Home to Stay Mobile App for Colorectal Surgery
ConditionColorectal Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
any patient who is being discharged to home after undergoing elective colorectal surgery
18 years or older
able to speak and understand English or French
provides informed consent
Disqualifiers
post-operative admission less than 3 days
requiring discharge to rehabilitation centre to recover prior to being able to go home
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile App
Other interventionThe 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.
Treatment groups
670 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
30 DaysSecondary outcomes
1
patient quality of recovery
Quality of Recovery 15 (QoR-15) questionnaire administered to patients in both groups
Time frame
4 weeks after hospital discharge2
patient self-efficacy to manage one's own health care
Patient Activation Measure (PAM-13) administered to patients in both groups
Time frame
4 weeks after hospital dischargeSponsors and contacts
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Source ClinicalTrials.gov