Evidence-based guideline for using negative pressure wound therapy in diabetic foot care

Transcription

1 Title Evidence-based guideline for using negative pressure wound therapy in diabetic foot care Author(s) Tang, Wan-yi, Winnie.; 鄧 韻 怡. Citation Issued Date 2011 URL Rights The author retains all proprietary rights, (such as patent rights) and the right to use in future works.

2 Abstract of thesis entitled Evidence-based guideline for using negative pressure wound therapy in diabetic foot care Submitted by Tang Wan Yi, Winnie For the degree of Master of Nursing at The University of Hong Kong in September 2011 Background Diabetic foot ulcer is well known to be the most costly and devastating complication of diabetes mellitus. In Hong Kong, it is a major reason for non-traumatic amputation. The high cost on wound treatment and loss of self-care ability of amputee places heavy burden psychosocially and economically on patients, their family, health care system and the society. Negative pressure wound therapy is an effective advanced wound management therapy in managing diabetic foot ulcer. Aim To develop an evidence-based guideline for implementing negative pressure wound therapy for patient with diabetic foot ulcer in orthopaedic ward. Method A systematic literature review was conducted on guidelines, systematic reviews and randomized controlled trials (RCTs). The review identified 7 RCTs and 2 economic

3 reviews. All selected studies were critically appraised using Critical Appraisal Skills Programme tools with moderate to good quality. Results From the literature review, key components were identified. Literatures suggested (i) assessment on peripheral perfusion, staging, bleeding tendency and nutritional status; and (ii) intervention on pressure setup, dressing frequency, pain control, wound packing and condition for therapy termination. A guideline was developed according to the key components identified. Implementation potential was assessed in terms of target setting, target audience, transferability, feasibility and cost/benefit ratio. Implementation plan was established consisted of a communication plan, pilot study and an evaluation plan. It is expected to have an increase in percentage of complete wound healing after implementing this guideline. Other expected outcome includes percentage of wound area reduction in a week, pain level, need for second high-level amputation and patients acceptance. Conclusion The findings of this translation research study show that NPWT is effective in promoting healing on diabetic foot ulcer. An evidence-based guideline was developed in this thesis to augment the use of NPWT in different stage of wound care for diabetic foot ulcer.

4 Evidence-based guideline for using negative pressure wound therapy in diabetic foot care by Tang Wan Yi, Winnie B.Nurs. C.U.H.K. R.N. H.K. A thesis submitted in partial fulfillment of the requirement for the degree of Master of Nursing at The University of Hong Kong. September 2011

5 Declaration I declare that this dissertation represents my own work, except where due acknowledgement is made, and that it has not been previously included in a thesis, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualifications. Signed Tang Wan Yi, Winnie i

6 Acknowledgement I would like to express my sincere gratitude to my supervisor Dr. Leung Yee Man, Angela for her patient guidance, insightful comments and ongoing support throughout the progress of the dissertation. This dissertation could not be accomplished without her grateful guidance and encouragement. I also extend my thanks to all staff from the School of Nursing of the University of Hong Kong for their support. I would also like to acknowledge the invaluable comments and suggestions from Dr. Sophia Chan, Dr. William Li and classmates for giving invaluable feedbacks during the presentation sessions. I am also indebted to Dr. Daniel Fong for his teaching regarding concepts on statistics and sample size calculation. Finally, I thank my family and friends, who provided ongoing patience, support and encouragement throughout this endeavor, when I worked into late nights, and during holidays. ii

7 Table of Contents Declaration Acknowledgement Table of contents List of figures and tables Appendix i ii iii vi vii Chapter 1 Introduction Background Diabetes Mellitus Diabetic Foot Ulcer Significance and affirming needs Research question, aim and objectives of the dissertation 6 Chapter 2 Critical Appraisal Search strategies Searching engines Study selection criteria Keywords Extraction of evidence Quality Assessment Critical appraisal and rating scheme for quality Results Overview of selected articles Summary for quality assessment 12 iii

8 2.5 Summary and synthesis of evidence 15 Chapter 3 Implementation Implementation potential Target setting Target audience Transferability of the findings Feasibility Cost / Benefit ration of the guideline Evidence-based guideline for using negative pressure wound therapy in 33 diabetic foot ulcer Target users of the protocol The objective of the guideline Rating scheme for the strength of the recommendations Recommendations 33 Chapter 4 Implementation Plan Communication Plan Management level Top management level Care provider Orthopaedic surgeon Therapist Clerical staff End user Pilot Study 45 iv

9 4.2.1 Objectives Target setting and target audience Sampling plan Workflow of pilot study Evaluation of pilot study Evaluation Plan Expected outcomes Patient outcome Health care provider outcome System outcome Patients involved Nature of patients involved Number of patients involved Data collection Data analysis Analyzing patient outcome Analyzing care provider outcome Analyzing system outcome Criteria for effectiveness Criteria for patient outcome Criteria for care provider outcome 60 Chapter 5 Conclusion 61 Reference 63 v

10 List of figures and tables Table 1. Staff training 28 Table 2. Comparison of material cost 30 Table 3. Cost of staff training 31 Figure 1. Work flow of pilot study 48 vi

11 Appendix Appendix 1. Wagner Scale on Diabetic Foot Ulcer Classification 76 Appendix 2. Stetler Model on Research Utilization to Facilitate Evidence-based 77 Practice Appendix 3. Search Strategies 78 Appendix 4. Tables of Evidence 79 Appendix 5. Table of Critical Appraisal 88 Appendix 6. Key to Evidence Statements and Grades of Recommendations 97 Appendix 7. Timeline of the Development of the Guideline 98 Appendix 8. Negative Pressure Wound Therapy Guideline Work Flow 99 Appendix 9. Assessment Form for Negative Pressure Wound Therapy on 101 Diabetic Foot Ulcer Patients Appendix 10. Nursing Procedure Audit Form 104 Appendix 11. Table of Outcome Measurement vii

12 Chapter 1 Introduction Diabetic foot ulcer (DFU) is well known to be the most costly and devastating complication of diabetes mellitus due to its complexity in wound treatment and as a major reason for non-traumatic amputation (CDC, 2007; International Diabetes federation, 2005; Wong, 2005). Effective diabetic foot care is essential in prevention of amputation (CDC, 2007). Studies have suggested different types of advanced wound management therapy in managing DFUs. Such as growth factors, silver, alginates, grafting, plasma gel and negative pressure wound therapy (NPWT) (Abbruzzese et al., 2010; Apelqvist, Armstrong, Lavery, & Boulton, 2008; Armstrong, & Lavery, 2005; Armstrong, Lavery, & Boulton, 2007; Blume, Walters, Payne, Ayala, & Lantis, 2008; Donaghue et al., 1998; Driver, Hanft, Fylling, Beriou, & AutoloGel diabetic foot ulcer study group, 2006; Edmonds, 2009; Eginton, Brown, Seabrook, Towne, & Cambria, 2003; Etoz, Ozgenzel, & Ozcan, 2004; Fife et al., 2007; Flack, Apelqvist, Keith, Trueman, & Williams, 2008; Jeffcoate et al., 2009; Jude, & Boulton, 1999; Jude, Apelqvist, Sprault, Martini, & the Silver dressing study group, 2007; Kakagia et al., 2007; Lavery, Barnes, Keith, Seaman, & Armstrong, 2008; Lyons et al., 2007; Margolis, Bartus, Hoffstad, Malay, & Berlin, 2005; McCallon et al., 2000; Moustafa et al., 2007; Munter et al., 2006; Niezgoda, Van Gils, Frykberg, Hodde, & the OASIS diabetic ulcer study group, 2005; Noble-Bell, & Forbes, 2008; 1

