Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (PRIMO)

Evidence-based guidelines emphasize that adequate management of osteoarthritis (OA) requires a combination of both medical and behavioral modalities. However, many of the recommended guidelines are not regularly incorporated into clinical practice, and the recommended behavioral strategies (e.g. exercise and weight management) are not practiced by most patients. Prior studies have examined strategies for improving patient behaviors to manage OA-related symptoms, but few studies have examined provider-based interventions specifically for patients with OA, or combinations of patient- and provider-based interventions. The objective of this study is to compare a patient-based intervention (involving exercise, weight management, and cognitive behavioral pain management), a provider-based intervention (involving provision of patient-specific recommendations for care, based on evidence-based guidelines), and a combination of the two interventions, relative to usual care. This study will provide novel, valuable information of the effectiveness (and cost-effectiveness) of these three interventions in the context of real-world clinical settings.

This will be a randomized controlled trial involving the following four study arms: 1) Patient Behavioral Intervention for OA Only, 2) Provider Intervention for OA Only, 3) Patient Behavioral Intervention + Provider Intervention for OA, and 4) Usual Care Control (no intervention). Approximately 10 primary care practices in the Duke Primary Care Research Consortium (PCRC) will be randomized to either the Provider Intervention or Provider Control group. Within each clinic, patients with symptomatic knee and/or hip OA (n=560 total) will be randomly assigned to either the Patient Intervention or Patient Control group. Participants will be equally allocated between the four study groups, with randomization stratified according to gender and race (white/non-white).

The patient behavioral intervention will be a twelve-month program that includes the following elements: written educational materials (focused on exercise, weight management, and cognitive behavioral pain management), an exercise video tailored for patients with lower extremity OA, and telephone calls by a counselor to support behavior change. All participants in the study will continue with any other usual medical care they receive for OA. The provider intervention will involve giving information on patients' OA symptoms and treatment, as well as patient-specific evidence-based recommendations for care. Providers will have access to this information, as well as facilitated referrals for patient-specific treatment recommendations (e.g. physical therapy, orthopedics), at the point of clinical care.

The primary time point for outcome assessment will be at 12-months. The investigators will also assess a limited set of outcomes via telephone at 6-months, 18-months, and 24-months. Following completion of study follow-up assessments, participants who were not assigned to one of the two Participant arms will be given the materials for that intervention, and health care providers who were not part of one of the two Provider arms will be given the information involved in that intervention. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Secondary outcomes will include objective physical function (Short Physical Performance Test) and depressive symptoms (PHQ-8). The main study analyses will compare outcomes between the four study groups. The investigators will also assess the cost-effectiveness of the interventions.