MAGDALENA ANNERSTEN GERSHATER PREVENTION OF FOOT ULCERS IN PATIENTS with DIABETES MELLITUS

Transcription

1 MALMÖ UNIVERSITY HEALTH AND SOCIETY DOCTORAL DISSERTATION 2011:5 MAGDALENA ANNERSTEN GERSHATER PREVENTION OF FOOT ULCERS IN PATIENTS with DIABETES MELLITUS Nursing in outpatient settings

2

3 PREVENTION OF FOOT ULCERS IN PATIENTS WITH DIABETES MELLITUS

4 Malmö University Health and Society Doctoral Dissertation 2011: 5 Copyright Magdalena Annersten Gershater 2011 Cover: Heidi Grill Magnusson Pictures 1-8 and by courtesy of Jan Apelqvist Picture 9: Magdalena Annersten Gershater ISBN ISSN Holmbergs, Malmö 2011

5 MAGDALENA ANNERSTEN GERSHATER PREVENTION OF FOOT ULCERS IN PATIENTS WITH DIABETES MELLITUS Nursing in outpatient settings Malmö University, 2011 Faculty of Health and Society

6

7 In memory of Inga Annersten ( )

8

9 CONTENTS ABSTRACT ORIGINAL PAPERS I-Iv DEFINITIONS Healed ulcer Multiple ulcers Health care assistant Home nursing Participant driven education INTRODUCTION BACKGROUND Diabetes Mellitus Micro vascular complications Macro vascular complications Treatment Foot ulcers in patients with diabetes Neuropathy Peripheral arterial disease Treatment of foot ulcers Health care organization Hospitals Primary health care centers Home nursing organization Registered nurses formal competence Leadership Nursing practice Education... 30

10 Research and Development Diabetes nursing Prevention Prevention of foot ulcers PREvIOUS STUDIES Factors related to ulceration and outcome Nursing in home nursing setting Prevention Patient education RATIONALE AIM Specific aims METHODS Study I Design Primary Outcome Setting Study population Inclusion criteria Procedure Data management and analysis Study II Design Setting Inclusion criteria Procedure Data management and analysis Study III Design Setting Study population Inclusion criteria Procedure Data management and analysis... 57

11 Study Iv Design Setting Study population Inclusion criteria Exclusion Criteria Procedure Data management and analysis ETHICAL CONSIDERATIONS RESULT Study I Demographic characteristics Study II Study III Performing leadership Performing education Performing the nursing process The registered nurses competence and professional development Study Iv Baseline Follow up at six months Intervention METHODOLOGICAL CONSIDERATIONS Identification of the research problem Study design and procedure Recruitment Reliability validity Educational intervention RESULT DISCUSSION The fragile patient The coordinating nurse Organization and prevention CLINICAL IMPLICATIONS... 94

12 FURTHER RESEARCH CONCLUSION ACKNOwLEDGEMENTS SAMMANFATTNING PÅ SvENSKA REFERENCES PAPERS

13 ABSTRACT Amputation in patients with diabetes mellitus preceded by a foot ulcer is a serious complication. Patients with the highest risk of developing a foot ulcer are often found in home nursing settings. The overall aim was to focus on how registered nurses are working with prevention of foot ulcers in patients with diabetes mellitus in outpatient settings: - to identify factors related to short term outcome of foot ulcers in patients treated in a multi-disciplinary system until healing was achieved. - to assess what was documented by registered nurses regarding diabetes care in a Swedish municipality s home nursing service; to what extent nursing actions were planned for, performed and evaluated according to the goals of metabolic control, treatment and prevention of complications.- to explore registered nurses professional work with foot ulcer prevention in home nursing settings. - to explore whether participant driven group information has an impact on ulceration in a patient group with previous diabetes foot ulcer. Study I used logistic regression analysis to identify factors related to outcome in a cohort of 2480 consecutive patients with diabetic foot ulcer at a multidisciplinary foot clinic. Results: Healed primarily: 65% (n=1617), 9% (n=250) after minor amputation, 8% (n=193) after major amputation and 17% (n=420) died unhealed. Primary healing was related to co- morbidity, duration of diabetes, extent of peripheral vascular disease and type of ulcer. In neuropathic ulcers, deep foot infection, site of ulcer and co-morbidity was related to amputation. In neuro-ischemic/ischemic ulcers amputation was related to co morbidity, peripheral arterial disease and type of ulcer. Study II was a cross sectional assessment of all nursing records of patients with diabetes (n=172) in a municipality s home nursing setting and analyzed with manifest content analysis. Results: The overall standard of nursing records was 11

