to nicotine (Vergara et al., 2017). The World Health Organization (World Health Organization [WHO], 2020) recognizes tobacco use as one of the major public health threats worldwide and a leading cause of illness and death. Tobacco use is a major risk factor for cardiovascular diseases, respiratory diseases, and cancers. Bronchitis, emphysema, and asthma are lung diseases, besides cancer, that may be activated by smoking (West, 2017). Besides lung diseases, smoking can also increase the risk of bone fracture, periodontitis, alveolar bone loss, and dental implant failure (Al-Bashaireh et al., 2018). The most recent studies by Logtenberg et al. (2021) provide strong evidence that smoking cigarettes decrease hippocampal and amygdala volume which is related to the development of psychiatric disorders. Cancer has a strong correlation with tobacco use. Kaiser et al. (2018) report that tobacco use is a significant risk factor and the leading cause of several types of cancer. Lung cancer is a primary health concern for smokers which is not directly caused by nicotine but by carcinogenic chemicals in tobacco (Kaiser et al., 2018). Smoking affects not only the lungs but contributes to cancers of the larynx, pharynx, stomach, mouth, and many other organs in the human body (WHO, 2017). Recent research from the WHO (2017) explains the mutual relationship between tobacco use and oral diseases, accentuating that oral health programs should be a priority for tobacco interventions. 24 The health consequences of tobacco use are not only limited to smokers but the surrounding people as well. Passive smoking increases the risk of many diseases, including lung cancer (Torres et al., 2018). Children are significantly affected by secondhand smoke, which may result in the development of asthma. Thirdhand smoke is a chemical residual remaining on surfaces after the smoke disappears (Roberts et al., 2017). The presence of this residual can affect people, particularly children when touching surfaces for common use. The potential risks can affect the lungs, liver, and even behavior, leading to hyperactivity (Roberts et al., 2017). Smoking in Individuals with Mental Health Disorder Various studies have explored the problem of cigarette smoking in vulnerable populations including individuals with a mental health disorder. There is a high comorbidity between tobacco use and mental disorders. For example, people with mental illnesses or a substance use disorder account for 25% of the adult population, but they consumed 40% of cigarettes sold in the United States (Lipari & Van Horn, 2017). Statistics show that people with mental disorders smoke two to four times more than the general population, especially those with a serious mental illness (Drope et al., 2018). Seventy to 85% of people with schizophrenia and 50 to 70% of people with bipolar disorder are reported to smoke (Skora, 2018). The most prevalent smoking rates are among patients with anxiety, depression, and substance use disorders since nicotine can temporarily reduce depressive symptoms by inducing the release of dopamine. The brief reduction in symptoms and elevation of mood makes addiction even worse. Romain et al. (2020) report that people with different mental illnesses have a mortality rate two to three times that of those without a mental illness and their life expectancy is reduced by 15 to 25 years. The authors state that lifestyle features of mentally ill people, including 25 tobacco dependence, make a significant contribution to the increased mortality rate (Romain et al., 2020). Harris et al. (2019), observed 421 adults experiencing homelessness and a variety of diagnoses such as schizophrenia, depression, posttraumatic stress disorder, bipolar disorder, and illicit substance use and found cases associated with a high rate of tobacco use. Smoking decreases the efficacy of many medications, particularly those that use the CYP450 enzyme system. The use of nicotine does not affect the drug interaction, rather the action of smoking tobacco changes the absorption, distribution, metabolism, and elimination of psychiatric medications often resulting in the need for higher doses. Tobacco smoke induces the CYP450 enzyme CYP1A2 activity and decreases the blood concentration of various antipsychotics, antidepressants, hypnotics, and anxiolytics and can lead to the drug’s reduced efficiency (Taylor et al., 2020). Recommended Cessation Methods Various researchers have suggested different approaches for both management and treatment of smoking disorders (USPSTF, 2021). Studies show that people's anxiety, depression, stress levels, and quality of life improve after they stop smoking when compared with those who continue to smoke. Mental health disorders affect not just tobacco use, but cessation attempts as well. The negative consequences to a person’s health due to tobacco use often help people battle their addiction. Moreover, research studies found that smoking cessation works best when NRT is used in combination with behavioral therapy (AHRQ, 2018). Tobacco cessation is best performed through behavioral therapies combined with FDA-approved medications (Sheffer et al., 2016). There are seven FDA-approved medications for smoking cessation including five forms of NRT (i.e., the patch, gum, inhaler, nasal spray, and lozenge) and two non-NRT 26 medications (i.e., bupropion SR [brand name Zyban] and varenicline [brand name Chantix] (CDC, 2021a). The nicotine patch, gum, and lozenge are available without a prescription. The nicotine inhaler and nasal spray, bupropion, and varenicline are available by prescription only. The NRT method reduces negative and positive nicotine reinforcement by stabilizing the chemical levels in the blood (Flowers, 2017). It is used for hospitalized smokers to limit withdrawal effects and is recommended for those attempting to quit. The long-acting nicotine formulation (i.e., patch) offers constant levels of nicotine and prevents the onset of severe withdrawal symptoms, while the short-acting formulation (i.e., gum, lozenge, inhaler, or nasal spray) delivers nicotine at a faster rate and is used as needed to control breakthrough cravings and withdrawal symptoms (NIDA, 2021). Common side effects of nicotine patch use include skin irritation, trouble sleeping, and vivid dreams. Mouth, nasal, and throat irritation, heartburn, nausea, and cough are common side effects of nicotine gum, lozenge, inhaler, and nasal spray use. Bupropion is an antidepressant medication FDA-approved for major depressive disorder, seasonal affective disorder, and nicotine addiction (Stahl, 2017). Notable side effects include dry mouth, insomnia, headache, and weight loss. Contraindications of use include a history of seizures, history of eating disorder, and use of monoamine oxidase inhibitors in the past 14 days. Bupropion SR or Zyban treatment for nicotine addiction should begin 1-2 weeks before smoking starting with an initial dose of 150 mg/day and increasing gradually up to a maximum of m 300 mg/day for six weeks (Stahl, 2017). Varenicline or Chantix is another FDA-approved medication used for nicotine addiction and dependence (Stahl, 2017). It reduces withdrawal symptoms and the urge to smoke and increases abstinence. Notable side effects include dose- 27 dependent gastrointestinal distress, insomnia, headache, and abnormal dreams. Other precautions include monitoring patients for changes in mood and behavior, worsening of preexisting psychiatric illnesses, and suicidal ideations. Recommended treatment duration is 12 weeks starting with 0.5 mg/day and gradually increasing to 1 mg twice a day (Stahl, 2017). The primary target symptoms are cravings associated with nicotine withdrawal. According to Stahl (2017), Varenicline is more effective than other pharmacotherapies for smoking cessation, but it is not well studied in patients with comorbid psychiatric disorders. Behavioral treatment is reported to result in higher quit rates than basic interventions (Sheffer et al., 2016). Behavioral methods include CBT, motivational interviewing, mindfulness, Quitline, telephone counseling, text messaging, and web-based support. Rogers et al. (2016) found that specialized telephone counseling led to 30-days of abstinence after six months of intervention. When compared to Quitline, Rogers et al. (2020) established that telephone counseling was more effective as 26% on the call method quit smoking after six months versus 18% on the Quitline. Counseling over the telephone and through the Quitline is more embraced and effective than text messaging and web-based support (Rogers et al., 2020; Hecht et al., 2019). Nevertheless, these technological methods are most effective when combined with medications (CDC, 2021b). Momin et al. (2017) have observed the use of population-based tobacco cessation interventions, namely state Quitline and interventions based on the Web, promoted by the National Comprehensive Cancer Control Program (NCCCP) and National Tobacco Control Program (NTCP). The researchers observed nearly 8000 smokers, with half of them being Quitline users and the other half being Web-intervention users to ascertain the prevalence of 30- 28 day abstinence rates seven months after registering for smoking cessation services (Momin et al., 2017). They compared the effectiveness of state Quitline and Web-based tobacco cessation interventions and conclude that the Quitline users had a 1.26 higher rate of abstinence in comparison with Web-based users. CBT is widely used and studied as one of the best behavioral methods of smoking cessation. According to NIDA (2020), CBT involves training patients on trigger identification, relapse prevention techniques, and coping strategies. In a study involving smokers with and without mental disorders, Loreto et al. (2017) found that combining CBT with other medical methods yielded the best results in cessation. More specifically, CBT used alongside nicotine transdermal patch and bupropion was the most effective, followed by a combination of the first two methods and nicotine gum. Most importantly, the researchers noted that the methods were more effective on smokers with mental health disorders than on those without mental health disorders (Loreto et al., 2017). Although NRT alone increases quitting rates by 50% for smokers without mental health disorders, mental health smokers require highly intensive and engaging methods, necessitating the need to include group CBT with NRT treatment (Loreto et al., 2017). Since most smokers with mental health disorders begin the quitting process during hospitalization, there should be methods to sustain the abstinence and cessation process after discharge. Hecht et al. (2019) established that sustaining cessation effects requires follow-up through telephone, interactive voice response, the web, and text messaging. The study subjects were grouped into those receiving sustained care and others under usual care. The