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

Dr. Liane S. Feldman

Status: Completed

Conditions: Colorectal Disorders

Treatments: Other: Control.; Device: Mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT03277053

McgillGensurgAPPRCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• intellectual disabilities
• major simultaneous procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

104 participants in 3 patient groups

control

Sham Comparator group

Description:

Patients receive an ipad with no app.

Treatment:

Other: Control.

Mobile application no stoma

Experimental group

Description:

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

Treatment:

Device: Mobile application

Mobile application stoma

Experimental group

Description:

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

Treatment:

Device: Mobile application