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Educational Intervention for Knee Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00324857
First received: May 9, 2006
Last updated: April 18, 2013
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis
 Behavioral: Decision Aid Video
Behavioral: Motivational Interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Knee Replacement Disparity: A Randomized, Controlled Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Effectiveness of the proposed intervention among AA patients to improve willingness to consider knee replacement, to improve understanding of its risks, benefits and expected outcomes, and to increase primary care referrals for surgical evaluation. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine and compare the effectiveness of the proposed intervention strategies to increase AA patient likelihood of receiving knee replacement within 12 months of the intervention. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: September 2006
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
A randomized, controlled 2x2 factorial design will be utilized to examine and compare the effectiveness of the proposed educational interventions compared with attention control on select key patient-centered and process of care outcomes.
 Behavioral: Decision Aid Video
The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled "Treatment Choices for Knee Osteoarthritis." The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.
Other Name: DA
Behavioral: Motivational Interviewing
The research intervention will conduct the fact-to-face MI session with the participant. The MI session will do the following things: 1) Assessing Readiness, Importance, and Confidence; 2) Eliciting Barriers, Concerns and Positive Motivational; 3) Summarizing Pros and Cons; 4) Assess Patient Values and Goals; 5) Provide a Menu of Options.
Other Name: MI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324857

Locations
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106-3800
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Division of General Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Said A. Ibrahim, MD MPH VA Medical Center, Philadelphia
Principal Investigator: C. Kent Kwoh, MD Center for Health Equity Research and Promotion
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00324857     History of Changes
Other Study ID Numbers: IIR 05-234
Study First Received: May 9, 2006
Last Updated: April 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Osteoarthritis, Knee
race
ethnicity
knee replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013