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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

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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.

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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

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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

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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.

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Table of Contents

Declaration ………………………………………………………………………………………………………. i Acknowledge ……………………………………………………………………………………………………. ii Table of Contents …………………………………………………………………………………………........ iii Summary data list …………………………………………………………………………………………….. v Appendices List …………………………………………………………………………………………………. v Abbreviations ……………………………………………………………………………………………………. vi CHAPTER 1: INTRODUCTION Page 1.1 Background 1 1.2 Affirming Needs 2 1.3 Significance 3 1.4 Research Question 4 1.5 Objectives 4 CHAPTER 2: CRITICAL APPRAISAL 2.1 Searching Strategies 5 2.2 Quality assessment 7 2.3 Data Summary 10 2.4 Data Synthesis 18 CHAPTER 3: IMPLEMENTATION POTENTIAL 3.1 Introduction 21 3.2 Target Setting and Target patient 21 3.3 Transferability 21 3.4 Feasibility 23 3.5 Cost-‐Benefit ratio of the innovation 25 CHAPTER 4: DEVELOPING EBP GUIDELINE 4.1 Introduction 27 4.2 Title 27 4.3 Objectives 27 4.4 Target group 27

4.5 Rating scheme for the level of evidence 28 4.6 Recommendations 28 CHAPTER 5: IMPLEMENTATION PLAN 5.1 Identifying the stakeholders 32 5.2 Communication plan with stakeholders 34 5.3 Pilot study plan 37 CHAPTER 6: EVALUATION PLAN 6.1 Introduction 40 6.2 Identify outcomes to be achieved 40 6.3 The nature of clients to be involved 41 6.4 The number of clients involved and study design 41 6.5 Deciding when and how often to take measurements 42 6.6 Basis for an effective change of practice 43

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Page CHAPTER 7: CONCLUSION 45 APPENDICES 46 REFERENCES LIST 64

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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

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Abbreviations

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

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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 2010. 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

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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

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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.

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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.

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CHAPTER 2 CRITICAL APPRAISAL

2.1 Searching strategies

2.1.1 Databases

Four electronic bibliographical databases were searched for the concerned

research papers between August and September 2012. 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.

2.1.2 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)

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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.

2.1.4 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).

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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 2011. 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)

2.2.1 Critical Appraisal on RCTs

2.2.1.1 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).

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2.2.1.2 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).

2.2.1.3 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

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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.

2.2.1.4 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).

2.2.1.5 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.

2.2.1.6 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.,

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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).

2.2.1.7 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

2.3.1 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.

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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 50-‐70. 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.,

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2009). It was because some of the outcome measures focused on the muscle

strength and return of normal mobility after the surgery.

2.3.3 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.

2.3.4 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 2.1

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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

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2.3.4.1 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).

2.3.4.2 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).

2.3.4.3 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).

2.3.4.4 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

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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.

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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

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(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 70.

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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.

2.4.1 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

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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.

2.4.2 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.

2.4.3 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

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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).

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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.

22

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 50-‐70

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.

3.3.2 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.

3.3.4 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

2012. 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

23

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.

3.3.4 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.

24

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

25

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

3.5.1 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.

3.5.2 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

26

hospital-‐acquired diseases. Due to the long stay, healthcare providers will have

additional workload on managing the patients. Therefore, a new innovation is required.

3.5.3 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.

3.5.4 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

$240.

27

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 18-‐70

3. Having an independent lifestyle preoperatively

28

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


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+)

29

INTERVENTION 2.0

Preoperative education 2.1

Recommendation 2.1.1

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


Early resumption of oral feeding within 24 hour after the surgery, first oral fluid is

allowed immediately after the surgery if patient can tolerate.



-‐ 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

30

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


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



-‐ 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+)

31

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.



-‐ 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.



-‐ 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-‐)

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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.

5.1.1 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.

33

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.

5.1.3 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.

5.1.4 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.