13 Piaggesi et al., 2001; Purandare, & Supe, 2007; Robson et al., 2005; Rullan, Cerda, Frontera, Masmiquelt, & Llobera, 2008; Tsang et al., 2003; Veves, Sheehan, Pham, 2002; Wieman, Smiell, & Su, 1998; Zimny, Schatz, & Pfohl, 2003). Negative pressure wound therapy was found to be the most comprehensively researched on its safety, efficacy and cost effectiveness. In this chapter, the background information of DFUs, the significance and the need in change of practice, the aim and objectives of the dissertation will be discussed. 1.1 Background Diabetes Mellitus Diabetes mellitus is a serious, complex and life-long metabolic disorder. It is, characterized by high levels of blood glucose. Either with deficiency of insulin or enhancement of insulin resistance or both cause chronic hyperglycemia which results in vascular abnormalities and tissue damages (Chan, Yeung, Chow, Ko, Cockram, & Chan, 2005). It is classified into two types: type I and type II. Type I is mainly due to autoimmune disorder. Type II is because of genetic and environment determinants such as physical inactivity and high fat diet etc. Patients from both types of diabetes can suffer from diabetic foot ulcers. All studies retrieved for NPWT included patients with both types of diabetes (Apelqvist et al., 2008; Armstrong, & Lavery, 2005; 2

14 Armstrong, Lavery, & Boulton, 2007; Blume et al., 2008; Eginton et al., 2003; Etoz, Ozgenel, & Ozcan, 2004; Flack et al., 2008; Lavery, et al., 2008; McCallon et al., 2000). According to International Diabetes Federation (2009), more than 280 million people have diabetes in 2010 worldwide, which is 6.6% of global prevalence. By 2030, 42,321people in China will suffer from diabetes comparing with 20,757 in 2000 (Wild, Roglic, Green, Sicree, & King, 2004). That is 106% increase. In Hong Kong, diabetes mellitus is the 10 th leading cause of death (Centre for Health Protection, 2010a). Although only 3.8% of the population is reported with doctor-diagnosed diabetes mellitus in 2005 by Centre for Health Protection, it is believed that the prevalence is underreported. Janus (1997) found that about 70% of Hong Kong population is unaware of their diabetic status (as cited in Department of Health, 2008). About 40% of medical ward admissions involve diabetes (Chan et al., 2005). It claimed about 25,000 in-patients discharges and deaths in all Hong Kong hospital that is 1.2% of all deaths in This number is again underestimated as for its late complication (Centre for Health Protection, 2010b) Diabetic Foot Ulcer The exact etiology of DFUs is still unknown and different from individual to 3

15 individual. A diabetic triad consisting of neuropathy, vasculopathy and immunopathy are believed to be the permissive factors in the pathogenesis of DFUs (Frykberg, 1998). Vasculopathy causing ischemia and immunopathy causing risk of infection are the predisposing factors (Frykberg, 1998). Patients with neuropathy would experience first, insensate injuries due to sensory neuropathy; second, intrinsic muscle wasting results in significant increase in pressure over metatarsal area due to motor neuropathy; last, loss of sweating ability causing skin dryness results in cracking and fissure over ankle area due to autonomic neuropathy (Erasmus, 2008). With the starting of neuropathy and contribution of ischemia and risk of infection, DFUs result. Estimated by Gordois, Scuffham, Sherer, Oglesby, & Tobian (2003), 15% of diabetic patients would have a foot ulcer at a point of their lives. They would also have a lifetime risk of developing a foot ulcer as high as 25% (Singh, Armstrong, & Lipsky, 2005). In Hong Kong, DFUs are so common that it appears in 10% of well controlled patients and over 70% of poorly controlled patients after 25 years of diabetes (Chan et al., 2005). 1.2 Significance and affirming needs As stated in the position statement of International Diabetes Federation 4

16 (2005), a lower limb is lost to diabetes somewhere in the world every 30seconds. Foot ulcers lead to 85% of all diabetes-related amputations. In the state, more than 60% of non-traumatic lower limb amputation occurs in patients with diabetes (CDC, 2007). In Hong Kong, diabetes is a co-morbidity of 53.3% of all lower limbs amputation (Wong, 2005). Only 43% of amputees are able to resume certain degree of mobility, about 40% of them have to be admitted in a nursing home. Amputation causes enormous destruction to individuals and their quality of life, places heavy burden to their family, the health care system and the society (Wong, 2005). The economic cost of a diabetic foot ulcer is above HKD 49,000. Any complications in healing and requiring amputation would increase the cost by over 6 times per person that is HKD 294,000 (CDC, 2007). Negative pressure wound therapy is recommended in Scottish Intercollegiate Guideline Network (2010) as a treatment for active DFU. Yet the recommendation is not followed in Hong Kong setting. In short, a structured and effective diabetic foot ulcer management programme should be established to prevent amputation. The investigator is working in an orthopaedic ward in which the prevalence of DFU recorded in is about 4%. Average length of stay is 5.6 days. 5

17 Average length of stay for patient with DFU is 51.6 days. Most of them are with large wounds in stage 2 or 3 of the Wagner s scale (Erasmus, 2008). DFU defined as stage 2 are those probing to tendon or capsule and stage 3 are deep with osteomyelitis. For stage 4 to 5, conditions are too severe for nurses to manage (Appendix 1). It might need extensive surgical intervention or even amputation. For stage 0 or 1, wounds are superficial. According to hospital record, no patient is admitted to the Orthopaedic and Traumatology unit due to stage 0 or 1 DFU, thus nurse seldom encounter those patients in ward. The challenge for orthopaedic nurse is those DFUs in stage 2 and 3. Nurses should establish a wound management regimen to care for those wounds and keep the limb from fate of amputation. Since there is a lack of evidence based guideline for DFU in Hong Kong, decision on the dressing regimen depends mainly on the experience and preference of the nurse. There is a definite need for an evidence based guideline on managing the DFU mentioned. 1.3 Research question, aim and objectives of the dissertation After affirming significance and need of change in practice, Stetler mordel (Stetler, 2001) (Appendix 2) is adopted to guide the process in developing evidence based practice. Research question, aim and objectives of the dissertation will be defined. 6

