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

NCT ID: NCT06203509

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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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

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Care Transitions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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THRIVE Intervention

THRIVE Intervention

1-month intensive post discharge case management and care coordination

Group Type EXPERIMENTAL

Thrive Intervention

Intervention Type BEHAVIORAL

• 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.

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacqueline M Brooks Carthon, PhD,RN

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Upenn School of Nursing Centre For Health Outcomes Policy Research

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacqueline M Brooks Carthon, PhD,RN

Role: CONTACT

2158988050

Erin Babe, MPH

Role: CONTACT

2158984417

Facility Contacts

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Jacqueline M Brooks Carthon, PhD,RN

Role: primary

215-898-8050

Kelvin Amenyedor, PhD,RN

Role: backup

2158984417

References

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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.

Reference Type DERIVED
PMID: 39728639 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39531274 (View on PubMed)

Other Identifiers

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1R18HS029815-01

Identifier Type: AHRQ

Identifier Source: secondary_id

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1R18HS029815-01

Identifier Type: AHRQ

Identifier Source: org_study_id

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