34

5.2 communication plan with stakeholders

Effective communication with stakeholders is the cornerstone of a successful

new clinical guideline (Ingersoll, 2005). Effective communication can facilitate better

collaboration of different parties, and hence, the implementation of the program will be

smoother and easier, and less conflict will be aroused from misunderstanding. Therefore,

detailed consideration on communication plan is essential before starting a protocol.

Strategies and the overall communication plan are as follow. The program briefing will

last for one month.

5.2.1 Communication with Management level of the surgical department

The management level of the surgical department is the first target that we will

communicate with. It is because they are the decision makers for introducing a new

protocol into the department. Their agreement and support is essential. In addition, they

are the communication bridge between the frontline staffs and the hospital

administrators. Suggestions and feedback can be exchanged effectively between the

frontline staff and the administrators with the facilitation from this sector. During

routine senior meetings among the COS, DOM and all ward managers in the surgical unit,

the ideas from the new protocol will be brought out in the form of PowerPoint

presentation. The main content of the presentation is to point out the insufficiency of

current practice and show, based on the sufficient evidences and statistics, how the new

innovation can lead to a change. This first presentation aims to gain the approval and

support from the management level. All the steps related to the innovation will be

clearly presented and it should be significant enough to convince them to make a

consideration on this innovation. The content will also include the feasibility of the

program and the whole implementation plan. Without the support from this sector, it is

35

hard for the program to process to the next step. They will then communicate with the

hospital CEO and GMN for the preparation of the program.

5.2.2 Setting up a Communication team

To facilitate the whole program and to coordinate different parties during the

implementation, a coordination committee will be set up. The team will include several

members in the department. The team leader will be the colorectal manager because it

is a nurse-‐led rehabilitation program; therefore it will be easier to collaborate with

others. Other members include four link nurses from each surgical ward. They are

responsible for attending bi-‐weekly regular committee meeting and update ward staffs

for the progress of the program. One doctor consultant and one medical officer from the

colorectal team will be the facilitator to give comments and guide the medical officers

throughout the program. Therefore, the communication team will consist of a total of

seven members.

5.2.3 Communication with ward managers (WM) and nursing officers (NO) in each

surgical ward

Email will be sent through internal email system by the colorectal manager to

inform WM and NO about the preparation of the innovation, so that they can facilitate

the implementation of the program. They will be informed with the latest progress

through email in a bi-‐weekly basis. Updated information will be disseminated to ward

staffs during the handover time each day.

36

5.2.4 Communication with the nurses in each surgical ward

After getting the approval for the implementation of the program from the

administrators and the setting up of the coordination team, the next step is to spread the

message to the users of the program: nurses in each surgical ward. The link nurse will be

responsible for briefing her colleagues during briefing session in the afternoon each day

for about 30 minutes. The idea and content of the program will be introduced. In

addition, one information file with details of the program will be prepared by the

committee team and put in each ward for reference. Two 30 minutes information

sessions will be held at lunchtime for all nurses to make enquiries. About 1 week before

starting the pilot program, a 2-‐hour journal club will be held by the committee team to

disseminate the findings of the latest journals regarding the program, with the purpose

of appreciating the possible benefits, so as to get their support towards the innovation.

5.2.5 Communication with colorectal surgeons in the department

Email containing details of the program will be sent to all surgeons in the

colorectal team. Colorectal team consultant will brief his colleagues during daily meeting

and gain their cooperation and support to the program.

5.2.6 Communication with allied health members

Link nurses in each ward will brief all health care assistants on how they can give

help in the program. Information leaflets will be provided and posted on the noticeboard

in each ward.

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5.3 PILOT STUDY PLAN

Pilot study is a small-‐scale pre-‐study before the implementation of the full-‐scale

innovation. Since there is no similar guideline before, it is essential to perform a trial to

ensure the feasibility and evaluate the effectiveness of the program, and hence give

confidence to the administrators to implement the full-‐scale program afterwards.