sustained care group received various follow-up efforts for eight weeks, while the usual care smokers only received health education while at the hospital (Hecht et al., 2019). The researchers also 29 recommended enrolling smokers with mental health disorders in NRT treatment, which is widely accessible across the country (Hecht et al., 2019). The results showed that a history of mental health disorders such as schizophrenia, posttraumatic stress disorder, depression, bipolar disorder, and illicit substance use was associated with daily tobacco use. The 5A’s smoking cessation model is the foundation of the quitting process at many healthcare centers (Martinez et al., 2017). The model involves five steps: asking patients about their smoking status, advising smokers to quit, assessing quitting willingness, assisting smokers through referrals and treatment, and arranging to follow up to support cessation (Martinez et al., 2017). While the model is effective in identifying smokers and facilitating cessation, health workers frequently perform the first three steps and neglect the last two (Martinez et al., 2017). The use of the 5A model is effective in identifying smokers and initiating treatment and sustaining adopted interventions. Barriers to cessation exist on the provider and patient’s side. According to Schroeder et al. (2018), some of the barriers related to smokers include lack of motivation, stigma, comorbidity with mental illnesses, and the workload of treatment. The health care providers lack enough resources to facilitate learning and improvement of treatment of smokers with mental health disorders (Simonavicius et al., 2017). Limited knowledge on treatment options for both patients and health care providers hinder cessation efforts. Practitioners expressed little information relating to the 5A’s implementation, the connection between smoking and psychiatric disorders, tailoring cessation efforts to smokers with a mental health disorder, and interaction between patients and smoking treatments (Simonavicius et al., 2017). Therefore, 30 knowledge and resource limitations are leading barriers to cessation for both care providers and smokers. Strengths of Evidence Outlining the strengths of evidence to the problem of tobacco cessation among individuals with mental health disorders presented in this work, one can make certain conclusions. First, the majority of reviewed research reveals higher rates of smoking among mentally ill people, which is the most practical argument that there is an association between mental health disorders and tobacco dependence. Second, many researchers and professionals actively explore this field to collect more data and find more effective ways of helping mentally ill people to quit smoking. Third, there have been many surveys conducted and many experiments performed, and some have been successful, but most of the studies raise new questions and require further investigation. The essential argument of the literature review is that the problem of tobacco use among patients living with mental health illnesses is serious and should be of primary concern to the world health care system. Weaknesses of Evidence A summary of the weaknesses of the evidence concludes that there is not a set method to make sure all the literature on this topic was considered. Thus, the chances of the review being biased increases. The main goal of this review was to identify relevant literature on this topic which is not the final evaluation product. Research on tobacco use and its effect allowed us to understand the urgency of the issue in the general population and specific vulnerable groups. It also became the ground for developing and upgrading the treatment options for tobacco smoking, especially for patients with mental illnesses. 31 Gaps and Limitations The literature reviewed has strengths, weaknesses, gaps, and limitations as do scientific studies. Most of the conclusions are drawn from real-world data instead of simulations, giving the results strong evidence through the validity of the information. In addition, data from large national databases are representative of the general population and provide strong evidence. However, data sourced from public databases contain information from changing subjects, which could adversely affect the results. In addition, participants are samples of a bigger population, and representation is not guaranteed. Self-reporting from participants poses challenges of honesty, sampling and response biases, introspective ability, and differences in interpreting the questions. Existing gaps in the literature include a study on retention efforts, genetics and tobacco use, and neurological connections to smoking and addiction. Research in these areas will improve prevention, treatment, continuing efforts, and interventions. A large amount of existing literature about smoking cessation increases the chances to overlook relevant studies and miss important results. Although many studies seem very promising, there is still not enough information to make definite conclusions, and further exploration is required. The studies described above show that tobacco use and mental health issues have a mutual interconnection in many cases. Various mental health conditions may both increase tobacco use if a mentally ill individual has dependence already and be a reason for that dependence. Although specific studies were designed to find a solution to the problem, and have given encouraging results, there is still a need to explore the field deeper to understand better how to help people with mental illnesses stop smoking. 32 METHODS The purpose of this study was to evaluate the effects of a tailored intervention for smoking cessation in an inpatient behavioral health facility. The evidence suggests that when tobacco users are treated with a comprehensive, targeted program using evidence-based combinations of behavioral therapy and pharmacotherapy, long-term quit rates significantly increase and can reach 40–50% (Kendra et al., 2020). Clinical guidelines suggest that smoking cessation interventions should include both behavioral support and pharmacotherapy. The project followed the 2008 updated version of the U.S. Public Health Service Guideline recommendations on the treatment of tobacco use and dependence (Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff, 2008). The guideline provides specific suggestions regarding brief and intensive tobacco cessation interventions as well as system-level changes designed to promote the assessment and treatment of tobacco use in clinical settings. This project intended to use the unique role of the clinician in addressing tobacco dependence and delivering brief tobacco interventions as part of the current standard of care practice. The Transtheoretical Model of Health Behavioral change by Prochaska and DiClemente was used to assess readiness for change, identify the level of readiness, and assist with transition (Prochaska & Velicer, 1997). The “5 A’s” model was developed by the US Department of Health and Human Services in 2008 as a tool for encouraging smoking cessation (2008 PHS Guideline Update Panel, Liaisons, and Staff, 2008). The 5 A’s model was used to engage the patients who are ready to quit and encourage behavior change through its five steps Ask, Advise, Assess, Assist, and Arrange. The clinician used the “5 R’s” model recommended by the Agency 33 for Healthcare Research and Quality to motivate smokers who are unwilling to quit (AHRQ, 2012b). The 5 R’s motivational counseling intervention addressed Relevance, Risk, Rewards, Roadblocks, and Repetition. Motivational interviewing is a therapy designed to strengthen a person’s motivation and commitment to change and was originally developed for those who struggled with alcohol and substance abuse and were ambivalent about treatment (Froiland, 2020). The purpose of this chapter is to present the research methodology developed for this QI initiative to improve tobacco cessation efforts in the behavioral health population. The project intended to increase tobacco use screening and tobacco cessation treatment assistance in acute behavioral health settings by translating evidence into practice and impacting healthcare outcomes through direct care. This chapter describes the various stages of the research, which include explaining the project design, model of implementation, selection of participants, data collection and analysis procedures, and outcomes. Project Design The QI project design focused on the lack of systematic smoking cessation interventions and follow-up offered for hospitalized adults who smoke tobacco. A needs assessment was conducted to analyze the situation, identify the problem, and find the target population. Research data has shown that people with mental illness are not only more likely to smoke, but they also smoke more often than people with no mental illness and have an increased rate of relapse and cessation failure (Lightfoot et al., 2020). The study was looking to answer the PICO questions: “Does the addition of brief motivational intervention to traditional nicotine replacement therapy 34 in adult smokers with a psychiatric disorder result in increased quit attempts and sustained smoking cessation?” The first step of this project design was to conduct a need assessment to identify the target population, analyze the situation, and identify the problem. The target population included adult smokers with a mental health disorder admitted to an inpatient behavioral health facility for psychiatric evaluation and treatment. The subjects were chosen as a convenience sample of patients admitted to the adult inpatient behavioral health unit. Consistent with the organization’s mission to improve the health of our community, and in response to increasing evidence of health and safety risks associated with tobacco use and exposure to second-hand smoke, smoking and all tobacco use are prohibited in all health care network facilities. As a result, each patient was screened on admission for tobacco use and offered NRT in the form of a nicotine patch, nicotine gum, or nicotine lozenge. There was no other form of clinical intervention for patients who use tobacco, nor post-discharge follow-up. Therefore, the major problem affecting this population was the lack of systematic smoking cessation interventions and outpatient follow-up offered during hospitalization. A practice gap was found after comparing the differences between current practice and current evidence-based practice (EBP) about smoking cessation treatment offered for tobacco users in an inpatient adult behavioral health unit. The current practice offered NRT to adult tobacco users admitted to the inpatient behavioral unit. The current EBP proves that smoking cessation works best when nicotine replacement therapy is used in combination with behavioral therapy. To address this practice gap clinical-based