- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05714605
Implementation and Evaluation of A Health Innovation to Support Medicaid-Insured Individuals Following Hospitalization
July 14, 2026 updated by: University of Pennsylvania
Implementation and Evaluation of THRIVE: A Health Innovation to Support Care Transitions for Medicaid-Insured Individuals Following Hospitalization
The goal of this stepped wedge pragmatic trial is to compare referral patterns and post discharge outcomes in Medicaid insured individuals discharge following a hospitalization].
The aims are to 1) evaluate the implementation of the THRIVE clinical pathway, including feasibility, appropriateness, and acceptability and 2) examine referral patterns, 30- day readmission and Emergency Department (ED) utilization patterns for participants who receive THRIVE support services.
During hospitalization participants will receive a referral to home care services and will be seen by a home care nurse within 48 hours following discharge.
A discharging physician or Advanced Practice Provider will maintain clinical oversight for 30 days or until the patient sees primary care provider or specialist.
A Care Coordination Team conducts weekly case conferences to ensure social and health needs are being addressed for 30 days post-discharge.
Researchers will compare Medicaid insured patients discharged during the study, to those receiving usual care to determine if there are differences in post-acute utilization outcomes.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
This is a prospective single site Type 1 hybrid effectiveness-implementation parallel mixed methods (QUANT + qual) quasi-experimental study.
This study design involves simultaneous collection and analysis of quantitative and qualitative data, giving priority weight to the quantitative data to evaluate program referrals, outcomes, and program fidelity, while qualitative data will evaluate process through detailed descriptions of perspectives of barriers and facilitators faced by health care providers in implementing the THRIVE intervention.
Qualitative interviews will also assess stakeholder perspectives of the value of the intervention in addressing health inequities among Medicaid insured individuals cared for in the acute and home care settings.
Nesting the qualitative interview within a single-site randomized trial of a the THRIVE intervention will allow us to determine whether the intervention improved primary outcomes (referrals to homecare, 30-day readmission, ED utilization, connection to PCP) and to identify professional and organizational barriers to implementation.
Combining these insights with that of effectiveness outcome date will allow consideration for meaningful contextual factors that are viewed as critical to the implementation of THRIVE and subsequent outcomes.
Our stepped wedge design with include a randomized roll-out to case managers at Pennsylvania Hospital and the study will be carried out over 18 months.
To begin, 5 case managers will be randomized to receive training on the THRIVE clinical pathway.
Following training they will be invited to begin offering referrals to the THRIVE clinical pathway.
After 2 months the remaining 4 case managers will be trained on the THRIVE intervention and will be able to begin submitting referrals.
Study Type
Interventional
Enrollment (Estimated)
267
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
-
-
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
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Medicaid insured
- Residing in the state of Pennsylvania
- Experienced a hospitalization at study hospital
- Agrees to home care at partner home care setting.
Exclusion Criteria:
- Individuals under age 18
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: THRIVE Intervention
1 month intensive post discharge case management and care coordination.
|
The THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals following hospitalization.
|
|
No Intervention: Usual Care
Discharge to home without intensive post acute case management or care coordination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rates of Referrals to Homecare
Time Frame: Through study completion, an average of 18 months
|
We will evaluate changes in home care referrals between case managers exposed to the intervention compared to those who were not.
|
Through study completion, an average of 18 months
|
|
Rates of Readmissions
Time Frame: 30 days following hospital discharge
|
We will evaluate the rate of readmissions over the course of the study for THRIVE participants compared to those receiving usual care.
|
30 days following hospital discharge
|
|
Rates of Emergency Department Visit
Time Frame: 30 days following hospital discharge
|
We will evaluate the rate of ED visits over the course of the study for THRIVE participants compared to those receiving usual care.
|
30 days following hospital discharge
|
|
Primary Care or Specialist Visit
Time Frame: 30 Days following hospital discharge
|
We will compare the rates of primary care provider and specialist visits within 30 days following discharge compared to those receiving usual care.
|
30 Days following hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility, Acceptability, Appropriateness, Workload
Time Frame: Through study completion, an average of 18 months
|
We will conduct interviews of clinicians at the conclusion of the study to gather perceptions of the THRIVE clinical pathway and facilitators and barriers to engaging with the intervention.
|
Through study completion, an average of 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Margo B Brooks Carthon, PhD RN, University of Pennsylvania
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.
General Publications
- Brom H, Henderson J, Bettencourt AP, Babe E, Brooks Carthon JM. Association of intervention fidelity and outcomes in implementation of the Thrive transitional care program for Medicaid-insured individuals. J Hosp Med. 2026 Jul 3. doi: 10.1002/jhm.70388. Online ahead of print.
- Brom H, Golinelli D, Grantham-Murillo M, Harhay MO, Chittams J, Clark R, Vyas K, Miles D, Brooks Carthon JM. A Stepped-Wedge Cluster-Randomized Trial to Increase Home Health Referrals for Medicaid-Insured Patients: The Thrive Trial. J Gen Intern Med. 2026 Apr 29. doi: 10.1007/s11606-026-10468-6. Online ahead of print.
- Brooks Carthon JM, Brom H, Grantham-Murrillo M, Sliwinski K, Mason A, Roeser M, Miles D, Garcia D, Bennett J, Harhay MO, Flores E, Amenyedor K, Clark R. Equity-Centered Postdischarge Support for Medicaid-Insured People: Protocol for a Type 1 Hybrid Effectiveness-Implementation Stepped Wedge Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 26;13:e54211. doi: 10.2196/54211.
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)
March 27, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
February 1, 2023
First Posted (Actual)
February 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 16, 2026
Last Update Submitted That Met QC Criteria
July 14, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 10080229
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
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.