Clinical trial NCT03277053: A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery
Official title: A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Disorders
Keywords: colorectal
laparoscopic
application
ERP
adherence
mobile
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Society of American Gastrointestinal and Endoscopic Surgeons
First posted: 2017-09-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* intellectual disabilities
* major simultaneous procedures

Primary outcomes:
measure: Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
timeFrame: postoperative day 2
Secondary outcomes:
measure: Length of stay
timeFrame: one month
measure: Complications
timeFrame: one month
measure: Successful Recovery
timeFrame: postoperative day 4
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal general Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Liane Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: