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Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial |
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| Authors: | Daniel C Cherkin Karen J Sherman Janet Kahn Janet H Erro Richard A Deyo Sebastien J Haneuse Andrea J Cook |
| Institution: | 1. Department of Medicine, Duke University Medical Center, Durham, NC, USA 2. Center for Health Services Research in Primary Care, Veterans Affairs Medical Center, Durham, NC, USA 3. President's Office, University of Medicine and Dentistry of New Jersey, Newark, NJ, USA 4. Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC, USA 5. Department of Biostatistics & Bioinformatics, Duke University, Durham, NC, USA 6. Department of Community and Family Medicine, Duke University Medical Center, Durham, NC, USA 7. Cancer Prevention, Detection, and Control Research Program, Duke University Medical Center, Durham, NC, USA 8. Nutrition Sciences, University of Alabama, Birmingham, AL, USA 9. Department of Nephrology, Billings Clinic, Billings, MT, USA 10. Cary Kidney Center, Cary, NC, USA 11. Duke Hypertension Center, Duke University Medical Center, Durham, NC, USA 12. Sarah W Stedman Nutrition and Metabolism Center, Duke University Medical Center, Durham, NC, USA |
| Abstract: | BackgroundHypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.Methods and designThis paper describes the protocol of a nested 2 × 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.DiscussionOverall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.Trial registrationClinicalTrials.gov identifier NCT00201136 |
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