COMPOSING A PATIENT EDUCATION PAMPHLET FOR DEEP VEIN THROMBOSIS By Julie Sue Anderson, RN, BSN Submitted in Partial Fulfillment of the Requirements for the Master of Science in Nursing Degree Edinboro University of Pennsylvania Composing a patient education pamphlet for deep uein thrombosis / by Julie Sue Anderson. Thesis Nurs. 2001 A547c c .2 Approved by: Ju^^hScWllin& C~ ; PhD fl (Committee Chairperson rffet^jeisel, PhD, RN Committee Member Date Table of Contents Contents Page Abstract... i Chapter 1: Introduction. 1 Background of the Problem. 1 Evolution of Patient Education. 1 Patient Education Materials. 4 Problem Statement 5 Theoretical Framework. 5 Statement of Purpose. ..7 Assumptions 8 Definition of Terms. 8 Summary 9 11 Chapter II: Review of the Literature. Deep Vein Thrombosis (DVT) Pathophysiology 14 Risk Factors... Clinical Features Diagnosis Treatment of DVT... Anticoagulation.... Unfractionated heparin ii Low molecular weight heparin 19 Oral anticoagulation. 22 Fibrinolytic Therapy 23 Surgical Interventions. 23 Complications 24 Post-thrombotic syndrome. 24 Pulmonary embolism. 24 Recurrent DVT 25 Patient Education. 26 Definition of Patient Education. 26 Purpose of Patient Education. 26 Process of Patient Education 26 Educational process 27 ASSURE model. 28 29 Patient Education Materials (PEMs) Self-composed PEMs. 30 Readability of PEMs 30 Principles of self-composed PEMs................ 32 Models for Composing and Evaluating PEMs. 34 36 Summary.... 37 Chapter III: Methodology 37 Pre-design Phase.... iii Design Phase 37 Pilot Phase. 38 Distribution and Implementation Phase. 39 Evaluation Phase 40 Summary. 40 References 41 Appendix A: Medical Risk Factors Predisposing to Thromboembolism. 48 Appendix B: Clinical Probability of Deep Vein Thrombosis. 50 Appendix C: DVT Patient Education Pamphlet. 52 iv COMPOSING A PATIENT EDUCATION PAMPHLET FOR DEEP VEIN THROMBOSIS Abstract An estimated 1 to 5 million Americans develop a deep vein thrombosis (DVT) each year (Kurowski, 1997). Educating patients about this health-related problem is necessary to alter their health behavior and improve their potential for optimal health outcomes (Falvo, 1994). Patient education is constantly changing to meet the demands placed by today’s health care system (Bastable, 1997; Falvo, 1994; Whitman, Gliet, Graham, and Boyd, 1992). The nurse practitioner assumes a vital role in the patient education process (Close, 1988). The use of printed education materials (PEMs) is one method to facilitate the achievement of health. Using Bernier and Yasko’s (1991) EPEM model for designing and evaluating PEMs, a patient education pamphlet was designed for use with patients diagnosed with, or who are high risk for, DVT. The purpose of the pamphlet is to supplement and reinforce oral instructions given to the patient by the health care provider. After construction, the pamphlet was submitted to a patient education committee in a northwestern Pennsylvania acute care facility for evaluation. Once the recommended changes were instituted, the PEM was relinquished to the committee for publication and distribution throughout the institution. i 1 Chapter 1 Introduction This objective of this scholarly project is to create a patient education pamphlet discussing deep vein thrombosis (DVT). Contained within this chapter is a brief overview of the evolution of today’s patient education practices, types of educational materials available, and the education needed by a patient with a deep vein thrombosis. Also provided is the theoretical framework for this scholarly project, Dorothea Orem’s (2001) Self-care Deficit Theory of Nursing. The problem statement, the statement of purpose, the assumptions, and the definition of terms for this project are also discussed. Background of the Problem Because patients in today’s acute care hospitals are admitted with higher acuities and are being discharged home sooner, patient education continues to gain increasing importance in today’s health care environment (Lange, 1989) The increased demand for primary and secondary prevention, and management of illness in the outpatient setting, also highlight the need for patient education (Bastable, 1997). The nurse practitioner is vital to the patient education process (Close, 1988). Evolution of Patient Education Whitman, Graham, Gleit, and Boyd (1992) wrote, “a more informed and health-conscious public has been evolving for some time” (p. 4). In response to the demands of the public and the ever-changing health care system, numerous acts of legislatures have been instituted and revised over the last century to 2 promote patient education. The National League for Nursing Education in 1918 provided the earliest impetus by recognizing the significance of patient education and the role of the nurse as an educator (Bastable, 1997; Boyd, 1992a). Consequently, nurse practice acts incorporated patient education as a function of nursing. In 1950, the Society of Public Health and Education was created to promote health and education in the community (Boyd, 1992a). By the 1970s, consumers became more involved in health care and formed several public interest groups such as Healthright, Medicine in the Public Interest, and the Patients’ Rights Organization (Boyd, 1992a). The private sector founded the National Center for Health Education. The American Hospital Association introduced the Patient’s Bill of Rights in 1973, revised in 1992, in order to establish the right of patients to be informed about their health status (Bastable, 1997; Boyd, 1992a; Falvo, 1994). From a legislative standpoint, The National Health Planning and Resources Development Act of 1974 was passed in order to include health education of the public as one of the top ten priorities for the nation (Boyd, 1992a). In the 1980s, the Joint Commission on Accreditation of Health Care Organizations identified the importance of nurses as patient educators (Boyd, 1992a). Also, the development of Diagnostic Related Groups (DRGs) in the 1980s sponsored the vital role in health education as a means for cost containment. DRGs placed limits on reimbursement for the institutional care of health problems which led to decreased lengths of stay in acute care facilities and 3 an increase in home health care, thus, highlighting the need for effective patient education (Whitman et al., 1992). More recently, managed care gained increasing recognition in the 1990s (Kremer & Faut-Callahan, 1998). Managed care seeks to drive down health care costs through such measures as prevention and health education. Lastly, Healthy People 2000: National Promotion and Disease Prevention Objectives was published in 1990 (United States Department of Health and Human Services [USDHH], 1990). Healthy People 2000 indicated health education as being essential to achieving health promotion and disease prevention. Released on January 25, 2000, Healthy People 2010 (USDHH, 2000) continues the commitment to patient education. One of the goals for 2010 is to improve the quality, availability, and effectiveness of educational and community oriented programs created to prevent disease, and to enhance health and quality of life. The methods of improving education in the health care setting are to provide quality patient and family education, and to increase patient satisfaction and community health promotion activities. Prior to the evolution of patient education to today’s standards, patient information was often presented in a haphazard fashion with little evaluation of the patient’s understanding (Falvo, 1994). Patients were expected to assume a passive role and not question their care. This attitude is now changing. The onset of ever advancing technology has contributed to an increased life expectancy and incidence of chronic diseases (Falvo, 1994). DRGs with their effects on health 4 care reimbursement, in-patient acuity, shorter lengths of stay, and an increase use of home health care (Boyd, 1992a) in combination with patients acquiring a more active role in their health care has necessitated reform in health care education (Bastable, 1997; Boyd, 1992a; Falvo, 