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

Colorectal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277053
• Other study ID #: McgillGensurgAPPRCT
• Status: Completed
• Phase: N/A
• First received: July 11, 2017
• Last updated: March 22, 2018
• Start date: August 24, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective laparoscopic colorectal resection.

• Proficient in english or french

Exclusion Criteria:

• intellectual disabilities

• major simultaneous procedures

Related Conditions & MeSH terms

• Colorectal Disorders

Intervention

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

Other:
• Control.
Patient receive an ipad with no application.

Locations

Country	Name	City	State
Canada	Montreal general Hospital	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Liane S. Feldman	Society of American Gastrointestinal and Endoscopic Surgeons

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.	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	Length of stay	Number of days spent in the hospital after surgery	one month
Secondary	Complications	Comprehensive complication index (CCI)	one month
Secondary	Successful Recovery	Discharge by postoperative day 4 with no complications.	postoperative day 4