Home to Stay Mobile App for Colorectal Surgery

NCT04236128 | Recruiting

• 1 other identifier: 18-0200-E
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Colorectal surgery includes surgery for colorectal cancer, inflammatory bowel disease and other benign diseases such as diverticulitis. In Canada, approximately 21,000 colorectal surgeries are performed each year. Patients undergoing colorectal surgery face high rates of unplanned hospital visits including readmission to hospital and Emergency Room (ER) visits. These unplanned hospital visits lead to significant distress and anxiety for patients and increased health care costs. Research Aims: The goal is to evaluate the use of an integrated discharge monitoring system with a mobile application (app) to support colorectal surgery patients at home following discharge from hospital. Methods: The study will include 3 hospitals across Canada. Patients will be assigned to either a control group or intervention group. Control group patients will receive standard follow up care after going home following surgery. Intervention group patients will be enrolled in an integrated discharge monitoring system using an app to monitor their progress at home following discharge after surgery. The main outcomes are to measure the number of patients with unplanned hospital visits within 30 days of discharge following surgery, the quality of patient recovery and confidence managing one's own health care. Patients are eligible if they are being discharge home after having elective colorectal surgery, are 18 years or older and speak and understand English or French. At the end of the study, the outcomes between the control group and intervention group will be compared to look for important differences. Expected Outcomes: It is expected that the results of this study will show that the integrated discharge monitoring system will lead to a significant improvement in the quality of patient recovery and self-confidence with one's own health care, as well as significantly reduce the number of unplanned hospital visits for patients undergoing colorectal surgery in Canada.

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

• 30-day unplanned hospital visit rate

  Proportion of patients who are either readmitted to any hospital or present to the ER at any hospital in the first 30 post-operative days.

  30 Days

Secondary Outcomes (2)

• patient quality of recovery

  4 weeks after hospital discharge

• patient self-efficacy to manage one's own health care

  4 weeks after hospital discharge

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive the same usual care as the control group plus be enrolled in the integrated discharge monitoring system.

Other: Mobile App

Control Group

ACTIVE COMPARATOR

The control group will receive usual follow up care that is currently provided at the 3 participating centres.

Other: Mobile App

Interventions

Mobile App OTHER

The app will be provided to patients in hospital on post-operative day 3. On the day of discharge, the patient will be emailed a "Daily Health Check" and receive subsequent "Daily Health Check" emails on Day 1-14, 21 and 30 days following discharge. The "Daily Health Check" is a tailored questionnaire to elicit their symptoms and status of post-operative recovery. After the patient has completed the "Daily Health Check", a "Daily Health Check Summary" is emailed to the patient that summarizes their responses and provides appropriate action recommendations based on their responses ranging from: (i) suggestions for educational modules, (ii) expect a call from your health care team in the next 24 hours, (iii) call your surgeon's office today or (iv) go to the nearest emergency room. The patient's "Daily Health Check" responses are displayed in real time on a secure website that automatically "red flags" extreme responses to alert the health care team to contact the patient by telephone.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any patient who is being discharged to home after undergoing elective colorectal surgery
• years or older
• able to speak and understand English or French
• provides informed consent

You may not qualify if:

• post-operative admission less than 3 days
• requiring discharge to rehabilitation centre to recover prior to being able to go home

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

Study Officials

• Erin Kennedy

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selina Research Coordinator

CONTACT

416-586-4800; selina.schmocker@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Surgeon (Principal Investigator)

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: May 25, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)