Dose Diabetic Education Reduce The Incidence Of Foot Ulcer - Research Paper Example

Does diabetic education reduce the incidence of foot ulcer? 1. The condition to be studied: Diabetes is established to be one of the grave diseases affecting human population, being stated as a chronic problem. Of this foot disease is found to be a major complications leading to tragic consequences as amputation. With world wide half amputations done are attributed to diabetes. It has been effectively identified that the patient education and creating awareness among them is very important tool that helps in reducing the risk of amputation and for wider control of the foot ulceration progression.( Palumbo, &Melton ,1985)This becomes important as the annual total cost associated with the diabetes foot disease management and amputation is as close to 1 billion American $ per year that obviously excludes the surgeon fees, rehabilitation cost and the time lost on abstaining from work. Another main point is that chance of amputation of another extremity following the first one is as high as 50% with a increased mortality rate of 39 to 69% observed post the amputation. ( Reiber etal.,1995)With the data search shows the presence of many studies that are done on the type and mode of patient education and more researches qualitative trying to establish the improvement in patients cognition, it was seen that fewer studies or researches tried to explain the quantitative aspect of effect of patient education on diabetes foot ulcer occurrence. Hence it was thought that this study could take up as the need of the hour. Aim of the study: The main aim of this study is to quantitatively establish the effect of diabetes patient education on the incidence of diabetic foot ulcers. This study is based on the hypothesis, Hypothesis: “The diabetes patient education has an effect on the occurrence of foot ulceration”. Thus the entire research plan would be set up to either accept or reject this hypothesis at the end of the study period. 2. Research Question: Does diabetic education reduce the incidence of foot ulcer? 3. The significance of the research: The significance of the research could be established in two areas. One, by reinforcing the gravity of the background issue, and another by explaining the importance of this particular research. The importance of selection of particular disease condition would be understood with the call by US Department of Health 2000 to people to reduce the LEA- Lower Extremity Amputation by 40%, the special target population being the diabetic population. This was formatted by them based on the fact that 50% amputation occurring in the world is done for diabetic. (U.S. Department of Health and Human Services: Healthy People 2000) .It has been established that 15% of patients with diabetes are experiencing foot sores and ulcers that could be prevented by proper foot care. Another study shows that 80% of diabetic people who are at the risk of amputation are due to the lack of proper patient education and self awareness. Further studies have established the fact that corrects knowledge and behavior are found to significantly reduce the risk of foot ulcer. The study further specifies the diabetes instructor or nurse specialist to be the correct person to fit into the bill. It is also widely observed that under estimating the severity of a diabetic foot lesion in turn is found to prolong morbidity and possibly causes the unnecessary amputation. (Levin etal., 1993) Though this cannot be glorified as an area that has not yet been researched, the literature reviews shows a different picture. Many researches that have been taken up in the last 10 years mostly are focused around the patient education. Researches that tend to emphasizes how to formulate the patient education program, what are the effective modes- telephonic, pamphlets or mailing etc, the duration of education and type. And the other types of research observed were qualitative that tries to bring out the effect of patient education on patients cognitive and behavioral effects rather than clinically bringing out the direct effect of the education on ulceration. Also there is wide spread myth that most of the nursing researches are usually qualitative, trying to bring out the feeling of patient rather than concentrating on the clinical side, that laid the stone for this research. (NaliniSingh etal, 2005) Thus it is obvious from above that if proven that patients education might bring down the prevalence of ulceration, this would in turn benefit a large number of people in the community, by helping to improve their health and thereby decreasing the cost of health and mental agony. At this point this is strongly felt that the result and the knowledge obtained from this study would greatly help to modulate, the current practices. The step for change in practice could be started from the nursing education itself with much emphasize could be laid on the need of effective patient education that in future may bring about a positive change in the governing policies. This may also be a catalyst in enthusiasing future research to be taken up that could bring ion more benefits in itself. 