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

Primary Purpose

Colorectal Cancer, Inflammatory Bowel Diseases, Utilization, Health Care

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home To Stay Mobile Health Application
Sponsored by
Division of General Surgery , Mt. Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Mt Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

30-day re-admission
Patient reported re-admission to any hospital within 30 days of discharge following surgery

Secondary Outcome Measures

30-day ER visits
Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery
30-day primary care visits
Patient reported presentation to their primary care physician within 30 days of discharge following surgery
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.
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

Full Information

First Posted
July 13, 2021
Last Updated
July 13, 2021
Sponsor
Division of General Surgery , Mt. Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04968145
Brief Title
Home To Stay: a Randomized Trial Evaluating a Post-discharge Mobile App for Elective Colorectal Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
January 21, 2020 (Actual)
Study Completion Date
January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Division of General Surgery , Mt. Sinai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Inflammatory Bowel Diseases, Utilization, Health Care, Surgery, Post Discharge Monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Home To Stay Mobile Health Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-day re-admission
Description
Patient reported re-admission to any hospital within 30 days of discharge following surgery
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
30-day ER visits
Description
Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery
Time Frame
30 Days
Title
30-day primary care visits
Description
Patient reported presentation to their primary care physician within 30 days of discharge following surgery
Time Frame
30 Days
Title
30-day unplanned health care visits
Description
A composite of any re-admission, ER presentation or primary care visit within 30 days following the date of discharge.
Time Frame
30 Days
Title
Patient reported outcomes
Description
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
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Mt Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Home To Stay: a Randomized Trial Evaluating a Post-discharge Mobile App for Elective Colorectal Surgery

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