guidelines and evidence-based treatment for tobacco dependence such as the 5 A’s and 5 R’s models were implemented. Closing the gap 35 could have multiple benefits including improved physical and mental health, increase life expectancy, reduced risk of smoking-related diseases, and financial stress. The short hospital stay did provide a realistic opportunity for an effective and inexpensive treatment for nicotine dependence, where smoking cessation interventions will be offered to all smokers willing to make a quit attempt. Model for Implementation The Ottawa Model for Smoking Cessation (OMSC) is a validated, evidence-based process that combines knowledge translation and organizational change practices to implement smoking cessation treatment and support as part of routine care (University of Ottawa Heart Institute [UOHI], 2021). OMSC was originally designed for use in hospitals, but is adaptable to any type of healthcare setting. The use of OMSC results in the identification, treatment, and follow-up of smokers as part of routine care. It is cost-effective and results in fewer healthcare costs for patients who receive the program. The OMSC has six phases of implementation with each phase over a specific period: introduction (2 weeks), pre-implementation evaluation (4 weeks), program planning and protocol development (4 weeks), training and promotion (4 weeks), program implementation (8 weeks), and post-implementation evaluation and program sustainability (6 weeks). The implementation of EBP in an organization requires a problem-solving approach based on the application of the best research in making health care decisions and improving the quality of health services (Rahmayant et al., 2020). Successful implementation of EBP requires staff education and training, management support, and proper policies. A “fishbone” root cause analysis identified important contextual factors that could create barriers to the program 36 implementation. These barriers were divided into five categories: process, resources, patient, provider, and policy. The change was indicated for several reasons such as improving or adjusting existing programs, solving an identified problem, and implementing a new program. People often feel threatened by change and may react with resistance and hostility. According to Shimoni (2017), resistance is something within the individual's psychological disposition, in the social context, and between change creators and acceptors. Setting and Stakeholders The setting for this QI project was an adult inpatient behavioral health unit, part of a large healthcare network based in eastern rural Pennsylvania. There were two policy strategies implemented at this mental health treatment facility to encourage smoking cessation: a smokefree psychiatric hospital policy prohibiting the use of any tobacco products, and NRT offered as nicotine substitutes to those interested. But there was no other specific intervention in place to identify users or interventions based on the patient’s willingness to quit. The 36-bed secure unit features private and semi-private rooms, a lounge, dining room, activity therapy room, and other common areas. The most common conditions treated in the facility include depressive disorder, anxiety disorder, bipolar disorder, schizophrenia spectrum, and other mental disorders. The treatment is provided by a multi-disciplinary treatment team. The team consists of two psychiatrists, two advanced practice clinicians, three social workers, one mental health tech, one occupational therapist, one psychologist, and nursing staff including RNs, LPNs, and CNAs. The average admission rate on the unit is between 7-10 patients per week. The unit is a smoke-free facility whose core values are compassion, integrity, collaboration, and excellence. When stabilized, each patient is provided with an appropriate 37 transition among different levels and types of behavioral health care services. Including the right people on a process improvement team is critical to a successful improvement effort (IHI, n.d.). Teamwork and collaboration are essential in any organization to solve problems and deliver services (Hickey & Brosnan, 2017). The implementation team included the principal investigator and a clinical expert. The current and potential stakeholders included patients, healthcare providers, insurance providers, the organizations’ funding sources, local and regional government agencies or entities, and other nonprofit groups working in the area. Conducting a stakeholder analysis helped identify which groups might have an interest in the project and its outcomes, which groups could help or obstruct the project, the availability and source of resources, and their level of influence and authority over the population and the project. The results of the stakeholder analysis did sort the right partners to support the project versus those who may have restricted or opposed it. Planning the Intervention The 5A’s approach provided health professionals who are not smoking cessation specialists with a useful framework for structuring brief smoking cessation advice and interventions that are feasible and dependable. The 5 A’s intervention tool was used to ask each new patient admitted to the adult inpatient behavioral unit about their current smoking status, provide advice to quit, and assess willingness to quit. The subject willing to quit was assisted with counseling, appropriate pharmacotherapy, and resources for support. After reviewing past quit attempts, including counseling and medication used, the subject was asked to set a quit date within 30 days. This was followed by a discussion about potential withdrawal symptoms, potential triggers, and coping strategies. The pharmacological treatment offered was NRT 38 including the nicotine patch, gum, and lozenge. The subject was assisted with a referral to additional and free cessation help post-hospital discharge such as Pennsylvania’s free Quitline, a telephone-based tobacco cessation counseling service. Pennsylvania’s free Quitline is a partnership between the Pennsylvania Department of Health and the American Cancer Society offering free coaching and free nicotine replacement therapy (Pennsylvania Department of Health., n.d.). The participants work with trained quit coaches available 24/7 who help create an individualized quit plan, set a quit date, identify tobacco triggers, manage cravings, and address relapses. Additional resources offered for follow-up were the “Time to Quit Nicotine Cessation Program”, a free program held weekly for six weeks at the local community counseling center, and information about QuitGuide, a free app that helps participants understand the smoking pattern and build the skills needed to become and stay smoke-free. The services provided at the counseling center are available in person, by video, or by telephone and cover topics such as the use of NRT, coping without tobacco, stress management, avoiding weight gain, and preventing relapse. The subjects who decided to make a quit attempt were followed up by telephone within two weeks of the patient’s hospital discharge. The subjects not willing to quit were provided a brief motivational message, setting expectations, and left the door open for further conversation in an effort to increase their motivation to quit. The 5R’s motivational intervention was repeated every time the unmotivated subject had an intervention with the clinician during the hospitalization. The message was clear, strong, and personalized, delivered by using nonjudgmental language. The subjects who were not using tobacco currently were asked if they ever used tobacco. The tobacco users who have failed in previous quit attempts were told that most people make repeated quit attempts before they are 39 successful. The former smokers were asked how recently they quit, what challenges they faced, and if they needed support. They were congratulated, encouraged to continue abstinence, assisted with relapse prevention education, and asked to share their experience during the smoking cessation group. The subjects who recently relapsed were provided with encouragement and support to try to quit again. All subjects including current and former tobacco users were invited to participate in the weekly smoking cessation group. The first five minutes were used for welcoming every participant and introducing the presenter and the topic of the group. The following 10 minutes provided facts and statistical data about tobacco smoking in the U.S., smoking cessation for individuals with mental illnesses, health benefits of quitting smoking over time, and tips to quit in an oral and written presentation. The next 10 minutes concentrated on a brief motivational intervention that was used to increase readiness for smoking cessation including the relevance of quitting smoking, outlining the risks of continuing smoking, stressing the benefits of quitting, and asking about the perceived roadblocks to quitting. In addition, a 10 minutes video presentation was used to target myths and facts about smoking and quitting in people with mental illness and addiction, to explain what happens to the body when quitting smoking, to present smoking cessation interventions for the behavioral health population, education about withdrawal symptoms, NRT, and effective ways to quit smoking for good. The last 10 minutes of the group allowed patients to ask questions, share their personal experiences, and provide peer support. 40 Participants and Recruitment The targeted population for this project consisted of male and female adult tobacco users admitted to an inpatient behavioral health unit for psychiatric evaluation and treatment. Inclusion criteria for participants included any adult smokers admitted to the behavioral health unit with a mental health diagnosis, between ages 21 and 55, who reside in the U.S, able to give legal consent, able to speak, read, and write in English, and smoking a minimum of 5 cigarettes/day on average over the last year. Exclusion criteria included nonEnglish-speaking individuals, with the inability to read and write English, reside outside the US, under the age of 21 and older than 55-year-old; those who have contraindications for use of nicotine patch, gum, or lozenge use, have serious mental health illness (e.g., dementia, psychosis, acute mania, schizophrenia), exhibit aggressive, intoxicated, and disruptive behavior, and have impaired decision-making capacity. If a patient was not able to give legal consent they were excluded from the study. All new patients were screened about their current smoking status within a 24–48-hour period after admission and offered nicotine replacement therapy. The recruitment was performed by the principal investigator and the co-investigator during the oneon-one psychosocial assessment in the inpatient behavioral unit, interview room. The major potential benefits to participants included access to a potentially beneficial intervention, increased knowledge about their condition and treatment options, and post-discharge support. The potential risks to participants included psychological and/or emotional distress resulting from self-disclosure, risk of stigma by having a mental health diagnosis, fear of gaining weight, and unanticipated side effects (e.g., nicotine withdrawal symptoms such as headache, insomnia, craving). The benefits of smoking cessation outweighed the risks. 