4. Review of appropriate literature: It is a well known fact that a well reviewed summary of various research topics related to the study is very essential for the proper progression of study. This part of the review is structured first to explain the condition of diabetes foot ulcer, the gravity of the study, and then followed by review of various researches done in the field to possibly evaluate the effectiveness of the study. The review here is framed on a conceptual framework, as it would validate our study as Wood and Brink said, it would give an idea of where to place the study in the universe of nursing research. The search of relevant material of various studies and researches reported were collected and reviewed from journals, publication etc. Apart from that the articles were also be retrieved from databases as Mediscape, CINAHL, OVID, Cochrane etc. the inclusion criteria was to review research studies and publication from 1995 on ward as that would be relevant and publications older than that was excluded. The keywords used to search in the internet was “Diabetes and foot ulcer”, “Effect of patient education on incidence of foot ulcer”, “ Patient education” etc 4.1 Diabetes and foot ulcer: Diabetes is one of the crucial diseases that have found to affect majority of population with in US also it was found to be prevalent in 3.5% of the population. Among the people diagnosed as diabetic, one of the major complication predicted is foot ulcer that was estimated to affect about 15% of total diabetic population. (Reiber, 1996) .Recent studies also have shown that the percentage of affected population is seen to be on rise from 1.0 % to 4.1 %. The reported Lower Extremity complications includes , the peripheral retrial disease, peripheral neuropathy, foot ulceration that on extreme conditions leads to amputations. (Reiber,2001) The rate of amputation on comparison is found to be high in diabetic person than non diabetic person, with the limb amputation occurring 10 to 30 times more often in diabetics. In diabetics itself, 8 to 105 is found to be of non traumatic while for 85% it is following the foot ulcer. The foot ulcers are found to affect the individual affected in emotional, physical and in economical aspects as it considerably pampers the productivity. The results of a study conducted to analyze the cost of treatment of foot ulcer shows that from $28,000 it has increased to 34,000$. The rate of mortality following amputation is found to range from 13% to 40% at 1 year, 35% to 65% at 3 years, and 39% to 80% at 5 years—worse than the percentage observed in other serious malignancies. (Vileikyte,2001) With understanding the enormous disease burden of diabetic foot ulcers, it is crucial and sensible to analyze the question is it curable. The ensuing portion of review tries to summarize and critically evaluates the evidence on the efficacy of identifying diabetic persons at high risk for foot ulcers and the design of effective interventions designed to prevent them. (Ramsey etal,1999) 4.2 The effective measures for prevention of foot ulceration: By understanding the gravity of issue the importance of preventive measures are understandable. There are many simple screening and preventive tools available to tackle the complication. The tools includes patient report, clinical examination that could help in quantifying the loss of peripheral sensation, observation of the foot deformity, peripheral vascular complication and an effective follow-up of any previous ulcers. Based on these observations the patients are categorized as at low, moderate and high risk. Identifying patients' risk category is very important to plan the future course of management. For inspection, tools as monofilaments, tuning fork are all used.(Cavanah etal ,2000) Many studies have established the fact that careful and regular inspection of foot is the most effective measure that helps in reduction of both cost and morbidity. Other prevention measures mentioned are, tight medical management of glucose level, correct behavior, habits and selection of shoes, close attention of toe nails and callus , regular checkup on foot infection, and early and appropriate referrals to foot specialist- podiatrist, vascular and orthopedic surgeon and neurologist. The management of foot ulcer includes steps as education of dos and don’ts, regular podiatry visit, dressing of ulcerations and treatment with antibiotics, and in severe cases, referral to podiatrist.