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OsteoarthritisNCT00324857

Educational Intervention for Knee Pain

A study testing Decision Aid Video, Motivational Interviewing and MI plus Decision aid in people with Osteoarthritis, run by VA Office of Research and Development at 3 sites 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

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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Decision Aid Video, Motivational Interviewing and MI plus Decision aid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
663 participants
Where
3 sitesUnited States
Study dates
Sep 2006to Sep 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • VA Medical Center, Cleveland

    Cleveland, Ohio, 44106-3800

  • VA Medical Center, Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Division of General Medicine

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Knee Replacement Disparity: A Randomized, Controlled Intervention

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.

Read the detailed description

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.

Conditions
Osteoarthritis
Being tested
Decision Aid Video, Motivational Interviewing, MI plus Decision aid, Attention control
Keywords
Osteoarthritis, Knee, race, ethnicity, knee replacement
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

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

  • Decision Aid VideoBehavioural

    Also called DA

    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 InterviewingBehavioural

    Also called MI

    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.

  • MI plus Decision aidBehavioural

    Patient viewed the video and then underwent MI.

  • Attention controlOther

    patients received a booklet.

Study groups in NCT00324857
Study groupRoleWhat they receive
Arm 1/Attention ControlPlacebo comparatorSubjects 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
Receives: Other: Attention control
Arm 2/Decision Aid (DA)Active comparatorDecision 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.
Receives: Behavioral: Decision Aid Video
Arm 3/ Motivational Interview (MI)Active comparatorMotivational 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
Receives: Behavioral: Motivational Interviewing
Arm 4/ DA and MIActive comparatorDecision 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
Receives: Behavioral: MI plus Decision aid

What is being measured

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

  1. Change in Willingness.

    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.

    Measured: Follow-Up

Secondary outcomes (1)
  1. 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.

    Measured: 12 months

Timeline

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

  1. First posted11 May 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionJul 2011
  4. Study completionSep 2011

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
Factorial
Masking
None (open label)
Enrolment
663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324857
Sponsor's protocol ID
IIR 05-234
Status last verified
Sep 2018
First submitted
9 May 2006
Last updated
10 Oct 2018
Data monitoring committee
No

Publications

  • Ibrahim SA. Racial variations in the utilization of knee and hip joint replacement: an introduction and review of the most recent literature. Curr Orthop Pract. 2010 Mar;21(2):126-131. doi: 10.1097/BCO.0b013e3181d08223.

    PubMed 21132110
  • Emejuaiwe N, Jones AC, Ibrahim SA, Kwoh CK. Disparities in joint replacement utilization: a quality of care issue. Clin Exp Rheumatol. 2007 Nov-Dec;25(6 Suppl 47):44-9.

    PubMed 18021506
  • Ibrahim SA. Decision Aids and Elective Joint Replacement - How Knowledge Affects Utilization. N Engl J Med. 2017 Jun 29;376(26):2509-2511. doi: 10.1056/NEJMp1703432. No abstract available.

    PubMed 28657869
  • Ibrahim SA, Hanusa BH, Hannon MJ, Kresevic D, Long J, Kent Kwoh C. Willingness and access to joint replacement among African American patients with knee osteoarthritis: a randomized, controlled intervention. Arthritis Rheum. 2013 May;65(5):1253-61. doi: 10.1002/art.37899.

    PubMed 23613362

Questions about this trial

What is this clinical trial studying?

A study testing Decision Aid Video, Motivational Interviewing and MI plus Decision aid in people with Osteoarthritis, run by VA Office of Research and Development at 3 sites 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 1 inclusion and 8 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 22 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Willingness. (time frame: Follow-Up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00324857, which also lists 4 linked publications.

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 10 Oct 2018.

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