14 insufficient. Evaluation of blood glucose was documented in 61% (n=105) of the records, weight was documented in 6% (n=10), blood pressure in 10% (n=17) and ongoing foot ulcers were documented in 21% (n=36). Study III was a qualitative interview study of 15 registered nurses from four municipalities, analyzed with manifest content analysis. Results: Registered nurses in home nursing settings worked mainly through health care assistants. The nurses used leadership and education as the main tools to enable the nursing process. They mainly relied on experience based competence. Study IV was a randomized controlled trial comparing participant driven education in group with standard information, in patients with diabetes and previous foot ulcers. An interim analysis was made 6 months after intervention of 131 included patients. Results: After 6 months follow up, 58% (n=57) of the 98 evaluated patients had not developed a new foot ulcer. There was no statistical difference between the two interventions. The most common reasons for ulceration were plantar stress ulcer and minor external trauma. Five patients had deceased and 13 had withdrawn consent to participate. Conclusion: Patients with diabetes and high risk of developing foot ulcer constitute a fragile group that needs special foot protective attention. This requires a well educated staff in the home nursing organization and well educated registered nurses regarding leadership and pedagogy. In the future patient education should target low risk patients. 12

15 ORIGINAL PAPERS I-IV This PhD thesis is based on the following papers which are referred to by Roman numerals: I. Annersten Gershater, M., Löndahl, M., Nyberg, P., Larsson, J., Thörne, J., Eneroth, M. & Apelqvist, J. (2009) Complexity of factors related to outcome of neuropathic and neuroischemic/ischemic diabetic foot ulcers. A Cohort Study. Diabetologia, 52(3): II. Gershater, M.A., Pilhammar, E. & Alm-Roijer, C. (2011) Documentation of diabetes care in home nursing service in a Swedish municipality: a cross sectional study on nurses documentation. Scandinavian Journal of Caring Sciences, 25(2):220-6 III. Annersten Gershater, M., Pilhammar, E. & Alm-Roijer, C. (2011) Prevention of foot ulcers in patients with diabetes in home nursing settings an interview study among registered nurses. Scandinavian Journal of Caring Sciences (submitted) IV. Annersten Gershater, M., Pilhammar, E., Apelqvist, J. & Alm-Roijer, C. (2011) Patient education for prevention of diabetic foot ulcers: Interim analysis of a randomized controlled trial due to morbidity and mortality of participants. European diabetes Nursing (submitted) Papers I and II have been reprinted with kind permission from the publishers. 13

16 DEFINITIONS Healed ulcer Healed ulcer was defined when epithelisation has occurred, as Wagner 0 (1). See picture 1. Foot Ulcer Foot ulcer was defined as Wagner 1 or more at or below the ankle. See picture 2. Deep ulcer Deep ulcer was defined as Wagner 2. See picture 3. Foot infection Foot infection was defined as Wagner 3 or deep soft tissue infection with or without osteomyelitis: an open lesion fulfilling at least three of the following criteria: cellulitis, positive bacterial culture, radiological or scintigraphic evidence, and histological diagnosis (2). See picture 4. Gangrene Gangrene was defined as a continuous necrosis of the skin and underlying structures indicating irreversible damage that would be unlikely to heal without loss of some part of the extremity, Wagner grades 4 5. See pictures 5 and 6. Multiple ulcers Multiple ulcers was defined in study I and IV as three or more ulcers on the same foot. Patients with several concurrent lesions were represented by the ulcer with the worst outcome in study I. See picture 7. Minor amputation Minor amputation was defined as amputation of toe(s) or fore foot below the ankle. See picture 8. 14