18 Research question Would negative pressure wound therapy (NPWT) improve the wound healing process in patient with diabetic foot ulcer? Aim To develop an evidence-based guideline for implementing negative pressure wound therapy for patient with diabetic foot ulcer in orthopaedic ward. Objectives 1. To gather empirical evidence on the effectiveness of negative pressure wound therapy on healing process in the patients with diabetic foot ulcer. 2. To develop an evidence-based guideline for using negative pressure wound therapy in diabetic foot care. 3. To assess the implementation potential of negative pressure wound therapy in the orthopaedic ward in Hong Kong. 4. To plan for the implementation and evaluation of the proposed guideline. 5. To evaluate the effectiveness of negative pressure wound therapy on healing of diabetic foot ulcer. 7

19 Chapter 2 Critical Appraisal In previous chapter, background of DFU was discussed. Significance and need were affirmed on developing an evidence-based guideline on negative pressure wound therapy for patients with DFU. Next step is to select relevant studies, critique and synopsis the data (Stetler, 2001) (Appendix 2). In this chapter, search strategies, extraction of evidence, quality assessment, summary and synthesis will be discussed. 2.1 Search strategies Searching Engines A systematic search was done in the period 1 September 2010 to 7 July 2011 through various searching engines. Practical or clinical guidelines search was done in the Cochrane Library ( ), the National Guideline Clearinghouse, National Institute for Clinical Excellence, Joanna Briggs Institute and Scottish Intercollegiate Guidelines Network (SIGN). No relevant studies yielded. A total of 44 relevant studies were yielded from electronic engines included British Nursing Index (Ovid June 2011), Cumulative Index of Nursing and Allied Health Literature PLUS (CINAHL) (EBSCOhost ), Medline (Ovid 1948 June week ) and 8

20 PubMed ( ). Reference lists and related studies were assessed with no additional studies identified to be relevant in title Study selection criteria Inclusion Criteria The included patients would be adults with age equal to or older than eighteen suffering from stage 2 or 3 DFU after debridement or partial amputation up to transmetatarsal level. The intervention would be negative pressure wound therapy. As the question in this dissertation is therapeutic, only meta-analysis, systematic reviews, guidelines and randomized controlled trials are included. Other inclusion criteria are in English or Chinese, published from earliest available to present and studies in human only. Exclusion Criteria Studies would be excluded when (1) subjects were with wounds other than DFU; (2) subjects were in need of major amputation; (3) intervention involved not only with NPWT Keywords Keywords used for searching were diabet* or diabetes mellitus, diabetic 9

21 foot ulcer* or foot ulcer* or diabetic foot and negative pressure wound* or negative pressure wound therapy with the function of explode and MeSH. A detailed search strategy is attached in Appendix 3. Limitation was set as evidence-based care sheet, guideline, meta-analysis, practical guideline, protocol, randomized controlled trial or systematic review. A total of 9 articles assembled after manual selection by reviewing the title, abstract and full text sequentially according to the study selection criteria mentioned above. Studies excluded are mainly due to (1) involving wounds other than DFU; (2) involving intervention other than NPWT or; (3) duplication. 2.2 Extraction of Evidence Data from the selected studies are extracted into table of evidence according to SIGN 50: A guideline developer s handbook ANNEX D (SIGN, 2009b). Tables of evidence are attached in Appendix Quality Assessment Critical Appraisal and Rating Scheme for quality Critical Appraisal Skills Programme (CASP) tools were used to evaluate the quality of the articles selected (Solutions for Public Health, 2010). Appraisal tools for 10

22 randomized controlled trials (RCT) and economic evaluation studies were used for the quality assessment. The tables of Critical Appraisal were attached as Appendix 5. With the critical appraisal and the study type, quality of the selected articles is rated in terms of levels of evidence according to the grading system of SIGN (2009a) (Appendix 6). Proportion of criteria fulfilled in the critical appraisal is stated at the end of each table of critical appraisal in Appendix Results Overview of reviewed articles The 9 reviewed studies included 7 RCTs (Armstrong, & Lavery, 2005; Armstrong et al., 2007; Blume et al., 2008; Eginton et al., 2003; Etoz et al., 2004; Lavery et al., 2008; McCallon et al., 2000)and 2 economic evaluations (Apelqvist et al., 2008; Flack et al., 2008). 5 studies were funded by the KCI USA Inc which is the company providing the vacuum-assisted closure device for those studies (Apelqvist et al., 2008; Armstrong, & Lavery, 2005; Blume et al., 2008; Flack et al., 2008; McCallon et al., 2000). 3 RCTs (Armstrong, & Lavery, 2005; Armstrong et al., 2007; Lavery et al., 2008) and 1 economic review (Apelqvist et al., 2008) were using the same primary dataset (Armstrong, & Lavery, 2005). All of the studies were done in either the USA or Canada including both out-patient and in-patient settings except 11

23 Etoz et al. (2004) remained unknown. Sample size for studies ranges from 10 to studies (Apelqvist et al., 2008; Armstrong, Lavery, &Boulton, 2007; Blume et al., 2008; McCallon et al., 2000) used number of wound achieving complete closure as outcome measurement. Yet all of the studies did not measure patient satisfaction, pain level or quality of life Summary for quality assessment (see Appendix 4 and 5) Randomized controlled trials (7 studies) The RCTs are at the evidence level 1+ to 1- with 5.5/10 to 8.5/10 criteria fulfilled. All studies asked clearly-focused question. 4 studies was unclear in the randomization allocation (Armstrong, & Lavery, 2005; Armstrong et al., 2007; Lavery et al., 2008; McCallon et al., 2000). Blinding for patient and observer is inappropriate with NPWT as intervention. NPWT needs machine to induce suction force that patient must have noticed. The effect of NPWT to the granulation of wound bed could also be identified easily by an experienced wound observer. Blinding in this appraisal is to evaluate the effort done in monitoring the compliance and adopting an objective outcome measurement. Only Blume et al. (2008) reported 6 non-compliance cases in the study, but the method for monitoring was unknown. 5 studies adopted a computerized wound tracing technology in wound size or amount of granulation tissue 12

24 measurement (Armstrong, & Lavery, 2005; Armstrong, Lavery, &Boulton, 2007; Blume et al., 2008; Eginton et al., 2003; Lavery et al., 2008) except Etoz et al. (2004) and McCallon et al. (2000). Sample size calculation was only available in 4 studies (Armstrong, & Lavery, 2005; Armstrong, Lavery, &Boulton, 2007; Blume et al., 2008; Lavery et al., 2008) in which, 3 (Armstrong, & Lavery, 2005; Armstrong, Lavery, &Boulton, 2007; Lavery et al., 2008) came from the same primary dataset of 1 study (Armstrong, & Lavery, 2005). The precision of the results is fair. Major outcome of the studies with larger sample size were presented with p-value and a large effect size, yet the 95% confidence intervals were either missing or with large range. The applicability of most of the studies is high as they involve both in-patients and out-patient setting, with chronic and acute ulcers or partial amputation wounds due to diabetes. Economic evaluations (2 studies) Both studies are at the evidence level of 1+ with 10/12 criteria fulfilled. Apelqvist et al. (2008) used the primary dataset from an RCT (Armstrong, & Lavery, 2005). Flack et al. (2008) carried out an estimation using RCTs or comparative studies in existing electronic database on the economic review. 13

