A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery

Study Overview
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Brief Summary
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A randomized control trial on patients undergoing laparoscopic colorectal resection in an Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application containing guidelines, information, and tailored feedback. The hypothesis is that the application will improve adherence to the ERP.

Detailed Description
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Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative morbidity and shorten length of hospital stay with no increase in readmission rates. However, poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of mobile device applications has the potential to improve patient compliance with treatment guidelines. We recently developed and pilot tested a mobile app to support an ERP for colorectal surgery which collects patient-reported recovery information and engages patients as stakeholders in their recovery process. The overall aim of this study is to estimate the extent to which the use of this mobile device app impacts adherence to postoperative ERP elements in comparison to standard preoperative education. Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult patients with colorectal diseases planned for surgical resection. Participants will be randomly assigned into one of two groups: usual perioperative education and audit, or a mobile device application for postoperative education and self-audit. The intervention will be delivered through a tablet present at the bedside with an application which links education, recovery planning, and daily self-assessment to a plan of care. It educates patients about daily recovery milestones and track their adherence. The primary outcome will be patient adherence to postoperative enhanced recovery elements. Other targeted outcomes include self-reported recovery, satisfaction and patient activation. According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted for this trial. Significance: This study will contribute evidence regarding the use of mobile device technology for education and the direct involvement of patients as stakeholders in postoperative recovery. The study findings have the potential to increase patient engagement in the care pathway, which has the potential to increase compliance to pathway elements and improve postoperative outcomes.

Official Title
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A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial

Conditions
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Colorectal Disorders

Intervention / Treatment
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* Device: Mobile application
* Other: Control.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective laparoscopic colorectal resection. Proficient in english or french Exclusion Criteria: intellectual disabilities major simultaneous procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control<br>Patients receive an ipad with no app. | Other: Control.<br>* Patient receive an ipad with no application.<br>|
| Experimental: Mobile application no stoma<br>Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it. | Device: Mobile application<br>* A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback<br>|
| Experimental: Mobile application stoma<br>Patients who receive a stoma receive an ipad containing the app and are instructed how to use it. | Device: Mobile application<br>* A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery. | Questionnaire including 5 pathway interventions that involve patient participation during the first 48 hours after surgery (mobilization, gum chewing, consumption of oral liquids, breathing exercises, nutritional supplement). | postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Number of days spent in the hospital after surgery | one month | 
| Complications | Comprehensive complication index (CCI) | one month | 
| Successful Recovery | Discharge by postoperative day 4 with no complications. | postoperative day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal, laparoscopic, application, ERP, adherence, mobile