A modified nurse-led rehabilitation program to accelerate overall recovery of patients after colorectal surgery. Title. Citation.

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1 Title A modified nurse-led rehabilitation program to accelerate overall recovery of patients after colorectal surgery Author(s) Lam, Chun-ki; 林 進 其 Citation Issued Date 2013 URL Rights The author retains all proprietary rights, (such as patent rights) and the right to use in future works.

2 Abstract of the thesis entitled A modified nurse- led rehabilitation program to accelerate overall recovery of patient after colorectal surgery Submitted by LAM CHUN KI For the Degree of Master of Nursing At the University of Hong Kong In August 2013 The number of patients diagnosed with colorectal cancer had increased dramatically in recent years (Hong Kong cancer registry, 2012), and surgical resection is the first line treatment of colorectal. To enhance patients recovery process, there is a need to develop a comprehensive and user- friendly, with most important, an evidence- based guideline for promoting patients recovery process. Traditional post- operative management is associated with different postoperative complications, delayed recovery, and lengthened hospital stay. Recent research documented that using a specific rehabilitation programme focused on education; early mobilization and early diet regime could enhance patients recovery. Therefore, this transitional research aims to evaluate the current evidence on the effect of adopting a specific rehabilitation programme, to formulate an evidence- based guideline, assess its implementation potential, and to develop an implementation and evaluation plan. Ten related literature were retrieved from four electronic bibliographical databases. Critical appraisal had been done to ensure the quality and validity of the i

3 selected evidences. A clinical guideline is developed based upon the information from the identified high level of literature. The implementation potential is assessed based on the similarity and the readiness of the target setting to the proposed environment. It was found that the transferability of the protocol was high and it was feasible to be implemented into the target site. Little expenditure and input was expected, as the protocol was a systematic reformation of practice, rather than developing a set of totally new practice to current clinical setting. An implementation plan was then planned, which included the communication plan with all the stakeholders. After reaching a consensus among the stakeholders, a two- month pilot study will be carried out for examining the readiness before the full- scale implementation of the program. The evaluation plan of the effectiveness of the proposed program is developed. Result will be used to provide recommendation for further adjustment on the protocol to yield a better outcome. The implementation of this nurse- led rehabilitation program is suggested to be worthy of adoption in the clinical setting for bringing benefits to patients, the hospital and staffs. ii

4 A modified nurse- led rehabilitation program to accelerate overall recovery of patient after colorectal surgery By LAM CHUN KI (B.Nurs. H.K.U.) A thesis submitted in partial fulfillment of the requirement for the Degree of Master of Nursing at the University of Hong Kong August 2013 iii

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: LAM CHUN KI iv

6 Acknowledgements I would like to show my sincere gratitude to my supervisor Ms. Veronica Lam for her patient guidance and way long support in my dissertation in this 2 years. Without her insightful comments and suggestions, this dissertation can definitely not be finished. I would like to say thank you to her. I would also like to thank my classmates and group- mates for their support in the past 2- year of study. I have had a fruitful time in my master study. Finally, thanks to my family for their continuous encouragement and backup in my life, making it goes smooth and delighted. v

7 Table of Contents Declaration. Acknowledge. Table of Contents... Summary data list.. Appendices List. Abbreviations. i ii iii v v vi CHAPTER 1: INTRODUCTION Page 1.1 Background Affirming Needs Significance Research Question Objectives 4 CHAPTER 2: CRITICAL APPRAISAL 2.1 Searching Strategies Quality assessment Data Summary Data Synthesis 18 CHAPTER 3: IMPLEMENTATION POTENTIAL 3.1 Introduction Target Setting and Target patient Transferability Feasibility Cost- Benefit ratio of the innovation 25 CHAPTER 4: DEVELOPING EBP GUIDELINE 4.1 Introduction Title Objectives Target group Rating scheme for the level of evidence Recommendations 28 CHAPTER 5: IMPLEMENTATION PLAN 5.1 Identifying the stakeholders Communication plan with stakeholders Pilot study plan 37 CHAPTER 6: EVALUATION PLAN 6.1 Introduction Identify outcomes to be achieved The nature of clients to be involved The number of clients involved and study design Deciding when and how often to take measurements Basis for an effective change of practice 43 vi

8 CHAPTER 7: CONCLUSION APPENDICES REFERENCES LIST Page vii

9 Table List Table 2.1 Feeding regimen in the 3 literatures concerning early feeding Table 2.2 Components of the rehabilitation program Table 2.3 Length of hospital stay Table 2.4 Number of patients having complications Table 2.5 Days to return of bowel function Table 2.6 Patients mobility Appendices List Appendix 1 Summary of Searching details.p.46 Appendix 2 Table of evidence..p.47 Appendix 3 Summary of quality assessment - Methodology checklists for randomized control trials from the Scottish Intercollegiate Guidelines Network (SIGN). P.55 Appendix 4 Recommended grading of level of evidence from SIGN P.57 Appendix 5 Program timeline...p.58. Appendix 6 Rehabilitation program concept guideline. P.59 Appendix 7 Rehabilitation program In- patient recording chart.p.60 Appendix 8 Patient satisfaction questionnaire P.61 Appendix 9 Staff satisfaction questionnaire..p.63 viii

