Patient and Provider Interventions for Managing Osteoarthritis in Primary Care

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.

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

- Motor neuron diseases, Parkinson's Disease, multiple sclerosis

- Quadriplegic or paraplegic

- Serious / terminal illness as indicated by referral to hospice or palliative care

- Other self-reported health problem that would prohibit participation in the study

- Nursing home resident

- Other health conditions or personal issues judged by a study team member or primary
care physician to make the patient inappropriate for the study

- Female participants: pregnant or planning to become pregnant

- Metastatic Cancer

- History of gout in knee or hip

- Total joint replacement (knee or hip) surgery, other knee or hip surgery, meniscus
tear (verified by MRI), or ACL tear in the past 6 months

- Have not seen their VA-assigned primary health care provider for more than a year