(Lavery etal.,1998) (Boike & Hall,2002) Many studies have proven that patient education is a very effective tool in the prevention of complications of foot ulcer. It is seen that patient with effective education showed more positive changes in appropriate self care behaviors and reported lesser foot problems. A study done to analyze effective patient education, was shown to be the one that contained detailed foot care recommendation, that request patients commitment to self-care, demonstrate effectively the foot care practice and that persistently communicated the message. The recommendation could include instruction as washing, drying, inspecting the feet , cutting toenails, instruction for treatment of minor foot problem, selection of a suitable foot wear , and when to contact the physician. The study concludes by saying that the negative effects foot disease could be controlled with routine examination, assessment of ulcerations risk factor, and patient education about effective self-care. The study concludes with a remark that patient education may be essential for risk factor reduction and for earlier recognition of risk factors. (Walk etal.,2002) Patient education was defined by Piccini and Drover (2000) , as the process by which the patient is able to attain knowledge about his health status. The principal providers of education are usually the healthcare professionals. Here the aim of patient education would be to provide knowledge targeting the reduction in ulceration and amputation and in preventing complications and assisting in early detection. A study conducted by US Veteran Administration center showed that, patient satisfaction might be the end tool to assess education. Here May reports that many reports and research seen in this field aims at explaining and evaluating the education management, hinting at the lack of many clinical study to prove the effect of education on incidence of foot ulceration. 4.3 Researches on patient education and diabetic foot ulcer: In a randomized study done by Rith-Najarian & Reiber ,2001, it was shown that a multi displinary team showed that patients in the education intervention group were more diagnosed by physicians promptly for risk of ulceration than the control group. They also showed that the intervention had a great effect in reducing the economic expenditure of amputation. On calculation the benefit was seem to be higher for patients in education intervention. The study also brought out the essential successful feature of patient education as foot care recommendation, patient commitment and effective communication as the key for success. Another study, carried out by Mayfield etal.,1998 etal showed that screening of all patients with diabetes is the effective way to identify the risk for foot ulceration. These diagnosed patients were in turn found to be benefited from certain prophylactic interventions as patient education, prescription footwear, intensive podiatric care, and evaluation for surgical interventions. Another study done in England (Andrew J.M. Boulton,1998) showed that Effective patient education can reduce the incidence of foot ulceration and amputation by over 50 %; and in turn they advice the patients with a high risk of foot take up appropriate education. They conclude by saying that the risk of foot ulceration and amputation can be reduced by careful screening and patient education, without the need for expensive equipment. In a study carried on by Subrata Basu etal, in 1999, in UK it was seen that of 110 patients screened, 33% of them had no idea about foot care and were at risk of development of ulcer. Another study by, McCabe etal 1998, showed that reduction in ulceration and amputation against process outcome as patient compliance found more compliant people had less risk. Ronnemaa etal in 1997, when studied the impact of podiatrist care in primary prevention of foot problems in diabetic subjects, showed that Education and primary preventive measures provided individually by a podiatrist resulted in significant improvements in knowledge and foot self-care scores and in improvements in the prevalence of some minor foot problems. Plank etal, 2003 in their study established that secondary preventive measures by a chiropodist may reduce recurrence of foot ulcers in diabetic patients. A study by Andrew J.M. Boulton showed that the risk of foot ulceration and amputation can be reduced by careful screening and patient education, without the need for expensive equipment. From the review it could be seen that many studies have proven that there is effect of education in the patient welfare when concerned with foot ulceration. But the observed studies are the one that either explains the type of education or that bring out the qualitative analysis of effect of education in the incidence of diabetic foot ulcer. So it was felt that the quantitative study of effect of education in the incidence of diabetic foot ulcer would be a worthwhile study. 