10 Abbreviations CEO COS DOM ERAS FT program GMN NO SIGN WM Chief Executive Officer Chief of Service Department Operation Manager Enhanced Recovery after surgery Fast Track Program General Manager of Nursing Nursing Officer Scottish Intercollegiate Guidelines Network Ward Manager ix

11 CHAPTER 1 INTRODUCTION 1.1 Background Colorectal carcinoma is the second most common cancer in Hong Kong. According to the latest statistics from Hong Kong Cancer Registry, there were 4370 new registries of colorectal cancer in When compared to 07 s and 08 s figures, which are 4084 and 4031 respectively, the number is increasing and it is a concern of health care providers. Surgical resection is the first line treatment of colorectal cancer. With the well- developed screening program, the number of patients receiving surgery are expected to increase in coming years. Due to this increase, management of the colonic surgery will be one of the biggest challenges for all health care providers. Traditional care to this group of patients is associated with different postoperative complications, delayed recovery and lengthened hospital stay. They are the factors that have contributed to the increased hospital expenditure (Delaney et al., 2001). This undesirable situation urges a specific rehabilitation program to facilitate patients recovery. The program is developed based on the ideas from Henrik Kehlet, who pioneered a multidisciplinary program for patients after the colonic surgery (Basse et al., 2000). The main concepts of the program include sufficient pre- operative education for patients, early resumption of oral feeding and mobilization after the surgery. By reducing unnecessary treatment (e.g. postoperative fasting and bed rest time), patients can have a faster recovery (Basse et al., 2000). Different rehabilitation programs such as the enhanced recovery after surgery (ERAS) and the fast- track program (FT) have been developed for the colorectal management and significant benefits on patients outcomes have been repeatedly reported from foreign countries. Evidences have confirmed that 1

12 these rehabilitation programs can accelerate patients postoperative recovery, resulting in less morbidity and shorter duration of hospitalization (Carli et al., 2009; Garcia- Botello et al., 2010 and Kehlet, 2005). 1.2 Affirming needs Despite the importance of a good management for colorectal cancer, a well- designed rehabilitation program has yet widely applied in Hong Kong. In addition, a universal consideration of a rehabilitation protocol is not achieved; some hospitals are still using traditional care for colorectal patients. In the hospital where I am working, a specific rehabilitation program for patients undergoing colorectal surgery is adopted. However, patients compliance to the program is low and the observed benefit is small. Reviewing the program, I found that it usually terminated at the early stage due to various reasons (e.g. incoherent practice of different surgeons and misunderstanding on the content of the recovery program). Possible reasons of the failure of the existing rehabilitation may include the protocol is overly detailed and not flexible enough and it is difficult for the healthcare staffs to follow and fulfill all the guidelines. In addition, the program involves too many parties (e.g. surgeons, anesthetists, nurses, physiotherapist and dietitians), strong communication and cooperation is a need to ensure the smooth running of the program (Lloyd et al., 2010). However, due to the harsh situation of Hong Kong clinical environment in which the ratio of health care providers to patients is so high, a complex scheme is difficult to be implemented and gain a significant benefit. Lastly, some surgeons prefer the traditional care because some of the concept in the program (e.g. early feeding after the surgery regardless the return of bowel function) violates the principle of traditional postoperative care (da Fonseca et al., 2011), resulting with an incoherence of practice on patients management. Therefore, if our 2

13 ultimate goal is to provide the benefits for the patients, the rehabilitation program should be re- designed and modified, so as to fit into the clinical environment of Hong Kong. 1.3 Significance A good rehabilitation can accelerate patients recovery after the surgery, so as to shorten the length of hospital stay and hence, decrease the hospital expenditure and preserve resources for the upcoming challenges. Due to the hectic clinical environment of Hong Kong, a good rehabilitation program should be simple and user- friendly. It should involve fewer parties so that it can be handle easily and applied in a busy workplace (Lloyd et al., 2010). Also, it should be sufficiently flexible for fitting into different clinical environments. The program should be systematic and consider different situations of the patients. With similar or even better outcome to the patients, health care providers are looking for a simpler and applicable rehabilitation program. And not surprisingly, nurse should be suitable for running and maintaining this program. Nurses are the persons who can accompany with the patients during their duties and they can have a close monitor on patients status. If there are sufficient evidences to back up, nurse can be the one who initiate a rehabilitation program (Wulff et al., 2012). From the hospital view, a nurse- led program can reserve more manpower and resources, and of course, the pre- condition of the single- disciplinary approach is that, the recovery of the patients will not be affected or delayed. The program seems to be more applicable if it is simplified and ran by a nurse. Therefore, I am looking for the possibility that whether a colorectal rehabilitation program can be simplified and implemented by nurses. 3

14 1.4 Research question Every clinical enquiry start with evidences searching and every evidence searching start with a research question. My research question is: Does a modified nurse- led rehabilitation program can accelerate overall recovery of patients after colorectal surgery? In the form of PICO, the above research question can be presented as: Population of interest (P) Patients undergoing colorectal surgery Intervention (I) A modified nurse- led rehabilitation program Comparison (C) Traditional postoperative care Outcome (O) Overall recovery of patients, including return of bowel function, mobility and complications 1.5 Objectives The objectives of my study were: 1. to review the published findings from the existing rehabilitation programs; 2. to extract appropriate information from the literature and integrate them into a table of evidence, so as to obtain a clear comparison among all the papers; 3. to perform quality assessment of the research papers in order to assess their reliability; 4. to summarize all the data from the selected literature and synthesize their findings to inform areas of modification and improvement of a rehabilitation program; 5. to develop a protocol that guide nurses to run a rehabilitation program. 4

