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Knee OsteoarthritisREPAIRNCT02413411

Race and Preference for Knee Replacement: A Patient-Centered Intervention

A study testing DA/MI Intervention and an educational program (an NIH-developed booklet) in people with Knee Osteoarthritis, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
DA/MI Intervention and an educational program (an NIH-developed booklet)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
1 siteUnited States
Study dates
May 2010to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

The study involves a baseline questionnaire, educational intervention, primary care follow-up phone call questionnaire (approximately 2 weeks after primary care appointment), and follow-up questionnaires by phone calls at 3 months and 1 year. All eligible, consented patients will complete the baseline questionnaire, conducted by a REPAIR research staff member. The baseline questionnaire will include the following instruments that have been field-tested by our team in previous and ongoing studies: 1.) Willingness to Consider Joint Replacement Question 2.) Knowledge Regarding Knee OA and Joint Replacement (developed by The Foundation for Informed Medical Decision Making) 3.) Hospital for Special Surgery Knee Expectations Survey 4.) Socioeconomic Survey 5.) Access to Health Care, Charleson Comorbidity Index 6.) Quality of Life SF-12v2. This survey can be done over the phone or in person. It should take approximately 30-40 minutes. At the completion of the baseline questionnaire, patients will be randomized into either study Decision Aid (DA) supplemented by motivational interview (MI) (hereafter referred to as DA/MI intervention) arm or the attention control arm. Patient appointments for the DA/MI intervention or attention control activity will be scheduled to occur 2 weeks prior to the patients next primary care appointment (up to the date of the appointment). The DA/MI intervention (referred to as an information session in patient material) will be completed by a REPAIR research study interventionist (the interventionist will not administer the baseline assessment). In the intervention arm, patients 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.The completion time for the educational intervention will vary from 30 to 80 minutes. The attention control arm will be conducted by the REPAIR research staff. Patients will be given written educational material adapted from the NIH/NIAMS publication Osteoarthritis to review at his/her leisure.The completion time for the attention control arm is approximately 10 minutes. Follow-up procedures will occur at the following time points: 1.) approximately 2 weeks after the participants primary care appointment, 2.) 3-months post intervention, 3.) 12-months post intervention, and 4.) medical chart assessment. All followup procedures will be administered by a REPAIR research team member that was not involved in the educational intervention. Participants in both the DA/MI intervention and the attention control will complete a primary care follow-up survey approximately 2 weeks following the patients next primary care appointment. This survey will be comprised of the following: 1.) Willingness to consider joint replacement question 2.) Hospital for Special Surgery Knee Expectations Survey 3.) Knowledge Regarding Knee OA and Joint Replacement 4.) Communication questions regarding who the patient talked to about their knee pain and/or the intervention. The follow-up will take 10-15 minutes to complete, and will be administered preferably by phone. Participants in both the DA/MI intervention and the attention control will complete a 3-month follow-up (completed approximately 3 months post intervention) survey over the phone. This survey will be comprised the same as the primary care followup survey. This survey will take 10-15 minutes to complete. Lastly, participants in both the DA/MI intervention and the attention control will complete a 12-month follow-up (completed approximately 12 months post intervention) survey over the phone. The survey will be comprised of the following: Willingness to consider joint replacement, Hospital for Special Surgery Knee Expectations Survey, Knowledge Regarding Knee OA and Joint Replacement, and a survey regarding referrals to orthopedics and for joint replacement. At the time of the 12-month follow-up, the patients medical record will be accessed to check for a referral to orthopedics and a joint replacement procedure.

Being tested
DA/MI Intervention, an educational program (an NIH-developed booklet)
Keywords
Arthroplasty, Osteoarthritis, Replacement, Intervention
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DA/MI InterventionBehavioural

    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.

  • an educational program (an NIH-developed booklet)Behavioural

Study groups in NCT02413411
Study groupRoleWhat they receive
DA/MI InterventionExperimentalPatients 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.
Receives: Behavioral: DA/MI Intervention
Attention ControlActive 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.
Receives: Behavioral: an educational program (an NIH-developed booklet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12-months post-intervention

Secondary outcomes (1)
  1. Receipt of knee joint replacement

    Receipt of knee joint replacement will be assessed for all patients 12-months post-intervention initially through telephone survey and then validated by medical record review

    Measured: 12-months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2015 (estimated)
  2. Study startMay 2010
  3. Primary completionMay 2013
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02413411
Sponsor's protocol ID
1-RO1-AR-054474-5
Other IDs
1R01AR054474
Acronym
REPAIR
Status last verified
Apr 2015
First submitted
6 Apr 2015
Last updated
9 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing DA/MI Intervention and an educational program (an NIH-developed booklet) in people with Knee Osteoarthritis, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Referral to knee joint replacement (time frame: 12-months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015; AzTrials last refreshed its copy on 3 Nov 2026.

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