Care TransitionsNCT05714605
Implementation and Evaluation of A Health Innovation to Support Medicaid-Insured Individuals Following Hospitalization
A study testing THRIVE Intervention in people with Care Transitions, run by University of Pennsylvania at 1 site in United States.
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Care Transitions
- What is being tested?
- THRIVE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medicaid insured
- Residing in the state of Pennsylvania
- Experienced a hospitalization at study hospital
- Agrees to home care at partner home care setting.
Who cannot join
- Individuals under age 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the 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.
- Conditions
- Care Transitions
- Being tested
- THRIVE Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE InterventionBehavioural
The THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals following hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE Intervention | Experimental | 1 month intensive post discharge case management and care coordination. Receives: Behavioral: THRIVE Intervention |
| Usual Care | No intervention | Discharge to home without intensive post acute case management or care coordination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Referrals to Homecare
We will evaluate changes in home care referrals between case managers exposed to the intervention compared to those who were not.
Measured: Through study completion, an average of 18 months
Rates of Readmissions
We will evaluate the rate of readmissions over the course of the study for THRIVE participants compared to those receiving usual care.
Measured: 30 days following hospital discharge
Rates of Emergency Department Visit
We will evaluate the rate of ED visits over the course of the study for THRIVE participants compared to those receiving usual care.
Measured: 30 days following hospital discharge
Primary Care or Specialist Visit
We will compare the rates of primary care provider and specialist visits within 30 days following discharge compared to those receiving usual care.
Measured: 30 Days following hospital discharge
Secondary outcomes (1)
Feasibility, Acceptability, Appropriateness, Workload
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.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start27 Mar 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Care TransitionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Responsible party
- Sponsor
- Investigators
- Margo B Brooks Carthon, PhD RN, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714605
- Sponsor's protocol ID
- 10080229
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42396715Brom 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.
PubMed 42056364Brooks 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.
PubMed 38530349
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of THRIVE: A Health Innovation to Support Care Transitions for Medicaid-Insured Individuals Following Hospitalization
- ClinicalTrials.gov ID
- NCT05714605
- Acronym / sponsor ID
- 10080229
- Conditions
- Care Transitions
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE Intervention | Experimental | Behavioral: THRIVE Intervention1 month intensive post discharge case management and care coordination. |
| Usual Care | No intervention | –Discharge to home without intensive post acute case management or care coordination. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medicaid insured
- Residing in the state of Pennsylvania
- Experienced a hospitalization at study hospital
- Agrees to home care at partner home care setting.
Key exclusion criteria (1 listed)
- Individuals under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVE InterventionThe THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals following hospitalization. | Behavioural | THRIVE Intervention |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Feasibility, Acceptability, Appropriateness, Workload
Time frame: Through study completion, an average of 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 42396715Brom 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.
- Derived from this study: PubMed 42056364Brom 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.
- Derived from this study: PubMed 38530349Brooks 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margo B Brooks Carthon, PhD RN principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE Intervention in people with Care Transitions, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Referrals to Homecare (time frame: Through study completion, an average of 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05714605, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.