17 Major amputation Major amputation was defined as amputation above the ankle. See picture 9. Health care assistant Health care assistant was defined as assistive nursing personnel without university education in nursing, for example upper secondary school educated nursing assistants, students or uneducated substitutes. Home nursing Home nursing was defined as a setting outside the hospital in the patients home or in an assisted living facility where registered nurses are responsible. Professional work Professional work was defined as work according to national legislation on nursing profession. Chiropody Chiropody was defined as foot care by a person without higher education. Podiatry Podiatry was defined as foot care by a person with a university degree in podiatric medicine. Participant driven education Participant driven education was defined as a group session based on participants own perceived problems and questions. 15

18 Picture 1 Wagner 0 Picture 2 Wagner 1 16

19 Picture 3 Wagner 2 Picture 4 Wagner 3 Picture 5 Wagner 4 17

20 Picture 6 Wagner 5 Picture 7 Multiple ulcers Picture 8 Minor amputation 18

21 Picture 9 Major amputation 19

22 INTRODUCTION This thesis has been written with a particularly vulnerable patient group in mind. Patients with diabetes mellitus who have suffered from an amputation, have an ongoing or healed foot ulcer, or who are at risk for development of a foot ulcer, all have both physical and psychosocial needs that registered nurses can meet in their professional work. Prevention of foot ulcers has been considered beneficial for patients quality of life (3), and competent nurses in a well functioning organization are facilitating factors for meeting these needs. Amputation of a leg in patients with diabetes mellitus is a severe and feared complication as about 40-70% of all non traumatic lower extremity amputations in the world are related to diabetes. The main reasons are gangrene and/or deep infection preceded by a foot ulcer (4). Patients at greatest risk of ulceration can easily be identified by careful clinical examination of the feet. International and national guidelines state the need of targeted education and frequent follow up for these patients (4-7). Registered nurses around the world subscribe to International Council of Nurses code of ethics. The code states four fundamental work areas: promoting health, preventing disease, restoring health and alleviating suffering (8). By applying this code, registered nurses can contribute greatly to the work with prevention of foot ulcers. In Sweden s health care organization prevention has been integrated into the formal description of registered nurses competencies, and according to Board of Health and Welfare the registered nurses have four areas to fulfil this work: leadership, nursing theory and praxis, education and research & development (9). However, there has not been described what registered nurses can do to compensate for patients unable to maintain their preventive self care of the feet. This thesis is an attempt to meet these knowledge gaps. 20

23 BACKGROUND Diabetes Mellitus Diabetes is a chronic disease that requires continuing medical care and patient self-management education to reduce the risk for acute and long term complications. The goal of self-management education is to enable the patients to take own responsibility for treatment and control of their disease by developing problem solving skills in the various aspects of diabetes management. Diabetes type 1 has its origin in destruction of pancreatic beta cells, leading to total insulin deficiency; diabetes type 2 on the other hand is described as relative insulin deficiency resulting from a progressive insulin secretion defect on the background of insulin resistance. Both conditions require lifelong pharmacological treatment with blood glucose lowering agents, and an adjusted life style comprising a well balanced diet and regular physical exercise (7, 10). In the European Union the average prevalence of diabetes mellitus between years of age was 8,6% in 2006, representing over 31 million people across the 27 EU member states. It is expected that the number of patients with diabetes will increase drastically within the near future. As a result patients affected by its long term complications will also contribute to increasing demands on health care organizations (11). Long term complications affect different organs of the body, depending if the complications are of micro or macro vascular origin. Micro vascular complications One of the most feared long term complications of diabetes is retinopathy and blindness, and another severe complication is diabetic nephropathy. Both conditions are associated with long standing hyperglycemia, damaging the small blood vessels in the eye and kidney (12, 13). Diabetes is ranked among the leading causes of blindness and diabetes renal failure is the single leading cause of end stage renal disease. For example: in the United States more than 21