5.3.1 The Objectives of the pilot study is to:

(1) test the feasibility and acceptability of the program

(2) examine the clinical effectiveness of the program

(3) assess staffs’ compliance towards the protocol

5.3.2 Pilot test setting

The pilot test will be performed in one of the four surgery wards in the department.

5.3.3 Time frame

2 months after the program briefing

5.3.4 Target patient and sampling

Inclusion criteria of the target patient will be identical to the full-‐scale study.

They will be adult patients who undergo elective colorectal surgery. Patients who are

admitted to the surgical ward within these 2 months and fulfill the inclusion criteria will

be recruited. According to hospital colorectal team statistics, monthly admission rate for

elective colorectal surgery is approximately 8 patients in a ward and therefore there will

be 16 patients for the pilot study. Informed consent will be signed once they are being

38

recruited. Details of the program will be explained and their progress will be recorded

and updated by team nurse.

5.3.5 Outcomes measures

The length of stay of the patients is the primary outcome measure of the program.

Time for returning of bowel function of the patient, time for the patient to walk

independently and the occurrence of complications are the secondary outcomes that we

would like to obtain.

5.3.6 The feasibility and acceptability of the program

The feasibility and the acceptability of the program will be evaluated in the form

of survey. The client satisfaction survey (Appendix 7) will be distributed to patients at

the day when they are discharged. A 5-‐points-‐scale questionnaire will be used to assess

patients’ satisfaction towards the rehabilitation program. Also, open-‐ended questions

are prepared to encourage patients to comment and give feedback to the program, and

to evaluate whether are confident to follow the protocol. For nurses and allied health

members, another set of questionnaire (Appendix 8) will be given at the end of the pilot

study. The questionnaire mainly concerns the difficulties they have encountered during

the implementation. Open-‐ended questions included in the questionnaire will elicit their

suggestions for the improvements of the program. Workload, job satisfaction will also be

evaluated in the survey. In additions, all ward staffs are invited to attend a focus group

interview held by the committee team after the pilot study for comments and

suggestions regarding the implementation and the use of the program.

39

5.3.7 Clinical effectiveness of the program

The flow and the details of the rehabilitation program, together with the progress

record will be printed in an A4 sheet (Appendix 6) and put inside patient’s kardex to

remind nurses and doctors. Nurses can follow the flow chart to perform corresponding

care to the patients. Relevant data, including time for passing out first flatus, walking

distance, and length of stay, will be recorded when it is observed. All forms will be

collected at the end of the pilot study. Data will be analyzed by the colorectal manager.

Result will be discussed in one of the meetings with the committee team. After

reviewing the data, recommendations and modifications for the full-‐scale program will

be made.

5.3.8 Compliance of staffs to the protocol

Staffs compliance will directly affect the effectiveness of the program, therefore,

it is necessary to assess the difficulties they encountered during the implementation, so

as to maximize the effect of the full-‐scale program. Several Barriers (i.e. unclear program

instructions, heavy workload, and lack of supports from the leaders) are associated with

negative program outcomes and negative staff outcomes. They are required to check the

boxes of the corresponding items in the program flowchart after they have performed

the action. Colorectal manager will visit the target ward twice a week to collect verbal

opinions from nurses. In addition, survey at the end of the pilot study and completeness

of the work flowchart can also reflect staffs’ compliance towards the program.

40

CHAPTER 6 EVALUATION PLAN

6.1 INTRODUCTION

Evaluation is the major and final part of an intervention, it decides whether the

program objectives have been achieved. It also outlines if further modification is needed

to provide better outcome of an innovation. It is a continuous process that requires pre-‐

decided framework to optimize the concerned outcomes. It also validates the effort of

the stakeholders on the planning of the innovation. Details of the evaluation plan are as

follow:

6.2 IDENTIFYING OUTCOMES TO BE ACHIEVED

Outcomes are mainly classified on three aspects: Patients, health care providers

and organization.