1994). Patient Education Materials Patient education materials consist of videotapes, audiotapes, slides, films, closed circuit television, movies, pamphlets, books, and fact sheets (Boyd, 1992b; Hainsworth, 1997; Falvo, 1994; Pohl, 1981). In recent years, computer based education has also been developed (Homer et al., 2000). Although these materials are many and varied, Falvo (1994) and Boyd (1992b) cautioned the nurse practitioner to use teaching aids to reinforce and illustrate information, not in lieu of practitioner-patient interaction. Printed education materials (PEMs) are the most accessible and widely used (Hainsworth, 1997; Mathis, 1989). PEMs are less expensive than other forms of patient education materials and have the advantage of being portable and serve as a take home reference (Bernier & Yasko, 1991, Boyd, 1992b). Pohl (1981) noted that PEMs are the most valuable of patient education materials because they may be presented either to the patient before the topic is discussed, to arouse interest, or may serve as reinforcement and provide supplementary information. The utilization of commercially available PEMs is less time consuming; however, Hainsworth (1997) proposed using self-composed PEMs to increase ld readability of content, and to decrease cost. In addition, accuracy, adequacy, am 5 self composed PEMs can be tailored to meet the specific teaching needs of the targeted patient population (Falvo, 1994; Farrell-Miller & Gentry, 1989; Hainsworth, 1997; Pohl, 1981). Problem Statement An estimated 1 to 5 million Americans develop a deep vein thrombosis (DVT) each year (Kurowski, 1997), and DVT is estimated to account for more than 600,000 hospitalizations annually (Yeager & Matheny, 1999). An acute DVT is a serious and potentially fatal illness that can complicate the hospital course of inpatients as well as affect outpatients and otherwise healthy persons (Lensing & Prandoni, 1999). DVT is associated with several complications (Kurowski, 1997; Lensing & Prandoni, 1999; Gorman, Davis, & Donnelly, 2000) and the management of DVT is costly (Boccalon, Elias, Chale, Cadene & Gabriel, 2000). Ineffective patient education compounds these costs and complications (Falvo, 1994). Theoretical Framework For the purpose of this project, Dorothea Orem’s (2001) Self-Care Deficit Theory of Nursing will be utilized as the theoretical framework. In her theory, Orem described three key theoretical concepts, self-care deficit, self-care (dependent care), and nursing systems. A self-care deficit speaks to the relationship between the ability of the person to care for one’s self and the care that is demanded (Orem, 2001). If the patient is unable to meet the required self-care demand, a self-care deficit exists. 6 Self care, on the other hand, occurs when individuals initiate and perform acts on their own behalf to maintain life, health, and well-being (Orem, 2001). Dependent care occurs when another individual must perform these activities for someone who is socially dependent such as a child. Finally, nursing systems is the sum of all the actions and interactions of the nurse and patient (Orem, 2001). This concept incorporates the theories of self-care deficit and self-care. The nurse is capable of determining if nursing help is necessary by examining the actual or potential deficit relationships between the abilities of the patient and the need for action by the patient to maintain or achieve health. An individual benefits from nursing because of health related limitations in providing care for self. The goal of the nursing system is to maximize the individual’s ability to meet a health need or to decrease the demand through the methods of helping (Orem, 2001). Orem identified the following as methods of helping: (a) performing for another, (b) guiding and leading another, (c) administering physical and psychological support, (d) providing an environment that encourages development, and (e) teaching. Thus, through these acts, the nurse assists the patient in achieving self-care requirements. Teaching is an important function of the nurse (Orem, 2001). Orem wrote, teaching another who requires instruction to develop specific knowledge or skills is a valid method of helping. In order to effectively teach, the nurse must identify the patient’s background, lifestyle, and modes of thinking and understanding, as well as self-care requisites. The nurse utilizes this information 7 to provide personalized patient instruction that will best assist the patient to achieve self-care. When applying Orem’s theory of nursing to this project, the patient with a DVT is the self-care agent. The nurse practitioner, using the supportive-educative nursing system, identifies the patient’s self-care knowledge deficits. The practitioner then instructs and provides printed education material about DVT to assist the patient in achieving self-care requisites. Statement of Purpose Patient education is a means of improving the health of the American people (Whitman et al, 1992). By teaching patients about their illness, treatment, and preventative measures, patients achieve an increased ability to make choices about their health (Falvo, 1994; Orr, 1990). The use of printed education materials (PEMs) is one method to facilitate the achievement of health (Falvo, 1994). Patients with DVTs provide one such opportunity for the use of PEMs for health improvement. The purpose of this project is to create a patient education pamphlet addressing the risks, signs and symptoms, diagnosis, complications, and treatment of DVT including preventative measures. The pamphlet is to be used to supplement verbal instructions given by the nurse practitioner to the patient with a DVT. 8 Assumptions For the purposes of this project, the following assumptions were identified: 1 The patient has been diagnosed with or is at risk for deep vein thrombosis. 2. The patient has a self-care knowledge deficit. 3. The patient is able to read and comprehend English at a minimum of the seventh grade level. 4. The patient is motivated to learn. 5. The patient is able to apply learning to alleviate self-care deficit. 6. Nurse practitioners are effective patient educators. Definition of Terms For the purposes of this research project, the following terms have been identified: 1. The patient is a receiver of care including education (Orem, 2001). 2. Teaching is a deliberate act that involves the planning and delivery of instructional activities and experiences to meet intended learner objectives (Bastable, 1997). 3. Learning is the process through which change in a person’s behavior, knowledge, skill, or attitudes occurs in response to exposure to environmental stimuli (Bastable, 1997; Boyd, 1992b; Pohl, 1981). 9 4. Patient education is the process by which persons acquire health-related behaviors that are assimilated into daily life with the goal of obtaining optimal health and independent self-care (Bastable, 1997; Orem, 2001) 5. Deep vein thrombosis (DVT) is the occurrence of a blood clot within or between the deep veins of an extremity which leads to venous obstruction and damage to the valves of the vein (Gorman, Davis, & Donnelly, 2000). 6. Heparin is an anticoagulant that acts by preventing the conversion of prothrombin to thrombin and the liberation of thromboplastin from platelets (Thomas, 1997). 7. Standard unfractionated heparin (UFH) is intravenous heparin with an average molecular weight of 15 kilodaltons (Fitzgerald, 1999). 8. Low molecular weight heparin is subcutaneous heparin with a molecular weight between 4 to 6.5 kilodaltons (Fitzgerald, 1999). Summary Patient education is constantly changing to meet the demands placed by today’s health care system (Bastable, 1997; Falvo, 1994; Whitman et al, 1992). Many acts, laws, and regulations have been passed that reflect this dynamic process. Subsequently, a multitude of commercially prepared patient education materials have been produced (Bastable, 1997; Boyd, 1992b; Falvo, 1994; Pohl, 1981). These materials, however, often do not meet the needs of the targeted patient population (Falvo, 1994; Farrell-Miller & Gentry, 1989; Hainsworth, 1997; Pohl, 1981). 