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Open Access Study protocol

Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials

Kelli D Allen1236*, Hayden B Bosworth12346, Dorothea S Brock27, Jennifer G Chapman16, Ranee Chatterjee27, Cynthia J Coffman156, Santanu K Datta126, Rowena J Dolor127, Amy S Jeffreys16, Karen A Juntilla16, Jennifer Kruszewski27, Laurie E Marbrey16, Jennifer McDuffie126, Eugene Z Oddone126, Nina Sperber126, Mary P Sochacki27, Catherine Stanwyck27, Jennifer L Strauss146 and William S Yancy Jr126

Author Affiliations

1 Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, USA

2 Department of Medicine, Duke University Medical Center, Durham, NC, USA

3 Center for Aging and Human Development, Duke University, Durham, NC, USA

4 Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, USA

5 Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA

6 HSR&D (152), VA Medical Center, 508 Fulton Street, Durham, NC, 27705, USA

7 Division of General Internal Medicine, Duke University Medical Center, 411 West Chapel Hill Street Suite 500, Durham, NC, 27701, USA

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BMC Musculoskeletal Disorders 2012, 13:60  doi:10.1186/1471-2474-13-60

Published: 24 April 2012

Abstract

Background

Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.

Methods / Design

One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among nā€‰=ā€‰300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among nā€‰=ā€‰560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.

Discussion

Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.

Trial registration

NCT01130740 (VA); NCT 01435109 (NIH)

Keywords:
Osteoarthritis; Physical activity; Weight reduction program; Pain management; Intervention study