25 Both studies calculated the direct cost for NPWT and standard therapy such as cost for dressing material, staff time, antibiotics used, and surgical procedures involved. Flack et al. (2008) included quality-adjusted life year as a major outcome. The studies were with high quality in incremental analysis, sensitivity analysis. For the applicability, both studies are questionable as economic environment is totally different between Hong Kong and the US. Yet Flack et al. (2008) is rated lower as the conclusion is a based on simulation. 2.5 Summary and Synthesis of Evidence With the critical appraisal of all the available evidence, summary and synthesis of evidence will be presented as follow. Study Population All selected studies are carried out in the Western country or estimation from the US population. Number of Participants Sample size of reviewed studies varies. It ranges from 10 patients to studies reported the sample size ranged 162 to 335. One economic review recruited 1000 participants data via electronic search engine. For most of the studies, reason for 14

26 loss-to-follow-up is not mentioned but is similar in both groups. The rate of participant is regarded as high. Characteristics of participants Patients are majority male. All of them are diabetic adults. Most of them are with large DFU classified with Stage 2 or 3 by either Wagner s scale (Blume et al., 2008) or Classification by University of Texas (Apelqvist et al., 2008: Armstrong, & Larvery, 2005; Armstrong, Lavery, & Boulton, 2007; Lavery et al., 2008). 3 studies included patients with vague defined wound condition (Eginton et al., 2003; Etoz et al. 2004; McCallon et al., 2000), that is wounds not expected to heal, non-healing wounds or wounds not healed in a month respectively. Adequate perfusion with transcutaneous oxygen tension on dorsum of foot larger than or equal to 30mmHg is set to be definitive recruitment criteria in entering studies with higher quality. Same criteria is also applied to the standard therapy group. According to Jude, & Boulton (1999), 30mmHg should be the minimal tissue oxygenation pressure for a DFU to heal. Other demographic characteristics such as: age, nutrition and smoking status, peripheral perfusion, and sensory neuropathy are comparable between intervention and control group. 15

27 Intervention In all selected studies, intervention is negative pressure wound therapy delivered by a Vacuum-assisted closure (V.A.C.) system except Etoz et al. (2004). In Etoz et al. (2004), the negative pressure is created by a medical aspirator system. In both systems, NPWT involves a suction pump creating a controlled and localized negative pressure, which is the V.A.C. machine or the medical aspirator system. Wound bed is prepared by surgical debridement prior to initiation of therapy. A latex free, sterile polyurethane or polyvinyl alcohol foam dressing cut into shape of the wound is used for packing of wound bed or a polyurethane ether sponge is used. A TRAC pad placed on top of the foam is connected to the V.A.C. machine by a plastic tube or a tube is paced underneath the sponge and connected to the medical aspirator system. The foam, the tube and peri-wound area are sealed with a semi-occlusive adhesive drape to create an airtight environment. Negative pressure would set to be mmhg (Blume et al., 2008) intermittently or continuously (Eginton et al., 2003; Etoz et al., 2004; McCallon et al., 2000). Frequency of dressing change is consistent in all studies for every 48 hours to not less than 3 times a week. The intervention is mainly done by clinicians in the studies selected. Role of nursing is not mentioned. However, culture is different in the US and Hong Kong. The use of NPWT is a clinical decision of nurses in Hong Kong. 16

28 Comparison 7 studies compare NPWT with advanced moist wound therapy including the use of alginates, hydrocolloids, foams, hydrogels and collagens (Apelqvist et al., 2008; Armstrong, & Lavery, 2005; Armstrong, Lavery, &Boulton, 2007; Blume et al., 2008; Eginton et al., 2003; Flack et al., 2008; Lavery et al., 2008). These types of dressing were changed daily. Only 2 studies compared NPWT with simple moist wound therapy involving the use of saline-moistened gauze only (Etoz et al.,2004; McCallon et al., 2000). Dressing change twice per day is needed for this type of therapy. Follow Up Length of follow-up is mainly 112 days. The shortest study would be Eginton et al. (2003) with 2 weeks in each group. Total length of follow-up was not mentioned in 2 studies (Etoz et al., 2004; McCallon et al., 2000). Outcome Measures Rate of healing is used in 4 studies as outcome measurement (Eginton et al., 2003; Etoz et al., 2004; Flack et al., 2008; Lavery et al., 2009). 4 calculated the % of wounds achieved complete closure (Armstrong & Lavery, 2005; Armstrong et al., 2007; Blume et al., 2008; McCallon et al., 2000). Wound tracing by computer 17

29 planimety is a commonly adopted tool to measure wound area or volume. Only Etoz et al. (2004) and McCallon et al., (2000) used tracing by hand with acetate film and marker. Synthesis of Evidence 1. Assessment 1.1 Contraindication and risk assessment Pre-treatment assessment is essential to screen patient with contraindications and risk factors to NPWT. The contraindications for NPWT includes: exposed vasculature, nerves, organs, anatomotic sites; untreated osteomyelitis; non-enteric and unexposed fistulars; maglignancy in wound and necrotic tissue with eschar. Common risk factors include bleeding tendency or anticoagulant therapy (US Food and Drug Administration, 2009). A thorough history taking and wound examination prior to treatment is essential. 1.2 Ensure adequate peripheral perfusion As previously mentioned, adequate blood circulation is essential in wound healing. Assessment on ankle brachial index, dorsum transcutaneous oxygen tension test, and toe pressure are needed. Refer vascular surgeon for revascularization prior to 18

30 NPWT would be beneficial for patient with inadequate perfusion. 1.3 Staging of wound Proper staging is essential before determining the use of NPWT. Studies are done on DFU with a classification of stage 2 or 3 of Wagner scale (Blume et al., 2008) or University of Texas (Apelqvist et al., 2008; Armstrong, & Lavery, 2005; Armstrong et al., 2007; Lavery et al., 2008). NPWT on wounds other than these stages is not supported by evidence. 2. Treatment 2.1 System setup Apply the system with negative pressure set to mmhg according to amount of exudates and wound condition. Observe dressing condition and educate patient on dressing observation to ensure proper application of therapy. Monitor on the proper function of the system closely to prevent adverse event such as excessive bleeding from wound (US Food and Drug Administration, 2009) or sudden drop of negative pressure causing retention of exudates and maceration of peri-wound area results as noted in Eginton et al.(2003). 2.2 Wound packing 19