10 Dorothea Orem’s Self-care Deficit Theory of Nursing (2001) recognizes that the ill patient may have self-care knowledge deficits. Patient education is a means to improve the health of the ill patient (Whitman et al., 1992). DVT is a serious and potentially fatal illness that provides an opportunity for education and health improvement (Lensing & Prandoni, 1991). In this instance, the nurse practitioner may wish to use self-composed education materials. Finally, this chapter identified six basic assumptions of this project. Terms germane to this project were also defined. 11 Chapter 2 Review of the Literature Included in this chapter is a general discussion of deep vein thrombosis (DVT). The pathophysiology, risk factors, clinical features, diagnosis, treatment, and complications of DVT are discussed within the context of a review of the literature. Also addressed in this chapter is patient education. Through a review of the literature, the definition, purpose, and principles of patient education are identified. Additionally, the development of printed education materials (PEMs) and self-composed PEMs are reviewed. Finally, emphasis is placed on the readability of PEMs as well as two models for designing and evaluating PEMs, are discussed. Deep Vein Thrombosis (DVT) DVT accounts for greater than 600,000 hospital admissions annually in the United States (Yeager & Matheny, 1999). DVT is often asymptomatic (Gorman, Davis, & Donnelly, 2000), yet substantial suffering may also occur (Rodriguez, 1998). This potentially fatal disease may affect both outpatients and the hospitalized (Lensing & Prandoni, 1999). An estimated 1 to 5 million Americans develops deep vein thrombosis (DVT) each year (Kurowski, 1997). The true incidence of DVT is not easily established (Lensing & Prandoni. 1999). This difficulty is due to the under use of standardized diagnostic procedures in some studios, and the fact that patients with DVT are often asymptomatic. The incidence of DVT, however, is rare in young 12 persons. As the U.S. population ages, the risk of DVT increases, thus, highlighting the importance of accurate treatment and prevention (Rodriguez, 1998). Nordstrom, Lindblad, and Kjellstrom (1992) completed a prospective study of the incidence of DVT within the defined urban population of Malmo, Sweden in 1992. The study revealed an incidence of DVT of 1.6 per 1000 inhabitants per year. This finding is similar to the incidence of 1.8 per 1000 observation-years discovered in a longitudinal study of men bom in 1913 (Hansson, Werlin, Tibbin, & Eriksson, 1997). These studies are reflective of predominantly white populations. Pathophysiology A century of research has been performed to establish the etiology of DVT (Rodriguez, 1998). Virchow’s triad is the accepted explanation for the formation of a venous thrombosis (Burroughs, 1999; Lensing & Prandoni, 1999; Rodriguez, 1998). Virchow’s triad consists of three elements that predispose an individual to venous thrombosis: (a) a hypercoagulable state, (b) damage to the vascular intima, and (c) venous stasis. Hypercoagulable states include deficiencies of antithrombin, proteins C and S, factor V Leiden, and plasminogen; resistance to activated protein C; mutation in the factor II gene, mutation in the factor V gene, and increased levels of factors VIII, IX, or XI or Fibrinogen (Lensing & Prandoni, 1999; Kurowski, 1997; Rodriguez, 1998; Seligshon & Lubetsky, 2001). Less commonly, increased levels of homocystein may also result in hypercoagulation (Seligsohn & 13 Lubetsky, 2001). Recently, a genetic link has been established for these hypercoagulable states. Approximately 40% to 60% of patients presenting with a first episode of DVT have one or more of the aforementioned hypercoagulable states (Lensing & Prandoni, 1999). Damage to the vascular intima usually results from trauma or surgery (Rodriguez, 1998). Surgeries with the greatest risk for DVT are orthopedic surgery, especially involving the hip and knee, neurosurgery, urological and gynecological surgeries (Estrada & McElligott, 1999; Gorman et al., 2000; Kurowski, 1997). Venous stasis is the most common predisposing factor (Rodriguez, 1998). Those patients who have limited or no mobility are at highest risk. The venous system is comprised of deep and superficial veins (Tortora & Anagnostakos, 1987). The superficial veins of the upper extremities are the cephalics, basilics, and median antebrachials and of the lower extremities are the great and small saphenous veins. The deep veins of the upper extremities are the radials, ulnars, brachials, axillaries, and subclavians and of the lower extremities are the posterior and anterior tibials, popliteal, and femorals. The majority of thrombi begin in the valve cusps of deep calf veins (Beers & Berkow, 1999). Gorman et al. (2000) described thrombus formation in the lower extremity in the following manner. First, the thrombosis usually forms secondary to venous stasis or the slowing of the flow of blood around venous valve sinuses. Then, extension of the primary thrombus between the deep and superficial veins of the 14 leg occurs. The resulting thrombus causes venous obstruction, injury to valves, and possible thromboembolism. Risk Factors The risk factors for DVT are numerous and varied. Rodriguez (1998) presents a comprehensive listing of risk factors following Virchow's triad of hypercoagulability, stasis, and vascular injury (Appendix A). Most sources agree on the following risk factors: (a) advanced age, (b) malignancy, (c) surgery, (d) immobilization; (e) fractures, (f) pregnancy and puerperium, (g) use of estrogen, (h) presence of varicosities, (i) hypercoagulable states, and (j) previous DVT (Huffman, 1998; Gorman et al, 2000; Kurowski, 1997; Lensing & Prandoni, 1999; Rodriguez, 1998). Lensing and Prandoni (1999) noted that obesity is not a clearly established independent risk factor. Clinical Features The predominant symptom of a unilateral DVT is asymmetrical lower extremity swelling of 48 to 72 hours in duration (Hunt, 1999). The affected lower extremity is often three centimeters larger in comparison to the unaffected lower extremity. Other clinical signs of a DVT are (a) pain, (b) discoloration, (c) warmth, (d) superficial venous distension, (e) palpable cords, (f) distal lower extremity edema, (g) Homan’s sign and (h) superficial thrombophlebitis (Hunt, 1999; Gorman et al, 2000). Two florid presentations can also occur, phlegmasia cerulea dolens-the blue leg, and phlegmasia alba dolens-the white leg (Hunt, 1999). 15 The clinical signs and symptoms of DVT vary greatly and clinical assessment alone is not reliable in diagnosing DVT (Huffman, 1998; Hunt, 1999; Rodriguez, 1998). The sole utilization of clinical judgment to diagnose DVT is accurate in approximately 50% of cases (Hobson, Minz, & Jamil, 1990; Kurowski, 1997). Thus, clinical evaluation and diagnostic testing should be used in combination to increase accurate identification of DVT (Huffman, 1998; Hunt, 1999; Rodriguez, 1998). Diagnosis There are several available diagnostic tests for DVT (Gorman et al, 2000; Hunt, 1999; Kurowski, 1997; Lensing & Prandoni, 1999; & Rodriquez, 1998). The most common are contrast venography, compression ultrasonography with doppler, and impedance plethsmography. The gold standard for the diagnosis of DVT is contrast venography (Gorman et al. 2000; Hunt, 1999; Kurowski, 1997; Lensing & Prandoni, 1999; & Rodriquez, 1998). This invasive procedure involves visualization of targeted veins using a contrast medium and roentenography (Thomas, 1997). Contrast venography is not the first line diagnostic test for DVT due to its invasive nature, cost, technical difficulty, time-consuming nature, discomfort to the patient, and risks of phlebitis, thromboembolism, and allergic reaction to contrast medium (Gorman, et al. 2000; Hunt, 1999). Contrast venography is recommended when the results of clinical findings and noninvasive tests are unconvincing (Hunt, 1999) and for diagnosing thromboses arising below the knee (Rodriguez, 1998). 