15 CHAPTER 2 CRITICAL APPRAISAL 2.1 Searching strategies Databases Four electronic bibliographical databases were searched for the concerned research papers between August and September The databases included PubMed, Cochrane Library, Medline and CINAHL, and Google scholar. In addition, information from the Internet and the reference list from journals were other sources that I used for identifying relevant research papers Keywords and Searching Different keywords were used, including colorectal, fast- track, rehabilitation program, nurse or nurse- led, ERAS, early feeding, early mobilization, because they were directly related to my concerned topic, which is a special clinical rehabilitation protocol. A combined search was performed with different combination of keywords with Boolean operators to allocate a relevant paper precisely. Manual screening on the title and abstract was then performed for selecting the search results. Search records were kept for each database and, after combining and eliminating the duplicates, 9 papers were obtained. In addition, 1 paper was found by manual search from the Internet. And finally, a total of 10 papers were obtained for review. The search details were summarized in a form of table. (Appendix I) 5

16 2.1.3 Selection Criteria Research papers were selected according to pre- set criteria: Inclusion criteria: (1) Full text; (2) Randomized controlled trials, which is the gold standard to evaluate the effectiveness of a clinical trial (Melnyk & Fineout- Overholt, 2005); (3) Papers that were published from 2002 till now (approximate 10 years). Due to the substantial advancement of the surgery approach to colorectal cancer, recent studies conducted in the past 10 years may yield a more reliable outcome (Bree et al., 2011); (4) Patients underwent surgery as their major treatment of colorectal cancer; (5) Patients did not engage in other rehabilitation programs at the same time; (6) The trial was conducted in hospital setting; (7) Rehabilitation program focused specifically on colorectal surgery Exclusion criteria Papers were excluded if they met the following criteria: (1) Patients who were having chemotherapy as their major treatment; (2) Colorectal surgery that was not related to cancer causes (e.g. emergency trauma to the intestine resulting of bowel resection or reversal of stoma due to previous colonic surgery); and (3) Research focus was on surgery approach (e.g. open surgery versus laparoscopic surgery). 6

17 2.1.5 Search result and paper nature After all the selection and exclusion, a total of 10 papers were reviewed. All 10 papers were randomized controlled trial and were published from 2002 to All of the trials were performed in a hospital setting. Of the 10 papers, 3 papers compared early postoperative feeding with traditional feeding (Dag et al., 2011; da Fonseca et al., 2007 & Feo et al., 2003). The other 7 papers compared a rehabilitation program with the traditional care among the colorectal patients (Ionescu et al., 2009; Wang G et al, 2011, Henriksen et al., 2002; Khoo et al., 2007; Muller et al., 2009, Garcia- Botello et al., 2010; Feo et al., 2003 & Delaney et al., 2003). Details of the 10 papers are summarized in the form of Table of Evidence. (Appendix II) 2.2 Quality assessment To assess the quality of selected papers, the methodology checklists for randomized controlled trials from the Scottish Intercollegiate Guidelines Network (SIGN) was used. (Appendix 3) The quality of each paper was scored by the recommended grading of level of evidence from SIGN. (Appendix 4) Critical Appraisal on RCTs Research Question Most of the papers clearly stated their research question, their targeted population, intervention, comparison group, and outcomes. Two papers were rated as adequately address because their targeted outcomes was not adequately stated at the beginning (da Fonseca et al., 2010 & Khoo et al., 2007). 7

18 Randomization The method of randomization was clearly stated in most of the papers. Two papers used sealed envelopes (Delaney et al., 2003 & Garcia- Botello et al., 2010), for the other 8 papers, a computer program was used for the randomization process. In one paper, although randomization process was claimed to be done in the study, there was insufficient information on how it was achieved. Therefore, a comment of Not reported was given to this paper (Wang et al., 2011) Concealment and blinding Allocation concealment allows the researchers unaware of which treatment group that the subjects before they enter the study (Melnyk & Fineout- Overholt, 2005). The purpose of allocation concealment is to prevent researchers overestimating the effect of the intervention (Melnyk & Fineout- Overholt, 2005). Although most of the study did not mention the allocation method, the nature of the study design and the randomization method had already prevented the researchers from identifying which groups of the patients were allocated once they entered the trial. The baseline condition of the subjects in the trial were similar and thus did not carry a directive characteristic that allow the researchers to intentionally direct the group allocation. Two papers used concealed envelopes to enhance the concealment process (Delaney et al., 2003 & Garcia- Botello et al., 2010). For the blinding process, it can ensure the researchers and subjects unaware of what treatment they received, and thus, minimizing the overall bias of the intervention (Melnyk & Fineout- Overholt, 2005). However, it was difficult to design the binding process for the subjects and the health care providers in such kind of studies. Patients who participated in the rehabilitation program in all the studies had to sign an informed 8

