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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jul 21, 2024
Date Accepted: Aug 8, 2024

The final, peer-reviewed published version of this preprint can be found here:

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

Brooks Carthon JM, Brom H, Amenyedor KE, Harhay M, Grantham-Murillo M, Nikpour J, Lasater KB, Golinelli D, Cacchione P, Bettencourt A

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;13:e64575

DOI: 10.2196/64575

PMID: 39531274

PMCID: 11599882

Transitional Care Support for Medicaid Insured Patients with Serious Mental Illness: A Type 1 Hybrid Effectiveness Implementation Stepped-Wedge Cluster Randomized Trial

  • J Margo Brooks Carthon; 
  • Heather Brom; 
  • Kelvin Eyram Amenyedor; 
  • Michael Harhay; 
  • Marsha Grantham-Murillo; 
  • Jacqueline Nikpour; 
  • Karen Blanchette Lasater; 
  • Daniela Golinelli; 
  • Pamela Cacchione; 
  • Amanda Bettencourt

ABSTRACT

Background:

People diagnosed with a co-occurring serious mental illness (SMI, i.e., major depressive disorder, bipolar disorder, or schizophrenia) but hospitalized for a non-psychiatric condition experience higher rates of readmissions and other adverse outcomes, in part due to poorly coordinated care transitions. Current hospital-to-home transitional care programs lack a focus on the integrated social, medical, and mental health needs of these patients. The Thrive clinical pathway provides transitional care support for patients insured by Medicaid with multiple chronic conditions by focusing on post-hospitalization medical concerns and the social determinants of health. This study seeks to evaluate an adapted version of Thrive that also meets the needs of patients with co-occurring SMI discharged from a non-psychiatric hospitalization.

Objective:

The objectives of this study are to (1) engage staff and community advisors in participatory implementation processes to adapt the Thrive clinical pathway for all Medicaid-insured patients, including those with SMI, (2) examine utilization outcomes (i.e., Thrive referral, readmission, emergency department, primary and specialty care visits) for Medicaid-insured individuals with and without SMI who receive Thrive compared to usual care, and (3) evaluate the acceptability, appropriateness, feasibility, and cost-benefit of an adapted Thrive clinical pathway that is tailored for Medicaid-insured patients with co-occurring SMI.

Methods:

This study will employ a prospective Type 1 hybrid effectiveness-implementation stepped-wedge cluster randomized design. We will randomize the initiation of Thrive referrals at the unit level. Data collection will occur over 24 months. Inclusion criteria for Thrive referral include (1) Medicaid-insured, dually-enrolled in Medicaid and Medicare, or Medicaid-eligible individuals, (2) resident of Philadelphia, (3) admitted for a medical diagnosis for over 24 hours at the study hospital, (4) discharge planned to home, (5) agreement to receive home care services, and (6) age 18 years or older. Qualitative data will be collected via interviews of patients, clinicians, and healthcare system leaders. Quantitative data will be captured from the electronic health record.

Results:

This research project was funded in October 2023 and approved by the institutional review board on October 4, 2023. Results are anticipated to be published in 2025-2027.

Conclusions:

We anticipate that patients with and without co-occurring SMI will benefit from the adapted Thrive clinical pathway. We also anticipate the adapted version of Thrive to be deemed feasible, acceptable, and appropriate by patients, clinicians, and health system leaders. Clinical Trial: ClinicalTrials.gov NCT06203509;


 Citation

Please cite as:

Brooks Carthon JM, Brom H, Amenyedor KE, Harhay M, Grantham-Murillo M, Nikpour J, Lasater KB, Golinelli D, Cacchione P, Bettencourt A

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;13:e64575

DOI: 10.2196/64575

PMID: 39531274

PMCID: 11599882

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