16 Compression ultrasonography with doppler imaging is the most widely used diagnostic test for DVT (Gorman, et al., 2000; Hunt, 1999; Lensing & Prandoni, 1999; Miller, 1999; & Rodriquez, 1998). Ultrasonography is nomnvasive, safer, and less costly than venography. Ultrasonography involves the compression of the proximal veins with the ultrasound transducer (Lensing & Prandoni, 1999). The inability to compress a vein is indicative of a deep vein thrombosis. Duplex and color-coded doppler imaging may be added to assess venous flow, however, there is some disagreement as to the usefulness of doppler studies in establishing the diagnosis of a DVT. Weinmann & Salzman (1994) noted compression ultrasonography with doppler to have both a sensitivity and specificity of 97%. The sensitivity and specificity of compression ultrasonography is enhanced with the addition of Ddimer testing and the use of clinical scores (Gorman et al., 2000; Hunt, 1999; Lensing & Prandoni, 1999). D-dimer is a byproduct of fibrin production (Gorman et al., 2000). The elevation of the serum concentration of D-dimer is indicative of a thrombosis, but the elevated D-dimer is not specific for DVT (Gorman et al., 2000, Hunt, 1999, Lensing & Prandoni, 1999). D-dimer may also be elevated as a nonspecific response to a concurrent illness, not just a thrombosis (Gorman et al., 2000). D- dimer is best used in combination with compression ultrasonography for the diagnosis of DVT. The sensitivity of this combination is 98% with a high negative predictive value for ruling out DVT. 17 Combining the use of clinical scoring with compression ultrasonography increases diagnostic accuracy. (Gorman et al., 2000; Hunt, 1999). Wells, Hirsch, and Anderson (1995) created a method of clinical scoring that categorizes the patient as having a high or low probability of DVT based on established clinical points (Appendix B). Another noninvasive diagnostic test for DVT is impedance plethysmography (Hunt, 1999; Rodriguez, 1998). Rodriquez (1998) described impedance plethysmography gas measuring “the maximal filling of the venous system in the leg after extrinsic venous compression with a thigh cuff and venous emptying during the first 3 seconds after its release” (p. 715). Treatment of DVT Treatment of DVT includes anticoagulation, fibinolytic therapy, and surgery. Germane to all treatment modalities is anticoagulation. Regardless of the method, the goal of treatment is to reduce symptoms and prevent complications (Gorman et al., 2000). Anticoagulation Anticoagulation of an acute DVT is a necessary treatment (Burroughs, 1999; Estrada et al., 2000; Gorman et al., 2000; Hunt, 1999; Kurowski, 1997; Lensing & Prandoni, 1999; Rodriguez, 1998; Yeager & Matheny, 1999). Anticoagulation therapy is available as unfractionated heparin, low molecular weight heparin, and warfarin. 18 1)^ Traditional treatment of an acute DVT has been hospitalization for 5 to 7 days and intravenous administration of UFH with an overlap of oral anticoagulation (Burroughs, 1999; Estrada et al., 2000; Gorman et al., 2000; Hunt, 1999; Kurowski, 1997; Lensing & Prandoni, 1999; Rodriguez, 1998; Yeager & Matheny, 1999). The development of low molecular weight heparin (LMWH) has made the traditional role of UFH less clear (Gorman et al., 2000; Hunt, 1999; Lensing & Prandoni, Yeager & Matheny, 1999). These researchers note that UFH should be reserved for complicated DVT. UFH establishes rapid anticoagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin (Thomas, 1997). An intravenous bolus of UFH followed by a continuous infusion should be initiated immediately upon diagnosis of a DVT (Gorman et al., 2000; Hunt, 1999; Kurowski, 1997; Lensing & Prandoni, 1999; Rodriguez, 1998; Yeager & Matheny, 1999). The infusion is titrated to maintain an activated partial thromboplastin time (aPTT) of 1.5 to 2.5 times control. This requires frequent, daily monitoring of the aPTT utilizing an algorithm to adjust the dose of heparin. There are associated side effects with the use of heparin therapy, regardless of the molecular weight, and absolute contraindications (Kurowski, 1997). The main side effects of heparin are bleeding and thrombocytopenia. The absolute contraindications are: (a) known major bleeding diatheses, (b) central nervous system or eye surgery within the last 6 weeks, (c) known hypersensitivity to heparin, and (d) major abdominal or chest surgery within the last 48 hours. 19 LMWH in combination with oral anticoagulation is FDA approved for the inpatient treatment of acute DVT with and without pulmonary embolism (Yeager & Matheny, 1999). LMWH can also be used for the outpatient treatment of acute DVT without pulmonary embolism. LMWH inhibits factor Xa, augments tissue-factor-pathway inhibitor, and minimally effects antithrombin thereby eliminating the measurement of aPTT as seen with UFH (Yeager & Matheny, 1999). When compared to UFH, LMWH has greater bioavailability and minimal inter-patient and intra-patient variability in response to a given dose. These differences result from the decreased ability of LMWH to bind to plasma proteins, endothelium, and macrophages. Consequently, the dosage for LMWH is calculated using body weight without the need for monitoring laboratory values. Also, several studies have demonstrated efficacy, safety, and cost-effectiveness of the use of LMWH in the treatment of uncomplicated DVT (Yeager & Matheny, 1999). Two large Canadian clinical trials conducted by Harrison, McGinnis, Crowther, Ginsberg, and Hirsh (1998) confirmed that the use of LMWH for outpatient treatment of DVT is safe and effective. The research design was a prospective cohort study of consecutive patients presenting to two thromboembolism clinics in an Ontario metropolis. The rate of fatal embolism was 1%, the rate of recurrent DVT or pulmonary embolism was 6%, and the incidence of a major bleeding episode was 1%. These clinical trials also demonstrated that more than 75% of patients with diagnosed DVT referred to the 20 two tertiary care centers eou!d be treated at home, thus, decreasing the overall cost of care. This percentage was confirmed by another Canadian study by Wells et al. (1998). In this study, 194 of 233 consecutive patients at atertiaty care hospital were eligible for outpatient treatment of acute DVT. The researchers noted that more than 80% of patients at the studied tertiary care hospital could have received outpatient treatment for DVT. The Tinzaparine ou Heparine Standard: Evaluations dans 1’Embolie Pulmonaire (THESEE) study in France, the Columbus Investigators study in the Netherlands, and the American-Canadian Thrombosis Study Group were conducted to evaluate the efficacy and safety of LMWH in comparison to UFH (Saunders, 2000). All the studies revealed LMHW to be at least as effective and safe as UFH. Estrada, Mansfield, and Heudebert (2000) designed a decision model in which a cohort of 1,000 patients with DVT of the lower extremity was categorized by treatment with UFH in an inpatient setting or LMWH in the outpatient setting in North Carolina. The clinical outcomes measured were, (a) recurrent thrombosis, (b) mortality, (c) direct medical costs, and (d) marginal cost-effectiveness ratios from the payer’s perspective. The results per 1,000 patients were: (a) 10 fewer eases of recurrent thrombosis, (b) 1.2 fewer deaths, (c) 14% reduction in cost of care, and (d) the cost-effectiveness ratio was J9,667 and $80,685 per recurrent thrombosis or death prevented, respeedvely, in favor of LMWH. 21 The Vascular Midi-Pyrenees Study compared hospital versus home treatment of DVT with LMWH (Boccalon, Elias, Chale, Cadene, & Gabriel, 2000). The study was conducted with 201 patients presenting with a proximal DVT. The patients were randomized to receive LMWH and warfarin either as an inpatient for the first 10 days of therapy (n=102) or as an outpatient from the outset (n=99). This research revealed a cost savings of 56% with home treatment. There was no statistical difference (p< 0.20) between the groups in terms of clinical outcomes. The research concluded, “home treatment using a low- molecular-weight heparin is an effective, safe, and cost-saving strategy” (p. 