24 45% of new cases of patients requiring renal replacement therapy have diabetes (11, 14). Neuropathy as a micro vascular complication will be discussed later in connection with the diabetic foot ulcer. Macro vascular complications The major cause of mortality and morbidity for individuals with diabetes is cardiovascular disease (coronary heart disease, ischemic stroke and peripheral arterial disease with ischemic feet), based on atherosclerosis in the major blood vessels. The background mechanisms are to be sought in common risk factors such as hypertension, obesity, physical inactivity, elevated blood lipids and smoking (15, 16). About 75-80% of patients with diabetes, die of cardiovascular events, which is the number one cause of death in Europe for both men and women. Patients with type 2 diabetes have a 2-4 times higher risk of coronary heart disease than the rest of the population (11, 14). Peripheral arterial disease in combination with infection is an important factor for amputation, and mortality in this patients group is high (17-20). Treatment The main goal in the treatment of diabetes is to reduce the progression of micro and macro vascular complications. There is evidence that good control of blood glucose levels can substantially reduce the risk and inhibit the progression of complications in all types of diabetes (7, 12, 15). Management of high blood pressure and of raised blood lipids is equally beneficial for the patients, as well as physical activity, reduction of stress, and a smoking free lifestyle (10). The goals are believed to be reached by a physically active life style, intake of calories not exceeding expenditures, low intake of saturated fat, smoking cessation, prescription of pharmacological drugs, screening for early detection of signs of complications, and an extensive patient education program to enable the patients to take their own responsibility for treatment and control (7, 10). Foot ulcers in patients with diabetes One severe complication of diabetes is amputation, which is preceded by a foot ulcer. It is believed that every 30 seconds a lower limb is lost somewhere in the world as a consequence of diabetes (21). The point prevalence of foot ulcers varies between 1,5-10% in different populations; a corresponding incidence of 2,2-5,9% (4). Previous studies have revealed substantial costs for society, particularly after amputation. The most expensive share in the care of diabetic foot ulcers is the cost of institutional living that becomes necessary after losing a limb, as many patients will not be able to walk again with prosthesis due to severe co-morbidity (3). 22

25 The foot ulcer has severe consequences for patients, family, health care system and society, and many patients with foot ulcers become dependent on home nursing services. Mortality in this patient group is high especially for patients with critical ischemia (4, 5, 20-23). The most common death causes reported for these patients are cardiac diseases and cerebrovascular disease (17), and it has also been reported that peripheral arterial disease is associated with an 67% increased risk of cardiac death (24). Common direct causes of ulceration are minor trauma from ill fitting shoes, plantar stress ulcer when prominent bone press the skin from inside in absence of fat padding, or walking bare foot on a sharp item (4, 5, 25, 26). Initially a very small ulcer may not be detected for several weeks. The patient eventually is convinced that it has appeared from nowhere, having forgotten the trauma which caused it. The main background mechanisms of development of foot ulcers are neuropathy with reduced sensation muscle wasting, foot deformity and peripheral arterial disease, both conditions may develop after long diabetes duration. Neuropathy The most important background causes of diabetic foot ulcers are sensory, motor and autonomic neuropathies together with peripheral arterial disease. The typical polyneuropathy is chronic and symmetrical, and is developed with a background of long-standing hyperglycaemia and cardiovascular risk factors (27). Sensory neuropathy is associated with loss of pain. Motor neuropathy lead to atrophy of plantar fat padding and muscles, resulting in flexion deformity of the toes and abnormal walking pattern. Autonomic neuropathy results in reduced or absent sweat secretion leading to dry skin with cracks and fissures, and atherio-venous shunting causing a red and swollen foot (4). Regular examination of the feet in all patients with diabetes mellitus is essential to detect early signs of neuropathy and other risk factors. It can be diagnosed using vibratory pressure threshold measured by a Biothesiometer (BioMedical Instruments, New Burry, OH, USA), Monofilament (28) or Ipswich touch test (29). There is no cure for neuropathy, but metabolic control is related to progress and development of sensorimotor neuropathy (27). See picture

26 Picture 10: Neuropathic foot. Peripheral arterial disease Peripheral arterial disease (PAD) is caused by arteriosclerosis in the major arterial blood vessels, and is associated with high risk for amputation, cardiovascular comorbidity and high mortality. This indicates a severe health status of the patients and has huge impact of patients quality of life (19, 23, 30-32). Contributing factors are hypertension, obesity, physical inactivity, elevated blood lipids and smoking. Treatments to improve peripheral arterial blood circulation are cessation of smoking, reduction of blood pressure and weight, low intake of saturated fat, increased physical activity, pharmacological treatment of lipids, anti coagulant drugs, and vascular surgery (17, 18). In a European multicentre study, about 50% of all patients at first visit to a diabetes foot clinic presented signs of peripheral arterial disease (19). See picture

