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

NCT ID: NCT03277053

Last Updated: 2018-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-24

Study Completion Date

2017-12-01

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:

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.

Conditions

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Colorectal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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control

Patients receive an ipad with no app.

Group Type SHAM_COMPARATOR

Control.

Intervention Type OTHER

Patient receive an ipad with no application.

Mobile application no stoma

Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback

Mobile application stoma

Patients who receive a stoma receive an ipad containing the app and are instructed how to use it.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback

Interventions

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Mobile application

A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback

Intervention Type DEVICE

Control.

Patient receive an ipad with no application.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* intellectual disabilities
* major simultaneous procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society of American Gastrointestinal and Endoscopic Surgeons

OTHER

Sponsor Role collaborator

Dr. Liane S. Feldman

OTHER

Sponsor Role lead

Responsible Party

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Dr. Liane S. Feldman

Professor, Department of Surgery, McGill University Director, General Surgery Clinical Teaching Unit, Montreal General Hospital. Director, Division of General Surgery at the MUHC and McGill University. Program Director, MIS Fellowship Program.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Liane Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

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Montreal general Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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McgillGensurgAPPRCT

Identifier Type: -

Identifier Source: org_study_id

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