Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial.
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2024-01
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Abstract
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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.Type
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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
Tolulope Oyesanya
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.
Wei Pan
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 modeling, data analytics, meta-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.
Anushka Palipana
Dr. Anushka Palipana is a Biostatistician in the Health Statistics and Data Science division at the Duke University School of Nursing. She earned her Ph.D. in Statistics from the University of Cincinnati and her B.Sc. in Statistics from the University of Peradeniya, Sri Lanka. Her research interests encompass longitudinal modeling, survival analysis, and the joint modeling of longitudinal and survival data, with a focus on their applications in health science.
Prior to joining Duke University School of Nursing, Dr. Palipana was a postdoctoral research fellow at Cincinnati Children's Hospital Medical Center (CCHMC). At CCHMC, her research involved designing and analyzing medical monitoring investigations and integrating geo- and bio-markers to enhance the prediction and early detection of disease progression in conditions such as lymphangioleiomyomatosis and cystic fibrosis.
Dr. Palipana has authored numerous peer-reviewed journal articles published in methodological and clinical journals, including CHEST, Biometrics, Pediatric Pulmonology, PLoS One, and the Journal of Cystic Fibrosis, among others.
Jordan Komisarow
Katherine Ramos
Rosa Gonzalez-Guarda
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.
Courtney Harold Van Houtven
Dr. Courtney Van Houtven is a Professor in The Department of Population Health Science, Duke University School of Medicine and Duke-Margolis Center for Health Policy. She is also a Research Career Scientist in The Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System. Dr. Van Houtven’s aging and economics research interests encompass long-term care financing, intra-household decision-making, unpaid family and friend care, and home- and community-based services. She examines how family caregiving affects health care utilization, expenditures, health and work outcomes of care recipients and caregivers. She is also interested in understanding how best to support family caregivers to optimize caregiver and care recipient outcomes.
Dr. Van Houtven is co-PI on the QUERI Program Project, “Optimizing Function and Independence”, in which her caregiver skills training program developed as an RCT in VA, now called Caregivers FIRST, has been implemented at 125 VA sites nationally. The team will evaluate how intensification of an implementation strategy changes adoption. She directs the VA-CARES Evaluation Center, which evaluates the VA’s Caregiver Support Program. She leads a mixed methods R01 study as PI from the National Institute on Aging that will assess the value of "home time" for persons living with dementia and their caregivers (RF1 AG072364).
Areas of expertise: Health Services Research and Health Economics
Suresh Kumar Agarwal
Janet Prvu Bettger
Dr. Bettger’s research is dedicated to establishing real world evidence aimed to improve health care quality and policies that reduce the burden of disease and disability. As a health services researcher and implementation scientist, her research extends from observational studies to randomized and pragmatic trials. She was the Founding Director of Duke Roybal Center for Translational Research in the Behavioral and Social Sciences of Aging and the Founding Director of Undergraduate Initiatives for the Duke-Margolis Center for Health Policy. She has examined implementation of several integrated care models to improve the transition home from the hospital (VERITAS with virtual exercise therapy after knee replacement, COMPASS for stroke, RECOVER for stroke in rural China, and coordinated care for trauma patients in Tanzania). She also studies implementation of community-based models of care that can prevent functional decline. These include the CTSA-funded IMPAC RCT of integrating physical therapists into primary care as first line providers to address musculoskeletal pain, the VA-funded Gerofit program of structured and progressive in-person and virtual group exercise for older Veterans, MRC-funded SINEMA RCT of a village-based model supporting stroke recovery in China, and a NIDCD study comparing three primary care protocols for older adult hearing healthcare.
In addition to the evidence translation studies in China (RECOVER and SINEMA) and Tanzania, she has partnered with experts in Singapore on stroke systems research, and worked on large cluster randomized trials to improve evidence-based care in Brazil, Peru, Argentina (BRIDGE-Stroke) and China (CNSR and Golden Bridge). To address health locally, she was the faculty sponsor to launch Exercise is Medicine at Duke and Help Desk, a student volunteer community resource navigator model addressing social determinants of health.
Dr. Bettger received her BA from the University of Western Ontario, Canada and her MS from the University of Wisconsin–LaCrosse where she studied community reintegration for stroke and brain-injured patients transitioning from hospital to home. Her doctoral training in Rehabilitation Sciences, completed at Boston University, concluded with an investigation of patterns of functional recovery and factors affecting outcomes in patients transitioning home following acute rehabilitation. While working on her doctorate, she also worked in state government as the director of the Paul Coverdell National Acute Stroke Registry. Dr. Bettger completed post-doctoral training at the University of Pennsylvania with a NIH NRSA research fellowship in neurorehabilitation, a research fellowship at the NewCourtland Center for Transitions and Health, and a Switzer Fellowship funded by the National Institute on Disability and Rehabilitation Research to study the role of the environment on functional outcomes. She completed additional research training at Duke as a mentored scholar in comparative effectiveness research funded by AHRQ. As of July 2022, she is an Adjunct Associate Professor for Duke's Department of Orthopaedics and has transitioned out of her role as Co-Director of the Duke Clinical and Translational Institute (CTSA) Pilots Accelerator Core working with NCCU. She is affiliate faculty with Duke's Science and Society, Duke-Margolis Center for Health Policy, the Duke Clinical Research Institute (DCRI) and Duke Global Health Institute (DGHI), is a Senior Fellow of the Duke Center for the Study of Aging and Human Development, and is a Fellow of the American Heart Association.
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