5. The research approach: Considering the aim that had been set up for the study a qualitative research would be more appropriate. At any given type the research can either be qualitative or quantitative or at time a proper mixing of both. The choice of the study is based on the demand of research and the researcher’s choice. As a nutshell introduction it could be said that Qualitative research is the one that offers insight into the social, emotional and experimental phenomenon’s and concept of healthcare, whereas the quantitative research is a formal, systemic and objective process where the numerical data is used to explain the concept. Thus usually the qualitative research tends to explore what, why and how, whereas the quantitative research tends to fish out or explore, whether to or how much. Thus when qualitative research is subjective, inductive, non generalisable, and expressed in words, quantitative on the other hand is objective, deductive, generalisable and could be described in numbers. (Polit etal., 2001) In nursing research an undeniable fact is that the research question is the one that decides the nature and approach of the study. They are, infact found to be the key that drives the selection of research method, subject selection, data collection methods and data analysis method selection. Thus for the research question of the particular study it needs a statistically established fact more than brining that of out the effect on the human experience. (Creswell, 2003)The question needs a statistically provable numeric result for which quantitative research approach might be the logical option and solution. Thus the research tends to derive a reliable a generalisable result for which quantitative research approach is selected. 6. Methodology intended to be used: 6.1 Research design: It is quite understandable that research design is frame work guide used for the planning and implementation of the study, or a plan formulated for effectively answering the research question. For the quantitative research type chosen this research is planned to be of Quasi experimental in nature that is effective in testing the predictive hypothesis. due to ethical reason and the nature of study is on human being, a experimental study is not feasible, so, a quasi experimental design , whose goal is to test the cause and effect by observing hoe the subject reacts is, serves the purpose of the study it is selected. This in this a comparison group that can be used as a control is effected with a non random assignment of sample. To be more precise a Non-equivalent pretest-posttest control group design is planned that has a non randomly selected subjects with only the experimental group is exposed to a treatment. (Walker, 2005) 6.2 Sample selection and size: The research is intended to be carried on for a period of six, months to effectively study the effect .the study due to the time constraint is planned to be carried out as a small feasible study with a large sample size of around 150 to 200 participant in each group. The participant would be patients’ referring to a particular nursing home, with obtaining ethical consent.the sample size is selected to be around 200 as any difference would lead to a large mean value that would be helpful in calculating the statistical difference. To avoid bias the patients to be studied would be by the same nurse practitioner as skill varies with persons. Next the sample would be selected not in a random manner as any given time the number of patients referred would be highly variable. Also the patients are to be grouped based on the risk level. (Seer, 2001) As a first stage, the patients referring to the diabetolgist of particular nursing homes assessment of state of risk is done. This includes, Examining the patient’s history – of previous foot complication, previous education about foot care, current diabetic control, latest HbA1c, structural and biomechanical abnormalities, circulation, and self-care and knowledge assessment. Then physical examination, of skin and soft tissue as inspection of legs, dorsal, planar, at the posterior surface of foot, and between toes. Check the skin and nails for any fungal infection that are the primary cause of ulceration, musco skeletal assessment, - assessing the foot movement, neurological and foot deformity assessment. (Ramsey etal.,1999) The inspection is done with instrument as monofilament, which is delivered to give standard stimulus independent of pressure applied, response of patients to the count of touch helps to classify them. Also tuning fork plantar pressure identification is done to assess the stage. Then the patients are classified into three class as low risk- no sign of peripheral neuropathy, Moderate risk patient with cclinical evidence of neuropathy [10g monofilament] ,absence of foot pulses ,presence of foot deformity ,visual impairment ,and physical disability and High risk patient with clinical evidence of neuropathy [10g monofilament] with callus ,presence of foot deformity with callus ,present or previous history of ulceration ,peripheral vascular disease - absent pedal pulses with history of intermittent claudicating or rest pain or in combination with neuropathy ,previous amputation and previous Charcot's Arthropathy. Thus five risk factors are assess for classification, namely, (Mayfield etal., 1999) Presence/History of Foot Ulcers Protective Sensation Structural Abnormalities Circulation Self-care Knowledge and Behavior (American Diabetes Association,2003) For study, the high risk patients are selected in them no age group, is seen. The inclusion criteria includes patient who has high risk of ulceration and who can take up the education provides. The exclusion criterion includes the patients below 15 and above 70, who cannot follow the education principles, patients who are at the verge of developing ulceration as the medical intervention might cause a bias in the sample and patients with other major complication as CHD, nephropathy etc. The expected outcome or the result to be quantified would be, decrease in occurrence of foot ulceration and amputation. Foot ulceration is full-thickness skin defect that required >14 days for healing , as secondary factor, decrease in the in incidence of hospital admission or emergency room visits due to ulceration and decrease in the incidence of lower proximity amputation, is considered. 6.3 Data collection: The sample is divided in to two group with the experimental group subjected to education and control group not involved. This division is done randomly. The education given to them involves concepts as importance of self care, prevention of lesion and trauma, aiding the healing of already established lesions, avoids hospitalization and augments patient mobility. The education aims at increasing patient’s awareness, increasing annual checkup rate, daily self inspection, proper nail and skin care, injury prevention. The patient education for selected experimental group is planned tpo be a seminar session in the beginning, followed by the provision of pamphlets that has the dos and don’ts. Then they are regularly followed up and reminded once in 15 days by telephone and mail. They are called upon for checkup once in 60 days were again refreshing of education is done. With the course of study, patients could be advised to call the researcher or drop into the research area of clinic if they suspect a foot ulcer, when it is not the checkup due. Also the concept of non respondence or the case of forgettance in returning the mail or refreshing questionnaire could be dealt with personal contact with their consent whenever possible meeting them at their next scheduled clinic visit at this medical center. Also the feature of study subject turning up to any other medical personnel cannot be overlooked. This problem can be overcome by the researcher notifying the research clinic, specifying them to notify the researcher on any turnips of diabetic ulcer cases. At each checkup the ulceration if is there is assessed and by the end of six months the level of ulceration is measured in control and experimental group and compared. For providing the education, the nurses need knowledge and skills in the following areas to competently assess a client’s risk for foot ulcers and provide the required education and referral: the skills are Skills in conducting an assessment of the five risk factors Knowledge and skill in educating clients The pamphlet bare prepared with appropriate reading style, with ease of understanding, in readable size and print and language, correct content collected from reliable resource. (Rith-Najarian & Reiber, 2000) The endpoint or the expected outcome from the study is finding of first ulceration from the day of study. 6.4 Data analysis: The results from the study could be statistically tested using the Independent t-test that would indicate the significant difference between the experiment group and control group rate of ulceration and obviously the impact of education. This is would take into accord the according to the ‘p’ value for the rate of formation of ulceration at the 95% significance level of a one-tailed t-test. An independent t-test is selected as helps us to look at the difference between the two sets of means of both groups. SSPS version 9.0 statistics programme can also be used for the analysis of the results The analysis of the data’s by this statistical method requires the calculation of mean, standard deviation and standard error mean. Then Levine’s test of equality variance may be employed for calculating the variance and significance respectively. With a significant difference seen, the hypothesis can be accepted or else rejected. 6.5 Ethical consideration Obtaining the patients consent would be the main step. Any thing might the sample size, it has to be informed to the concerned department and the ethical approval should be obtained prior to the study. The patients consent could be legitimized by obtaining the, explanatory or contact letter patients consent form Information sheet signed duly. The anonymity of the patients has to be preserved to maintain the ethical codes. These both in reports and publication and during storage have to be taken care of. The storage of data can be manual or computerized in both the cases, care should be taken to ensure that the data’s are maintained by the researcher alone and other member doesn’t have the entry rights. The patient undergoing education would not have any risk and steps as maintaining anonymity if subjects would be maintained. The communication with the subject would be initially through a seminar followed by personal communication. Then follow-ups through mail and telephone with prior consent would be done with again personal meeting on checkups. The participant would be informed that they can withdraw at nay point of research without any fear of consequences. 