6.2.1 Patient outcomes

The aim of the protocol is to enhance patient’s recovery and shorten the length of

stay of patients (Ionescu et al., 2009). From the studies reviewed, a modified

rehabilitation program has a direct positive relationship to the patient’s recovery rate,

which can be measured by an earlier return of bowel function and mobilization ability.

The primary outcome is patients’ length of stay, which is directly influenced by the data

of days to have first flatus and days to walk independently after the operation. The

secondary outcome is post-‐operative complications. Data will be recorded by nurses

once it is observed. Result will be analyzed and evaluated by the committee team for the

41

effectiveness of the protocol. Besides, patient’s satisfactory level towards the program

will also be assessed.

6.2.2 Health care providers outcomes

Outcomes of health care providers include staff’s compliance and satisfaction for

the rehabilitation program. These are the main factors that determine the

implementation of the full-‐scale program.

6.2.3 Organization outcomes

Additional cost-‐effectiveness analysis will be calculated, achieving by using data

of the patient primary outcome, which is the length of hospital stay. As mentioned, the

program is just a modification and reform of the current practice (minimal expenditure

is expected) and therefore the focus on this part will be the cost saved by the program.

6.3 THE NATURE OF CLIENTS TO BE INVOLVED

Patient’s eligibility for the evaluation plan is identical to the target population.

They are patients who have diagnosed with stage I-‐III colorectal carcinoma and admit to

the department for an elective surgery. Age range should be around 18-‐70 and having an

independent lifestyle.

6.4 THE NUMBER OF CLIENTS INVOLVED AND STUDY DESIGN

By using online sample size calculator by Lenth (2006), the number of patients to

be involved in the evaluation plan should be at least 33. The calculation is based on the

primary outcome, which is the length of hospital stay of the patient. The full-‐scale

program is a one-‐group design and all subjects receive the same rehabilitation program.

42

The evaluation objective is to determine whether the length of stay of the patients

receiving the innovation is reduced. Comparison data is from the hospital statistics and

reviewed studies. Through a one sample paired t test, with alpha value of 0.05 and a

power of 80%, the required sample size is at least 33 after calculation.

6.5 DECIDING WHEN AND HOW OFTEN TO TAKE MEASUREMENTS

The full-‐scale program will be implemented for approximately 6 months in the

surgical department. Measurement will take place continuously towards different

parties at different time. For patients, the outcomes are the length of hospital stay, post-‐

operative days to pass out first flatus or stool, complications, and days to walk

independently. They are all short-‐term measures and all are recorded by nurses at the

time when they are observed. In addition, patient’s satisfactory level to the program is

measured by a self-‐report questionnaire and will be distributed to patient at the day

they are discharge home. The questionnaire is a five-‐points scale ‘5-‐strongly agree’, ’4-‐

agree’, ’3-‐ neural’, ‘2-‐disagree’, ‘1-‐strongly disagree’, to indicate patient’s view towards

the program. Open-‐end questions are listed to elicit patients’ comments and suggestions.

For nurses and other health care providers, another set of questionnaire will be given at

two-‐time points (at the end of the third month and end of the program) to assess staffs’

satisfactory level and difficulties encountered during the implementation period. It is an

intermediate to long-‐term measurement. Colorectal manager will visit the ward

regularly and evaluate staff’s compliance to the program. All questionnaires will be

collected and analyzed by the colorectal manager.

