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

July 13, 2021 updated by: Amandeep Pooni, Division of General Surgery , Mt. Sinai Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mt Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day re-admission
Time Frame: 30 Days
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
Time Frame: 30 Days
Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery
30 Days
30-day primary care visits
Time Frame: 30 Days
Patient reported presentation to their primary care physician within 30 days of discharge following surgery
30 Days
30-day unplanned health care visits
Time Frame: 30 Days
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
Time Frame: 30 Days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Division of General Surgery , Mt. Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2017

Primary Completion (Actual)

January 21, 2020

Study Completion (Actual)

January 21, 2020

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HomeToStay

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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