CClinicalTrials.gg
RecruitingNCT06203509THRIVE-SMIUpdated Aug 12, 2026

Improving Care Transitions for Medicaid Insured Individuals With Co-occurring Serious Mental Illness

An interventional study of Thrive Intervention in Care Transitions, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
267
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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:

  1. To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness.
  2. 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.

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Conditions studied

  • Care Transitions
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Individuals under age 18
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
267 participants (estimated)

Study arms

  • Experimental
    THRIVE Intervention

    THRIVE Intervention 1-month intensive post discharge case management and care coordination

    Behavioral: Thrive Intervention

  • No intervention
    Usual Care

    Discharge to home without intensive post-acute case management or care coordination.

Interventions

  • BehavioralThrive 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, an average of 18 months

  2. 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

    Time frame: 30 days following hospital discharge

  3. 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.

    Time frame: 30 days following hospital discharge

  4. 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

    Time frame: 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

    Time frame: Through study completion, an average of 18 months

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Study locations

1 of 1 sites recruiting
  • Upenn School of Nursing Centre For Health Outcomes Policy Research
    Philadelphia, Pennsylvania 19104, United States
    • Jacqueline M Brooks Carthon, PhD,RN · Contact · jmbrooks@nursing.upenn.edu · 215-898-8050
    • Kelvin Amenyedor, PhD,RN · Contact · kelvinam@upenn.edu · 2158984417
    • Jacqueline M Brooks Carthon, PhD,RN · Principal investigator
    Recruiting
08

References and documents

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 42396715 ↗
  • Brooks 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 39728639 ↗
  • Brooks 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06203509
Lead sponsor
University of Pennsylvania
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Sponsor
First posted
Jan 12, 2024
Start date
Apr 15, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Aug 12, 2026

Study contacts

Jacqueline M Brooks Carthon, PhD,RN
Contact
jmbrooks@nursing.upenn.edu
2158988050
Erin Babe, MPH
Contact
erinbabe@nursing.upenn.edu
2158984417
Jacqueline M Brooks Carthon, PhD,RN
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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