43

6.6 BASIS FOR AN EFFECTIVE CHANGE OF PRACTICE

Operationalized the definition of effective is essential for an innovation to

become valid and proceed forward. The rehabilitation program will be considered as

effective according to following results:

6.6.1 Patient’s outcomes

The effectiveness of the program will be determined by comparing the observed

findings from the target setting with the reviewed studies. The primary outcomes of the

program is the length of hospital stay of patients. It is affected by two parameters: days

to walk independently and days to pass out first flatus or stool. They indicate the

recovery process of the patient. From the reviewed studies, length of stay of patients

receiving usual care is around 7-‐9 days and 4-‐5 days when the patients are under special

rehabilitation protocol. With reference to one study done by Kehlet et al. (2000),

approximate 80-‐90% of the patients had reduced length of stay after receiving a clinical

protocol. The program can be considered effective when 80% of the patients’ length of

stay is within 4-‐5 days. The recorded complications, walking ability and bowel recovery

will also be compared with the studies reviewed. Improved results can be considered as

an evidence of effectiveness of the program. 95% confident interval will be performed to

evaluate the validity of the data.

44

6.6.2 Patients and staffs satisfactory level

When more than 60% of the items in the satisfactory questionnaire from both

staffs and patients achieve the grade of ‘3-‐neutral’ or above, the program will be regard

as ‘satisfactory’ (Jenkinson et al., 2002). Open-‐end answers will be concluded and

summarized into descriptive data, degree of effectiveness will be concluded by the

colorectal manager.

45

CHAPTER 7 CONCLUSION

In view of the prevalence of colorectal cancer, more patients will receive

colorectal surgery. Based on the findings of the reviewed literatures, a modified

rehabilitation program for this group of patients can accelerate overall recovery,

including patients’ bowel function and mobility recovery. It is believed that patients will

have a shorter length of hospital stay when this evidence-‐based rehabilitation program

is adopted. To implement this program successfully, a well implementation planning and

other peripheral considerations (e.g. environment, manpower, cost) is the foundation. In

addition, good communication plan among different parties is the major determining

issue in the entire program.

From the reviewed literatures, the rehabilitation program is implemented with

the patients who undergo elective open colorectal surgery. Its benefits over the

traditional open approach is well supported by the existing evidences (Lloyd et al., 2010,

Zhou et al., 2011 & da Fonseca et al., 2010). With advance of surgical technique,

laparoscopic surgery will soon become a main stream of surgical approach to colorectal

cancer. Therefore, this rehabilitation program should be reviewed and advanced if the

laparoscopic surgery become the main stream of surgical approach.

46

Appendix 1

Summary of Searching details

Appendix 2

47

Bibliographic citation Study type Patient characteristics

Intervention (n) Comparison (n) Length of follow up

Outcomes measures Effect size (Intervention to comparison group)

Dag, A., Colak, T., Turkmenoglu, O., Gundogdu, R. & Aydin, S. (2011). A randomized controlled trial evaluating early versus traditional oral feeding after colorectal surgery. Clinics. 66(12):2001-‐2005

Randomized controlled trial (1-)

-‐ Patients undergoing elective open colorectal cancer surgery without the creation of a colostomy or ileostomy -‐ Median age: 61 -‐ Post-‐op pain control by PCA -‐ Mostly Ca rectum or Ca sigmoid colon

Early postoperative oral feeding commencing approximately 12 hours after the surgery with a fluid diet, gradually increased to solid diet if tolerated (n=99)

Fasting until the patient passed first flatus or stools (n=100)

-‐ Primary: (1) Hospital stay [days] Secondary: (2) Time of intestinal movements [days] (3) Time of defecation [days] (4) Time to toleration of a regular diet [days] (5) Postoperative complication [n]

(1) -‐3.45 (p=0.0001) (2) -‐1.51 (p=0.0001) (3) -‐0.97 (p=0.0001) (4)-‐2.29 (p=0.0001) (5) -‐2 (p=0.541)

da Fonseca, L. M., Profeta da Luz, M. M., Lacerda-‐Filho, A., Correia, M. I. T. D. & Gomes da Silva, R. (2011). A simplified rehabilitation program for patients undergoing elective colonic surgery – randomized controlled clinical trial. Int J Colorectal Dis. 26:609-‐616

Randomized controlled trial (1+)