1769). O’Brien et al. (1999) conducted a study of the cost-effectiveness of outpatient treatment of DVT with LMWH in Hamilton, Ontario. Data were collected prospectively on resource use and health related quality of life from the 300 patients in the trial. The sample was created by selecting the first 300 to present as outpatients with the diagnosis of proximal DVT. The patients were then randomized to receive hospitalization and UFH (n=l 51) or to receive LMWH as outpatients (n=149). This economic study revealed a mean cost per patient who received UFH to be 5323 Canadian dollars as compared to 227 Canadian dollars for LMWH. These research studies have demonstrated LMWH to be an efficacious, safe, and cost-effective alternative to the use of traditional UFH. Other advantages to LMWH in comparison to UFH are ease of administration (subcutaneous route versus intravenous route), decrease in heparin-induced thrombocytopenia, 22 decrease incidence of bleeding, and lack of need for laboratory monitoring (Lensing & Prandoni, 1999). Oral anticoagulation. Regardless of the method of initial anticoagulation, oral anticoagulation therapy is required (Burroughs, 1999; Gorman et al., 2000; Hunt, 1999; Kurowski, 1997; Lensing & Prandoni, 1999; Rodriguez, 1998; Yeager & Matheny, 1999). Warfarin is an oral anticoagulant that inhibits the production of vitamin K- dependent coagulation factors (Levine, 1999). Warfarin is initiated concomitantly with either UFH or LMWH (Burroughs, 1999; Gorman et al., 2000; Hunt, 1999; Kurowski, 1997; Lensing & Prandoni, 1999; Rodriguez, 1998; Yeager & Matheny, 1999). Frequent monitoring of the international normalized ratio (INR) is required and dosage of warfarin is adjusted until an INR of 1.5 times the control is achieved. Periodic assessment of the INR is required until warfarin treatment is discontinued. Non-oral forms of anticoagulation are discontinued once the INR is stabilized within the range of 2.0 to 3.0. There are no definitive guidelines for the optimal duration of anticoagulation therapy (Lensing & Prandoni, 1999; Solymoss, 1999). The duration of oral anticoagulation is guided by the temporary or persistent risk factors of recurrent DVT weighed against the risk of bleeding. Warfarin should be continued 3 months in an uncomplicated episode of DVT or 6 months for a complicated DVT (Gorman et al., 2000; Lensing & Prandoni, 1999; Kurowski, 1997; Rodriguez, 1998). Lifelong therapy should be considered in those patients with a risk of recurrent thrombosis exceeding the risks associated with prolonged anticoagulation (Gorman et al., 2000, Kurowski, 199 ) 23 Fibrinolytic Therapy Another treatment option for acute DVT is fibrinolytic therapy (Burroughs, 1999; Kurowski, 1997; Lensing & Prandoni, 1999). Catheter- directed infusion of a fibrinolytic agent such as t-PA, streptokinase, or urokinase accelerates the lysis of the venous thrombi. Early lysis of the thrombus is more likely to preserve valve function than other treatments. The infusion must be accompanied by the intravenous infusion of UFH with subsequent warfarin therapy. Because fibrinolytic therapy is associated with a 3 to 4 fold increased risk of bleeding, fibrinolytic therapy is recommended only for patients with massive limb-threatening ischemia (Lensing & Prandoni, 1999). Burroughs (1999) also recommended the use of catheter directed lysis in those patients with suspected vascular anomalies. Surgical Interventions Surgical interventions may also be employed to treat an acute DVT (Gorman et al., 2000; Kurowski, 1997; Lensing & Prandoni, 1999). Inferior vena cava filters and thrombectomy are two surgical procedures that may be implemented. For patients who have contraindications to or failure of anticoagulation therapy or have recurrent pulmonary embolism despite adequate anticoagulation, an inferior vena cava filter is indicated (Gorman et al, 2000; Kurowski, 1997; Lensing & Prandoni, 1999). Inferior vena cava filters will decrease the incidence of pulmonary embolism but have no effect on other DVT complications. 24 Thrombectomy is not a routine treatment of an acute DVT (Gorman et al., 2000; Lensing & Prandoni, 1999). Only those patients with life threatening or massive venous thrombosis unresponsive to other treatments are candidates for thrombectomy. Complications An acute DVT may give rise to several complications (Gorman et al., 2000; Kurowski, 1997; Lensing & Prandoni, 1999; Miller, 1999; Rodriguez, 1998; Saunders, 2000). The most common complications are post-thrombotic syndrome, pulmonary embolism, and recurrent DVT. Post-thrombotic syndrome Post-thrombotic syndrome results from venous hypertension, caused by prolonged venous obstruction and damage to venous valves, and from abnormal microcirculation (Gorman et al., 2000; Lensing & Prandoni, 1999). The clinical manifestations are pain, dermatitis, ulceration, and lifelong swelling of the affected extremity (Kurowski, 1997). Lensing and Prandoni noted that the exact incidence of post-thrombotic syndrome after DVT is not precisely known due to limited or biased studies. Gorman et al. estimated the occurrence to be 50% to 75%. Pulmonary embolism Pulmonary embolism (PE) is the most serious complication of DVT (Rodriguez, 1998). Approximate!, 30% to 40% of patients with clinical DVT 25 develop PE (Kurowski, 1997), and an estimated 50,000 Americans yearly die from PE (Rodriguez, 1998). Miller (1999) estimated more than 600,000 Americans a year are diagnosed with PE which results in the death of one sixth of these patients. Kurowski noted PE to be the third leading cause of immediate death in the United States. Approximately 80% of pulmonary emboli originate from a lower extremity DVT (Miller, 1999). The thrombi from the deep leg veins are transported to a pulmonary artery causing the obstruction of blood flow to one or both lungs (Saunders, 2000). The obstruction of pulmonary blood flow causes the failure of the right ventricular. Death from PE is usually secondary to right ventricular failure. Recurrent DVT Recurrent DVT is another complication of DVT (Gorman et al., 2000; Lensing & Prandoni, 1999). Lensing and Prandoni noted the diagnosis of a recurrent DVT is difficult due to the nonspecific nature of clinical diagnosis and limitations of available diagnostic testing. An estimated one-third of patients with an initial episode of DVT will present within the following year with signs and symptoms suggestive of a recurrent DVT. Only one in three of these patients will have a confirmed recurrent DVT. Accurate diagnosis and treatment of DVT is important in order to prevent serious, even fatal, complications (Falvo, 1994). Patient education about the many facets of their health-related problem is necessary to improve their potential for optimal health outcomes and minimize complicatio 26 Patient Education The issue of cost containment of health expenditures has led to decreased lengths of stay in acute care facilities, increased home health care, and outpatient management of illness (Whitman, Graham, Gleit, & Boyd, 1992). In response to the changing health care system, the role of patient education has gained increased importance. Definition of Patient Education Patient education, as described by Bastable (1997), is the process of assisting individuals to learn health behaviors in order to integrate them into everyday life. Whitman et al. (1992) wrote that patient education is implemented for those persons, their families, and significant others who are dependent on the health care system for diagnosis, treatment, or rehabilitation. Purpose of Patient Education Whitman et al. (1992) noted that the purpose of patient education is to improve the health status of the American public. Bastable (1997) concurred by writing the purpose of patient education is achieving optimal health and independent self-care. Patient education increases the patient’s knowledge about a health-related condition, treatment, or measures of prevention with the purpose of increasing the patient’s ability to make decisions pertaining to healthy behaviors (Falvo, 1994). Process of Patient Education Patient