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.

Autor: Brooks Carthon JM; Center for Health Outcomes and Policy Research, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States., Brom H; Center for Health Outcomes and Policy Research, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States., Amenyedor KE; Center for Health Outcomes and Policy Research, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States., Harhay MO; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States.; Institute for Medical Informatics and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States., Grantham-Murillo M; Penn Medicine at Home, University of Pennsylvania, Philadelphia, PA, United States., Nikpour J; Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA, United States., Lasater KB; Center for Health Outcomes and Policy Research, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States., Golinelli D; Center for Health Outcomes and Policy Research, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States., Cacchione PZ; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States.; New Courtland Center for Transitions and Health, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.; Penn Presbyterian Medical Center, Philadelphia, PA, United States., Bettencourt AP; Center for Health Outcomes and Policy Research, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States.; Penn Implementation Science Center, University of Pennsylvania, Philadelphia, PA, United States.
Jazyk: angličtina
Zdroj: JMIR research protocols [JMIR Res Protoc] 2024 Nov 12; Vol. 13, pp. e64575. Date of Electronic Publication: 2024 Nov 12.
DOI: 10.2196/64575
Abstrakt: Background: People diagnosed with a co-occurring serious mental illness (SMI; ie, major depressive disorder, bipolar disorder, or schizophrenia) but hospitalized for a nonpsychiatric 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 posthospitalization 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 nonpsychiatric hospitalization.
Objective: This study aimed 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 (ie, Thrive referral, readmission, emergency department [ED], primary, and specialty care visits) for Medicaid-insured individuals with and without SMI who receive Thrive compared with 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 use a prospective, type I hybrid effectiveness-implementation, stepped-wedge, cluster randomized controlled trial 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 individuals who (1) are Medicaid insured, dually enrolled in Medicaid and Medicare, or Medicaid eligible; (2) reside in Philadelphia; (3) are admitted for a medical diagnosis for over 24 hours at the study hospital; (4) are planned for discharge to home; (5) agree to receive home care services; and (6) are aged ≥18 years. Primary analyses will use a mixed-effects negative binomial regression model to evaluate readmission and ED utilization, comparing those with and without SMI who receive Thrive to those with and without SMI who receive usual care. Using a convergent parallel mixed methods design, analyses will be conducted simultaneously for the survey and interview data of patients, clinicians, and health care system leaders. The cost of Thrive will be calculated from budget monitoring data for the research budget, the cost of staff time, and average Medicaid facility fee payments.
Results: This research project was funded in October 2023. Data collection will occur from April 2024 through December 2025. 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.
Trial Registration: ClinicalTrials.gov NCT06203509; https://clinicaltrials.gov/ct2/show/NCT06203509.
International Registered Report Identifier (irrid): DERR1-10.2196/64575.
(©J Margo Brooks Carthon, Heather Brom, Kelvin Eyram Amenyedor, Michael O Harhay, Marsha Grantham-Murillo, Jacqueline Nikpour, Karen B Lasater, Daniela Golinelli, Pamela Z Cacchione, Amanda P Bettencourt. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.11.2024.)
Databáze: MEDLINE