41 Figure 1 Study participants flow chart 110 patients screened for eligibility 60 eligible 16 not willing to quit 26 enrolled 50 ineligibles 16 never smoked 16 did not meet criteria 18 former smokers Two weeks phone call follow up 14 did not answer 2 went back to smoking 7 cut down smoking 3 continues smoking cessation with NRT 42 Consent and Ethical Considerations Informed consent is based on a person’s evaluation of the potential risks and benefits of participation and to protect them from harm (Melnyk & Fineout-Overholt, 2019). The implementation of this QI intervention was based on the voluntary participation of subjects, and the participants had the right to withdraw from the program at any time. Each participant was required to sign an informed consent which provided information about the purpose of the study, potential risks, and benefits, confidentiality, voluntary participation, right to withdraw from the study, and whom to contact with further questions. The project did honor the four principles of bioethics autonomy: beneficence, non-maleficence, autonomy, and justice (Gaines, 2020). The participants were granted personal freedom to choose if they wish to participate in the program. Human subject research is performed to enhance knowledge that is “reliable, valid, and generalizable” in a particular field and acquires information that would expand the understanding in practice (Sylvia & Terhaar, 2018, p. 296). Participants’ information was protected and safeguarded to prevent unauthorized persons from accessing, using, disclosing, changing, or destroying health information. Accountability in electronic health records is essential to creating trust among parties (Techapanupreed & Kurutach, 2020). Because the project uses human subject research institutional review board approval (IRB) was required and obtained from the university and clinical facility to ensure the ethical rights of those individuals taking part in the research study are protected (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Having health care data in an electronic format means that de-identified data can be transformed in such a way that formal privacy requirements are met with minimal loss of 43 information to keep data quality (Eicher et al., 2017). To protect privacy, safeguard was implemented in the form of anonymization by removing personally identifiable information from data sets (e.g., full name, patient ID or MRN, SSN, personal address, personal characteristics, telephone number, or email address). Appropriate data included age, gender, race, insurance, mental health diagnosis, and current tobacco use. The smoking cessation intervention was intended to do good and prevent or avoid harming the participants involved. The intervention did not harm the participants involved. The risk and benefits of the proposed smoking cessation treatment were distributed equally among all groups of participants. The project did not require federal funding and did not conduct drug or medical device research regulated by the FDA. There was no monetary compensation for participation. Data Collection The tobacco screening was implemented as part of an initial psycho-social interview concurrently with an assessment for other substance dependencies. The short-stay hospitalization was used as an opportunity to promote smoking cessation, address barriers to cessation, initiate treatment, and provide a resource for a successful quit attempt. The goal of the inpatient smoking cessation service was to educate patients on the health effects of smoking, address nicotine withdrawal symptoms, explain the different pharmacotherapies available, advise them on how to quit, give self-help materials, and refer to telephone Quitline and outpatient programs postdischarge. Following the first assessment, the collected information was documented in the patient’s chart, including recommendations for NRT, desire to attend the group counseling sessions during hospitalization, and willingness to continue cessation post-hospital discharge. 44 All data related to this project was well-documented and easy to find within the organization and kept secure, compliant, and confidential with relevant organization regulations. All participants’ information related to the project (e.g., demographics, tobacco use history, insurance, diagnosis code) was retrieved from the current EMR and was securely stored and managed in a locked box kept in the investigator’s office. The EMR was used to identify all adult tobacco users and keep track of their history of tobacco use and the method of smoking replacement therapy use during the hospital stay. Patient education databases and online procedure manuals were used to provide evidence-based treatment options, guidelines resources, and smoking cessation follow-ups. Before beginning the project implementation, the principal investigator completed three hours of clinical research education with the network research compliance specialist. The research regulatory and informed consent training provided valuable education about the required regulatory documents, documentation of delegation of authority, source documentation, informed consent, and the Institutional Review Boards (IRB) system. The documents required for the prospective investigator-initiated research included a research binder and a research participant binder. The research binder included the IRB documents, documents resulting from departmental scientific and Network Office of Research and Innovation (NORI) feasibility review, correspondence and delegation of duty log, and conflict of interest. The screening log, enrollment log, and master participant identification log were all part of the research binder. The research participant binder collected all signed informed consents, source documents, data collection forms, and documentation notes. 45 Data Analysis The empirical phase of the project included collecting the data and preparing the data for analysis. Key demographics and variations in the group were age, gender, race, insurance, diagnosis, current tobacco use, and readiness to make a quit attempt. The sampling strategy was convenience sampling which is based on the accessibility of subjects in the population. Verbally collected data was translated into numeric data through the coding process. For example, participants’ responses to their gender question were coded “1” for females and “2” for males. The analytic phase of the project involved analyzing the data and interpreting the results. The collected data was analyzed through statistical analysis. The results were interpreted by making sense of the study results and examining their implications. All this data was available from the EMR as being part of the admission assessment. The patients who were assisted in a quit attempt were followed up with a phone call or text message two weeks post-discharge. RESULTS The process and implementation evaluation assessed how well the smoking cessation program was working and provided descriptive information about the process of the program implemented and how it functioned. The process and implementation analysis did evaluate the program at different stages of implementation by addressing and answering questions such as “Did the program operate the way it was designed?” (e.g., combination treatment of nicotine replacement therapy and psychotherapy; “How did the program differ from current practice?” (e.g., the current practice of nicotine replacement therapy alone); “Which were the barriers to its 46 Figure 2 Total patients screened Total patients screened 24% 31% Enrolled Former smoker Never smoker Not meeting criteria 16% 15% Not willing to quit 14% Figure 3 Daily tobacco use Daily tobacco use 3% 8% 7% 0.25 pack 0.5 pack 36% 46% 1 pack 1.5 pack 2 packs 47 Figure 4 Primary diagnosis Primary diagnosis 3% Depressive disorder 17% Bipolar disorder 33% Schizophrenia spectrum Substance related and adictive disorder 47% . Figure 5 Two weeks phone call follow-up Two weeks phone call follow up 11% Did not answer Back to smoking 27% 54% Cut down smoking Continues smoking cessation 8% 48 implementation?” (e.g., lack of resources, lack of support, fear of failure, poor communication); and “How did staff and patients feel about the intervention?” (e.g., teamwork, coordinated-care approach, improving health, sustained smoking cessation). Assessing the answers to those questions throughout the program implementation helped review the interventions, implementation process, and their effectiveness. The indicators linked to performing the program are the number of participants, characteristics of the participants, program performance and fidelity to the implementation plan, and opinions, experience, perceptions, and satisfaction with the smoking cessation program (Martínez et al., 2017). The principal outcome measures were quit readiness and abstinence from smoking at two weeks post-hospital discharge. Research studies have shown that repeated tobacco screening and counseling is “one of the three most important and cost-effective preventive services that can be provided in medical practice” (Solberg et al. as cited in Martínez et al., 2017). Proactive identification and referral of tobacco users to comprehensive tobacco treatment are also cost-effective for health systems. Over ten weeks, 110 patients, 46 female, and 64 males, were screened for eligibility (Figure 1). Of those 110 patients, 60 patients (55%) were found eligible to enroll, and 50 patients (45%) were found ineligible to enroll in the smoking cessation program. Of the 60 eligible participants, 34 (31%) were not willing to quit, and 26 (24%) did enroll in the program (Figure 2). The main characteristics of the eligible participants were age (30% between 21-30 years old, 43% between 31-40 years old, and 27% between 41-55 years old), race (93% white, 5% black or African American, and 2% other), and primary diagnosis (47% bipolar disorder, 33% schizophrenia spectrum, 17% depressive disorder, and 3% substance-related and addictive 49 disorder, Figure 4). All eligible participants were asked how much they smoke in packs per day. The collected data showed that 7% smoked 0.25 packs per day, 36% smoked 0.5 packs per day, 46% smoked one pack per day, 3% smoked 1.5 packs per day, and 8% smoked two packs per day (Figure 3). Of the 60 eligible participants, 37 (62%) did not attempt to quit before, and 23 (38%) did have at least one quit attempt