-‐ Patients undergoing elective colonic surgery without the creation of stoma -‐ Mean age: 55 -‐Post-‐op pain control by bolus IV drugs

Early feeding group: On the first postoperative day, received an oral liquid diet (~500cm3), advanced to a regular diet within the next 24h if tolerated (n=24)

Traditional care group: Received nothing by mouth until the elimination of the first flatus, then received an oral liquid diet, followed by a regular diet within the next 24h as the same of the intervention group

30 days Primary: (1) Length of hospital stay [days] (2) Time to first flatus after surgery [days] (3) Tolerance of solid diet [n] (4) General post-‐op complications [n] Secondary: (5) Hospital readmission

(1) -‐3.6 (p<0.001) (2) -‐0.5 (p=0.019) (3) +4 (p=0.093) (4) 4 in intervention group vs 9 in control group (p=0.480) (5) -‐4(p= Not sig

Appendix 2

48

(n=26)

Ionescu, D. et al. (2009). Implementing Fast-‐Track Protocol for colorectal Surgery: A Prospective Randomized clinical Trial. World J Surg. 33:2433-‐2438

Randomized controlled trial (1-)

-‐ Patients undergone elective open colorectal surgery -‐ No previous history of abdominal surgery -‐ Median age: 62 -‐ Post-‐op pain control by epidural infusion / PCA

Fast track group: Information on the surgical procedure, recovery pathway was given before OT. Fluids on the day of surgery, mobilization, turning and sitting in bed. On post-‐op day 1: Walking exercise, fluids or soft solid food Post-‐op day 2: normal feeding (n=48)

Conventional group: NPO on the day of surgery, nasogastric tube, mobilized in bed. On post-‐op day 1: keep NPO with nasogastric tube, mobilized out of bed Post-‐op day2: Remove NG tube if bowel passage, and start fluid orally, otherwise, keep NG tube (n=48)

-‐ Primary: (1) Time to complete mobilization (hour) (2) Bowel function restoring (hour) (3) Tolerance to fluid diet (hour) (4) Tolerance to normal solid diet (hour) (5) Hospitalization time (days) Secondary: (6) Morphine requirements (mg/24h)

(1) 19.6 vs 37.1 (p=0.001) (2) 43.7 vs 52.02 (p=0.042) (3) 10.9 vs 23.54 (p=0.001) (4) 42.17 vs 64.27 (p=0.01) (5) 6.43 vs 9.16 (p=0.001) (6) 46.61 vs 64.53 (p=0.007)

Appendix 2

49

Wang, G., Jiang, ZW., Xu, Jing., Gong, JF., Bao, Y., Xie, LF & Li, JS.(2011). Fast-‐track rehabilitation program vs conventional care after colorectal resection: A randomized clinical trial. World J Gastroenterol. 17(5): 671-‐676.


-‐ Patients underwent resection colorectal cancer -‐ Mainly Ca colon and Ca rectum -‐Median age is around 55

Fast track group: Preoperative education of patients, no bowel preparation and fasting, but with carbohydrate liquids before surgery, use of epidural catheter for pain control, no nasogastric tube, early removal of urinary catheters, early feeding and enforced ambulation on the day of surgery (n=106)

Conventional group: Standard education and pre-‐op bowel preparation, bolus IV administration of drugs as pain control, diet increased on daily basis, mobilization according to surgeon (n=104)

30 days Primary: (1) Post-‐op first flatus (days) (2)Hospital stay time (days) (3) Overall complications (n)

(1) 2.1 vs 3.2 (p=0.001) (2) 5.1 vs 7.6 (p=0.001) (3) 20 vs 39 (p=0.015)

Appendix 2

50

Henriksen, M.G., Jensen, M.B., Hansen, H.V., Jespersen, T.W. & Hessov, I. (2002). Enforced mobilization, early oral feeding, and balanced analgesia improve convalescence after colorectal surgery. Nutrition. 18:147-‐152.

