Secondary prevention risk interventions via telemedicine and tailored patient education (SPRITE): a randomized trial to improve postmyocardial infarction management.
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2011-03
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Abstract
Background
Secondary prevention by risk factor modification improves patient outcomes, yet it is often not achieved in clinical practice. Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors. We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors.Methods
To evaluate this intervention, we propose enrolling 450 patients with a recent myocardial infarction and hypertension into a 3-arm randomized, controlled trial. The first arm (n=150) will receive home blood pressure (BP) monitors plus a nurse-delivered, telephone-based tailored patient education intervention and will be enrolled into HealthVault, a Microsoft electronic health record platform. The second arm (n=150) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault. However, the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention. Both arms will be compared with a control group receiving standard care (n=150). All participants will have an in-person assessment at baseline and at completion of the study, including standardized measurements of BP, LDL cholesterol, and glycosylated hemoglobin (in diabetic subjects). The study design will allow assessment of a telephone-based, nurse-administered disease management program versus standard care. The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months. Secondary outcomes assessed will include reductions in LDL cholesterol, body weight, and glycosylated hemoglobin, as well as adherence to evidence-based therapies and improvement in health behaviors.Conclusion
If successful in optimizing BP control, managing other coronary heart disease risk factors, and demonstrating a lower cost, the Web-based disease management tool has the potential to enhance coronary artery disease management, quality of care, and ultimately, patient outcomes. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00901277.Type
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Shah, Bimal R, Martha Adams, Eric D Peterson, Benjamin Powers, Eugene Z Oddone, Kira Royal, Felicia McCant, Steven C Grambow, et al. (2011). Secondary prevention risk interventions via telemedicine and tailored patient education (SPRITE): a randomized trial to improve postmyocardial infarction management. Circulation. Cardiovascular quality and outcomes, 4(2). pp. 235–242. 10.1161/circoutcomes.110.951160 Retrieved from https://hdl.handle.net/10161/30099.
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Scholars@Duke
Bimal Ramesh Shah
Martha Bennett Adams
My focus has been at the interface of clinical research in medicine, a special emphasis on the impact of emerging technologies on information management, for example, developing a framework for clinical decision support in antimicrobial stewardship, creating an enterprise-wide solution for research data security management, and leading studies of mobile technology adoption and telegenetics.
Eugene Zaverio Oddone
I am a health services researcher whose primary research interests are: 1) evaluating the effectiveness of primary care with an emphasis on chronic disease, 2) assessing the reasons and testing interventions to reduce racial variation in access the health care and utilization of health services, 3) determining appropriate interventions to improve blood pressure control for hypertensive patients treated in primary care. I have research expertise in racial variation, blood pressure control, disease management, and tele-medicine. I also have methodologic expertise in designing and testing health services interventions in multi-site clinical trials.
Key words: primary care, racial variation, quality of care, hypertension
Steven C. Grambow
I am an academic statistician with a focus on educational leadership and administration, teaching, mentoring, and collaborative clinical research. I serve as the director of multiple education programs, both formal degree programs and certificate-based training programs. I also provide administrative oversight of multiple graduate degree programs and educational initiatives focusing on clinical and translational science workforce development at the student, staff, and faculty levels.
I have many years of experience with in-person and online teaching across a variety of teaching venues (formal degree programs, domestic and international certificate-based training programs, faculty development seminars, residency/fellowship training programs) and health sciences audiences (medical students, residents, fellows, faculty, and other health professionals), including more than 21 years as a statistics course director in the Duke Clinical Research Training Program.
As a collaborative scientist I have experience with a broad range of clinical research areas and clinical research designs, including observational studies, epidemiology investigations, and randomized clinical trials, including those utilizing web, mobile, and telemedicine-based health behavior interventions. I have collaborated on projects spanning a broad range of clinical research areas, including amyotrophic lateral sclerosis (ALS), post-traumatic stress disorder (PTSD), Prader-Willi syndrome (PWS), prostate cancer, quality of colorectal cancer care, osteoarthritis, lifestyle modification through weight loss, CVD risk reduction through hypertension control, smoking cessation, and substance abuse recovery.
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
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