Race and Preference for Knee Replacement: A Patient-Centered Intervention
REPAIR
2 other identifiers
interventional
493
1 country
1
Brief Summary
A randomized, controlled design will be utilized to examine and compare the effectiveness of the proposed educational intervention, which includes a combination of an educational decision aid and motivational interviewing with attention control on select key patient-centered and process of care outcomes. The study sample will consist of approximately 450 African-American patients with osteoarthritis of the knee. Patients will be recruited from the University of Pennsylvania Health System 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 supplemented with targeted counseling (motivational interviewing) on African American patient preferences, expectations, and the likelihood of achieving a referral for surgical evaluation. The long-term goal of this research is to widely implement a patient-centered educational intervention targeting African Americans who are potential candidates for joint replacement, in a national effort to reduce and ultimately eliminate racial disparities in the utilization of this effective treatment option. Study Aim:To examine the effect of the knee osteoarthritis Decision Aid (DA)/Motivational Interviewing (MI) intervention on orthopedic surgery referral rates for African American (AA) patients. Hypothesis: Compared to attention control, the DA/MI intervention will lead to higher orthopedic surgery referral rates for AA patients. Secondary aim: To examine the effect of the DA/MI intervention on the rate of knee replacement receipt among AA patients. Hypothesis: AA patients randomized to receive the intervention will have higher rates of knee replacement compared to those in the attention control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started May 2010
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 6, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedApril 9, 2015
April 1, 2015
3 years
April 6, 2015
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Referral to knee joint replacement
Referral to knee joint replacement will be assessed for all patients 12 months post-intervention initially through telephone survey and then validated by medical record review
12-months post-intervention
Secondary Outcomes (1)
Receipt of knee joint replacement
12-months post-intervention
Study Arms (2)
DA/MI Intervention
EXPERIMENTALPatients randomized to the DA/MI intervention arm will be shown a decision aid video entitled, Treatment Choices for Knee Osteoarthritis. Following the viewing of the decision aid video, the participant will be engaged in a motivational interview by the research study interventionist.
Attention Control
ACTIVE COMPARATORPatients randomized to the attention control arm will receive an educational program (an NIH-developed booklet) that summarizes how to live with knee OA but does not specifically mention joint replacement. This booklet provides examples of exercises one could do to improve pain and reduce stiffness from knee OA.
Interventions
Patients randomized to the DA/MI intervention arm will be shown a decision aid video entitled, Treatment Choices for Knee Osteoarthritis. Following the viewing of the decision aid video, the participant will be engaged in a motivational interview by the research study interventionist.
Eligibility Criteria
You may qualify if:
- African American primary care patients
- Age 50 or older
- Chronic, frequent knee pain based on the NHANES questions
- Moderate to sever knee osteoarthritis based on WOMAC index score greater than or equal to 39 or positive answer to knee treatment questions
- Radiographic evidence of knee osteoarthritis
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 sypondylarthoplasty.)
- Contra-indications to replacement surgery (e.g., lower extremity paralysis as a result of stroke.)
- Prosthetic leg
- Cognitive impairment (e.g., dementia)
- No home telephone service
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Said A Ibrahim, MD, MPH
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2015
First Posted
April 9, 2015
Study Start
May 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2014
Last Updated
April 9, 2015
Record last verified: 2015-04