31 Wound should be explored thoroughly to expose underlying cavity or fistula. Number and nature of materials packed into and removed from wound should be clearly documented. According to US Food and Drug Administration (2011), retention of dressing pieces in wound is a major reason causing wound infection. In conclusion, developing a NPWT guideline is necessary to guide orthopaedic nurses in managing DFU. The selected studies have showed that assessment for contraindication and risk factors, ensuring adequate peripheral perfusion, correct staging, system setup and wound packing are the key components for the proposed guideline. In the coming chapter, translation and application of the protocol will be discussed. 20

32 Chapter 3 Implementation After the literature review, NPWT is considered as an evidence-based intervention for treating DFU. In this chapter, the implementation potential will be assessed and evidence based practice protocol will be developed. 3.1 Implementation Potential The implementation potential will be evaluated in terms of transferability of the findings, feasibility and cost-benefit ratio of the innovation Target setting The target setting is a male adult orthopaedic and traumatology ward in a public hospital under Hospital Authority in Hong Kong with 45 bedsteads. The common diagnoses are fractures, spinal injuries, acute wounds and chronic ulcers. Patients with DFU required surgical intervention accounted for about 3.8% of the total number of admission Target audience The target audience involves the Diabetic Foot Ulcer Team and 19 ward nurses. The DFU Team consists of one orthopaedic nursing specialist, one advanced practice nurse and 2 registered nurses. The nursing specialist is the third tier of the 21

33 wound management cooperating with Nurse Consultant Transferability of the findings The findings are transferable because a similar target population and setting was found between the reviewed articles and the proposed clinical setting. Target population is similar in terms of age, sex, nature of ulcer and type II diabetes as majority. All studies were done in the western countries. Chinese are not exclusion criteria in these studies. Although limited local research has been done on NPWT, the healing rate for using advanced wound management therapy for the proposed setting is comparable with that in the studies. It is believed that the effect for NPWT is transferrable from the studies to the proposed setting. The target setting would be similar to the ones in the reviewed studies. Majority of the studies was carried out in special out-patient clinics where patients had the dressing changed and returned to their home (Apelqvist, Armstrong, Lavery, & Boulton, 2008; Armstrong, & Lavery, 2005; Armstrong, Lavery, & Boulton, 2007; Eginton, Brown, Seabrook, Towne, & Cambria, 2003; Etoz, Ozgenel, & Ozcan, 2004; Lavery, Barnes, Keith, Seaman, & Armstrong, 2008; McCallon et al., 2000), in-patients were also included for more ill cases (Blume et al., 2008; McCallon, 2000). Although the proposed setting is an acute ward, early discharge of patients and 22

34 subsequent follow up in Day Ward for dressing change on an every three days basis is having arranged. It is possible to carry out the proposed intervention in the proposed setting. According to core value announced by Hospital Authority (2010), the authority would provide high quality services and handle health-related crises in an effective and professional way in order to gain trust from the community and to enable quality of life of patient outside the wall of the hospital. The proposed innovation fits the core value well. It is an evidence based practice that is supported to have faster healing rate (Armstrong & Lavery, 2005; Blume et al., 2008; Armstrong et al., 2007; Flack et al., 2008), lower risk for wound infection (Armstrong & Lavery, 2005) and lower risk for secondary amputation (Armstrong & Lavery, 2005; Blume et al., 2008). Thus the positive outcome would decrease length of stay and improve quality of life of patient (Flack et al., 2008). The number of patient benefited from the proposed intervention will be sufficient. About 4% of the patients admitted into the target setting are diagnosed with DFU that required surgical intervention. 50% of the patients with DFU needed a primary amputation or revascularization due to the severity of the ulcer or poor peripheral perfusion. In other words, 60% of the patients would be expected to be 23

35 benefited from the NPWT, that is 78 patients in a year. This number of patient will be sufficiently large to show the benefit for the target setting due to a 28% reduction in length of stay in hospital (Flack et al., 2008). A 16-week pilot study will be proposed as most of the reviewed studies have 16-week follow-up (Apelqvist et al., 2008; Armstrong & Lavery, 2005; Armstrong et al., 2007; Blume et al., 2008; Lavery et al., 2008). The whole innovation will be completed in 18 months (Appendix 7 and Appendix 8) including 2 months for communication and training, 5 months for pilot, 5 months for full implementation and 6 months for data analysis and evaluation. This duration is reasonable for staff to familiarize with the skill, for the DFU team members to observe the progress of the wounds and for the management and administrative level to see the cost effectiveness of the innovation Feasibility The support and encouragement from the management level is found to enhance evidence based practice (Melnyk, & Fineout-Overholt, 2011). With the core value discussed, a programme on geriatric hip fracture was launched in the target department. This programme is an evidence based practice initiated by nurses involving not only nurses but also surgeons, physiotherapists and occupational 24

36 therapists in acute and rehabilitation setting. This programme is highly appreciated by the Chief of Service (COS) and Departmental Operational Manager (DOM) for its cost-effectiveness and resources utilization. In light of this programme, the organizational and administrative climate is more supportive on the development of evidence based guideline. The stakeholders for this guideline are COS, DOM, Nurse Consultant, the targeted ward manager, the DFU team, ward nurses, orthopaedic surgeons, therapists, clerical staff and the DFU patients. A priority communication with the stakeholders is essential for consensus and approval. The implementation of the proposed intervention is likely to reduce workload of the frontline staff and is not likely to interfere with the current function of staff. For the current function of the staff, nurses in the DFU team would have a thorough assessment on all patients diagnosed with DFU routinely. They then have the right, power and freedom to prescribe suitable dressing for patients with DFU. The team members are also in-charge of the changes of this kind of complicated dressing. Ward nurses need to take up the responsibility only when the team members are not available. Extra work that needed is on the preparation process as the criteria for adopting the therapy are strict. Preparation includes staging the wound, assessing for adequate peripheral perfusion, debridement, presence of Charcot arthropathy or malignancy of wound, use of antibiotic and anticoagulants. Nurses who are 25

37 responsible for recruitment of subjects, that is the DFU team members, need to have a thorough understanding on the criteria for the therapy. To ease the pressure of staff and facilitate a smooth recruitment process, a new assessment form will be developed integrating the criteria for NPWT into the existing assessment form (Appendix 9). The equipment for the assessment on peripheral perfusion is already available and readily provided by the department. The workload of nurses on conventional moist wound therapy is heavy. Dressing needs to be changed daily. Regular inspection on dressing is required at least every shift. Extra dressing change would be needed in case the dressing is soiled; loosened or excessive oozing is observed due to heavy exudates. Excessive oozing would be the most common reason for extra dressing change. The standard method for majority of the cases is packing with alginate silver or gauze. For the negative pressure wound therapy, dressing only needs to be changed every 48 hours (Apelqvist et al., 2008; Armstrong & Lavery, 2005; Armstrong, Lavery, & Boulton, 2007; Etoz et al., 2004; McCallon et al., 2000) or not less than three times a week (Blume et al., 2008; Eginton et al., 2003; Lavery et al., 2008). This would be two to three times less in term of frequency in dressing change. Exudates are constantly removed by the negative pressure. Extra dressing change due to excessive oozing will be largely diminished. The welcoming attitude among staff towards this intervention is observed due to this reason. The time used for monitoring is similar. 26