19 consent. In addition, the intervention had to be performed by health care staffs. In one paper (da Fonseca et al., 2010), the authors mentioned that it is one of the limitations to such kind of study, and they used only one author to evaluate all 50 patients, in order minimize the bias Outcome measure The primary outcomes in all the researches papers were clearly listed out by the authors; secondary outcomes, including hospital cost and patient s satisfaction, were also noted in few papers. Measurements, such as the days of passage of first stool after the surgery (Dag et al., 2011; da Fonseca et al, 2010; Ionescu et al., 2009; Khoo et al., 2007 & Feo et al., 2003), mobilization performance (Ionescu et al., 2009; Henriksen et al., 2002 & Khoo et al., 2007), were recorded manually by nurses. Although outcome errors may exist in recording, it is more or less unavoidable errors in this kind of study (Rogers et al., 2008) Dropout rate The dropout rate and the reasons of dropout are listed in the summary session. Four of the 10 papers provided details of the dropping out of the sample (Dag et al., 2011; Ionescu et al., 2009; Khoo et al., 2007 & Feo et al., 2003). High dropout rate (~20%) would be a concern to the study design Intention- to- treat principle During analysis, intention- to- treat principle is used when subjects had missing values, which is useful in handling trial with high dropout rate. Six of the 10 papers used the intention- to- treat principle to analyze the data (da Fonseca et al., 2010; Wang et al., 9

20 2011; Khoo et al., 2007; Muller et al., 2009; Garcia- Botella et al., 2010 & Delaney et al., 2003). For the remaining four papers, since no dropout subjects were observed, the intention to treat was not applied in those papers (Dag et al., 2011; Ionescu et al., 2009; Henriksen et al., 2002 & Feo et al., 2003) Statistical Analysis Calculation of sample size and power estimation were performed with 8 papers to ensure validity of the outcomes (Dag et al., 2011; da Fonseca et al., 2010; Ionescu et al., 2009; Khoo et al., 2007; Garcia- Botello et al., 2010; Feo et al., 2003; Muller et al., 2009 & Delanet et al., 2003). 2.3 Data summary Summary on the evidence level All 10 papers obtained from the databases were randomized controlled trials. Level of evidence ranged from 2+ to 1+ with reference to SIGN recommended grading. The papers were criticized in an objective and conservative way. Four of the 10 papers have a grade of 1+ (da Fonseca et al., 2010; Khoo et al., 2007; Garcia- Botello et al., 2010 & Delaney et al., 2003). They were well- conducted RCTs with low bias involved. The study from Wang et al. (2011) was scored as grade 2+ due to the unclear description on the randomization method. For the remaining 5 papers (Dag et al., 2011; Ionescu et al., 2009; Henriksen et al., 2002; Muller et al., 2009 & Feo et al., 2003), they were graded as 1- due to the insufficient description on handling of bias. 10

21 2.3.2 Patients characteristics Sample size ranged from 40 to 210 across the 10 papers. Patients in all the articles underwent an elective open colorectal surgery. They were all adult patients with mean age of The demographic characteristics of the patients were clearly listed in all papers, except the Feo et al. s paper (2003). Education level of the patients was not mentioned in all papers. One paper included both patients who had open and laparoscopic surgery (da Fonseca et al., 2010). Possible bias may happen due to the use of mixed surgical procedure. However, due to the nature of randomized allocation, bias related to surgical types should be minimal and the outcomes is unlikely to be largely affected. For the remaining 9 papers, only open surgery patients were used in the trial. Across the studies, patients were commonly excluded due to the follow reasons: i. Patients who had emergency operation were excluded in 4 research studies (da Fonseca et al., 2010; Wang et al., 2011; Muller et al.,2009 & Garcia- Botello et al., 2010). It was because the patients conditions were unpredictable and fluctuated in an emergency situation, which was not suitable to be included in the program. ii. Patients who had advanced metastasis were excluded in 7 research studies (Dag et al, 2011; da Fonseca et al, 2010; Ionescu et al, 2009; Wang et al., 2011; Henriksen et al., 2002; Khoo et al., 2007 & Feo et al., 2003). The focus of patients in this stage was comfort care and pain control but not rehabilitation. Therefore, they were not the candidates of the study. iii. Patients who had a dependent lifestyle were excluded in 4 research studies (da Fonseca et al., 2010; Khoo et al., 2007; Muller et al., 2009 & Garcia- Botello et al., 11

22 2009). It was because some of the outcome measures focused on the muscle strength and return of normal mobility after the surgery Dropout rate The dropout rate ranged from 8 to 26 patients across the 10 papers. Three research studies documented a refusal of participating or withdrawing from the study (Dag et al., 2011; Ionescu et al., 2009 & Khoo et al., 2007). They refused to continue at the latter part of the study as they thought that their recovery was being affected. Stated in two studies, another main reason of dropout was the change of surgical types (Khoo et al., 2007 & Feo et al., 2003). It was due to the change of patient s condition or additional diagnosis was found during the surgery Intervention The intervention across the 10 papers can be divided into two main streams. Three papers concerned the comparison of early feeding regime with traditional feeding after the surgery (Dag et al., 2011; da Fonseca et al., 2007 & Feo et al., 2003). The remaining 7 papers compared a rehabilitation program with the traditional management on colorectal cancer patients (Henriksen et al., 2002; Delaney et al., 2003; Khoo et al., 2007; Ionescu et al., 2009; Muller et al., 2009; Garcia- Botello et al., 2010 & Wang et al., 2011). For the three papers of early feeding, liquid was allowed starting from 12 hours to Day 1 after the surgery in the intervention group, while patients in the control group were kept NPO until either passage of stool or flatus. Diet was then gradually resumed once the bowel function returned. The details are listed in Table

