Mobile App for Colorectal Surgery Recovery

Overseen By Selina Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: Short hospital stay, Rehabilitation need

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

670 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Home to Stay Mobile App for colorectal surgery recovery?

Research suggests that using the Home to Stay Mobile App after colorectal surgery can help reduce the number of unplanned hospital visits and readmissions, which can lower patient anxiety and healthcare costs. ^{1 2 3 4 5}

Is the Mobile App for Colorectal Surgery Recovery safe for humans?

The mobile app used for colorectal surgery recovery has been tested in several studies, showing high patient satisfaction and usability. While the app helps monitor patients and detect complications early, no specific safety concerns have been reported in the studies. ^{1 3 4 5 6}

How does the mobile app for colorectal surgery recovery differ from other treatments?

This mobile app is unique because it provides remote monitoring and support for patients after colorectal surgery, helping to reduce hospital readmissions and improve recovery at home. Unlike traditional treatments, it uses technology to enhance communication between patients and caregivers, offering a more integrated and supportive recovery process. ^{1 2 3 4 7}

Research Team

Erin Kennedy

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

This trial is for adults who've had elective colorectal surgery and are going home afterwards. They must be over 18, able to speak English or French, and give informed consent. It's not for those with short post-op hospital stays under 3 days or needing rehab before going home.

Inclusion Criteria

Provides informed consent

I can speak and understand English or French.

I am 18 years old or older.

Exclusion Criteria

I need to stay in a rehab center before I can go home.

I was in the hospital for less than 3 days after surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colorectal surgery and are discharged home with either standard follow-up care or an integrated discharge monitoring system using a mobile app

Immediate post-surgery

Follow-up

Participants are monitored for unplanned hospital visits, quality of recovery, and self-efficacy using questionnaires

4 weeks

Regular app-based monitoring

Outcome Assessment

Assessment of primary and secondary outcomes including 30-day unplanned hospital visit rate and patient quality of recovery

30 days

Treatment Details

Interventions

• Home to Stay Mobile App

Trial Overview The study tests a mobile app designed to monitor patients at home after colorectal surgery against standard follow-up care. Participants will either use the app as part of an integrated discharge system or receive usual care, aiming to reduce unplanned hospital visits.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Findings from Research

The Home to Stay integrated discharge monitoring system was successfully used by 93 out of 106 patients after colorectal surgery, showing high patient satisfaction with 92% rating it as good or excellent.

The program significantly improved patients' Quality of Recovery scores from day 1 to day 14 and reduced the 30-day readmission rate to 6%, compared to an 18% rate in the four months prior to the study, indicating its potential effectiveness in post-surgery care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home to Stay: An Integrated Monitoring System Using a Mobile App to Support Patients at Home Following Colorectal Surgery. Keng, CJS., Goriawala, A., Rashid, S., et al.[2022]

A text-messaging system called FLO was successfully used by 16 out of 17 patients after elective colorectal surgery, demonstrating its feasibility for remote monitoring and support during recovery.

The system helped identify potential complications early, as it flagged two patients who were unwell before they were readmitted, indicating that telehealth can enhance patient safety and recovery management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a telehealth monitoring service after colorectal surgery: A feasibility study. Bragg, DD., Edis, H., Clark, S., et al.[2020]

This randomized controlled trial aims to assess the effectiveness of a mobile application in reducing unplanned hospital visits within 30 days post-colorectal surgery, involving a sample size of 670 patients.

The study anticipates that the mobile app will not only decrease emergency room visits but also enhance patients' quality of recovery, potentially leading to its wider adoption in clinical practice if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home to Stay: A randomized controlled trial protocol to assess use of a mobile app to reduce readmissions following colorectal surgery. Anpalagan, T., Schmocker, S., Raval, M., et al.[2023]

A smartphone-based health application was successfully used by 88% of colorectal surgery patients, allowing for effective perioperative follow-up and real-time communication with healthcare providers.

The app detected 12 adverse events post-discharge, with 83% of these issues resolved through the app, significantly reducing the need for emergency consultations and enhancing patient satisfaction (mean score of 4 out of 5).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gains and limitations of a connected tracking solution in the perioperative follow-up of colorectal surgery patients. Agri, F., Hahnloser, D., Demartines, N., et al.[2021]

In a study involving 282 patients who underwent elective colorectal surgery, a mobile app for postdischarge monitoring did not significantly reduce 30-day readmissions or emergency room visits compared to usual care.

However, the app significantly improved patient-reported outcomes, including higher satisfaction and well-being scores, and lower anxiety levels, suggesting it can be a valuable tool for supporting patients after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home to Stay: A Randomized Controlled Trial Evaluating the Effect of a Postdischarge Mobile App to Reduce 30-Day Readmission Following Elective Colorectal Surgery. Pooni, A., Brar, MS., Anpalagan, T., et al.[2023]

A mobile application was developed to monitor patients after colorectal surgery, showing high usability (76% satisfaction) and an impressive adherence rate of 89.6% over 15 days post-discharge, indicating strong acceptance among patients.

The app successfully collected 1220 notifications regarding potential complications, with the most common issues being pain, abnormal stools, and wound problems, suggesting it could be a valuable tool for early detection of complications and reducing readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital postoperative follow-up after colorectal resection: a multi-center preliminary qualitative study on a patient reporting and monitoring application. Bertoni, S., M M K Magema, JP., Van Geluwe, B., et al.[2023]

A digital monitoring application was developed through collaborative design with patients and health professionals to support colorectal cancer patients during the first 30 days post-surgery, aiming to improve patient care and outcomes.

The app allows patients to report concerns to healthcare providers, which can help in early identification of issues, reduce readmission rates, and enhance recovery experiences by providing timely support and relevant information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery. Miller, M., Roxburgh, CS., McCann, L., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Home to Stay: An Integrated Monitoring System Using a Mobile App to Support Patients at Home Following Colorectal Surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Development of a telehealth monitoring service after colorectal surgery: A feasibility study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Home to Stay: A randomized controlled trial protocol to assess use of a mobile app to reduce readmissions following colorectal surgery. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Gains and limitations of a connected tracking solution in the perioperative follow-up of colorectal surgery patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Home to Stay: A Randomized Controlled Trial Evaluating the Effect of a Postdischarge Mobile App to Reduce 30-Day Readmission Following Elective Colorectal Surgery. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

Digital postoperative follow-up after colorectal resection: a multi-center preliminary qualitative study on a patient reporting and monitoring application. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery. [2023]