38 Nurses need to inspect the integrity of the dressing, the magnitude of the negative pressure and the consistency of the drainage collected in the canister. They also need to response to the alarm system of the machine. Method for dressing is similar to current practice. Packing was done with the special foam cut to fit wound instead of alginate silver. Extra steps are required to apply the tubing on top of the foam and then connect it to the vacuum pump. Thus the overall nursing time for dressing is largely reduced. Friction towards the innovation should be minimal. NPWT has been applied to various types of wound such as DFU, unhealed surgical wounds and pressure sore since 2007 in the hospital. Yet the application of the therapy was limited by personal preference, limited financial support and limited evidence based guidance, thus the result is not promising. Staff and managers in the target setting are looking for a plan that could systematically implement and evaluate the therapy for a better patient outcome that could be comparable with the existing studies. The DFU team has contributed a lot on limb salvage for DFU patients and the contribution was appreciated in the Hospital Authority Convention The proposed guideline matches the expectation of the management level and the team perfectly. And as NPWT is currently in use in the setting, equipments are all readily available. Formal training for the use of NPWT is required. The management level would be willing to 27

39 release staff for the training sessions as regular refreshment training was routinely held in the setting. The training sessions would include 3 parts: Firstly a one hour information session mainly on the reviewed evidence and recruitment criteria. This session will be given by the investigator of this guideline to all DFU team members. Secondly, two identical sessions for fifteen minutes on the use of machine and monitoring will be given to all ward nurses by the nursing specialist of the DFU team. Lastly, all staff is welcome to either one of the two sessions on trouble shooting and sharing for 15 minutes. These two sessions will be held after the pilot study and will be held by the nursing specialist of the team. Tabele 1 shows the detail on staff training. Table 1. Staff training Details Instructor Target Information session - Recruitment criteria Investigator DFU team (1 hour) - Contents of guideline member Training session - Contents of guideline Nurse All ward nurses (15 minutes, 2 identical - Application of NPWT by specialist (21) sessions) video Sharing session - Trouble shooting Investigator All ward nurses (15 minutes, 2 identical - Sharing Nurse (21) sessions) specialist Other than the target setting, minimal friction could be anticipated from vascular surgeons and nursing staff in day clinic. As the screening for peripheral 28

40 perfusion will be made necessary for the implementation of NPWT, increased referral to vascular surgeons for possibility of revascularization is expected. Besides, patients will be discharged earlier to Day Ward for dressing change. Increased patient flow in Day Ward is expected. Dressing will still be done by the DFU team members, and therefore only administrative workload will be increased for the nurse in day clinic. The maximum number of patient increased will be six per month and thus, this is not a large increase compared with the daily workload. A prior communication will be needed to facilitate the change Cost / Benefit ration of the guideline Diabetic foot ulcer is well known for its high treatment cost and possibility of amputation. The wounds may take weeks or months to heal or even not healing at all (Dorresteijn-Johannes, Kriegsman-Didi & Valk-Gerlof, 2010). To determine the cost-effectiveness of treatment of DFU, the organization must consider not only material cost but also non-material cost. The cost on dressing material is HKD$40 for conventional dressing. NPWT takes HKD$300 for dressing material and HKD$700 as the daily rent of the suction machine. In comparison, NPWT is much more costly than conventional dressing. But the number of dressing change per patient decreases from 118 times to 41 times 29

41 (Apelqvist et al., 2008). The nursing time decreases from 59 hours to 20.5 hours. Length of stay could be reduced by 28% (Flack et al., 2008), that is a reduction from 56 days on average for patient with DFU in the setting to days. Despite the outrageous cost on dressing materials, the organization could still save HKD$85,671.2 for each DFU patient with all these reductions (see Table 2). The one-off training cost is only HKD$1, (see Table 3). All teaching notes and videos are supported by manufacturer and are readily available. Stationary is provided by the setting for free. Table 2. Comparison of material cost Moist wound therapy Negative pressure wound therapy (NPWT) 1. 1.Cost for each dressing (HKD$) Cost on daily rent of machine (HKD$) No. of dressing change per patient (Apelqvist et al., 2008) 4. Total nursing time on dressing (hours) 5. Nursing salary for each dressing (HKD$) 6. Total cost on dressing (HKD$) ,000/(44*4)*1/2 hour 40,000/(44*4)* 1/2 hour = =113.6 (Civil Service Bureau, 2010) ( )*118 ( )*41 = 18,124.8 = 16, Length of stay (days) (Flack et al., 2008) 8. Duration of therapy (days) (Blume et al., 2008) 9. Daily cost for each in-patient (HKD$) Total cost on each patient (HKD$) Saved on each patient if NPWT is used (HKD$) 18, *3,200 = 197, , ,653.6 = 85, , *3, *63.6 = 111,

42 Table 3. Cost of staff training Equation Subtotal 1 hr information session $37,112.50/30/8 $ mins training (21 staff) $27,400.00/30/8/4*21 $ mins sharing (21 staff) $27,400.00/30/8/4*21 $ Teaching staff (Investigator) $24,255.00/30/8 $ Teaching staff (NS) $49,480.00/30/8 $ Stationary, video Free Total cost on Training $1, Apart from the material benefit, there are non-material benefits as well. Accreditation is becoming elementary to the industry. The hospital could gain reputation on utilizing evidence based practice to reduce length of stay and nursing time. Stress on nurses could also be reduced as for better time utilization in this nursing shortage environment. Nurse autonomy and job satisfaction is increased as nurses could prescribe to improve patient outcome. The potential nonmaterial costs for the proposed innovation would be the risk of having complication for using NPWT. As reported by US Food and Drug Administration (2009), most of the adverse events happened at home or long-term care facilities where no close monitoring takes place. The most common complication was excessive bleeding causing 2 deaths and 17 injuries reported (US Food and Drug Administration, 2009). A sudden drop of negative pressure causing retention of 31

43 exudates and maceration of peri-wound area was also reported in one of the studies (Eginton et al., 2003). However, either therapy could have risks. According to Armstrong & Lavery (2005), patient with conventional dressing would have a higher risk on wound infection with 17% vs 6% in NPWT and secondary amputation with risk ration of Comparing the severity, conventional dressing might lead to a more serious consequence that is irreversible. For negative pressure wound therapy, the risks are easily preventable by close monitoring and education as suggested by the US Food and Drug Administration (2009). Other than all those direct benefits, the indirect benefits caused by NPWT involve some aspects that cannot be calculated in terms of numbers. Amputation is not only a personal tragedy but also regarded costly for its consequences of the loss of productivity, rehabilitation, home care and prosthesis used. All these must be taken into account. According to Wong (2005), only 43% of patients undergone amputation in Hong Kong were able to resume ambulation ability in community in 6 months. 40.7% of them became institutionalized. With the reduced risk in secondary amputation (Armstrong & Lavery, 2005), this social burden can be reduced. In short, instead of comparing the acquisition costs of dressing, the organization should be encouraged to consider the treatment outcomes and total treatment costs of wound care. 32