before. All eligible participants were prescribed nicotine replacement therapy, provided with a brief motivational message, and invited to participate in the weekly smoking cessation group. All participants were offered additional support in the form of resources with information about the risk of tobacco use, health benefits of quitting smoking over time, nicotine withdrawal symptoms, triggers, coping strategies, and tips to quit. On discharge, the patients unwilling to quit smoking were asked if they changed their willingness to quit and were provided with contact information about additional resources such as (1) Time to Quit Nicotine Cessation Program, a local community counseling center, (2) Pennsylvania’s Free Quitline, a telephone-based tobacco cessation counseling service, and (3) QuitGuide, a free app to help and assist becoming and staying smoke-free. Each enrolled participant was called via telephone for a follow-up assessment two weeks post-discharge. Each reachable participant was asked if they stayed quit or tried to quit since the hospital discharge. Of those 26 enrolled participants, 14 participants (54%) were unreachable, seven participants (27%) cut down on smoking by half, two participants (8%) went back to smoking as much as before, and three (11%) continued the smoking cessation program with NRT and weekly counseling sessions via Quitline (Figure 5). Of the 14 unreachable participants, five participants (36%) did not answer and had no option to leave a voicemail, five participants 50 (36%) did not answer but had the option to leave a voicemail, three participants (21%) were discharged to long-term inpatient rehab, and one participant (7%) could not provide a phone number to be reached. None of the participants who received a voicemail called back. Participants reporting unable to stay quit and going back to tobacco use cited not having enough willpower, having family members smoking in the house, illness among family members, and not taking the time to call Quitline as barriers to continuing smoking cessation program post-hospital discharge. To increase the smoking cessation program retention rate, the enrolled participants were encouraged and assisted to make the first Quitline intake phone call before they were discharged from the hospital. Eight out of 26 participants were assisted to make the initial Quitline before they were discharged from the hospital. At the end of the intake assessment, the participants were already scheduled with a second phone call a week later. Of the eight participants, three participants did cut down on smoking to half, one participant went back to smoking the same amounts of cigarettes, one participant could not be reached for follow-up, and three participants continued the quit attempt with NRT and Quitline counseling postdischarge. Three enrolled participants stayed quit for two weeks post-hospital discharge. One was a female patient who had three phone calls with a Quitline-trained coach in the hospital before she was discharged home. By the time she was discharged, the free NRT supplies were waiting for her at home. During her hospitalization, her roommate, who initially was not willing to quit, changed her mind and asked to enroll in the smoking cessation program. The second enrolled patient who did stay quit at two weeks post-hospital discharge was a male patient who continued to use NRT at home but did not follow up with the weekly Quitline counseling sessions. The 51 third enrolled participant was continuing to stay quit two weeks after he was discharged from the hospital. He was a young male with multiple medical comorbidities and using NRT along with weekly Quitline counseling sessions. Outcomes The smoking cessation program’s main goals were to achieve change that was thoughtfully planned and implemented gradually among the targeted population; to utilize each formal patient encounter to apply the 5A’s model along with patient-specific education about smoking cessation; to improve quitting attempt rates for adults with a mental health disorder by increasing participant’s knowledge, attitudes, and beliefs about tobacco use; and to implement a smoking cessation program founded on clinical guidelines and evidence-based interventions to improve the health of individuals and reduce the incidence of disease. The outcomes of the quality improvement project were assessed at three levels: patient, provider, and organization. At the patient level, the smoking cessation program met the intended outcome improvement of having a 10% quit rate after the brief intervention implementation for smoking cessation offered to adult smokers with a mental health disorders. The measurable outcomes showed 11% quit attempts in patients who benefit from both NRT and brief behavioral intervention. The lack of response from 54% of individuals enrolled in the program created incomplete data that affected the results and interpretation of study findings. Due to the specific of the chosen population, patients were only able to be followed two weeks subsequent their quit date, while the literature recommended a six-month follow-up. At the provider level, the outcomes included an increase in knowledge of evidence-based intervention and available assessment tools that can be implemented into practice without adding much time and burden to 52 the already busy workflow. The measured organizational outcome was the action performed by executives showing support of the evidence-based practice model. The significance of introducing smoking cessation programs among individuals with behavioral health conditions was important because the problem of smoking is more prevalent in the group of this population (CDC, 2020). The proposed project was to establish the patients' motivation to quit smoking and continue the cessation program after hospital discharge. Adding psychological support to the current NRT did enhance the treatment’s effectiveness and increased patient motivation for sustained smoking cessation. The research showed that the model of evidence-based decision-making improves the quality of patient care (Shahmoradi et al., 2017). DISCUSSION The quality improvement project identified each adult tobacco user admitted to the inpatient behavioral health unit over the ten weeks. The 5 A’s framework model - Ask, Advise, Assess, Assist, and Arrange – was used as a structured smoking cessation strategy to ensure that all identified tobacco users were advised on quitting, assessed about their willingness to quit, assisted with a quit plan, and arranged for follow up (Fiore, 2008). All identified tobacco users were prescribed nicotine replacement therapy, provided with brief tobacco cessation counseling, and referred to additional in-depth tobacco cessation counseling post-hospital discharge. A brief motivational message was provided to all tobacco users that were not willing to quit. The brief clinical intervention addressing tobacco use among adults with a mental health disorder met the goal of identifying smokers and encouraging smoking cessation through a combination of nicotine replacement therapy and counseling therapy. The quality improvement 53 project increased awareness of the importance of smoking cessation by providing evidence-based information, treatment, and support. The brief intervention used the inpatient behavioral health intake as an opportunity to reinforce tobacco cessation, assess the readiness to quit, and provide the needed intervention. The intervention implemented health promotion and disease prevention strategies for the targeted population, such as increasing tobacco use and dependence screening, supporting tobacco cessation treatment, and helping quit attempts. The brief intervention was used to extend the impact of tobacco cessation activity beyond simply asking the smoker about tobacco use during the intake visit. The outcomes of this project concluded that providing education and resource materials about tobacco use and smoking cessation and assisting patients with a quit plan and follow-up may help them decide on a quit date and subsequently move towards a quit attempt. This short, effective clinical intervention can be integrated into the routine clinical workflow and can be delivered by the entire clinical care team. The clinical intervention is sustainable and replicable in any inpatient or outpatient setting. Summary Tobacco use disproportionately affects individuals with mental illnesses who may not be receiving adequate information and cessation services. Because individuals with mental illness have a higher rate of tobacco use, they are at greater risk of smoking-related illnesses and higher morbidity. Individuals with mental illnesses deserve accurate information regarding tobacco use and options for quitting. There are real and perceived barriers to providing smoking cessation options in mental health settings. However, some clinicians believe that tobacco use is not a treatment priority, think that tobacco cessation strategies would be time-consuming, and argue 54 that the traditional smoking cessation programs are not as effective for persons with a serious mental illness. Like any addiction, intervention and cessation are extremely difficult. For individuals with mental illnesses, the complexity of treatment is even greater and requires intensive education and extended outreach. Researchers believe that individuals with mental illnesses have unique neurobiological features that may increase their tendency to use nicotine, making it more difficult to quit and more likely to experience complicated withdrawal symptoms. Individuals with serious mental illnesses have less access to general medical services and are less likely to seek other community resources. We often associate smoking with social activities and promoted it among peers. Individuals with severe mental illnesses tend to be more isolated and bored and will smoke more. Tobacco use may temporarily relieve feelings of tension and anxiety and is often used to cope with stress, a prevalent symptom among individuals with mental illnesses. Providers often perpetuate the stigma and think that individuals with mental illnesses cannot quit and that symptom management takes priority over promoting preventive health measures. The major strength of the smoking cessation project was the opportunity to use the hospitalization as a teachable moment, to provide knowledge, and to increase education and awareness about smoking cessation among people with mental health disorders. Rather than just educating providers and staff, the project focused on educating the individuals who smoke, are affected by smoking, and are interested in quitting. It provided the support and tools that are needed for those with mental illnesses to remain to decide on quitting and attempt to quit. Weekly sessions provided an opportunity to increase knowledge and familiarity with cessation treatment options. Several