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NCT Number: NCT04968145

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

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Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient Acceptance of Health Care Post Discharge Monitoring Rectal Diseases Surgery Treatment Adherence and Compliance Utilization, Health Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mt Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Home To Stay Mobile Health Application

Other

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 outcomes

  1. 30-day re-admission

    Time frame: 30 Days

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

Secondary outcomes

  1. 30-day ER visits

    Time frame: 30 Days

    Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery

  2. 30-day primary care visits

    Time frame: 30 Days

    Patient reported presentation to their primary care physician within 30 days of discharge following surgery

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Division of General Surgery , Mt. Sinai Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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