We will study 300 people with knee osteoarthritis (OA) who receive their medical care from a
large health maintenance organization (HMO) in Indianapolis. Our study will evaluate a
comprehensive plan for treatment of knee OA by primary care physicians. Primary care
physicians will provide standard care for knee OA to half of the study participants (150
people), and will use the comprehensive treatment plan guidelines to treat the other half.
The comprehensive plan includes careful use of medications along with non-drug approaches
such as patient education, exercise, and social support. People who participate in the study
will receive care for knee OA for 1 year. We will measure the results (outcomes) of
treatment at the start of the study and at 3 months, 6 months, and 12 months after patients
join the study. The results we will measure include joint pain, physical function, drug side
effects, quality of life, satisfaction with OA care, and the cost of medical care.
Anticipating trends toward generalism in medicine, the rheumatology community has begun to
set forth guidelines for managing osteoarthritis (OA). These guidelines emphasize a
comprehensive approach toward nondrug treatment (e.g., patient education, exercise, social
support) and a conservative approach to drug management to minimize the side effects of
nonsteroidal anti-inflammatory drugs (NSAIDs). Unfortunately, few primary care physicians
provide conservative, comprehensive care for OA as promoted in the recent rheumatology
literature. Also, although researchers have studied individual elements of a comprehensive
approach to OA care and largely validated them in isolation, no research support exists to
suggest that uniformly adopting OA care guidelines will result in better patient outcomes
and/or reduced costs of care.
In this project, we will implement, in a controlled fashion, and evaluate a comprehensive
plan for treating patients with knee OA by primary care physicians in a managed care
environment. Comprehensive care for knee OA will be guided by a procedure designed to
introduce and reinforce (a) an array of nondrug, self-care procedures intended to combat
joint pain and preserve function and (b) a stepped protocol for drug management of knee pain
that minimizes the risk of adverse side effects of NSAIDs.
Participants will be 300 patients with a confirmed clinical diagnosis of knee OA who receive
their medical care in a large health maintenance organization (HMO) in Indianapolis,
Indiana. We will randomly allocate geographically discrete offices of the HMOs to
experimental (OA care by algorithm) or control (routine OA care) conditions (150
subjects/group). Patients who enroll in the study at each location will receive care for
knee OA for 1 year under the guidelines specified by random assignment.
We will measure outcomes at baseline and 3 months, 6 months, and 12 months after enrollment,
and outcomes will include joint pain, physical function, drug side effects, quality of life
(i.e., general health status), satisfaction with OA care, and direct costs of medical care.
We think that comprehensive care, as guided by our algorithms, will result in significant
improvement in knee pain, physical function, and patient satisfaction, and lower direct
costs compared to care delivered under routine circumstances.
- Study participants must be treated for chronic knee pain by a primary care physician
at a participating HMO and satisfy American College of Rheumatology Clinical Criteria
for the diagnosis of knee OA.
- All subjects will be able to read and write English, have a telephone, and give
- Significant hematologic, renal, hepatic, or cardiovascular disease (but not including
mild/moderate hypertension) or any other serious medical condition that might
preclude the subject's ability to participate fully in the project, keep clinic
- Conditions other than knee OA which limit lower extremity function and mobility
and/or would confound the evaluation of knee pain and function (e.g., clinically
significant spinal or hip arthritis, painful or dysfunctional feet, peripheral
vascular disease, lumbar radiculopathy, stroke, etc.).
- A known "secondary" cause of OA, including acute or chronic infectious arthritis;
crystal-induced arthritis; systemic inflammatory connective tissue disease (e.g.,
rheumatoid arthritis, systemic lupus erythematosus); osteonecrosis; Paget's disease;
or metabolic diseases, such as hemochromatosis, Wilson's disease, or ochronosis.