patients shared their previous quit attempt experiences and 55 commented on their related behaviors by describing the methods that they used during previous unsuccessful quit attempts as barriers to action. Patients’ comments revealed an increased knowledge of their own relationship with tobacco and its use, suggesting a new awareness of behaviors that might be substituted for tobacco use. The smoking cessation program met the intended goal of having a 10% quit rate after the brief intervention implementation for smoking cessation offered to adult smokers with mental health disorders. The measurable outcomes showed an11% quit attempts in patients who benefited from both NRT and brief behavioral intervention. Interpretation Reducing the number of tobacco smokers benefits three parties: the people who suffer from tobacco abuse by decreasing and possibly preventing lethal repercussions of the usage, the providers fulfilling their calling as they help them, and the quality of life of the general population. It seems significant to assist tobacco users in understanding the severity of tobacco usage and the ways it affects not only their health but the people who surround them (De Chesnay & Anderson, 2016). The side effects of addiction treatment should be explained to the patient before the actual process so that the individuals will be thoroughly familiar with what can happen to them on their journey to live a healthy life. Inadequate planning can be detrimental as the tobacco users may return to their old habits and continue their tobacco abuse (Husted et al., 2015). Future research should replicate the brief clinical intervention in larger populations in different offices targeting the at-risk populations. Further research evaluating the long-term effect of contact with the Quitline, quit attempts, and overall success of long-term tobacco 56 smoking cessation is needed. We need additional research to evaluate whether self-referral to Quitlines’ pre-and post-discharge impacts smoking cessation outcomes. Implications (Practice, Education, Research, and Policy) The literature and systematic reviews about smoking cessation supported the evidencebased smoking cessation program interventions for people with mental illness who have a disproportionate tobacco-related disease burden and mortality (Seng et al., 2020). The education and counseling provided during hospitalization proved successful in raising awareness, increasing knowledge, and offering support about tobacco use and smoking cessation. The hospital unit provided an informal environment for group discussion in a small format where each participant asked questions, shared experiences, and provided feedback. The program was an opportunity for treatment team members to practice their skills and knowledge in providing professional education and treatment about tobacco use and smoking cessation. The research findings informed the local organization about the need for support and implementation of more comprehensive evidence-based smoking cessation programs that are efficient and cost-effective. The smoking cessation guidelines are effective smoking cessation interventions that are affordable, easily accessed, and supported by research. Using the 5 A’s and motivational interviewing is an effective way to engage patients in smoking cessation interventions during hospitalization. The results show the positive effect of using the 5A’s model along with motivational interviewing and connection with the Quitline. Using proactive approaches to refer patients is successful in encouraging patients to make healthy behavior changes. 57 Limitations The small sample size was a substantial limitation of the smoking cessation program. However, participation in the program was optional and a substantial number of patients did not meet the criteria to enroll in the smoking cessation program. The number of patients who initially enrolled in the program provided informed consent and agreed to a phone call follow-up two weeks post-hospital discharge was below the initial goal of 50 patients. There were 110 patients screened over a ten weeks period: 26 enrolled in the program, 34 were not willing to quit, 16 did not meet inclusion criteria, 16 never smoked, and 18 were former smokers. Another significant limitation of the smoking cessation program was related to the low rate of reaching the participants for follow-up via telephone. More than half of the enrolled participants were unreachable for the two weeks phone call follow-up. Out of 14 unreachable participants, five participants did not answer and had no option to leave a voicemail, five participants did not answer but had the option to leave a voicemail, three participants were discharged to long-term inpatient rehab, and one participant could not provide a phone number to be reached. None of the participants who received a voicemail called back. The lack of response from 54% of individuals enrolled in the program created incomplete data that affected the results and interpretation of study findings. This quality improvement project needs a larger study to confirm the findings. All the participants’ quit attempts and abstinence rates were self-reported and not validated using biochemical monitors such as carbon monoxide monitors. Additionally, the brief span of the study does not allow for evaluation of the long-term effects of proactive referrals or Quitline contacts with overall smoking abstinence. 58 This pilot study demonstrates that future research is needed to determine the effectiveness of proactive referrals to the Quitline. DNP Essentials Addressed The quality improvement project addressed all eight DNP Essentials required by the American Association of Colleges of Nursing (AACN, 2006): (1) scientific underpinnings for practice, (2) organizational and systems leadership for quality improvement and systems thinking, (3)clinical scholarship and analytical methods for evidence-based practice, (4) information systems/technology and patient care technology for the improvement and transformation of care, (5) health care policy for advocacy in health care, (6) interprofessional collaboration for improving patient and population health outcomes, (7) clinical prevention and population health for improving the nation’s health, and (8) advanced nursing practice. Current guidelines and evidence-based interventions were used to design, implement, and evaluate the quality improvement project. The results of the evidence search and literature synthesis guided the project and provided support and structure for practice implementation. The project aimed to improve health outcomes, ensure patient safety, identify organizational barriers, and facilitate changes in practice delivery. I conducted a critical appraisal of existing literature to determine and implement the best evidence and to improve current practice. Data came from practice information systems and databases. The project did advocate for the improvement of the current smoking cessation policy in the local facility that addresses issues of tobacco use in adults with mental health disorders. The identified tobacco users benefited from secondary and tertiary prevention by using medical and psychological support as nicotine replacement therapy and counseling as part of the brief clinical intervention program. The evidence-based intervention for 59 smoking cessation addressed a clinical need of a specific population from a particular clinical practice, and designed, implemented, and evaluated therapeutic interventions based on nursing science. Conclusions The significance of introducing smoking cessation programs among the behavioral health population is important because the problem of smoking is prevalent in the group of this population. Implementing evidence-based interventions for smoking cessation can have multiple benefits that include improvement of physical and mental health, increase in life expectancy, lower the risk of smoking-related diseases, and reduce financial stress. Studies show that a person’s anxiety, depression, stress levels, and quality of life improve after they stop smoking when compared with those who continue to smoke. Research studies found that smoking cessation works best when nicotine replacement therapy is used in combination with behavioral therapy. The result showed that a brief clinical intervention for tobacco cessation might have a great impact in assisting smokers to quit smoking or cut down on daily tobacco use. Evaluating the impact of the smoking cessation program identified the interventions that might yield positive results in increasing smoking cessation among adult smokers with mental health disorders. The emphasis on policy change and implementation of evidence-based tobacco cessation programs were significant for meeting the guidelines of the CDC (2020). When working with the mental health population, building trust and accepting an individual's situation is important. Understanding what life is like for these patients and considering their barriers to stopping smoking without judging them would help providers 60 address their needs and provide individualized care. Often, a multidisciplinary approach is required to identify patient issues and offer services. Overall, tobacco usage among the mental health population poses a question of the urgent need to advance a nursing intervention with a plan to assist tobacco users in recovering. Current tobacco cessation efforts in the behavioral health population are insufficient. That is why clinicians must use the information and tools to better understand and address the needs of adult smokers with a mental health disorder and to make progress in lowering the rates of smoking among them. Plan for Sustainability The project outcomes recognized that organizational changes and adjusting policies are effective ways of affecting tobacco use among individuals living with mental illnesses. Asking every patient about their tobacco use is a simple task that can be implemented in electronic health records, intake forms, or other forms that are regularly used for social assessment. This small intervention opens a discussion among providers, healthcare team members, and patients about a person’s tobacco use, why it would be beneficial to quit, and some available resources. I also addressed the barriers that people face in accessing cessation services and what we can do to reduce those barriers. Some participants faced barriers to accessing cessation services, like counseling and Quitline’s. For people with lower income, poor financial and social support, and mental health disorders, having access to reliable transportation, a telephone, and the internet can be difficult. A lack of education about the effects of smoking or not knowing how to quit also inhibits people from making quit attempts. We need more cessation services tailored to fit the needs of individuals with mental illnesses to improve accessibility and reduce the rate of smoking. 