6.6 Limitations The limitation of the study would be anything as drop out patients and patient may die, or may contract terminal illness that may terminate them from the study that is to be expected. Also getting ethical approval and getting p[patient’s approval might be challenging. 7. References: 1. Palumbo PJ, Melton LJ: Peripheral vascular disease in diabetes. In Diabetes in America. Harris MI, Hamman RF, Eds. Bethesda, Md., National Diabetes Data Group, NIH Pub. No. 85-1468, 1985, p.1-21. 2. Reiber GE, Boyko EJ, Smith DG: Lower extremity foot ulcers and amputations in diabetes. In Diabetes in America. 2nd ed., National Institutes of Health, NIDDK, NIH Pub. No. 95-1468, 1995. 3. U.S. Department of Health and Human Services: Healthy People 2000. In National Health Promotion and Disease Prevention Objectives. Washington, D.C., U.S. Govt. Printing Office, 1991 (DHHS pub. No. PHS 91-50212). 4. Levin ME, O'Neal, Bowker JH: Preface. In The Diabetic Foot (5th ed.). Levin ME, O'Neal, Bowers JH, Eds. St. Louis, Mosby-Year Book, 1993, p. xxi-xxii. 5. Nalini Singh, MD; David G. Armstrong, DPM, MSc, PhD; Benjamin A. Lipsky, MD Preventing Foot Ulcers in Patients With Diabetes JAMA. 2005;293:217-228. 6. Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13(suppl 1):S6-S11. 7. Reiber GE. Epidemiology of foot ulcers and amputations in the diabetic foot. In: Bowker JH, Pfeifer MA, eds. The Diabetic Foot. St Louis, Mo: Mosby; 2001:13-32. 8. Vileikyte L. Diabetic foot ulcers: a quality of life issue. Diabetes Metab Res Rev. 2001;17:246-249. 9. Ramsey SD, Newton K, Blough D, et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999;22:382-387. 10. Cavanagh PR, Boone EY, Plummer DL. The Foot in Diabetes: A Bibliography. College Station: Pennsylvania State University; 2000. 11. Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JG. Practical criteria for screening patients at high risk for diabetic foot ulceration. Arch Intern Med. 1998;158:157-162. 12. Boike AM, Hall JO. A practical guide for examining and treating the diabetic foot. Cleve Clin J Med. 2002;69:342-348 13. Valk GD, Kriegsman DM, Assendelft WJ. Patient education for preventing diabetic foot ulceration: a systematic review. Endocrinol Metab Clin North Am. 2002;31:633-658. 14. Piccininni JJ, Drover JM. Perspectives in patient education. Top Clin Chiro 2000;7(4):43–50. 15. Rith-Najarian SJ, Reiber GE. Prevention of foot problems in persons with diabetes. J Fam Practice 2000;49:S30--S39. 16. Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes. Diabetes Care 1998;21:2161--77. 17. Subrata Basu, Julie Hadley, Rebecca Marie Tan,Jenny Williams, C. P. Shearman, BSc, , Is There Enough Information About Foot Care Among Patients With Diabetes?, The International Journal of Lower Extremity Wounds, Vol. 3, No. 2, 64-68 (2004) 18. McCabe etal CJ, Stevenson RC, Dolan AM. Evaluation of a diabetic foot screening and protection programme. Diabet Med 1998; 15:80–84. 19. Ronnemaa T, Hamalainen H, Toikka T, Liukkonen I. Diabetes Care. 1997 Dec;20(12):1833-7. Evaluation of the impact of podiatrist care in the primary prevention of foot problems in diabetic subjects. 20. Plank J, Haas W, Rakovac I, Gorzer E, Sommer R, Siebenhofer A, Pieber TR. Diabetes Care. 2003 Jun; 26(6):1691-5. Evaluation of the impact of chiropodist care in the secondary prevention of foot ulcerations in diabetic subjects. 21. Andrew J.M. Boulton ,Lowering the risk of neuropathy, foot ulcers and amputations, Conference: 5th International Symposium on Type 2 Diabetes Mellitus: Breaking the Barriers for Improved Glycaemic Control, Copenhagen, 7 December 1998 to 8 December 1998. Novo Nordisk. 22. Polit DF, Beck CT, Hungler BP. Essentials of nursing research: methods, appraisal, and utilization. 5th ed. Philadelphia: Lippincott; 2001.         23. Creswell JW. Research design: qualitative, quantitative, and mixed methods approach. 2nd ed. Thousand Oaks: Sage Publications; 2003 24. Walker W. The strengths and weaknesses of research designs involving quantitative measures. J Res Nurs 2005; 10(5): 571-82.         25. Seers K, Crichton N. Quantitative research: Designs relevant to nursing and healthcare. NT Res 2001; 6(1): 487- 500 26. Ramsey SD, Newton K, Blough D, et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care 1999; 22:382--7. 27. American Diabetes Association. Preventive foot care in people with diabetes. Diabetes Care 2003;26(suppl 1):S78--S79. 28. Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes. Diabetes Care 1998;21:2161--77. 29. Rith-Najarian SJ, Reiber GE. Prevention of foot problems in persons with diabetes. J Fam Practice 2000;49:S30--S39. Read More