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

March 22, 2018 updated by: Dr. Liane S. Feldman

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. usual perioperative education and audit, or
  2. 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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, h3g1a4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective laparoscopic colorectal resection.
  • Proficient in english or french

Exclusion Criteria:

  • intellectual disabilities
  • major simultaneous procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

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.
Time Frame: postoperative day 2
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
Time Frame: one month
Number of days spent in the hospital after surgery
one month
Complications
Time Frame: one month
Comprehensive complication index (CCI)
one month
Successful Recovery
Time Frame: postoperative day 4
Discharge by postoperative day 4 with no complications.
postoperative day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Liane S. Feldman

Collaborators

Society of American Gastrointestinal and Endoscopic Surgeons

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • McgillGensurgAPPRCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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