44 3.2 Evidence-based guideline for using negative pressure wound therapy in diabetic foot care After evaluating the implementation potential of negative pressure wound therapy in promoting healing of diabetic foot ulcer, the next section is to describe an evidence-based guideline for using NPWT in DFU care Target users of the protocol The Diabetic foot ulcer team and nurses in the orthopaedic and traumatology unit The objectives of the guideline To promote wound healing for patient with DFU by NPWT Rating scheme for the strength of the recommendations According to the grading system of SIGN (2009a) (Appendix 6), a grade is given to each recommendation. Recommendation supported with the highest level of evidence will be presented with Grade A Recommendation 1 Assess the adequacy of peripheral perfusion by measuring ankle brachial index and toe pressure. The peripheral perfusion is regarded as adequate if ankle brachial 33

45 index in between or equal to 0.7 and 1.2 and toe pressure larger than or equal to 30mmHg. - Ankle brachial index can be obtained by the ratio of systolic blood pressure in the lower leg to that of the arm. - Toe pressure can be obtained by a small machine with a pressure cuff and an infra red cuff attached to patient s big toe. Supporting evidence - 30mmHg is the minimal perfusion for ulcerations to heal (Jude & Boulton, 1999). - Pressure lower that this should refer to vascular surgeon for assessment on possibilities on lower limb revascularization (Blume et al., 2008) (1+). Recommendation 2 Assess the stage of the wound and recruit those with stage 2 or 3 of Wagner-Meggitt wound classification to NPWT. - The stage of wounds can be classified as follow: (Erasmus, 2008) Stage 0: Pre- or post-ulcerative lesion Stage 1: Partial/full thickness ulcer 34

46 Stage 2: Probing to tendon or capsule Stage 3: Deep with osteomyelitis Stage 4: Partial foot gangrene Stage 5: Whole foot gangrene Supporting evidence - Ischemia is the only disease process after Stage 3, amputation is necessary (Armstrong, Lavery & Harkless, 1998) (4). Recommendation 3 Assess for the need of debridement before the therapy starts. - Remove all devitalized tissue, if present, in the wound. Supporting evidence - Debridement is a key component of healing process as it enables removal of devitalized and necrotic tissue and it is a key step to the initiation of healing (Blume et al., 2008) (1+). - Sharp debridement was to excise non-viable tissue whenever necessary during the 35

47 course of treatment (Armstrong et al., 2007; Armstrong & Lavery, 2005) (1+). - Non-viable tissue has shown to delay healing (Etoz et al., 2004) (1-). Recommendation 4 Assess on bleeding tendency by first, taking history on anticoagulant therapy; second inspecting wound for signs and symptoms for wound malignancy; lastly take blood for clotting profile. Supporting evidence - Bleeding is reported to be the most common complication and causes 2 death from (FDA, 2009) (4). Recommendation 5 Consult dietitian for dietary supplement as necessary. - Consult dietitian if blood result for pre-albumin concentration lower than 0.16g/L or albumin concentration lower than 30g/L (Armstrong & Lavery, 2005 (1+); Etoz et al., 2004 (1-)). Supporting evidence - Albumin and pre-albumin are essential elements for wound healing, concentration 36

48 lower than the above level will affect the progress of wound healing (Armstrong & Lavery, 2005 (1+); Etoz et al., 2004 (1-)). Recommendation 6 Using pressure from -100mmHg to -125mmHg continuously Supportive evidence - Depends on manufacturers guide or clinical judgment of nurse (Armstron et al., 2007 (1+); Armstrong & Lavery, 2005 (1+); Blume et al., 2008 (1+); Eginton et al., 2003 (1-)). Recommendation 7 Change dressing no less than three times a week Supportive evidence - For observing healing progress, inspecting signs and symptons of infection and need for debridement (Apelqvist et al., 2008 (1+); Armstrong & Lavery, 2005 (1+); Armstrong et al., 2007 (1+); Blume et al., 2008 (1+); Eginton et al., 2003 (1+); Etoz et al., 2004 (1-)) 37

49 Recommendation 8 Ensure adequate analgesic prior to dressing change. Supportive evidence - Granulation tissue might stick to the foam which causes pain upon removal (Etoz et al., 2004) (1-). Recommendation 9 Clear documentation on the number nature of material removed from and packed in wound. Supportive evidence - Pieces of dressing remained in wound might required surgery, additional hospitalization or antibiotics (FDA, 2010) (4). Recommendation 10 Remove NPWT on: - Complete ulcer closure (100% reepithelization), or - Time for ulcer closure by surgery or secondary intention (surgeon s 38

50 decision), or - A reduction in complications, including secondary amputation (surgeon s decision) Supportive evidence - In the situations listed above, the wound was either healed or prepared for another stage of management. (Apelqvist et al., 2008; Armstrong & Lavery, 2005; Armstrong et al., 2007; Blume et al., 2008; Lavery et al., 2008) (1+) NPWT was evaluated to be transferable, feasible and cost-effective in managing DFU in the target setting. It could also effectively prevent the social and economical consequences that secondary amputations bring. With the proposed evidence-based guideline, the target setting could start implementing this cost-effective and evidence supported innovation. This innovation is believed to be a great success and is able to contribute a lot on limb salvage. 39

51 Chapter 4 Implementation plan In this chapter, a plan for implementation including communication and pilot study with evaluation plan will be discussed. Implementation means change. Implementing the proposed guideline is to change the behavior of staff on the management of DFU. Change is not easy. Making strategic plan for communication and pilot testing is essential in facilitating a smooth transitional process. 4.1 Communication Plan The communication plan starts with identifying who to communicate. Stakeholder is defined as any person who is affected by the proposed change in any way (Ingersoll, 2005). Deliberate consideration to the needs of these stakeholders and the information they require is necessary to the initiation, sustained achievement and subsequent refinement of the proposed guideline. The stakeholders identified for this guideline are: 1. Top management level: Chief of Service (COS), Departmental Operational Manager (DOM) and Nurse Consultant 2. Management level: Ward Manager and Nurse Specialist 3. Care providers: DFU Team and ward nurses 4. Orthopaedic surgeons 40