61 Plan for Dissemination A poster presentation about the impact of the smoking cessation program is one of the elements of an effective dissemination plan. The entire project was presented to the stakeholders. The project findings will be disseminated to the local leadership, nursing staff, and clinical providers via webinar or town hall format. The present study showed that the 5A’s model was not fully implemented. Ask and Advise were the screening questions about tobacco use prior to this project. To strengthen the use of 5A’s model, the use of Assess, Assist, and Arrange steps must follow. The utilization of practical workshops would allow clinical providers and nursing staff to learn about the new screening tool, its significance in usage, and the importance of 5A’s implementation. Additional recommendations are changing the inpatient medical record systems to prompt and document tobacco cessation interventions, providing a discharge protocol that includes a prescription for nicotine replacement therapy and referral for continued cessation support after hospital discharge, and initiating the first call prior to discharge. Addressing the barriers that people face in accessing cessation services and follow-up and involving every health care team member would help improve efficiency and support a coordinated-care approach. The QI project concluded that an effective quit plan should be personalized, involving education, counseling, and appropriate pharmacotherapy. The education must include information about the addiction to smoking tobacco, health conditions that are worsened by smoking, and tips to manage withdrawal symptoms and cravings. Counseling is needed to address the behavioral aspects of smoking and identify and overcome potential roadblocks to successful quitting. Medical management provides nicotine replacement therapies to provide a steady nicotine level and cover situational cravings. 62 APPENDIX A: SITE APPROVAL/AUTHORIZATION LETTER 63 64 65 66 67 68 69 70 71 APPENDIX B: CONSENT DOCUMENT: PARTICIPANT INFORMED CONSENT AND AUTHORIZATION FORM 72 73 74 75 76 77 78 APPENDIX C: RECRUITMENT MATERIAL: PARTICIPANT SCREENING/ENROLMENT LOG 79 80 APPENDIX D: PARTICIPANT MATERIAL: WRITTEN GUIDELINES 81 82 83 84 85 86 87 Nicotine Cessation Program The Time to Quit Nicotine Cessation Program supports and assists you as you create a plan to become tobacco-free. Getting started is easy and help is just a phone call away. Call 570-622-5898 to set up an appointment. You can feel good again without depending on nicotine. Our professional counselors know it is not easy to quit. They also know what techniques and strategies work best. Discussion topics include: • Use of Nicotine Replacement Therapy • Coping without tobacco • Stress management • Avoiding weight gain • Preventing relapse The Nicotine Cessation Program is offered at no cost and is typically held weekly for six weeks at the following location: Lehigh Valley Hospital–Schuylkill - Counseling Center 502 South Second Street Suite A, St. Clair, PA 17970 Call 570-622-5898 today to begin a new life without nicotine! Services are available in person, by video, or by telephone during the pandemic. 88  Quitline is a telephone-based tobacco cessation counseling service offering free coaching, with no judgment. This program has a proven record of increasing your chances of staying smoke-free for good. Pennsylvania’s Free Quitline (1-800-784-8669) is offered as a partnership between the Pennsylvania Department of Health and the American Cancer Society. • Trained Quit Coaches, available 24/7, who will help create a plan that is right for you. • Up to five free coaching calls – and unlimited, inbound calls for additional support during times of high risk for using tobacco. • Free nicotine replacement therapy – if medically eligible. • Web-based and text-messaging support. Participants work with trained coaches to prepare a quit plan, set a quit date, identify tobacco triggers, manage cravings, and address relapses. A full pharmacotherapy program includes nicotine replacement therapy, education, and coordination of pharmacy benefits. Research shows combining nicotine replacement therapy and coaching produces the best chances of quitting. https://pa.quitlogix.org/en-US/Enroll-NowOpens In A New Window  QuitGuide is a free app that helps you understand your smoking patterns and build the skills needed to become and stay smoke-free. Use the app to track your cravings by the time of day and location and get motivational messages for each craving you track. 89 APPENDIX E: CHART AUDIT FORMS 90 91 92 93 APPENDIX F: PROJECT TIMELINE 94 95 APENDIX G: OTHER DOCUMENTS AS APPLICABLE TO THE PROJECT: FISHBONE DIAGRAM 96 97 REFERENCES American Association of Colleges of Nursing. (2006, October). DNP essentials. The American Association of Colleges of Nursing (AACN). https://www.aacnnursing.org/DNP/DNP-Essentials Adams, T. N., & Morris, J. (2020, July 21). Smoking (Tobacco) - StatPearls - NCBI bookshelf. National Center for Biotechnology Information. https://www.ncbi.nlm.nih.gov/books/NBK537066/ Agency for Healthcare Research and Quality. (2012a, December). Five major steps to intervention (The "5 A's"). https://www.ahrq.gov/prevention/guidelines/tobacco/5steps.html Agency for Healthcare Research and Quality. (2012b, December). Patients not ready to make a quit attempt now (The "5 R's"). https://www.ahrq.gov/prevention/guidelines/tobacco/5rs.html Agency for Healthcare Research and Quality. (2018). Clinical guidelines and recommendations. https://www.ahrq.gov/prevention/guidelines/index.html Agency for Healthcare Research and Quality. (2020, February). Treating tobacco use and dependence: 2008 update. https://www.ahrq.gov/prevention/guidelines/tobacco/index.html Al-Bashaireh, A. M., Haddad, L. G., Weaver, M., Kelly, D. L., Chengguo, X., & Yoon, S. (2018). The effect of tobacco smoking on musculoskeletal health: A systematic review. Journal of Environmental and Public Health, 2018, 4184190. https://doi-org.proxy-bloomu.klnpa.org/10.1155/2018/4184190 98 American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596 Catley, D., Grobe, J., Moreno, J. L., Stortz, S., Fox, A. T., Bradley-Ewing, A., Richter, K. P., Resnicow, K., Harris, K. J., & Goggin, K. (2021). Differential mechanisms of change in motivational interviewing versus health education for smoking cessation induction. Psychology of Addictive Behaviors, 35(7), 778–787. https://doi-org.proxy-bloomu.klnpa.org/10.1037/adb0000720.supp Centers for Disease Control and Prevention. (2020). Smoking & tobacco use. https://www.cdc.gov/tobacco/index.htm Centers for Disease Control and Prevention. (2021a, June 2). Coverage for tobacco use cessation treatments. https://www.cdc.gov/tobacco/quit_smoking/cessation/coverage Centers for Disease Control and Prevention. (2021b, November 16). Clinical interventions to treat tobacco use and dependence among adults. https://www.cdc.gov/tobacco/patient-care/care-settings/clinical/index.html Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff (2008). A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. public health service report. American journal of preventive medicine, 35(2), 158–176. https://doi.org/10.1016/j.amepre.2008.04.009 De Chesnay, M., & Anderson, B. A. (2016). Caring for the vulnerable: Perspectives in nursing theory, practice, and research (5th ed.). Sudbury, MA: Jones & Bartlett Learning. 99 Drope, J., Liber, A. C., Cahn, Z., Stoklosa, M., Kennedy, R., Douglas, C. E., Henson, R., & Drope, J. (2018). Who’s still smoking? Disparities in adult cigarette smoking prevalence in the United States. CA: A Cancer Journal for Clinicians, 68(2), 106–115. https://doi.org/10.3322/caac.21444 Eicher, J., Kuhn, K. A., & Prasser, F. (2017). An experimental comparison of quality models for health data de-identification. Studies in Health Technology and Informatics, 245, 704– 708. Fiore, M. C. (2008). Treating tobacco use and dependence: 2008 update U.S. public health service clinical practice guideline executive summary. Respiratory Care, 53(9), 1217– 1222. Flowers, L. (2017). Nicotine replacement therapy. American Journal of Psychiatry Residents' Journal, 4-7. https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp-rj.2016.110602 Flores-González, L. A., Gutiérrez-Ramírez, J. M., & Constanza, L. (2017). Quantic analysis of the effect of nicotine on neurotransmitters. World Journal of Pharmaceutical Research, 6(4), 317-326. https://www.researchgate.net/publication/315756276 Froiland, J. M. (2020). Motivational interviewing (MI). Salem Press Encyclopedia. Gaines, K. (2020, September 4). What is the nursing code of ethics? Nurse.org. https://nurse.org/education/nursing-code-of-ethics/ Gregg, S.R., Dupont, L., & Burns, M. (2020). A format template- SQUIRE and APA 7th ed. guidelines. University of Arizona Department of Nursing, DNP program. 100 Haddad, A., & Davis, A. M. (2016). Tobacco smoking cessation in adults and pregnant women: Behavioral and pharmacotherapy interventions. JAMA, 315(18), 2011–2012. https://doi-org.proxy-bloomu.klnpa.org/10.1001/jama.2016.2535 Harris, T., Winetrobe, H., Rhoades, H., & Wenzel, S. (2019). The role of mental health and substance use in homeless adults’ tobacco use and cessation attempts. Journal of Dual Diagnosis, 15(2), 76–87. https://doi-org.proxy-bloomu.klnpa.org/10.1080/15504263.2019.1579947 Hecht, J., Rigotti, N. A., Minami, H., Kjome, K. L., Bloom, E. L., Kahler, C. W., & Brown, R. A. (2019). Adaptation of a sustained care cessation intervention for smokers hospitalized for psychiatric disorders: Study protocol for a randomized controlled trial. Contemporary clinical trials, 83, 18-26. https://doi.org/10.1016/j.cct.2019.06.001 Hickey, J.V., & Brosnan, C.A. (2017). Evaluation and DNPs: The mandate for evaluation. New York, NY: Springer Publishing Company, LLC. Husted, G.L., Husted, J.H., Scotto, C. J., & Wolf, K.M. (2015). Bioethical decision making in nursing (5th ed.). NY: Springer Publishing. Institute for Healthcare Improvement. (n.d.). Science of improvement: How to improve | IHI Institute for healthcare improvement. Improving Health and Health Care Worldwide. https://www.ihi.org/resources/Pages/HowtoImprove/ScienceofImprovem Kaiser, E. G., Prochaska, J. J., & Kendra, M. S. (2018). Tobacco cessation in oncology care. Oncology, 95(3), 129–137. https://doi-org.proxy-bloomu.klnpa.org/10.1159/000489266 101 Kendra, M. S., Dang, J., Artandi, M., & Vemuri, M. (2020). Connecting tobacco users in the primary care setting to comprehensive tobacco treatment: a quality improvement initiative. Journal of Public Health: From Theory to Practice, 30, 1213–1218. https://doi.org/10.1007/s10389-020-01401-0 Kruger, J., O’Halloran, A., & Rosenthal, A. (2015). Assessment of compliance with U.S. Public Health Service clinical practice guideline for tobacco by primary care physicians. Harm Reduction Journal, 12, 7. https://doi-org.proxy-bloomu.klnpa.org/10.1186/s12954-015-0044-3 Lehigh Valley Health Network. (2019). 