Care TransitionsTHRIVE-SMINCT06203509
Improving Care Transitions for Medicaid Insured Individuals With Co-occurring Serious Mental Illness
A study testing Thrive Intervention in people with Care Transitions, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study aims to evaluate the THRIVE clinical pathway at HUP, focusing on supporting Medicaid-insured individuals, including those with serious mental illness, following hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 15 Apr 2024to 1 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- 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, 1 recruiting
- Recruiting
Upenn School of Nursing Centre For Health Outcomes Policy Research
Philadelphia, Pennsylvania, 19104
Jacqueline M Brooks Carthon, PhD,RN, 215-898-8050, jmbrooks@nursing.upenn.edu
Kelvin Amenyedor, PhD,RN, 2158984417, kelvinam@upenn.edu
About this study
Official title: An Equity-focused Intervention to Improve Care Transitions for Medicaid Insured Individuals With Co-occurring Chronic Medical Conditions and Serious Mental Illness
This study aims to evaluate the THRIVE clinical pathway at HUP, focusing on supporting Medicaid-insured individuals, including those with serious mental illness, following hospitalization. The study will assess clinician/administrator perspectives on the pathway's feasibility, appropriateness, and acceptability and analyze referral patterns and post-discharge outcomes.
The objectives are:
Read more
- To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness.
- To examine referral patterns, 30-day readmission rates, and ED utilization for THRIVE participants, comparing them with those receiving standard care.
Participants will be referred to home care services during hospitalization and seen by a home care nurse within 48 hours post-discharge. A discharging physician or Advanced Practice Provider will oversee care for 30 days or until a primary care or specialist visit. The Care Coordination Team will hold weekly case conferences for 30 days post-discharge to address both health and mental health needs. The study will compare outcomes of Medicaid-insured patients, including those with serious mental illness, to those receiving usual care.
Read the detailed description
Detailed Description:
This study is a single-site Type 1 hybrid effectiveness-implementation parallel mixed methods (quantitative + qualitative) quasi-experimental study at HUP, focusing on the THRIVE clinical pathway. It integrates simultaneous quantitative and qualitative data collection and analysis, with a stronger emphasis on quantitative data to evaluate referrals, outcomes, and program fidelity. The qualitative aspect will explore the implementation process, delving into the barriers and facilitators encountered by healthcare providers. It will also assess stakeholder perspectives on the intervention's impact on health inequities among Medicaid-insured individuals in both acute and home care settings. By nesting qualitative interviews within a quasi-experimental framework, the study aims to examine the intervention's effect on primary outcomes (homecare referrals, 30-day readmission, ED utilization, connection to PCP) and to identify professional and organizational barriers to its implementation. The combination of effectiveness data with contextual insights will inform understanding of factors critical to THRIVE's implementation and outcomes.
Qualitative Study:
The recruitment process is meticulously managed to track each participant's journey. Recruitment begins in early January, with participants contacted via email, providing study details and interview scheduling links. Follow-up reminders ensure participant engagement. Interviews, conducted virtually and recorded with consent, focus on maintaining confidentiality and privacy. Non-consented sessions are captured through detailed notes. Post-interview, recordings are transcribed for analysis, enabling categorization into codes and themes for a deeper understanding of participant perspectives.
Quantitative Study:
Employing a stepped wedge design, the study would begin early March and would involve a randomized training of case managers at HUP over several months. Initially, a subset of case managers receives training on the THRIVE pathway and starts offering referrals. After 8 weeks, the remaining case managers are trained and begin making referrals. This staggered approach allows for evaluation of the THRIVE intervention's rollout and its impact on patient care and outcomes.
- 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 being managed for both chronic diseases and serious mental illness following hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE Intervention | Experimental | THRIVE Intervention
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 posted12 Jan 2024
- Study start15 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 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
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Jacqueline M Brooks Carthon, PhD,RN, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203509
- Sponsor's protocol ID
- 1R18HS029815-01
- Other IDs
- 1R18HS029815-01
- Acronym
- THRIVE-SMI
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2024
- Last updated
- 12 Aug 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 42396715Brooks Carthon JM, Tibbitt C, Amenyedor KE, Bettencourt AP, Babe E, Cacchione PZ, Brom H. Pre-Implementation Strategies to Support Adaptation of Thrive: A Care Transitions Model for Economically Disadvantaged Patients with Serious Mental Illness. Nurs Rep. 2024 Dec 2;14(4):3803-3818. doi: 10.3390/nursrep14040278.