52 5. Therapists: Physiotherapists, Occupational Therapists and Prosthetist/Orthotist 6. Clerical staff 7. End users: DFU patients According to Kotter and Cohen (2002), the first step for a change to success is making sure people with sufficient urgency to change. The urgency should not be come from a sell-the-case approach but a change in vision. In order to create the vision, pictures or audio tapes about the life experience of patients with DFU will be used to construct an impact. Concrete data on duration of therapy, length of hospital stay and economic cost for complicated healing and amputation will be presented to show the significance of the problem to patients and to stakeholders. Incidence report on current practice of dressing of DFU will be put forward for discussion. Then followed by a summary and synthesis of the reviewed evidence and a clear and realistic guideline with details on: (1) aims and objectives, (2) a plan of implementation and evaluation, (3) potential benefits, barriers and solutions, and (4) a timetable. Presentation will be ended by showing positive outcome via real-life example to make individual emotionally engaged with the change. These standard content will be presented generally in a top-down approach to all stakeholders (sequence as above) as support from management level is important in promoting change (Bryar et al., 2003; LaPierre, Ritchey & Newhouse, 2004). The focus of 41

53 presentation will be different for different parties Management level Nurse Specialist and Ward Manager are selected as the first party to be presented. Ongoing discussion with nurse specialist has been done throughout the development of the guideline in that he is the expert in wound care. A presentation will be done to the nurse specialist as a roundup with the presence of the Ward Manager. Ward Manager and Nurse Specialist are the key persons in the target setting as they assign and coordinate work for ward staff and the DFU team respectively. Besides, the target setting is a pilot ward. Studies or trials are carried out from time to time. It is important to negotiate a timeframe with the Ward Manager for the implementation of the guideline. This is to avoid overlapping with other studies as it may increase confusion and burden on staff thus increase resistance and compromise compliance to the guideline. The opinion from Ward Manager and Nurse Specialist is of high value as they provide a perspective from the administrative point-of-view. Adjustment could be done to the proposed guideline so as to increase the feasibility of the guideline. Ward Manager and Nurse Specialist will be the first party to approve the guideline and also act as liaison with the top management level. 42

54 4.1.2 Top management level Presentation to COS, DOM and Nurse Consultant will be made in the Management and Manager meeting held on every Monday afternoon. In addition to the content mentioned earlier, the presentation will focus on the manpower and number of patients that will be involved together with a detailed budget plan and a timetable for the pilot of the guideline Care providers Prior to any formal communication, the idea of NPWT will be disseminated within the care providers by means of posters and sharing in journal club. Through these activities, discussion will be made among the care providers. Listening to their thoughts and feelings towards the issue will help investigator to identify skepticism, fear and misconception. These are barriers to the implementation of the guideline. Allowing individuals to express their concerns and clarifying misconceptions are the best strategy for overcoming these barriers (Melnyk, 2005). Subsequent presentations will be held in the training sessions. The skepticism, fear or misconception identified in previous activities will be elucidated. Apart from clarifying concerns, information that staff wants most is the impact that the change brings. Resistance from individuals is often due to their fear and anxiety to their role in the change and the uncertainty 43

55 about the benefits of the change (Melnyk, 2005). Therefore, the focus of the presentation is on the difference of their role between current practice and the proposed guideline as well as the potential benefits that the guideline will bring. Presentations will be held separately for the DFU team and ward nurses. After the standard content, the team will have details on the guideline while ward nurses will have a video showing a general idea on how to perform NPWT Orthopaedic surgeon Meeting with the surgeons will take place after the weekly x-ray meeting as all surgeons on duty must attend this meeting. After the standard content, recruitment criteria and their role will be pinpointed. NPWT is currently being used in different types of wounds in the setting such as chronic bedsores and surgical gap wounds. Clarifying criteria for recruitment will minimize confusion towards the guideline. For surgeons role, they are responsible for making decision on timing and extensiveness for debridement or amputation, surgical closure and the use of antibiotics Therapist The guideline will be introduced to the physiotherapists, occupational therapists and prosthetists/orthotists after the weekly grand round. They will grasp the idea and setup of NPWT via a video prepared by the manufacturer of the vacuum 44

56 system. This is to prepare the therapists to handle patients who need weight relieving devices for mobilization exercise thus to facilitate early discharge Clerical staff A briefing will be held to introduce the proposed guideline to the clerical staff. They will be educated on patient flow, document arrangement and evaluation process of the guideline End user According to the evidence reviewed and the proposed guideline, patients adopting NPWT for DFU management is expected to be discharged 40 days earlier than those who adopting moist wound therapy (Flack, Apelqvist, Keith, Trueman & Williams, 2008). Nurses have to prepare them for the discharge right from the beginning of the admission. General information about diabetic foot care will be post on board for the reference of relatives. Information sheet regarding the cause and treatment of DFU and a flow chat of care according to the guideline proposed will also be given to them. Informed consent will then be obtained. 4.2 Pilot Study The proposed guideline is under formal consideration for putting in use and 45

57 thus according to phase IV of Stetler model (Stetler, 2001), a pilot project with evaluation will be needed to determine whether the guideline is accepted with or without modification. Pilot study is a small-scale version of the actual study by which the feasibility can be test out and providing an opportunity to modify the actual study (Polit & Beck, 2008) Objectives The objectives of the pilot study for the proposed guideline are to assess: 1. The feasibility of subjects recruitment process; 2. The flow of the proposed guideline; 3. The compliance of the use of assessment form; 4. The feasibility of the audit form; 5. Patients acceptance on the proposed guideline; and 6. Unexpected problem and possible solutions for the actual study Target setting and target audience The target setting for the pilot study is identical to that of the proposed guideline as mentioned in the previous dissertation. The target audience will mainly involve the whole DFU team. Two ward nurses including the investigator and the 46

58 clerical staff from the Day Ward will be involved for the completion of the implementation taskforce. The DFU team has the needed knowledge, respect and organizational credibility in handling the change as well as a shared vision with the investigator in committing the change Sampling plan The period for recruiting samples will last for a month using convenience sampling. Inclusion and exclusion criteria will be the same with that of the actual study. According to the hospital record in , there are a total of 130 patients admitted because of DFU. About 78 of them preliminarily fulfilled the inclusion criteria for adopting the proposed guideline. With the highest dropout rate as 20% (Armstrong, & Lavery, 2005; Armstrong, Lavery, &Boulton, 2007; Blume, Walters, Payne, Ayala, & Lantis, 2008; Eginton, Brown, Seabrook, Towne, & Cambria, 2003; Etoz, Ozgenel, & Ozcan, 2004; Lavery, Barnes, Keith, Seaman, & Armstrong, 2008; McCallon et al., 2000), five to six cases will be expected to be recruited in one month. During the recruitment process, the patient should be assessed to ensure fulfillment of the criteria. Informed consent will be signed by patients who agree to participate. The information sheet given to patient also describe the study objectives, data collection plan, potential risk and benefit, right to refuse or withdraw and 47

59 confidentiality pledge (Polit & Beck, 2008) Workflow of pilot study The workflow of the pilot study will be the same as that of the actual study except a shorter period for recruitment that is one month instead of five months. Figure 1 shows the workflow of the pilot study. As one of the objectives for the pilot study is to assess the flow of the proposed guideline, running through the whole guideline is important especially for testing the transition of in-patient to out-patient care. The pilot study will take a total of five months to complete. Figure 1. Workflow of Pilot Study 48