23 Table2.1 Feeding Regimen of the 3 concerned literatures Table 2.2 summarizes the common components in the rehabilitation programs based on 7 papers. The major components are related to pre- operative education, early feeding and early mobilization after the surgery, but the timing of implantation are different. Table 2.2 Components of the Rehabilitation program 13

24 Pre- operative education Preoperative education is stated in 5 papers. Patients received information about the milestone of the rehabilitation program. The included information are the specific diet regime and the mobilization scheme after the surgery, for enhancing a good cooperation with healthcare staffs during the scheme afterwards (Ionescu et al., 2009; Wang et al., 2001; Henriksen et al., 2002; Garcia- Botello et al., 2010 & Delaney et al., 2003) Early feeding For early feeding, the timing of resumption of liquid ranged from immediately after the surgery to 6 hours after the surgery. The diet gradually stepped up to a normal diet on the next postoperative day (Henriksen et al., 2002; Delaney et al., 2003; Khoo et al., 2007; Ionescu et al., 2009; Muller et al., 2009; Garcia- Botello et al., 2010 & Wang et al., 2011) Mobilization 3 studies mentioned patients were encouraged to mobilize on bed on the day of surgery and to perform walking exercise on the next day (Ionescu et al., 2009; Wang et al., 2001 & Henriksen et al., 2002). The duration of exercise and goals are stated in some studies only (Wang et al., 2001; Henriksen et al., 2002 & Delaney et al., 2003) Outcome measures (1) Nine papers included hospital stay time as their outcomes (Dag et al.,2011; da Fonseca et al., 2010; Ionescu et al.,2009; Wang et al.,2011; Khoo et al., 2007; Muller et al.,2009; Garcia- Botello et al., 2010; Feo et al.,2003 & Delaney et al., 2003) and is listed in 14

25 Table 2.3. Seven of the 9 papers showed a significant reduction on the length of hospital stay for around 2- to- 5 days. Table 2.3 Length of hospital stay (Effect Size of Intervention to Control group) (2) Table 2.4 displays 7 papers which included complications as their outcomes (Dag et al., 2011; da Fonseca et al., 2010; Wang et al., 2011; Muller et al., 2009; Garcia- Botello et al., 2010; Feo et al.,2003 & Delaney et al., 2003). Three of the 7 papers showed a significant result of fewer patients having complications after the surgery. 15

26 Table 2.4 Number of patients having complications (3) Table 2.5 summarizes the 7 papers which included the return of bowel function as their outcomes (Dag et al, 2011; da Fonseca et al., 2010; Ionescu et al., 2009; Wang et al,2011; Khoo et al., 2007; Garcia- Botello et al., 2010 & Feo et al., 2003). Bowel function was defined as the passage of first stool or flatus after the surgery (Dag et al., 2011 & Khoo et al., 2011). Six of the 7 papers showed a significant result on faster restoration of bowel function in intervention group. Table 2.5 Days to return of bowel function 16

27 (4) Three papers included patients mobility as outcomes and is displayed in Table 2.6 (Ionescu et al., 2009; Henriksen et al., 2002 & Khoo et al., 2007). All 3 papers concerning mobility as outcomes showed improvement on mobilization ability among the intervention group. Table 2.6 Patients mobility Other outcome measures included hospital cost, quality of life, and patients satisfaction. Three papers mentioned that pre- operative education and mobilization scheme in the rehabilitation program could be guided by nurses (Henriksen et al., 2002, Feo et al., 2003 & Delaney et al., 2003). From 2 papers (Feo et al., 2003 & Delaney et al., 2003), their results showed that the rehabilitation program neither improved nor worsened patient s quality of life (QoL), and patients satisfaction was similar in both groups. One secondary outcome reported by Delaney et al. (2003) stated the rehabilitation program was particular beneficial to the patients who aged younger than

28 2.4 Data synthesis After the summarizing data from all 10 journals, few findings can be synthesized for informing a new practice or protocol. Attending to the research question, which is Does a modified nurse- led rehabilitation program can accelerate overall recovery of patients after colorectal surgery?, three focuses are stressed. They are modified, nurse- led and accelerate overall recovery. Reduction of patients length of hospital stay is the ultimate goal A modified program A complete rehabilitation program involved preoperative education, intraoperative anesthesia and pain management with combination of different drugs, early removal of catheters, early post- operative management, and physical exercise (Wang et al., 2011 & Ionescu et al., 2009). The common elements of the rehabilitation program documented in the 10 papers are preoperative education, early mobilization and early mobilization. They are the essential part of the program. Even for a simplified program, these three elements should not be omitted. Preoperative education should contain written information on the overall rehabilitation program, in order to enhance a better cooperation of patients with the healthcare staff. In addition, according to Wulff et al. (2012), patients have a strong request of information about the treatment plan for easing their uncertainties and worries. Since early feeding and early mobilization were violating the traditional care, sufficient information about the benefit and safety is needed to satisfy the patients. Therefore, it was an important stepping- stone for the start of a smooth running program. One more important thing, mentioned from the study of Wang et al. (2011) is that the preoperative education should introduce to the whole family rather than the patient 18