PubMed 39728639Brooks Carthon JM, Brom H, Amenyedor KE, Harhay MO, Grantham-Murillo M, Nikpour J, Lasater KB, Golinelli D, Cacchione PZ, Bettencourt AP. Transitional Care Support for Medicaid-Insured Patients With Serious Mental Illness: Protocol for a Type I Hybrid Effectiveness-Implementation Stepped-Wedge Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 12;13:e64575. doi: 10.2196/64575.
PubMed 39531274
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Equity-focused Intervention to Improve Care Transitions for Medicaid Insured Individuals With Co-occurring Chronic Medical Conditions and Serious Mental Illness
- ClinicalTrials.gov ID
- NCT06203509
- Acronym / sponsor ID
- THRIVE-SMI / 1R18HS029815-01
- Conditions
- Care Transitions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jan 2024 (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.
This study aims to evaluate the THRIVE clinical pathway at HUP, focusing on supporting Medicaid-insured individuals, including those with serious mental illness, following hospitalization. The study will assess clinician/administrator perspectives on the pathway's feasibility, appropriateness, and acceptability and analyze referral patterns and post-discharge outcomes.
The objectives are:
- To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness.
- To examine referral patterns, 30-day readmission rates, and ED utilization for THRIVE participants, comparing them with those receiving standard care.
Participants will be referred to home care services during hospitalization and seen by a home care nurse within 48 hours post-discharge. A discharging physician or Advanced Practice Provider will oversee care for 30 days or until a primary care or specialist visit. The Care Coordination Team will hold weekly case conferences for 30 days post-discharge to address both health and mental health needs. The study will compare outcomes of Medicaid-insured patients, including those with serious mental illness, to those receiving usual care.
Detailed description
Detailed Description:
This study is a single-site Type 1 hybrid effectiveness-implementation parallel mixed methods (quantitative + qualitative) quasi-experimental study at HUP, focusing on the THRIVE clinical pathway. It integrates simultaneous quantitative and qualitative data collection and analysis, with a stronger emphasis on quantitative data to evaluate referrals, outcomes, and program fidelity. The qualitative aspect will explore the implementation process, delving into the barriers and facilitators encountered by healthcare providers. It will also assess stakeholder perspectives on the intervention's impact on health inequities among Medicaid-insured individuals in both acute and home care settings. By nesting qualitative interviews within a quasi-experimental framework, the study aims to examine the intervention's effect on primary outcomes (homecare referrals, 30-day readmission, ED utilization, connection to PCP) and to identify professional and organizational barriers to its implementation. The combination of effectiveness data with contextual insights will inform understanding of factors critical to THRIVE's implementation and outcomes.
Qualitative Study:
The recruitment process is meticulously managed to track each participant's journey. Recruitment begins in early January, with participants contacted via email, providing study details and interview scheduling links. Follow-up reminders ensure participant engagement. Interviews, conducted virtually and recorded with consent, focus on maintaining confidentiality and privacy. Non-consented sessions are captured through detailed notes. Post-interview, recordings are transcribed for analysis, enabling categorization into codes and themes for a deeper understanding of participant perspectives.
Quantitative Study:
Employing a stepped wedge design, the study would begin early March and would involve a randomized training of case managers at HUP over several months. Initially, a subset of case managers receives training on the THRIVE pathway and starts offering referrals. After 8 weeks, the remaining case managers are trained and begin making referrals. This staggered approach allows for evaluation of the THRIVE intervention's rollout and its impact on patient care and outcomes.
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 InterventionTHRIVE Intervention 1-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 years and older
- Sex
- All
- Healthy volunteers
- 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 Intervention• The THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals being managed for both chronic diseases and serious mental illness 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 12 Aug 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 39728639Brooks Carthon JM, Tibbitt C, Amenyedor KE, Bettencourt AP, Babe E, Cacchione PZ, Brom H. Pre-Implementation Strategies to Support Adaptation of Thrive: A Care Transitions Model for Economically Disadvantaged Patients with Serious Mental Illness. Nurs Rep. 2024 Dec 2;14(4):3803-3818. doi: 10.3390/nursrep14040278.
- Derived from this study: PubMed 39531274Brooks Carthon JM, Brom H, Amenyedor KE, Harhay MO, Grantham-Murillo M, Nikpour J, Lasater KB, Golinelli D, Cacchione PZ, Bettencourt AP. Transitional Care Support for Medicaid-Insured Patients With Serious Mental Illness: Protocol for a Type I Hybrid Effectiveness-Implementation Stepped-Wedge Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 12;13:e64575. doi: 10.2196/64575.
- 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.
Jacqueline M 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: looking for participants now, as of the sponsor's last update on 12 Aug 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?
Contact Jacqueline M Brooks Carthon, PhD,RN (2158988050, jmbrooks@nursing.upenn.edu), or a site near the patient. 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 NCT06203509, 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 12 Aug 2026.