Randomized controlled trial (1-‐)

-‐ Patients undergoing elective colorectal surgery -‐ Median age is around 70

Given information on the importance of early mobilization. Encouraged to stay out of bed for 4h on post-‐op day 1, 6h on the next day, 8h on subsequent days. Further, they were asked to walk the length of the ward, 2 x 40m on post-‐op day 1, twice on day 2, three times on day 3 Same post-‐op nutritional regimen with control group

Mobilization without a fixed goal Same post-‐op nutritional regimen with intervention group (n=20)

-‐ Primary: (1) Mobilization (Ambulation times improved in hours) Secondary: Muscle Function (2a) After 1 month (2b) After 2 month

(1) 22h vs 3h on day 1 (p=0.0004) (2a) p=0.002 Intervention: 10% above the initial level (pre-‐operative level) Control: 12% below the initial level (2b) p=0.02 Intervention: 15% above the initial level Control: same as the preoperative level

Appendix 2

51

(n=20)

Khoo, C.K., Vickery, C.J., Forsyth, N., Vinall, N.S. & Eyre-‐Brook, I.A. (2007). A Prospective Randomized Controlled Trial of Multimodal Perioperative Management Protocol in Patients Undergoing Elective Colorectal Resection for Cancer. Annals of Surgery. 245:867-‐872.


-‐ Patient for elective resection for colorectal cancer -‐ Median age is around 70

Free oral fluids and diet were allowed immediately after the operation Mobilization was encouraged from the night of operation, with a pre-‐set goal (n=35)

Postoperatively, oral fluid was allowed 30ml/hr, increased stepwise to 60ml/hr after 12 hours, then free oral fluid on the next 12hr. Diet was commenced only on signs of returning bowel motility

10-‐14 post-‐op day

Primary: (1) Length of hospital stay [postop median days] (2) Independent mobility [postop median days] (3)Passage of stool [postop median days]

(1) -‐2 (p<0.001) (2) -‐2 (p<0.001) (3)-‐2 (p<0.001)

Appendix 2

52

Assisted to mobilize on the first post-‐op day, but not carry out aggressively (n=35)

Muller, S., Zalunardo, M.P., Hubner, M., Clavien, P.A., Demartines, N. & the Zurich Fast Track Study Group (2009). A Fast-‐Track Program Reduces Complications and Length of Hospital Stay After Open colonic Surgery. Gastroenterology. 136:842-‐847.


Patients undergoing open elective colonic resection Median age around 60

Encouraged to start early mobilization immediately after surgery Start drinking immediately after surgery, invited to resume oral nutrition on day 1 after surgery (n=76)

Encouraged to start early mobilization immediately after surgery Allow to start drinking on day 2 and start increasing oral nutrition from day 2, full oral nutrition on day 4 (n=75)

30 days Primary: (1) Total patients with complications (n) Secondary: (2) Hospital Stay (median day)

(1) -‐21 (p=0.0014) (2) -‐4 (p<0.0001)

Garcia-‐Botello, S. et al.(2011). Implementation of a perioperative multimodal rehabilitation protocol in elective colorectal surgery. A prospective randomized controlled study. CIR


Patients received elective surgery for colorectal disease Median age: 61 Mainly Cancer cases

Multimodal rehabilitation group: Recommendations and guidelines for the specific postoperative care were given during the pre-‐op visit

Traditional group: No Pre-‐op education to patients Keep NPO after the surgery Post-‐op day 1: NG tube was remained

30 days Primary: (1) Hospital stay (day) (2)Post-‐op first flatulence (day) (3)Wound complications (n) Secondary:

(1) -‐5.08 (p<0.001) (2)-‐2 (p<0.001) (3)-‐3 (p=0.105) (4) +44 (p=0.109) (5) –1.735.8 (p<0.001)