education is an orderly, sequential, and deliberate course of action comprised of teaching and learning (Babble, 1997). Teachtng and .earning are 27 interdependent and fom a continuous cycle. The edutational process is |ikened to the nursing process (Boyd, 1992b; Falvo, 1994). Assessment, plamting, implementation, and evaluation are necessary elements of effective patient education. Educational process. The educational process begins with assessment (Boyd, 1992b; Falvo, 1994; Whitman, Graham, Gleit, & Boyd, 1992)) and is the key to effective patient education (Close, 1988). Assessment involves collecting data and identifying needs and objectives (Boyd, 1992b; Falvo, 1994; FarrellMiller & Gentry, 1989; Mathis, 1989; Pohl, 1981). The following patient factors are considered in the assessment phase: (a) motivation, (b) readiness to learn, (c) social influences, (d) cultural influences, (e) health beliefs, (f) health needs, (g) life stage, (h) educational background, and (i) personality traits. The environment in which the patient learns, and any interfering medical treatments, should be identified. Planning requires the prioritization of educational needs and the organization of teaching (Boyd, 1992b; Falvo, 1994). Goals and objectives are identified during this phase. Objectives define the behavior the patient is expected to achieve, how the patient will acquire the behavior, and the criteria by which the successful performance of the behavior will be evaluated (Bastable, 1997; Boyd, 1992b; Rega, 1993; Pohl, 1981). Objectives must be patient oriented and realistic (Bastable, 1997; Rega, 1993). 28 Implementation follows the planning phase (Boyd, 1992b; Falvo, 1994). During this phase, the teaching plan is put into action. Evaluation is the final stage in the educational process (Boyd, 1992b; Close, 1988, Falvo, 1994; Farrell-Miller & Gentry, 1989; Lange, 1989; Mathis, 1989). Evaluation is an ongoing process. Each phase of the educational process should be evaluated according to the predetermined objectives. ASSURE model. Rega (1993) proposed the ASSURE model for patient education. This model also corresponds to the nursing process. “ASSURE is an acronym for: analyze learners, state objectives, select media and materials, utilize materials, require learner performance, and evaluate/revise the learning and teaching process” (Rega, 1993, p. 477). The goal of this model is to change the patient’s behaviors and attitudes to facilitate the achievement of self-care. Analysis of the learner is the most important function of the nurse practitioner in providing effective education (Rega, 1993). The determination of the patient’s learning style, reading level, past experiences, capability to learn, as well as social and cultural influences will assist the nurse practitioner in the development of a productive educational tool. Effective objectives are clear, attainable, and measurable (Rega, 1993). Objectives may be classified as (a) cognitive, involving intellectual assimilation of new information, (b) affective, involving attitudes, feelings, and emotions, or (c) psychomotor, involving motor skills. 29 The basis for the selection and utiiization of materials is the enhancement of patient learning (Rega, 1993). The educational materials should be specific to the patient and adaptable to the teaching environment. In order to achieve the learning objectives, the patient must be an active participant (Rega, 1993). The patient must comprehend and internalize the behavior in accordance with the objectives. Evaluation is an ongoing process integral to the education process (Bastable, 1997; Boyd, 1992b; Pohl, 1981; Rega, 1993). The ability of the printed education material (PEM) to meet the patient’s educational objectives is the standard the PEM is evaluated against. Evaluation detects the efficacy of the PEM and misinformation contained within the PEM. Evaluating the patient is equally important to determine the level and accuracy of comprehension as well as the needs of the patient. The evaluation process serves to reinforce the objectives and as a means to acquire feedback about the PEM Printed Education Materials (PEMs) PEMs are among the most economical and most widely employed methods for teaching individuals about health issues (Bastable, 1997, Bemier & Yasko, 1991; Pohl, 1981). PEMs consist of handouts, leaflets, books, pamphlets, brochures, and instruction sheets. The virtues of PEMs are that they are portable, flexible, cost-effective, and accessible (Bastable, 1997; Bernier & Yasko, 1991; Farrell-Miller & Gentry, 1989; Lange, 1989). When using PEMs, patients can control the time and rate of learning as »efi as share the .nformation with significant otters (Lange, 1989). 30 The written word is permanent and can, therefore, be need as a referenda and as a means of clarification of oral instruction (Bastable, 1997; Bernier & Yasko, 1991; Farrell-Miller & Gentry, 1989; Lange, 1989). Self-composed PEMs Despite the plethora of commercially available PEMs, the nurse practitioner may find that these materials do not meet the identified patient teaching needs (Bastable, 1997; Farrell-Miller & Gentry, 1989; Lange, 1989; Pohl, 1981; Whitman et al., 1992). Self-composed PEMs allows the nurse practitioner to create an education medium that is specific and unique for the provider-patient relationship. In addition, self-composed PEMs provide the nurse practitioner with an opportunity to create a teaching tool for which no previous literature exists (Lange, 1989) or to create a more readable PEM (Bastable, 1997; Boyd, 1992b; Davis, Michielutte, Askov, Willliams & Weiss, 1998; Doak & Doak, 1980; Falvo, 1994; Murphy, Chesson, Walker, Arnold, & Chesson, 2000; Whitman et al., 1992). Readability of PEMs A common problem among both commercially prepared and self composed PEMs is readability (Bastable, 1997, Boyd, 1992b, Davis et al., 1998, Doak&Doak, 1980; Falvo, 1994; Murphy et al„ 2000; Whitman « al„ 1992), Readability is determined by the patient’s ability to comprehend the material. Patient education is effective only if the patient is able to receive and comprehend ■he message the nurse practitioner is deiivering (Falvo, 1994). Gemta„e to tins concept is the patient’s literacy level. Literate persons are those who can read at 31 or above the eighth grade ievel (Boyd, 1987; Doak & Doak, J9S0; Whit™ « al, 1992). Approximately 20% of American adults cannot read or understand health care literature (Doak & Doak, 1996; Miles & Davis, 1995; Kirsch, Jungeblut, Jenkins, & Kolstad, 1993; Williams et al., 1995). The average reading level of adults in the United States is at or below the eighth grade (Boyd, 1987; Farrell- Miller & Gentry, 1989; Lange, 1989; Whitman et al., 1992). Murphy et al. (2000) conducted the Rapid Estimate of Adult Literacy in Medicine (REALM) test using participants in a patient education study. In concurrence with the U.S. average, the result was an average reading score of seventh to ninth grade. Forty percent of the participants were reading below the ninth grade level. Doak & Doak (1980) assessed the readability of 100 PEMs in an acute care facility. The study revealed the mean level of material to be at the tenth grade level. Similar studies revealed that between 60% and 92% of PEMs were composed above the eighth grade reading level (Boyd, 1987). The readability of PEMs can be determined by applying readability formulas (Boyd, 1987; Doak & Doak, 1980; Farrell-Miller & Gentry, 1989; Lange, 1989; Whitman et al., 1992). Some examples are the Fry, Fog, and Smog readability formulas. The Fry readability formula involves using a graph to indicate the reading level. The average sentence length and the number of syhables for each word are plotted on the graph to yield the reading grade level (Fry, IW 32 With the Fog formula, 100 words are counted in succession (Gunning, 1968). This number is divided by the number of complete sentences found within the 100 words. Next, the number of words that are three or mor. syllables are added. Finally, the result is multiplied by a constant of 0 .04. This number equals the reading grade