Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- US Department of Veterans Affairs
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.
Detailed Description
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. The objective of this study is examine the effectiveness of a combined intervention for patients (involving exercise, weight management, and cognitive behavioral pain management) and providers (involving provision of patient-specific recommendations for care, based on evidence-based guidelines) for improving OA-related outcomes in a real-world VA clinical setting. To our knowledge this is will be the first study to intervene at a both the patient and provider levels for managing OA. This will be a randomized controlled trial of n=300 patients with symptomatic knee or hip OA, with equal assignment to 2 study arms: 1) Patient and Provider Intervention for OA and 2.) Usual Care Control. We will randomize 30 primary care providers at the Durham VAMC and affiliated community based outpatient clinics to either intervention or control groups. We will then enroll 10 patients from each provider (5 White, 5 Non-White). The patient component of the 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. The provider component of the 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, via electronic medical records. The primary time point for outcome assessment will be at 12-months. We will also assess a limited set of outcomes via telephone at 6-months. 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 intervention and control groups. We will also assess the cost-effectiveness of the intervention.
Investigators
Eligibility Criteria
Inclusion Criteria
- •radiographic evidence of hip OA and / or radiographic of or meets clinical criteria for knee OA
- •current joint symptoms
- •BMI \>=25
- •physically inactive
Exclusion Criteria
- •Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
- •Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months
- •Active diagnosis of psychosis or serious personality disorder
- •On waiting list for / planning arthroplasty
- •Severely impaired hearing or speech (patients must be able to respond to phone calls)
- •Unable to speak English
- •No access to a telephone
- •Participating in another OA intervention or other lifestyle change study
- •Dementia or other memory loss condition
- •Current, uncontrolled substance abuse disorder
Outcomes
Primary Outcomes
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
Time Frame: 12-months
Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from "none" (0) to "severe / extreme" (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.
Secondary Outcomes
- Short Physical Performance Test Protocol(12-months)
- PHQ-8(12-months)