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Clinical Trials/NCT04968145
NCT04968145CompletedNot Applicable

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

Division of General Surgery , Mt. Sinai Hospital1 site in 1 country282 target enrollmentStarted: July 19, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
282
Locations
1
Primary Endpoint
30-day re-admission

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

Control Group

No Intervention

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.

Intervention Group

Experimental

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: Home To Stay Mobile Health Application (Other)

Outcomes

Primary Outcomes

30-day re-admission

Time Frame: 30 Days

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

Secondary Outcomes

  • 30-day primary care visits(30 Days)
  • 30-day unplanned health care visits(30 Days)
  • Patient reported outcomes(30 Days)
  • 30-day ER visits(30 Days)

Investigators

Sponsor
Division of General Surgery , Mt. Sinai Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amandeep Pooni

Research Fellow

Division of General Surgery , Mt. Sinai Hospital

Study Sites (1)

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