29 only. Family often is the biggest support for the patient. Taking the entire family as the treatment target can bring a better outcome to the patient A Nurse- led program With sufficient evidence to support, nurse can be the one who operates this simplified program. As stated by multiple researchers, nurse has an important role on health education (Henriksen et al., 2002; Feo et al., 2003; Delaney et al., 2003). Therefore, preoperative education can be done by well- trained nurses; information should include the overall caring plan and details of the surgery. Mobilization scheme should be set clearly with a fixed goal. Mobilization exercise is done on bed on the day of surgery, following by walking exercise on the next day. Nurses can assist the entire process and evaluate the goal according to patients performance. Liquid diet can be started from 2 hours to first day after the surgery. Patients diet is gradually changed to soft diet and to normal diet if patients tolerated. Nurses need to monitor any signs of vomiting or other complications after resumption of diet, as well as to initiate the diet step up process if patient tolerated the intake Overall recovery The hospital stay time of the rehabilitation program group was 2-4 days, comparing with the 7-9 days in conventional group as suggested by Feo et al. (2002). The effect was so significant. The time for returning bowel function in a program group was faster than the traditional group for at least 1-2 days with better diet tolerance in the intervention group. Furthermore, the mobility function of patients in the program 19

30 was also better. The needed time for independent mobilization was 1-2 days earlier than the traditional group (Henriksen et al., 2002 & Khoo et al., 2007). 20

31 CHAPTER 3 IMPLEMENTATION POTENTIAL 3.1 Introduction In the previous chapter, the heavy burden from the growing number of colorectal patients imposed on the hospital management is described. From the literatures, evidences support a nurse- led modified rehabilitation program, which could enhance faster overall recovery of the patients and decrease patient s hospital stay time. In this chapter, the implementation potential of this program is assessed. Transferability of the findings, feasibility and the cost/benefit ratio of the innovation is considered before putting the program into real practice. 3.2 Target setting and target patients The target setting is four general surgery wards in an acute hospital under Hospital Authority in Hong Kong. The capacity of the wards, on average, is 40 beds and mainly serves the patients coming from east cluster of Hong Kong Island. Patients diagnosed with different surgical problems and cancer diseases will be admitted to the ward. Patients who are diagnosed with colorectal carcinoma and having an elective open colorectal surgery performed are the target patients. 3.3 Transferability Comparison of the selected studies and the target setting are needed to assess whether the findings are transferable. 21

32 3.3.1 Environmental setting and patients All the clinical trials in the selected studies were performed in- patient surgical units of various acute hospitals, which are similar to the target setting. The majority of the selected studies were conducted in developed countries, such as Italy and Spain, where have a similar development and economic status with the proposed setting, Hong Kong. The characteristics of the patients in the reviewed studies are similar to the target patients in term of age and diagnosis. Specifically that are both adult patients aged and are diagnosed with colorectal cancer. Target patients will undergo surgical resection as the major treatment of their cancer. The proposed rehabilitation program is a good fit for the recovery journey of the patients after the operation Philosophy of care The core value of the target hospital is to provide high quality care. Patients comfort and their well- being are the prime consideration. The proposed innovation is an evidence- based practice that carries the purpose of increasing the overall recovery of the patients after the surgery and thus decreasing the length of stay in hospital. By using a simple and user- friendly rehabilitation program to guide the treatment pathway, patients will have better compliances to the program and gain a better recovery Patients to be benefited The proposed innovation will benefit the patients who undergo colorectal surgery. From the case report of the target hospital, there were around 140 patients admitted to the surgical department for colorectal surgery in the first half of the year The mean hospital stay time of this group of patients was 10.5 days. Prolonged length of hospital stay not only exerts heavy burden on the hospital resources, but also 22

33 affects the recovery of the patients. With significant decreased length of stay and lesser complications from the proposed innovation, it is believed that approximately 280 patients will be benefited in a year Time for implementation and evaluation The whole implementation period will be separated into three phases, preparation, intervention and evaluation phase. To start with, a coordination committee will be formed to facilitate the whole program and coordinate different parties. One month will be needed for the formation of committee team and the communication plan. Another one month will be required for staff training and program briefing. Then, a pilot program lasting for 2 months will be conducted, and will be followed by evaluation of the pilot and revamping of the program, which will take another one- month time. A full intervention will be carried out afterward for 6 months and evaluation will be carried out for 1 month afterwards. 3.4 Feasibility As mentioned, the core value of the target hospital is to provide high quality care and patient s health is the major consideration. It is no doubt that the administrators and the management level will fully support the proposed innovation, as it is an evidence- based practice that will provide a significant benefit and enhancement comparing to the traditional protocol. Departmental climate of running a research- grounded innovation is positive as nurses have the autonomy to carry out evidence- based practice, which is embodied by a previous experience of introduction of another evidenced- based practice for another clinical issue. 23

