Educational Intervention for Knee Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00324857
First received: May 9, 2006
Last updated: December 15, 2015
Last verified: December 2015
  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
Behavioral: MI plus Decision aid
Other: Attention control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Knee Replacement Disparity: A Randomized, Controlled Intervention

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Change in Willingness. [ Time Frame: Follow-Up ] [ Designated as safety issue: No ]
    Change in willingness assessed using the willingness likert scale. The primary outcome was change in patient willingness to undergo total knee replacement. The willingness rating is a 5-category ordinal response scale from "definitely not willing" to "definitely willing" which was later dichotomized for analysis. Responses "definitely" and "probably willing" were combined and compared to "unsure", "probably not willing", and "definitely not willing" combined.


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: 663
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
Placebo Comparator: Arm 1/Attention Control
Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
Other: Attention control
patients received a booklet.
Active Comparator: Arm 2/Decision Aid (DA)
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.
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
Active Comparator: Arm 3/ Motivational Interview (MI)
Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
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
Active Comparator: Arm 4/ DA and MI

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.

Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain

Behavioral: MI plus Decision aid
Patient viewed the video and then underwent MI.

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  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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)
    • contra-indications to replacement surgery (e.g., lower extremity paralysis as result of stroke)
  • Patients who are not willing to be randomized
  • Do not have the presence of knee OA
  • Do not have telephone service
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
VA Office of Research and Development
Investigators
Principal Investigator: Said A. Ibrahim, MD MPH VA Medical Center, Philadelphia
Principal Investigator: C. Kent Kwoh, MD University of Arizona
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00324857     History of Changes
Other Study ID Numbers: IIR 05-234 
Study First Received: May 9, 2006
Results First Received: December 18, 2014
Last Updated: December 15, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Osteoarthritis, Knee
race
ethnicity
knee replacement

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

ClinicalTrials.gov processed this record on July 25, 2016