27 Picture 11: Ischemic foot Treatment of foot ulcers In 1985 one of the five-year targets of the European Declaration of St Vincent was a 50% reduction in amputation caused by diabetes mellitus (33). To shorten ulcer duration and to reduce the number of amputations, multiple treatment strategies depending on type, site and cause of ulcer can be used. Infections are intensively treated by using antibiotics and surgical revisions of the ulcers. If needed, metabolic control can be improved by initiating treatment with insulin. Oedema is treated according to its predisposing cause, and vascular surgery may improve blood circulation in the ischemic foot. The affected limb can be off loaded with a total contact cast, wheel chair or other technical equipment, as well as individually adjusted shoe wear. Local wound treatment is performed with regular debridement and dressing changes. Pain relief is obtained by treating its background causes. Regular podiatry or chiropody should also be offered the patients to prevent further ulceration. This requires a close collaboration between many different professionals working in a multi disciplinary team (4). 25

28 Health care organization Patients with diabetes and complications are frequent visitors to the different settings that constitute the health care organization. The patient with diabetes and a foot ulcer has contact with different levels of health care providers: hospitals, health care centers and home nursing organizations. Hospital Health Care Centre Home Nursing Service Figure 1. Health care for patients with diabetes and foot ulcers. Hospitals The main hospitals in Sweden are managed by the county councils (34), and all have ambulatories for adult patients with type 1 and difficult type 2 diabetes. The health care professionals work in multi disciplinary teams that can consist of physicians with specialization in internal medicine and/or other sub specialties, registered nurses with education in diabetes nursing, physiotherapists, dieticians, nursing assistants, social workers, secretaries and chiropodists. For patients with complications, there is extensive consultant collaboration with other specialties, for example renal, ophthalmology and orthopedic surgery (7, 35). It is the registered nurse who coordinates the activities in the team (36, 37). In 2004 there were 43 multi disciplinary teams defining themselves as diabetic foot teams in Swedish hospitals, which manage the patients feet until healing is achieved (38). Primary health care centers Primary health care centers are managed by the county councils, and constitute the back bone in Swedish primary care (34).The centers are of different size, and responsible for a defined population within its geographical catchment area or for a certain number of listed patients. In the health care centers general practitioners (with specialization in family medicine), as well as district nurses, with a postgraduate diploma in specialist nursing (Public health 75 credits), work 26

29 together with other health care professions, depending on local circumstances. Some of the registered nurses also have an exam in diabetes nursing, 15 or 30 credits (35, 39, 40). Diabetes care in hospitals and primary care centers is based on regional guidelines determined by local county councils. Regional guidelines are based on Swedish national guidelines, and the quality is systematically followed up with the aid of the national diabetes register (7, 41, 42). The patients visit the diabetes responsible physician at least once a year, and the diabetes responsible registered nurse more often, according to individual and organizational circumstances (35, 40). However, in a survey from 2008, 30% of the interviewed patients (n=199) with type 2 diabetes stated that they had never discussed complications of diabetes with their health care provider, and 36% never had visited a diabetes responsible nurse (42). Home nursing organization Home care can be described as care provided by professionals to patients in their own homes with the ultimate goal of contributing to their life quality and functional health status, and when needed also to replace hospital care with care in the home for societal reasons. Home care therefore covers a wide range of activities, from preventive visits to terminal care (43). In this thesis home care refers to all professional social activities performed in the patients home, while home nursing service refers exclusively to the health care provided under the auspices of the registered nurses. Patients in home nursing service (in their own home or in assisted living facilities) have become dependent on others taking care of their self care due to aging and several concomitant health conditions; such as cognitive disorders, impaired vision and impaired mobility (44). With a patient s deteriorated health status, a burden of care is put on the next of kin. Municipality s home care and home nursing service can provide professional nursing and social care when the family members are no longer able to meet this burden (45). Depending on local political and financial frames home nursing service differ in its organization nationally and internationally (46-52). In Sweden it is an integrated part of the extensive primary care organization, mainly organized by the municipalities under a medically responsible nurse, but in some counties organized by the county council in collaboration with the municipalities social service (53). Patients eligible for home nursing services are assessed for social and nursing needs, and an individual care plan is created due to re-imbursement rules (34, 52, 54). The organization uses registered nurses as the highest medical 27