34 The program user, nurses, is another major consideration in determining the feasibility of the program. The proposed innovation is a nurse- led rehabilitation program. Nurses have the autonomy to run the program; they have the freedom to initiate or terminate the program based on their professional judgment and the supervision from experienced advanced practice nurses (APN). It is not difficult to understand that there will have barriers when the program puts into practice. It is predictable that some nurses may think that the new protocol will increase their workload and interfere with their routine practice. In addition, nurses may worry that they do not have enough knowledge to run the program by their own, or they may question the outcome of the innovation and prefer to stay for the old rule. In addition, patients may not accept the new rehabilitation plan if no significant benefit is presented. Some doctors may even concern about the nurse s ability to carry out the innovation. Therefore, a clear and well- planned information section before the implementation will be need to ease all the uncertainties from the users. To increase the feasibility of implementing the innovation, the cooperation between nurses and doctors is needed. The three main components of the proposed rehabilitation program are preoperative education, early oral feeding, and early mobilization. Of which, preoperative education and mobilization are the usual practice that can be performed by nurses. While, the decision of resuming a diet after the operation is usually from physicians, an issue concerning 'if nurse has enough power of making the decision of resuming an oral feeding' will be aroused. Traditionally, physicians will allow the patients to have their diet back once they have flatus or bowel open, which are indicators of the return of bowel after the surgery. Newly emerged evidences have shown that early oral intake regardless the sign of bowel function can be a stimulant to the intestine and enhance the return of function. It is the essence of the 24

35 proposed innovation. Evidences support that early oral feeding can accelerate the return of bowel function. To increase nurses confidence and ease their worries on the new practice, clinical trial or evidences with significant figure should be highlighted and presented. With support and advice from doctors, the momentum of the innovation will be stronger. Doctors are consulted regularly for opinions or modification of the program, so nurse can be competent to run the innovation. Cooperation between doctors and nurses will be the key determinant of the successfulness of the program. One important point that should be emphasized is that the proposed innovation does not add many new things into current practice. It reforms current practice into a systemic and directive protocol with a fixed and achievable goal, which is much easier to follow and can be operated by nurses, In addition, the outcomes is more beneficial as shown by the selected evidences. 3.5 Cost- benefit ratio of the innovation Potential risks of the proposed innovation Although selected evidences have proved the safety of the proposed innovation, some patients still suffer from post- operative complications. These undesirable outcomes have been noted in some of the selected literatures, but outcomes statistics have shown that the complication rate in the proposed rehabilitation program is similar or even lower than the traditional practice. Therefore, the risk is not significant Potential risks of maintaining current practice Accountable risk of continuing current practice includes a long hospital stay. It increases hospital s expenditure and the patients will also have higher chance of getting 25

36 hospital- acquired diseases. Due to the long stay, healthcare providers will have additional workload on managing the patients. Therefore, a new innovation is required Potential benefits of the innovation As concluded from the selected literatures, proposed rehabilitation program will bring patients with a shorter length of hospital stay, faster return of bowel function and tolerance to a normal diet, faster recovery on mobility and less post- operative complications. Clinical staffs will have higher job satisfaction as patients recovery is enhanced and discharge with shorter length of stay and, more importantly, lesser workload and pressure. For the organization, shorter length of patients stay can preserve more resource and manpower to cope with the coming clinical challenges Material costs The material costs mainly fall on the setting cost and the evaluation. Budget is used to organize training sessions and prepare evaluation. Materials required are minimal since the innovation is a reconstruction of current practice and most of the equipment is readily available. No extra staffs and skills are required. Education leaflets are required in our program. It is estimated around 20 patients will be admitted for surgery per month. Each patient required 3 individual leaflets concerning pre- operative preparation, feeding regime, and walking exercise instruction. Assuming each page costs around $2, the estimated cost of education leaflet for the 2- month pilot study will be $

37 CHAPTER 4 DEVELOPING EBP GUIDELINE 4.1 Introduction Based on the literature review of the 10 selected studies, a guideline for the rehabilitation of the colorectal cancer patient undergoing surgery is developed. (Appendix 5) 4.2 Title Nurse- led rehabilitation program for colorectal cancer patients after the surgery 4.3 Objectives 1. To enhance colorectal cancer patients overall recovery from the surgery and improve their satisfaction. 2. To shorten the length of hospital stay of the target patients, and hence, preserve hospital resources and lower the workload of healthcare providers. 3. To guide nurses on providing high quality, effective care and management to the colorectal cancer patients after the surgery based on the best available evidences. 4. To ensure patients receiving standardized, consistent and effective evidence- based nursing care. 4.4 Target group Patients who are 1. Diagnosed with stage I- III colorectal cancer and receiving elective surgery. 2. Aged Having an independent lifestyle preoperatively 27

38 4.5 Rating scheme for the level of evidence and grades of recommendations The level of evidence and grades of recommendations are graded with reference to SIGN framework. 4.6 Recommendations The recommendation consists of 3 parts, the assessment, intervention and the evaluation. ASSESSMENT 1.0 Recommendation 1.1 The target patient should be under the age of 70 Grade of recommendation: A Available evidence: - Patients younger than 70 years of age receive the optimal benefits and do well in the recovery pathway. A shortened length of stay is noted from the evidence in this group of patients. (Delaney et al., 2003)(1+) Recommendation 1.2 The target patients should have an independent lifestyle so that they can follow the program well Grade of recommendation: A Available evidence: - Patients who have cognitive deficits or having a dependent lifestyle should be excluded, as they cannot follow the protocol. (da Fonseca et al., 2010)(1+) / Khoo et al., 2007) (1+) / (Muller et al., 2009) (1- ) / (Garcia- Botello et al.,2009) (1+) 28

