- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05568355
Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement (GET2HOME)
February 2, 2026 updated by: Children's Hospital Medical Center, Cincinnati
The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
638
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
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families and their primary care providers
- Discharged from pediatric hospital medicine service at our hospital
Exclusion Criteria:
- Patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities
- Patients admitted for end of life care
- Patients admitted for suicidal or homicidal ideation
- Patients who previously enrolled in the study
- Patients in county custody
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Hospital-Based Care Coordination
Patients and families randomized to this arm will receive best practice standard of care hospital-based transition planning in the hospital with routine outpatient care team follow-up post-discharge.
|
|
|
Experimental: GET2HOME Intervention
The GET2HOME intervention includes: 1) a pre-discharge telehealth huddle with the family, inpatient team, primary care team, and home care nursing; 2) a visual discharge task tracker (DTT) to monitor progress across care management tasks; and if desired by family and primary care 3) a post-discharge telehealth huddle 2-7 days after discharge with the family, inpatient team, primary care team, and home care nursing
|
Intervention bundle designed to improve discharge effectiveness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urgent healthcare reutilization
Time Frame: 30-days post-discharge
|
Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit
|
30-days post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Quality of Life Scale
Time Frame: 7-, 30-, 60-, and 90-days post-discharge
|
Quality of Life assessment for child, caregiver and family; minimum score 0, maximum score 100; higher score means a better outcome
|
7-, 30-, 60-, and 90-days post-discharge
|
|
Return to baseline
Time Frame: 7-, 30-, 60-, and 90-days post-discharge
|
Capturing the time it takes to return to a normal routine (family designed measure)
|
7-, 30-, 60-, and 90-days post-discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of participants with transition process failures
Time Frame: 7-days post-discharge
|
Family-reported challenges with medications, medical supplies, and follow-up
|
7-days post-discharge
|
|
Transition quality
Time Frame: 7-days post-discharge
|
Pediatric Transition Experience Measure (P-TEM) is an 8-item, parent reported measure on a 0-100 scale, in which higher scores reflect better quality
|
7-days post-discharge
|
|
Urgent healthcare reutilization
Time Frame: 7-days post-discharge
|
Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit
|
7-days post-discharge
|
|
Medical and non-medical out-of-pocket costs
Time Frame: 30-days post-discharge
|
Family-reported measure of costs
|
30-days post-discharge
|
|
Caregiver time to manage illness post-discharge
Time Frame: 30-days post-discharge
|
Family-reported time measure
|
30-days post-discharge
|
|
Primary care provider transition time burden
Time Frame: 10 days post-discharge
|
Primary care provider reported measure quantifying the amount of time spent on the patients' hospital to home transition
|
10 days post-discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
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)
November 1, 2022
Primary Completion (Actual)
September 29, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
October 3, 2022
First Submitted That Met QC Criteria
October 4, 2022
First Posted (Actual)
October 5, 2022
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0511
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
product manufactured in and exported from the U.S.
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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