Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.
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2016-09
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Abstract
Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.
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Jackson, George L, Morris Weinberger, Miriam A Kirshner, Karen M Stechuchak, Stephanie D Melnyk, Hayden B Bosworth, Cynthia J Coffman, Brian Neelon, et al. (2016). Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemporary clinical trials, 50. pp. 5–15. 10.1016/j.cct.2016.07.009 Retrieved from https://hdl.handle.net/10161/29915.
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Scholars@Duke
George Lee Jackson
Areas of expertise: Epidemiology, Health Services Research, and Implementation Science
George L. Jackson, Ph.D., MHA is a healthcare epidemiologist and implementation scientist with a background in health administration. He joined the faculty of the UT Southwestern Medical Center in February of 2023 as a Professor and Director of the Advancing Implementation & Improvement Science Program in the Peter O'Donnell Jr. School of Public Health. Dr. Jackson is also a Veterans Affairs (VA) Health Services Research & Development (HSR&D) Research Health Scientist who works with the VA healthcare systems in both Durham, NC and Dallas, TX. He is the Director of the Implementation and Improvement Science Lab/Core at the Durham VA Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT). Additionally, he is a co-leader of a cooperative effort between the Dallas VA and Program on Implementation and Improvement Science designed to enhance the infrastructure for partnered health services and other research across the Dallas VA and UT Southwestern focused on enhancing the health and healthcare of Veterans in North Texas and across the Nation.
The UT Southwestern Advancing Implementation & Improvement Science Program seeks to further enhance collaborations between the UT Southwestern and affiliated health systems and community partners in the pursuit of common missions to enhance the health and healthcare of the people of North Texas. The goal is to develop a system to identify potentially successful projects using implementation and improvement science – which uses rigorous, data-driven research to expand programs and improve a community’s health.
Dr. Jackson’s own research and evaluation efforts focus on the development, testing, and implementation of team-based approaches to address the treatment and prevention of chronic conditions such as diabetes, hypertension, and cancer. He has also evaluated efforts to enhance the organization of mental health care. As an implementation scientist, Dr. Jackson studies strategies focused on the adoption and spread of evidence-informed practices across large health systems. He is currently the corresponding principal investigator for two VA program grants focused on the process of identifying, replicating, and spreading innovations across large healthcare systems. These include the Spreading Healthcare Access, Activities, Research and Knowledge (SHAARK) partnered evaluation of the Veterans Health Administration (VHA) Diffusion of Excellence program and the Dynamic Diffusion Network (DDN) QUERI Program, both funded by the VA Quality Enhancement Research Initiative (QUERI).
Dr. Jackson received his Doctor of Philosophy (Ph.D.) in epidemiology, Master of Health Administration (MHA), and Bachelor of Science in Public Health (BSPH) in health policy and administration degrees from the School of Public Health at the University of North Carolina at Chapel Hill. He completed an Agency for Healthcare Research and Quality (AHRQ) pre-doctoral fellowship in health services research at the Cecil G. Sheps Center for Health Services Research and AHRQ post-doctoral fellowship in health services research in the Duke Division of General Internal Medicine and HSR&D Center at the Durham VA. He came to UT Southwestern from Duke University, where he was a Professor in the Departments of Population Health Sciences, Medicine (Division of General Internal Medicine), and Family Medicine & Community Health. He also co-taught evidence-based practice in the Duke Physician Assistant (PA) Program. Dr. Jackson currently maintains appointments as an Adjunct Professor of Population Health Sciences at Duke and Adjunct Professor of Health Policy and Management at the University of North Carolina at Chapel Hill.
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
Cynthia Jan Coffman
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
David Edward Edelman
My general interests are in the improve quality of care for chronic illness, using diabetes as a model. While I have performed research on screening for, diagnosis of, and clinical severity of unrecognized diabetes in patient care settings, my current line of work is in using health systems interventions to prevent cardiovascular disease, and to improve outcomes from comorbid diabetes and hypertension.
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