39 INTERVENTION 2.0 Preoperative education 2.1 Recommendation To enhance better compliance for the innovation, details of the treatment plan and the stages of the program should be provided to patients and their families before the operation Grade of recommendation: B Available evidences: - Preoperative education is regarded as the crucial factors for the rehabilitation program. A better understanding of the program can lead to better cooperation. (Wang et al., 2011)(2+) - Recommendations and actions to be taken should be provided to patients hospital staffs in the postoperative program. (Garcia- Botello et al.,2009) (1+) Early oral feeding 2.2 Recommendation Early resumption of oral feeding within 24 hour after the surgery, first oral fluid is allowed immediately after the surgery if patient can tolerate. Grade of recommendation: A Available evidences: - Early initiation of oral nutrition within 24 hours after the gastrointestinal surgery reduces catabolism and morbidity. (da Fonseca et al., 2010)(1+) - Starvation changes the body s metabolism within 24 hours by increasing insulin resistance and reducing muscle function. Early oral intake has been suggested to 29

40 reduce sepsis risk because of decreased bacterial colonization in the intestine. (Dag et al., 2011)(1- ) - Early feeding during the first 24 hours after the surgery promotes the recovery of ileus and decreases infectious complications. (Wang et al., 2011) (2+) Early mobilization 2.3 Recommendation Assist patient to sit out of bed or do walking exercise with a pre- set goal on the day of surgery can enhance muscle recovery Grade of recommendation: A Available evidences: - Enforced postoperative mobilization can reduce pulmonary infection and venous thrombosis and also decreases protein loss due to long- term bedridden. (Wang et al., 2011) (2+) - - Enforced exercise can preserve more body minerals and increase muscle strength after the surgery. (Henriksen et al., 2002)(1- ) - Patients are required to meet predefined mobility targets on the day after the surgery to promote better recovery. (Khoo et al., 2007)(1+) 30

41 EVALUATION 3.0 Recommendation 3.1 Monitor patient s sign of nausea and vomiting after resuming first diet as it indicates patient s diet tolerance. Grade of recommendation: A Available evidences: - Patients who do not tolerate the first oral diet would have nausea and vomiting. (da Fonseca et al., 2010)(1+) Recommendation 3.2 Patients can be discharged with tolerance to diet, passage of first flatus, able to walk independently and absent of complications. Grade of recommendation: A Available evidences: - Length of hospital stay is a difficult outcome to measure when uniform criteria for discharge are not well established, which may result in bias. (da Fonseca et al., 2010)(1+) - Patients can be discharged when they tolerate diet and have no nausea and vomiting. (Ionescu et al., 2009)(1- ) 31

42 CHAPTER 5 IMPLEMENTATION PLAN The transferability and implementation potential of the innovation are discussed in the previous chapter. A deliberate consideration on the overall implementation plan would be the next crucial step for the innovation. This could be accomplished through deciding the communication plan, pilot testing plan, and evaluation plan. 5.1 identifying the stakeholders Stakeholder will be affected or benefited by the proposed innovation. Identification of this group of people is important as effective communication can build up a positive cooperative relationship and gain their support throughout the proposed program (Ingersoll, 2005). The key stakeholders in this rehabilitation program mainly fall on four levels. They are the frontline users of the wards, management level of the department, administrative level of the hospital, and the allied health of the ward Frontline users of the protocol of the wards Users of the proposed protocol were nurses in the surgical department. Surgeons are responsible for the planning of diet regime. Nurses can make the decision of starting the diet according to their professional judgment or doctor s suggestions. They are required to assist the patients in the diet regime and perform early walking exercises in the post- operative period. As nurses are the users of the protocol, effective communication and detailed explanation of the protocol with them is a necessity for a smooth implementation. 32

43 5.1.2 Management level of the department The Chief of Service (COS), Department Operation Manager (DOM) of the surgical department; Ward Managers, Nursing Officers (NO) and Advanced Practiced Nurses (APN) in each ward are the key persons in this level. They are experts in making clinical development and planning. Their approval and support are essential for the implementation of the new clinical guideline. In addition, support from the leader in a clinical environment can enhance positive staff s outcome and team spirit (Fry et al., 2012). An APN, titled as Colorectal Case Manager, will be informed with the details as he will be the host of the program Administrative level of the hospital As the policy maker of the hospital, they have to be informed and agreement will be obtained before the implementation of a new protocol. Besides, it will be easier to apply for funding from the hospital if a cost- effective guideline is presented to them. The hospital Chief Executive Officer (CEO) and General Manager of Nursing (GMN) are the representative of this group of stakeholder Allied Health Assistance from health care assistants (HCA) for helping patients to perform early post- op exercise is also important. They can help to alleviate nurse s workload when using the protocol. Therefore, their understanding of the program is also essential. 33