Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial.

Abstract

Objective

The purpose of this study is to examine the efficacy of BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) vs. usual transitional care management among diverse adults with traumatic brain injury (TBI) discharged home from acute hospital care and families.

Methods

This will be a single-site, two-arm, randomized controlled trial (N = 436 people, 218 patient/family dyads, 109 dyads per arm) of BETTER, a culturally- and linguistically-tailored, patient- and family-centered, TBI transitional care intervention for adult patients with TBI and families. Skilled clinical interventionists will follow a manualized protocol to address patient/family needs. The interventionists will co-establish goals with participants; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills for 16 weeks following hospital discharge. English- and Spanish-speaking adult patients with mild-to-severe TBI who are discharged directly home from the hospital without inpatient rehabilitation or transfer to other settings (community discharge) and associated family caregivers are eligible and will be randomized to treatment or usual transitional care management. We will use intention-to-treat analysis to determine if patients receiving BETTER have a higher quality of life (primary outcome, SF-36) at 16-weeks post-hospital discharge than those receiving usual transitional care management. We will conduct a descriptive, qualitative study with 45 dyads randomized to BETTER, using semi-structured interviews, to capture perspectives on barriers and facilitators to participation. Data will be analyzed using conventional content analysis. Finally, we will conduct a cost/budget impact analysis, evaluating differences in intervention costs and healthcare costs by arm.

Discussion

Findings will guide our team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to enhance the standard of care for adults with TBI and families. The new knowledge generated will drive advancements in health equity among diverse adults with TBI and families.

Trial registration

NCT05929833.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1371/journal.pone.0296083

Publication Info

Oyesanya, Tolu O, Stephanie O Ibemere, HyunBin You, Maralis Mercado Emerson, Wei Pan, Anushka Palipana, Melissa Kandel, Darius Ingram, et al. (2024). Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial. PloS one, 19(2). p. e0296083. 10.1371/journal.pone.0296083 Retrieved from https://hdl.handle.net/10161/30214.

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Scholars@Duke

Oyesanya

Tolulope Oyesanya

Associate Professor in the School of Nursing

Dr. Oyesanya is an Associate Professor at Duke University School of Nursing. Her research program centers on care of patients with traumatic brain injury (TBI) in acute and post-acute treatment settings, as well as support of their family caregivers. Her current research focuses on transitional care needs of patients with TBI, with an emphasis on improving patient and family quality of life post-discharge and self- and family-management of care.

Dr. Oyesanya earned her BSN, MSN, and PhD in Nursing from University of Wisconsin-Madison. She completed a post-doctoral fellowship in Brain Injury Research at Shepherd Center in Atlanta, GA. Her research has been supported by federally- and internally funded awards. Dr. Oyesanya is actively involved in several professional organizations, including serving as Chair of the Mentoring Task Force and Chair-Elect of the Career Development Networking Group of the American Congress of Rehabilitation Medicine and as a member of the Association of Rehabilitation Nurses and the International Brain Injury Association.

Pan

Wei Pan

Professor in the School of Nursing

Dr. Wei Pan is a Professor and Director of Health Statistics and Data Science at the Duke University School of Nursing. He also has a secondary appointment with the Department of Population Health Sciences at the Duke University School of Medicine. He received his Ph.D. in Measurement & Quantitative Methods from Michigan State University and M.S. in Statistics from Fuzhou University, China. His research interests are causal inference, advanced statistical modelingdata analyticsmeta-analysis, and psychometrics; and their applications in the social, behavioral, and health sciences. He has been involved as a Principal Investigator, Co-Investigator, and Principal Biostatistician in many research projects funded by federal agencies, such as NIH, NSF, and the like. He has published numerous refereed journal articles on both methodological and applied research. He was awarded the Outstanding Ph.D. Faculty Award by the Duke University School of Nursing. He was an Invited Expert Observer in the Reference Group on Health Statistics of the World Health Organization. He is a Science Board Member of the American Public Health Association. 

Komisarow

Jordan Komisarow

Assistant Professor of Neurosurgery
Ramos

Katherine Ramos

Assistant Professor in Psychiatry and Behavioral Sciences
Gonzalez-Guarda

Rosa Gonzalez-Guarda

Associate Professor in the School of Nursing

Rosa M. Gonzalez-Guarda, PhD, MPH, RN, FAAN, is Associate Professor at Duke University School of Nursing and Assistant Dean of the PhD Program. Her research describes the intersection of intimate partner violence, substance abuse, HIV and mental health among Latinos in the U.S. and the development of multi-level interventions to address these. She uses a syndemic orientation, mixed methods, and community engaged strategies to influence practice and policy changes to promote health equity for Latinos, survivors of intimate partner violence, and other historically marginalized populations. Dr. Gonzalez-Guarda serves on local and national organizations influencing services and policies addressing violence, abuse, mental health, and health equity for Latinos, including serving as the Chair of the Board of Director of El Futuro, a community based mental service organization serving Spanish speaking and uninsured immigrants in North Carolina, a member of the Scientific Advisory Board of Esperanza United, a National Technical Assistance provider for community based organization addressing Latino and immigrant families affected by violence, and a member of the executive team of LATIN-19 (Latinx Advocacy and Interdisciplinary Network for COVID-19), a local multisector coalition influencing systems change for Latinx inclusion. She also served as a previous Chair of the Violence Expert Panel of the American Academy of Nursing. Dr. Gonzalez-Guarda was a member of the National Academies of Medicine committee that produced the landmark Future of Nursing Report (2010) and has led various local and national initiatives to promote health equity research careers for populations systemically excluded from health professions. Dr. Gonzalez-Guarda has interdisciplinary training in nursing, public health, and psychology and is a fellow of the Substance Abuse Mental Health Service Administration Minority Fellowship Program and the Robert Wood Johnson Foundation Nurse Faculty Scholars program.


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