African American Preference for Knee Replacement: A Patient-Centered Intervention

Completed · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

A randomized, controlled design will be utilized to examine and compare the effectiveness of the proposed educational intervention, which includes an educational decision aid with attention control on select key patient-centered and process of care outcomes. The study sample will consist of approximately 300 African-American patients with osteoarthritis (OA) of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center and the Philadelphia VA Medical Center and will be randomized to one of the two study arms. The immediate goal of this randomized controlled trial is to assess the effect of a high-quality, evidence-based, patient-centered educational intervention on African American patient preferences, expectations, and the likelihood of receiving a recommendation for knee joint replacement surgery when clinically indicated. The long-term goal of this research is to implement effective strategies to improve minority patients' access to joint replacement and ultimately eliminate racial disparities in the utilization of this effective treatment for knee OA. Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis: The DA intervention will lead to higher rate of treatment recommendation within 6 months. Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will undergo knee replacement within 12 months at a higher rate than those in the attention control group.

Key facts

Study ID

NCT01851785

Run by

University of Pennsylvania

People needed

340

Starts

2010-07-01

Expected to finish

2019-07-08

Last updated by the study team

2019-10-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African-American patient referred to orthopedic doctor
• Age 50 or older
• Presence of knee OA by American College of Rheumatology as evidenced by:
• Chronic, frequent knee pain based on the NHANES questions.
• Moderate to severe knee OA based on WOMAC index score 39.
• Radiographic evidence of knee OA.

You may not qualify if…

• Prior history of any major joint replacement.
• Terminal Illness (e.g. end stage cancer).
• Physician diagnosed inflammatory arthritis (i.e., rheumatoid arthritis, connective tissue disease, ankylosing spondylitis, or other seronegative Spondyloarthropathy.)
• Contra-indications to replacement surgery (e.g., lower extremity paralysis as result of stroke).
• Prosthetic leg
• Cognitive impairment (e.g.,dementia)
• No home telephone service.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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