level. Readability using the Smog formula requires counting 10 consecutive sentences from the beginning of the material, 10 sentences from the middle, and 10 sentences from the end (McLaughlin, 1969). Next, the number of three syllable words is counted. The square root of this number plus the constant of three equals the reading grade level. The reading level of PEMs can be reduced using the following guidelines: (a) write short, simple sentences with one idea per sentence; (b) write in the active voice; (c) write in second person; (d) use no greater than two syllable words; (e) minimize eye span to a maximum of 60 to 70 characters; (f) use ample spacing, (g) avoid using jargon; (h) avoid using all capital letters, (i) use no less than 12 font; and (j) color can be used to illustrate key points (Bastable, 1997; Boyd, 1987;Falvo, 1994; Farrell-Miller & Gentry, 1989; Whitman et al., 1992). FarrellMiller & Gentry also recommend using examples to reinforce general or abstract concepts. Principles of Self-composed PEMs This review of literature established concordance among sources regarding the principles of composing PEMs. The hey principles ar. cont.nl, layout, 33 organization, illustration,, and readnbdit, comprehensjon Boyd. 1992b; Falvo. ,994; Farrell-Miller & Gentry, 1989; Mathis, 1989), Composing a FEM begins with the identification of the knowledge, skills, attitudes, or behavior the FEM will assist the patient to achieve (Bastable, 1997; Boyd, 1992b; Falvo, 1994; Farrell-Miller & Gentry, 1989; Mathis, 1989). These issues formulate the content for the PEM. The content of the PEM should be accurate, brief, objective, and focused on what the patient needs and wants to know. Also, the content must be reflective of the learning objectives. The layout of the PEM is advised to contain adequate use of white space and headings (Bastable, 1997; Boyd, 1992b; Farrell-Miller & Gentry, 1989; Mathis, 1989). Color can be used to set off headings or key material, but black ink is easier to read. Additionally, using serif type and a print size of at least 12 point is recommended. The objective of the layout is to facilitate readability of the content. Both the content and layout must be presented in an organized and thoughtful manner (Bastable, 1997; Boyd, 1992b; Falvo, 1994; Farrell-Miller & Gentry, 1989; Mathis, 1989). The headings must reflect the information contained beneath them and follow a logical progression. Each paragraph requires a topic sentence indicative of the information to be discussed. The purpose of illustrations is to enhance the understanding of key or complex points, filustrations ar. best utilized when they immediately Mow the relevant information and demonstrate a singie concept (Bastable, 1997; Falvo, 1994; Farrell-Miller & Gentry, 1989; Mathis, 1989). 34 In order to facilitate the readability of a self-composed PEM, the read! mg level of the target audience should be identified (Bastable, 1997; Boyd. 1987; Boyd. 1992b; Falvo, 1994; Farrell-MiUet & Gentry, 19S9; Mathis. 1989). Since writing consistently on a specific reading level is difficult, a range of reading levels simplifies the writing process (Boyd, 1987). Comprehension of the health issue is the goal of self-composed PEMs (Bastable, 1997; Boyd, 1992b; Falvo, 1994; Farrell-Miller & Gentry, 1989; Mathis, 1989). Specificity, repetition, conciseness, and organization are central components to enhancing comprehension. Boyd (1992b) also noted that patients remember the first one-third and the last one-fourth of information the best. Therefore, the nurse practitioner is advised to insert the chief health information within the beginning or end of the PEM. Models for Composing and Evaluating PEMs The use of a model for composing PEMs assists the nurse practitioner to organize the patient education process (Rega, 1993). Bernier and Yasko s (1991) model for Evaluating Printed Education Materials (EPEM) and Lange’s (1989) model will be discussed. Bernier and Yasko (1991) developed the EPEM model to identify and validate the creation and evaluation of PEMs. A pre-design phase, design phase, pilot phase, distribution and implementation, and evaluation are the components of the EPEM model. During the pre-design phase, the nurse practitioner performs a needs assessment (Bemier & Yasko, 1991). Careful consideration is given to the 35 identification of an educational need, th. puqMse ofthe pEM md outcomes. Writing ofthe first draft is the design phase (Bernier & Yasko, 1991). The educational content, structure and format of the text and illustrations, as well as organization are developed during this phase. The pilot phase involves employing a draft ofthe PEM (Bernier & Yasko, 1991). Bernier and Yasko suggested testing the PEM with current and former patients, experts, and health care professionals involved with the care ofthe patient for whom the PEM is intended. Distribution and implementation is the next phase ((Bernier & Yasko, 1991). This phase requires the identification of the means by which the PEM will be made available to the target patient population. The PEM is then distributed. The evaluation process requires the examination of the learning outcomes identified during the pre-design phase (Bernier & Yasko, 1991). If an outcome has not been achieved, the PEM is revised by the nurse practitioner. Lastly, Lange (1989) described a less formal model for developing PEMs. Her model begins with the identification of a learning need. Then support, both administrative and financial, is sought for the development of the PEM Following the definition of goals, the available resources are examined The next step is selecting content that is (a) appropriate for th. reader’s educational level, (b) win stimulate the reader’s interest, and (c) will faciiitatethe retention of key information. The nurse practitioner should then write a draft. Finally, the PEM is 36 evaluated to ascertain if the original needs were met, the content is appropriate, and the PEM is cost-effective. Summary This review of literature presented an overview of the pathophysiology, risk factors, and clinical features of DVT. Treatment options and complications of DVT were provided. Also included in this review of literature was patient education as a means for improved health status for a person with an illness such as DVT. The process, purpose and principles of patient education, including the ASSURE model, were identified. Additionally, PEMs and self-composed PEM’s were discussed. Readability was discussed as an important attribute of PEMs. Finally, two models for composing and evaluating PEMs were reviewed. 37 Chapter 3 Methodology The purpose of this research project was to create a patient education pamphlet addressing the definition, risks, signs and symptoms, diagnosis, complications, and treatment of DVT including preventative measures. The EPEM model (Bernier & Yasko, 1991) for the development and evaluation of PEMs was utilized. The phases of pre-design, design, pilot, distribution and implementation, and evaluation were applied to the development process. Pre-design Phase A patient education committee in a northwestern Pennsylvania community hospital identified the need for a PEM addressing DVT to be utilized in both the inpatient and outpatient settings. This PEM will serve to supplement and reinforce the oral education taught by the health care provider. The PEM, in the form of a pamphlet, is targeted toward patients diagnosed with DVT or who are at high risk for developing DVT. After reading the pamphlet, the patient will be able to identify the following: (a) what a DVT is, (b) why thromboses occur, (c) risk factors for DVT, (d) signs and symptoms of a DVT, (e) how a DVT is diagnosed, (f) treatment options for DVT, (g) complications of DVT, and (h) prevention of DVT. Design Phase After the identification of the learning objectives, a thorough review of literature was conducted. The gathered information was organized in a logical 38 progression, presenting only the most essential data. The information considered to be most relevant to the targeted audience was presented first. Readability