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OpenTrials
Completed

NCT Number: NCT03277053

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

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.

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Key information

Conditions

Colorectal Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal general Hospital

Montreal, Quebec, h3g1a4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • intellectual disabilities
  • major simultaneous procedures

Treatment and study plan

Mobile application

Device

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

Control.

Other

Patient receive an ipad with no application.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Length of stay

    Time frame: one month

    Number of days spent in the hospital after surgery

  2. Complications

    Time frame: one month

    Comprehensive complication index (CCI)

  3. Successful Recovery

    Time frame: postoperative day 4

    Discharge by postoperative day 4 with no complications.

Sponsors and collaborators

Lead sponsor

Dr. Liane S. Feldman

Other

Collaborators

  • Society of American Gastrointestinal and Endoscopic Surgeons

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2017
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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