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Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement (GET2HOME)

Primary Purpose

Children With Complex Chronic Conditions

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GET2HOME Intervention
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Children With Complex Chronic Conditions

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families
  • 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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Hospital-Based Care Coordination

GET2HOME Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Urgent healthcare reutilization
Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit

Secondary Outcome Measures

Global Quality of Life Scale
Quality of Life assessment for child, caregiver and family; minimum score 0, maximum score 100; higher score means a better outcome
Return to baseline
Capturing the time it takes to return to a normal routine (family designed measure)

Full Information

First Posted
October 3, 2022
Last Updated
October 18, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05568355
Brief Title
Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement
Acronym
GET2HOME
Official Title
Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Patient-Centered Outcomes Research Institute

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
The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Complex Chronic Conditions

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Hospital-Based Care Coordination
Arm Type
No Intervention
Arm Description
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.
Arm Title
GET2HOME Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
GET2HOME Intervention
Intervention Description
Intervention bundle designed to improve discharge effectiveness
Primary Outcome Measure Information:
Title
Urgent healthcare reutilization
Description
Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit
Time Frame
30-days post-discharge
Secondary Outcome Measure Information:
Title
Global Quality of Life Scale
Description
Quality of Life assessment for child, caregiver and family; minimum score 0, maximum score 100; higher score means a better outcome
Time Frame
7-, 30-, 60-, and 90-days post-discharge
Title
Return to baseline
Description
Capturing the time it takes to return to a normal routine (family designed measure)
Time Frame
7-, 30-, 60-, and 90-days post-discharge
Other Pre-specified Outcome Measures:
Title
Percent of participants with transition process failures
Description
Family-reported challenges with medications, medical supplies, and follow-up
Time Frame
7-days post-discharge
Title
Transition quality
Description
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
Time Frame
7-days post-discharge
Title
Urgent healthcare reutilization
Description
Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit
Time Frame
7-days post-discharge
Title
Medical and non-medical out-of-pocket costs
Description
Family-reported measure of costs
Time Frame
30-days post-discharge
Title
Caregiver time to manage illness post-discharge
Description
Family-reported time measure
Time Frame
30-days post-discharge
Title
Primary care provider transition time burden
Description
Primary care provider reported measure quantifying the amount of time spent on the patients' hospital to home transition
Time Frame
10 days post-discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement

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