Appendix 2

53

ESP. 89(3):159-‐166 NG tube was removed in the recovery room. Patients were encouraged to drink water 6 hours after the operation and to get out of bed if possible Post-‐op day 1: Try soft diet, walking and respiratory exercise Post-‐op day 2: normal diet if tolerated Post-‐op day 3: Discharge from the hospital if criteria was met (n= 61)

and keep complete fasting Post-‐op day 2: Allow water to patient if bowel sound is positive, NG tube was removed Post-‐op day 3: Move on to liquid diet if tolerated (n=58)

(4) Morphine administered by PCA (mg) (5) Hospital costs (Euros)

Feo, C.V. et al., (2004). Early oral feeding after colorectal resection: A randomized controlled study. ANZ J. Surg. 74:298-‐301.


Patients underwent elective colorectal resection of cancer. Mean age of 67.6

Group B: Post-‐op: No NG tube, allowed to drink the day after the operation, soft diet on the following day regardless the passage of flatus,

Group A: Post-‐op: Use of NG catheter and NPO until passage of flatus, followed by a liquid diet, and advanced to a soft and solid one as tolerated.

-‐ Primary: (1)Complications (n) (2) Bowel movement (median days) (3)Post-‐op hospital stay (median days) (4) Patients’ well

(1) +1 (p=NS) (2)+/-‐ 0 (p=NS) (3)+/-‐0 (p=NS) (4) Similar in both group (p=NS) (5) -‐81.8 (p=NS)

Appendix 2

54

No previous abdominal operation No metastatic disease

and were advanced to solid food as tolerated (n=50)

(n=50) being (SF-‐36) Secondary: (5) Costs (euros)

Delaney, C.P., Zutshi, M., Senagore, A.J., Remzi, F.H., Hammel, J. & Fazio, V.W. (2003). Prospective, Randomized, Controlled Trial Between a Pathway of Controlled Rehabilitation with early ambulation and Diet and Traditional Postoperative Care After Laparotomy and Intestinal Resection. Diseases of the Colon & Rectum. 46(7): 851-‐859.


Patients scheduled for elective segmental intestinal or rectal resection by laparotomy, including patients undergoing re-‐operation or pelvis surgery Mean age=46.3

CREAD group: Before OT, Given supporting written information documenting the expected postoperative milestone. No NG tube. Permitted to walk and were offered liquids as desired on the evening of surgery Day-‐1: encouraged to walk at least one circuit of the nursing floor, approx..60m for 5 times, sit out of

TRAD group: NG tube remained and removed on post-‐op day 1 if drainage is less than 200ml for 4hrs. Day 1: Sat out of bed Day2: Walk four to five times a day Allowed sips of clear liquid unless flatus or stool had passed, then resume diet gradually (n=33)

30 days Primary: (1a) Total length of stay (days) (All patients) Secondary: (1b) Total length of stay (days) (Patients under 70) (2) Readmission (n) (3) Complications (n) (4)Pain score at Day 10 (5)Quality of life (CGQL) at Day10

(1a) -‐1.7 (p=0.022) (1b) -‐2.1 (p=0.01) (2) -‐3 (p=0.48) (3) -‐3 (p=0.58) (4)+/-‐0 (p=0.79) (5)-‐0.7 (p=0.4)

Appendix 2

55

bed between exercise, regular incentive spirometry. Solid fluid is allowed if fluid is tolerated. (n=31)

56

Appendix 3 Summary of quality (PART 1)

57

Summary of quality (PART 2)

58

Appendix 4

Recommended grading of level of evidence from SIGN

59

Appendix 5

Program Timeline

One month

Evaluation

Six months

Full scale Program

One month

Pilot Test Evaluation

Two months

Pilot Test

One Month

Program Training and BrieAing

One Month

Committee Formation

60

Appendix 6

Rehabilitation program concept guideline

61

Appendix 7

Rehabilitation program In-‐patient recording chart

62

Appendix 8

Patient satisfaction questionnaire

64

Appendix 9

Staff satisfaction questionnaire

65

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