30 competence with physicians employed by the county council available daytime at the health care centers. In the region where the present studies took place, one ambulant physician was available during evenings and nights (55). There is a formal specialization in geriatric nursing, but very few registered nurses working in home nursing organization have this specialization. It is more common that they are district nurses or have no specialization at all (56, 57). Registered nurses in home nursing service work under two legislations: The Health and Medical Service Act (34), and The Act of Social Service (54). The registered nurses are responsible for the nursing process, while health care assistants, beside their duties of providing social service, perform many of the nursing tasks. Health care assistants often have a 3 year secondary school education consisting of social work and health promotion, but due to shortage of staff, in many municipalities a mix of educational background is common (58). A written delegation from the registered nurse is made after some training in accordance with legislated patient safety (54, 59). The registered nurses can for example delegate administration of pre packed tablets (ApoDos ) and insulin injections, plasma glucose monitoring, and changing of ulcer dressings. Patients with ongoing foot ulcers need regular wound management in between visits to the foot clinic. Those who are not able to perform visits to a registered nurse at the health care centre for dressing changes, have them changed at home by a registered nurse from the municipalities home nursing service or by a health care assistant under his/her supervision. The foot clinics provide the patients with written prescriptions about the dressings, off loading strategies, and changes in medication. Time to healing is often long; this implicates long term relationships between patients and registered nurses. If one foot is ulcerated, the other foot might be at high risk for ulceration, as the same risk factors probably are present, and the registered nurse visiting the patient has an opportunity to assess for risk factors in the home environment. The registered nurse in home nursing service also coordinates and implements treatment strategies of other co-morbidities, pain management, oedema, nutrition and off loading, and integrates these efforts into the patient s life at home. Registered nurses formal competence According to the International Council of Nurses, registered nurses should promote health, prevent disease and help patients cope with illness (8). In many countries in Europe, the United States, and other parts of the world, legal descriptions of nurses professional competence illustrate these duties in different wording. They all have in common that nurses should focus on leadership, nursing 28

31 practice according to nursing theory, participate in research and development of their work and education of patients, next of kin and health care professionals (9, 60-64). In Sweden and in many other countries, registered nurses have a three year bachelor degree in nursing as a legal pre requisite for the profession (9). The Swedish description of registered nurses competence is built up on recommendations of professional knowledge (technical, theoretical, and general knowledge), competence (skills based on experience, understanding, and judgment), and attitudes (engagement, courage, and responsibility), and of practical skills (9). The registered nurses should apply evidence based care that can be found in research, in national guidelines, compilations of scientific studies and accepted empirical research or local in local guidelines. They can also make decisions based on experience based knowledge and share decisions through patient participation. Leadership In Sweden the work around the patient is often organised in teams, which are led by the registered nurse. It is the registered nurses formal duty to lead and coordinate the work, depending on the patients needs, and to prioritize according to available resources. It is also the registered nurses duty to evaluate the work and to motivate other health care professionals in the team to work patient oriented and evidence based. This teamwork requires a good documentation and a quality assurance system due to the complexity of care. When different professions come together in teams, it is particularly important that the holistic nursing perspective is reflected in the professional nurse s work, and that the registered nurses have achieved skills in reflection and critical thinking (9). Participation in quality and safety work, as well as organizational planning and follow up of the local health service are also important tasks for registered nurses (9, 62-64). Nursing practice The formal description of registered nurses competence states that they should apply the nursing process independently. This requires observation and assessment of the patients basal and specific nursing needs, determine nursing diagnose(s) and prescribe relevant actions to be taken, plan and perform the actions, and evaluate the effect on the patients. Changes in the patients physical or psychological condition should be observed, documented, and accordingly acted upon (9). To enable this, it is necessary that the work is documented according to legal requirements and that registered nurses critically assess their own documentation for quality improvement (65). By working through 29