2019 Community health needs assessment health profile Lehigh Valley Hospital–Schuylkill. Welcome to Lehigh Valley Health Network | Lehigh Valley Health Network. https://www.lvhn.org/sites/default/files/201904/N06053_CHNA_Schuylkill_Report_2018_FINAL.pdf Lightfoot, K., Panagiotaki, G., & Nobes, G. (2020). Effectiveness of psychological interventions for smoking cessation in adults with mental health problems: A systematic review. British Journal of Health Psychology, 25(3), 615–638. https://doi-org.proxy-bloomu.klnpa.org/10.1111/bjhp.12431 Lipari, R. & Van Horn, S. (2017, June 20). Smoking and mental illness among adults in the United States. SAMHSA - Substance Abuse and Mental Health Services Administration. https://www.samhsa.gov/data/sites/default/files/report_2738/ShortReport-2738.html Logtenberg, E., Overbeek, M., Pasman, J., Abdellaoui, A., Luijten, M., Van Holst, R., . . . Treur, J. (2021). Investigating the causal nature of the relationship of subcortical brain volume 102 with smoking and alcohol use. The British Journal of Psychiatry, 1-9. doi:10.1192/bjp.2021.81 https://www.cambridge.org/core/journals/the-british-journal-ofpsychiatry/article/investigating-the-causal-nature-of-the-relationship-of-subcortical-brainvolume-with-smoking-and-alcohol-use/2E6450C48C0862B2674990E0E32DF6C2 Loreto, A. R., Carvalho, C. F. C., Frallonardo, F. P., Ismael, F., Andrade, A. G. de, & Castaldelli-Maia, J. M. (2017). Smoking cessation treatment for patients with mental disorders using CBT and combined pharmacotherapy. Journal of Dual Diagnosis, 13(4), 238–246. https://doi.org/10.1080/15504263.2017.1328149 Mager, N. D., & Moore, T. S. (2020). Healthy people 2030: Roadmap for public health for the next decade. American Journal of Pharmaceutical Education, 84(11), 8462. https://doi.org/10.5688/ajpe8462 Martinez, C., Castellano, Y., Andrés, A., Fu, M., Antón, L., Ballbè, M., & Fernández, E. (2017). Factors associated with implementation of the 5A’s smoking cessation model. Tobacco induced diseases, 15(1), 1-11. https://doi.org/10.1186/s12971-017-0146-7 Melnyk, B. M. & Fineout-Overholt, E. (2019). Evidence-based practice in nursing & healthcare: A guide to best practice (3rd ed.). Lippincott Williams & Wilkins. Momin, B., Neri, A., Zhang, L., Kahende, J., Duke, J., Green, S. G., Malarcher, A., & Stewart, S. L. (2017). Mixed-methods for comparing tobacco cessation interventions. Journal of Smoking Cessation, 12(1), 15–21. 103 https://doi.org/10.1017/jsc.2015.7 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmontreport/index.html National Institute on Drug Abuse. (2021a, April 12). How does tobacco deliver its effects? https://www.drugabuse.gov/publications/research-reports/tobacco-nicotine-ecigarettes/how-does-tobacco-deliver-its-effects National Institute on Drug Abuse. (2021b, April 12). What are treatments for tobacco dependence? https://nida.nih.gov/publications/research-reports/tobacco-nicotine-e-cigarettes/what-aretreatments-tobacco-dependence National Institute on Drug Abuse. (2020). Tobacco, nicotine, and e-cigarettes research report. https://nida.nih.gov/download/1344/tobacco-nicotine-e-cigarettes-researchreport.pdf?v=4b566e8f4994f24caa650ee93b59ec41 Office of Disease Prevention and Health Promotion. (n.d.). Health care access and quality. Healthy People 2030. U.S. Department of Health and Human Services. https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-careaccess-and-quality 104 Pennsylvania Department of Health. (n.d.). Quitline. Department of Health. https://www.health.pa.gov/topics/programs/tobacco/Pages/Quitline.aspx Prochaska, J. O., & DiClemente, C. C. (1983). Stages and processes of self-change of smoking: Toward an integrative model of change. Journal of Consulting and Clinical Psychology, 51(3), 390–395. https://doi.org/10.1037/0022-006X.51.3.390 Prochaska, J., O. & Velicer, W., F. (1997). The transtheoretical model of health behavior change. PubMed. https://www..ncbi.nlm.nih.gov/10170434/ Prochaska, J. J., Das, S., & Young-Wolff, K. C. (2017). Smoking, mental illness, and public health. Annual review of public health, 38, 165–185. https://doi.org/10.1146/annurev-publhealth-031816-044618 Rahmayanti, E. I., Kadar, K. S., & Saleh, A. (2020). Readiness, barriers and potential strength of nursing in implementing evidence-based practice. International Journal of Caring Sciences, 13(2), 1203–1211 Roberts, C., Wagler, G., & Carr, M. M. (2017). Environmental tobacco smoke: Public perception of risks of exposing children to second-and thirdhand tobacco smoke. Journal of Pediatric Health Care, 31(1), e7-e13. https://doi.org/10.1016/j.pedhc.2016.08.008 Rogers, E. S., Smelson, D. A., Gillespie, C. C., Elbel, B., Poole, S., Hagedorn, H. J., & Sherman, S. E. (2016). Telephone smoking-cessation counseling for smokers in mental health 105 clinics: A patient-randomized controlled trial. American Journal of Preventive Medicine, 50(4), 518-527. https://doi.org/10.1016/j.amepre.2015.10.004 Romain, A. J., Trottier, A., Karelis, A. D., & Abdel-Baki, A. (2020). Do mental health professionals promote a healthy lifestyle among individuals experiencing serious mental illness. Issues in Mental Health Nursing, 41(6), 531–539. https://doi.org/10.1080/01612840.2019.1688436 Sealock, T., & Sharma, S. (2020, April 30). Smoking cessation - StatPearls - NCBI bookshelf. National Center for Biotechnology Information. https://www.ncbi.nlm.nih.gov/books/NBK482442/ Schroeder, S. A., Clark, B., Cheng, C., & Saucedo, C. B. (2018). Helping smokers quit: The smoking cessation leadership center engages behavioral health by challenging old myths and traditions. Journal of Psychoactive Drugs, 50(2), 151-158. https://doi.org/10.1080/02791072.2017.1412547 Seng, S., Otachi, J. K., & Okoli, C. T. (2020). Reasons for tobacco use and perceived tobaccorelated health risks in an inpatient psychiatric population. Issues in Mental Health Nursing, 41(2), 161-167. https://doi.org/10.1080/01612840.2019.1630533 Shahmoradi, L., Safadari, R., & Jimma, W. (2017). Knowledge Management Implementation and the Tools Utilized in Healthcare for Evidence-Based Decision Making: A Systematic Review. Ethiopian journal of health sciences, 27(5), 541–558. https://doi.org/10.4314/ejhs.v27i5.13 106 Sheffer, C. E., Al-Zalabani, A., Aubrey, A., Bader, R., Beltrez, C., Bennett, S., Carl, E., Cranos, C., Darville, A., Greyber, J., Karam-Hage, M., Hawari, F., Hutcheson, T., Hynes, V., Kotsen, C., Leone, F., McConaha, J., McCary, H., Meade, C., … Wendling, A. (2021). The emerging global tobacco treatment workforce: Characteristics of tobacco treatment specialists trained in council-accredited training programs from 2017 to 2019. International Journal of Environmental Research and Public Health, 18(5). https://doi-org.proxy-bloomu.klnpa.org/10.3390/ijerph18052416 Shimoni, B. (2017). What is resistance to change? A habitus-oriented approach. Academy of Management Perspectives, 31(4), 257–270. https://doi.org/10.5465/amp.2016.0073 Simonavicius, E., Robson, D., McEwen, A., & Brose, L. S. (2017). Cessation support for smokers with mental health problems: A survey of resources and training needs. Journal of Substance Abuse Treatment, 80, 37-44. https://doi.org/10.1016/j.jsat.2017.06.008 Skora, A. (2018). Tobacco-related disparities among individuals affected by mental illness. The Journal, 2018, 50-56 Stahl, S.M. (2017). Stahl’s essential psychopharmacology: Prescriber’s guide (6th ed.). New York: Cambridge University Press. Substance Abuse and Mental Health Services Administration. (2019, September). Advisory: Implementing tobacco cessation treatment for individuals with serious mental illness: A quick guide for program directors and clinicians. SAMHSA Publications and Digital Products. 107 https://store.samhsa.gov/product/Implementing-Tobacco-Cessation-Treatment-forIndividuals-with-Serious-Mental-Illness-A-Quick-Guide-for-Program-Directors-andClinicians/PEP19-02-00-001 Sylvia, M. L., & Terhaar, M. F. (2018). Clinical analytics and data management for the DNP (2nd ed.). Springer Publishing Company. Taylor, G., Itani, T., Thomas, K. H., Rai, D., Jones, T., Windmeijer, F., Martin, R. M., Munafò, M. R., Davies, N. M., & Taylor, A. E. (2020). Prescribing prevalence, effectiveness, and mental health safety of smoking cessation medicines in patients with mental disorders. Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco, 22(1), 48–57. https://doi.org/10.1093/ntr/ntz072 Techapanupreed, C., & Kurutach, W. (2020). Enhancing transaction security for handling accountability in electronic health records. Security & Communication Networks, 1–18. https://doi-org.proxy-bloomu.klnpa.org/10.1155/2020/8899409 Torres, S., Merino, C., Paton, B., Correig, X., & Ramírez, N. (2018). Biomarkers of exposure to secondhand and thirdhand tobacco smoke: Recent advances and future perspectives. International Journal of Environmental Research and Public. Twyman, L., Bonevski, B., Paul, C., & Bryant, J. (2014). Perceived barriers to smoking cessation in selected vulnerable groups: a systematic review of the qualitative and quantitative literature. BMJ Open, 4(12), 1. Health, 15(12). https://doi-org.proxy-bloomu.klnpa.org/10.3390/ijerph15122693 108 US Department of Health and Human Services. (2008, May). Treating tobacco use and dependence: 2008 update - NCBI bookshelf. National Center for Biotechnology Information. https://www.ncbi.nlm.nih.gov/books/NBK63952/ US Preventive Services Task Force. (2021, January 19). USPSTF recommendation: Interventions for tobacco smoking cessation in adults. JAMA Network | Home of JAMA and the Specialty Journals of the American Medical Association. https://jamanetwork.com/journals/jama/fullarticle/2775287 United States Public Health Service Office of the Surgeon General; National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. (2020). Smoking cessation - NCBI bookshelf. National Center for Biotechnology Information. https://www.ncbi.nlm.nih.gov/books/NBK555591/ University of Ottawa Heart Institute. (2021). About OMSC. Ottawa model for smoking cessation. https://ottawamodel.ottawaheart.ca/about-omsc Vergara, V. M., Liu, J., Claus, E. D., Hutchison, K., & Calhoun, V. (2017). Alterations of resting state functional network connectivity in the brain of nicotine and alcohol users. NeuroImage, 151, 45–54. https://doi.org/10.1016/j.neuroimage.2016.11.012 West, R. (2017). Tobacco smoking: Health impact, prevalence, correlates and interventions. Psychology & Health, 32(8), 1018–1036. 109 World Health Organization. (2017, June 14). WHO monograph on tobacco cessation and oral health integration. WHO | World Health Organization. https://www.who.int/publications/i/item/who-monograph-on-tobacco-cessation-and-oralhealth-integration World Health Organization. (2020, May 27). Tobacco. WHO | World Health Organization. https://www.who.int/news-room/fact-sheets/detail/tobacco