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View Clinical Trial (Medical Research Study)
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Educational Intervention for Knee Pain - NCT00324857-15213 (Clinical Trial 141937)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy141937.aspx
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| City: |
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15213 |
| Conditions: |
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Osteoarthritis |
| Purpose: |
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The purpose of this study is to demonstrate the efficacy of interventions to improve
understanding of knee replacement risks, benefits, and expected outcomes among AA primary
care patients, increase willingness to consider knee replacement among AA primary care
patients, and increase primary care referral rates for surgical consideration for AA
patients who meet the indications for knee replacement.
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| Study summary: |
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The proposed project represents the next phase in a trajectory of VA research designed to
eliminate racial disparities in the utilization of knee joint replacement - an effective
treatment option for end-stage knee osteoarthritis (OA). Numerous studies have documented
the existence of marked racial disparities in the utilization of knee joint replacement in
OA. African-Americans (AA) are two to five times less likely than white patients to receive
knee joint replacement for lower extremity OA. Our prior work has shown that compared to
white patients, AA patients expect worse outcomes from this treatment and, consequently, are
less willing to consider joint replacement even when clinically indicated and recommended by
a physician. Patient willingness, an attitudinal disposition modifiable with education and
counseling, has emerged as a key patient-level mediator in the utilization of elective
medical procedures, such as knee joint replacement.
The short-term goals of this randomized, controlled trial are to demonstrate the efficacy of
interventions to improve understanding of knee joint replacement risks, benefits, and
expected outcomes among AA primary care patients, increase willingness to consider knee
joint replacement among AA primary care patients, and increase primary care referral rates
for surgical consideration for AA patients who meet the indications for knee joint
replacement. We will test a multi-faceted intervention consisting of a knee OA decision aid
video developed by the Foundation for Informed Medical Decision Making alone or in
combination with individually tailored patient counseling using Motivational Interviewing
versus an attention control. The long-term objective is to reduce or eliminate the racial
gap in the utilization of knee joint replacement. The central hypothesis of this proposal is
that the scientifically accurate, high quality patient-centered information on knee
arthritis and joint replacement provided by the knee OA decision aid, alone or in
combination with motivational interviewing, will improve patient understanding of knee joint
replacement outcomes, increase patient willingness to consider knee joint replacement, and
consequently lead to higher rates of referral for surgical consideration when clinically
indicated. With increased referral rates, currently a major bottleneck in the path to joint
replacement, more AA patients will receive recommendations for surgery, thus potentially
reducing racial differences in the utilization of this procedure. This proposal is
innovative because it is the first patient-centered evidence-based VA intervention trial to
use a decision aid alone or in combination with motivational interviewing to intervene on a
well-documented and marked racial disparity in joint replacement that exists within and
outside the VA health care system.
Primary Specific Aims:
1. To examine the effectiveness of the proposed intervention strategies (DA alone, MI
alone or a combined DA+MI)) to improve willingness to consider knee joint replacement
when clinically indicated among AA primary care patients.
2. To examine the effectiveness of the proposed intervention strategies on patient
expectations of knee joint replacement risks/benefits among AA primary care patients.
3. To examine the effectiveness of the proposed intervention strategies in increasing
primary care referrals for surgical evaluation of AA patients with knee OA.
Secondary Specific Aim: To examine the effectiveness of the proposed intervention strategies
to increase AA patient likelihood of receiving knee joint replacement within 12 months of
the intervention.
A randomized, controlled factorial design will be utilized to examine the effectiveness of
knee OA decision aid and/or MI compared with attention control on select key
patient-centered and process of care outcomes. We will recruit approximately 600 AA primary
care patients (150 at the VAPHS, 150 at the LSCDVAMC, and 300 at the PVAMC) who meet the
American College of Rheumatology clinical indications for knee joint replacement and
randomize them into either intervention arms or attention control. We will assess patient
expectations, willingness and referral to joint replacement. We will also collect
qualitative data on doctor-patient communication following the intervention or control so
that we can assess (in the future) whether or not the interventions impact study outcomes
through improved quality of communication. This study will provide hard evidence needed to
improve quality of care for African-American VA patients who have end-stage knee OA, a major
cause of disability and functional decline in VA elderly patients. |
| Criteria: |
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Inclusion Criteria:
VA Pittsburgh Healthcare System, Philadelphia VA Medical Center, Louis Stokes Cleveland
VAMC, AA primary care patients > age 50 who meet clinical criteria for knee OA (i.e.,
chronic, frequent knee pain based on the NHANES questions, WOMAC score = 39, and
radiographic evidence of knee OA with K-L grade =2) are eligible for enrollment
Exclusion Criteria:
Patients who have 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, or contra-indications to replacement surgery (e.g., lower extremity
paralysis as result of stroke) will be excluded from the study, as well those patients who
are not willing to be randomized, do not have the presence of knee OA, or do not have
telephone service. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 1, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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