Home To Stay: a Randomized Trial Evaluating a Post-discharge Mobile App for Elective Colorectal Surgery

Study Overview
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Brief Summary
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A single center randomized controlled trial to evaluate the effect of a post-discharge mobile health application on 30-day re-admission and patient reported outcomes following elective colorectal surgery

Detailed Description
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Background: Following elective colorectal surgery, rates of re-admission are high and result in significant healthcare resource use. However, up to 20% of these re-admissions may be preventable. This represents an opportunity to improve patient outcomes, reduce health care utilization and costs through targeted interventions. Home To Stay is an integrated discharge monitoring program using a mobile app platform that was developed to support the needs of patients following discharge after colorectal surgery. In the initial pilot testing, the 30-day re-admission rate for patients using Home to Stay was reduced from 18% to 6% and patient anxiety was reduced in over 75% of the participants. Methods: This study is a two arm, single center, randomized control trial that will be conducted in the colorectal unit of an academic tertiary care center. Patients will be randomized1:1 using a single randomized consent design to either usual follow up in the control group or post discharge monitoring with Home to Stay in the intervention group. Objective: The objective of this study is to evaluate the Home to Stay app and its effect on healthcare utilization and patient reported outcomes.

Official Title
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Home To Stay: a Randomized Controlled Trial Evaluating the Effect of a Post-discharge Mobile App on 30-day Re-admission Following Elective Colorectal Surgery

Conditions
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Colorectal Cancer, Inflammatory Bowel Diseases, Utilization, Health Care, Surgery, Post Discharge Monitoring

Intervention / Treatment
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* Other: Home To Stay Mobile Health Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective, inpatient colorectal surgery Able to speak and read in English Able to provide informed consent Have access to a smartphone/tablet or desktop computer with internet access Exclusion Criteria: Patients undergoing semi-elective/emergent procedure Patients undergoing elective day surgery Expected post operative admission of less than 3 days Discharge to another institution (rehabilitation facility/nursing home/long term care).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Participants in the control group receive routine follow up care which consists of (i) written instructions regarding potential complications and the contact information of their treating surgeon, (ii) a follow up telephone call 4 weeks following discharge by a member of the health care team and (iii) an in-person follow up visit in clinic with the treating surgeon 4-6 weeks following discharge. | |
| Experimental: Intervention Group<br>The participants in the intrevention group receive the same routine care as the control group in addition to post discharge monitoring with the Home to Stay app | Other: Home To Stay Mobile Health Application<br>* Home to stay is an integrated discharge monitoring system with a mobile application. Features of the application include a Daily Health Check to report on post-operative recovery, picture taking capability to photograph incisions/wounds and educational information on post-operative care at home. Patients will complete a Daily Health Check on post-discharge Day #1-14, #21 and #30. The Daily Health Check consists of a series of questions specific to colorectal surgery as well as the Quality of Recovery (QoR-15) questionnaire. After completion, the participant will receive a list of recommendations tailored to their responses including relevant education modules, to contact the surgical team or in urgent cases to go to the nearest emergency room. The participants' responses will be monitored daily via a secure web site. Any participants' responses in the extreme ranges are automatically red flagged and notify the health care team that a follow up telephone call is required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day re-admission | Patient reported re-admission to any hospital within 30 days of discharge following surgery | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day ER visits | Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery | 30 Days | 
| 30-day primary care visits | Patient reported presentation to their primary care physician within 30 days of discharge following surgery | 30 Days | 
| 30-day unplanned health care visits | A composite of any re-admission, ER presentation or primary care visit within 30 days following the date of discharge. | 30 Days | 
| Patient reported outcomes | satisfaction with the discharge process, overall well-being and level of anxiety during 30-day post-discharge period were rated on a 10- point Likert scale | 30 Days |