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

Official title

An Equity-focused Intervention to Improve Care Transitions for Medicaid Insured Individuals With Co-occurring Chronic Medical Conditions and Serious Mental Illness

Overview

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

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Rates of Referrals to Homecare [Time frame: Through study completion, an average of 18 months]
• Rates of Readmissions [Time frame: 30 days following hospital discharge]
• Rates of Emergency Department Visit [Time frame: 30 days following hospital discharge]
• Primary Care or Specialist Visit [Time frame: 30 Days following hospital discharge]

Secondary outcome measures (1)

• Feasibility, Acceptability, Appropriateness, Workload [Time frame: Through study completion, an average of 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Upenn School of Nursing Centre For Health Outcomes Policy Research — Philadelphia

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. PMID 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. PMID 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. PMID 39531274

Identifiers

NCT: NCT06203509 · 1R18HS029815-01 · 1R18HS029815-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