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

Sponsor
Dr. Liane S. Feldman (Other)
Overall Status
Completed
CT.gov ID
NCT03277053
Collaborator
Society of American Gastrointestinal and Endoscopic Surgeons (Other)
104
1
3
15.2
6.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Mobile application
  • Other: Control.
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
Actual Study Start Date :
Aug 24, 2016
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery. [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).

Secondary Outcome Measures

  1. Length of stay [one month]

    Number of days spent in the hospital after surgery

  2. Complications [one month]

    Comprehensive complication index (CCI)

  3. Successful Recovery [postoperative day 4]

    Discharge by postoperative day 4 with no complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • elective laparoscopic colorectal resection.

  • Proficient in english or french

Exclusion Criteria:
  • intellectual disabilities

  • major simultaneous procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montreal general Hospital Montréal Quebec Canada h3g1a4

Sponsors and Collaborators

  • Dr. Liane S. Feldman
  • Society of American Gastrointestinal and Endoscopic Surgeons

Investigators

  • Principal Investigator: Liane Feldman, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
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., McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:
NCT03277053
Other Study ID Numbers:
  • McgillGensurgAPPRCT
First Posted:
Sep 8, 2017
Last Update Posted:
Mar 26, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 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., McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Results

No Results Posted as of Mar 26, 2018