was enhanced by using short, simple sentences, topic headings, second person, active voice, diagrams to explain complex ideas, no less than a 12 font print size. Limiting eye span to 60-70 characters, one idea per paragraph, and use of three syllable words also improved readability. By applying the Fog formula (Gunning, 1968), the readability of the PEM was determined to be at the seventh grade level. The DVT pamphlet was designed using Microsoft Publisher®. The design was chosen using a brochure format that allowed for ample spacing of text and easy flow of information. Black ink was selected for the lettering, using a 14 font and bold lettering for headings, and 12 font for text. A colored border was added to the top margin to enhance the presentation of the pamphlet. The pamphlet was then printed on 11” x 14” paper and folded according to pamphlet style. Pilot Phase During the pilot phase, a draft of the DVT pamphlet was presented to the patient education committee. This committee consisted of a nurse from each of the following hospital units: medical-surgical, medical-cardiac, orthopedic, pediatric, neonatal intensive care unit (ICU), medical-cardiac ICU, surgical ICU, maternity, emergency room, preadmission patient teaching, endoscopy, and same day surgery. Also included on this committee were a pharmacist, respiratory therapist, patient education coordinator, and an outpatient-primary care provider 39 coordinator. In addition to the patient education committee, the pamphlet was presented to two laypersons. Both the committee and laypersons were asked to evaluate the pamphlet using the following criteria: (a) clarity of meaning, (b) readability, (c) completeness, (d) accuracy, and (e) further suggestions. Recommendations from the committee were the use of bold lettering to highlight the diagnostic tests being discussed, the addition of cancer and previous DVT to the list of risk factors, and explanation of an intravenous infusion of heparin. The laypersons offered no suggestions for change. The committee and the laypersons agreed that the information was clear, progressed logically, easy to read, complete, concise, and pertinent. The recommended changes from the committee were instituted. The revised pamphlet (Appendix C) was reviewed by the committee and approved for printing and distribution. Distribution and Implementation Phase Once the recommended changes were incorporated, the DVT pamphlet was relinquished to the patient education coordinator of the northwestern Pennsylvania community hospital. The coordinator arranged for the mass printing and distribution of the pamphlet throughout the institution and affiliated provider offices with the purpose of providing supplemental and reinforcement education to the oral teaching provided by the providers and staff for those patients with or at high risk for DVT. 40 Evaluation Phase This final phase is an ongoing process (Bernier & Yasko, 1991). The patient education committee at the northwestern Pennsylvania hospital where the DVT pamphlet is implemented routinely reviews, evaluates, and updates patient education materials in use throughout the facility. Thus, the accuracy and relevance of PEMs is assured as well as the provision of up-to-date medical knowledge. A proposed method of evaluation is to conduct a formal patient evaluation of the PEM via oral comments or a written survey. 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American Family Physician, 59, 945-952. 48 Appendix A Medical Risk Factors Predisposing to Thromboembolism (Rodriguez, 1998) General Factors Advancing age Cancer Obesity Pregnancy and puerperium Prior thromboembolism Sepsis Hypercoagulabi 1 ity Antithrombin III deficiency Disorders of plasminogen and plasminogen activation Dysfibrinogenemia Estrogen therapy Lupus anticoagulant Polycythemia Protein C deficiency Protein S deficiency Resistance to activated protein C Stasis Cardiomyopathy Chronic obstructive pulmonary disease Congestive heart failure 49 Myocardial infarction Nephrotic syndrome Paralysis Prolonged immobilization Stroke Vascular injury Trauma Venous catheterization 50 Appendix B Clinical Probability of Deep Vein Thrombosis (Wells, Hirsh, & Anderson, 1995) Major clinical points Active cancer Calf swelling 3 centimeters >asymptomatic side Localized tenderness along the deep venous system Paralysis, paresis, or recent limb cast Recently bedridden and /or major surgery within 4 weeks Strong family history of DVT Thigh and calf swollen (measured) Minor clinical points Dilated superficial veins in the symptomatic side only Erythema History of recent trauma to the affected leg Hospitalization within previous 6 months Pitting edema, affected leg only Clinical Probability with each indicator equal to one point High (80%-85%) >3 major points and no alternative diagnosis 2 major points plus 2 minor points, and no alternative diagnosis Low (<5%) 0 major points, >3 minor points, and an alternative diagnosis 0 major points, > 2 minor points, and no alternative diagnosis 51 1 major point, > 2 minor points, and an alternative diagnosis 1 major point, > 1 minor points, and no alternative diagnosis 52 Appendix C DVT Patient Education Pamphlet Deep Vein Thrombosis (DVT) Julie S. Anderson, RN, Student Family Nurse Practitioner Edinboro University of Pennsylvania 53 What is a DVT? A deep vein thrombosis (DVT) is a blood clot (thrombosis) that forms in the veins that are found deep within the muscles. These veins re turn 90% of the body’s blood back to the heart. DVT most often occurs in the deep veins in your legs. Why do clots occur? Blood clots can form if there has been damage to the vein decrease in blood flow o clotting disorders Who is at risk? You are at risk for DVT if you: » have recently had surgery ® are overweight are pregnant 54 • have cancer of any kind • have had a DVT in the past have limited or no movement of legs for long periods of time have varicose veins © have recently broken or badly bruised your leg 0 use estrogen have a blood clotting disorder What are the symptoms of DVT? About 50% of people with a DVT have no symptoms. However, the most common symptoms of DVT are 0 pain in one leg swelling of one leg o warmth of one leg Call your doctor or nurse if you notice any of these symptoms. 56 ° Blood thinners-yuu may be given blood thinners to allow the blood to flow easier around the clot and to prevent new clots from forming. Blood thinners can be given as a pill or intravenously (IV) into your vein or through a shot into your skin. Your doctor or nurse will choose the best combination for you. The length of time that you will take the blood thinners will be based on the severity of the blood clot and your risk fac tors. o Thrombolytics-]£ you have a large DVT you may be given a clot busting drug call a thrombolytic to dissolve the clot. • Surgery-surgery to remove the clot is rarely needed. It is considered when the other treatments fail. What are the possible complications of DVT? Some of the possible problems with DVT are: g Pulmonary embolism-occurs when the clot becomes dislodged and 57 travels from the legs to the lungs. Post-thrombotic syndrome-rssvAts from the decrease in blood flow to the leg. This can cause swelling or ulcers in the leg. • Recurrent DVT-yow may get another DVT. How can you prevent DVT? • Exercise-if you must sit or stand for long periods of time, break up these periods by taking short walks. This prevents the blood from pooling in your legs and returns the blood back to the heart. ® Support stockings-your doctor or nurse may order special support stockings for your legs. These stock ings help return the blood from your legs back to your heart. • Blood thinners-\f you are at high risk for a DVT, your doctor or nurse may choose to give you blood thinners every day to prevent a DVT from oc curring. 58 Remember to call your doc tor or nurse if you notice any tenderness, swelling, or warmth in your leg. If you have any questions, your doctor or nurse will be glad to answer them. 59 1 Julie S. Anderson, RN, Student Family Nurse Practitioner Edinboro University of Pennsylvania Edinboro, PA 16444 —