Clinical trial NCT00324857: Educational Intervention for Knee Pain
Official title: Knee Replacement Disparity: A Randomized, Controlled Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Knee
race
ethnicity
knee replacement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-05-11
Enrollment: 663
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 surgical consideration for AA patients who meet the indications for knee replacement.

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.

Eligibility 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

Primary outcomes:
measure: Change in Willingness.
timeFrame: Follow-Up
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Division of General Medicine
state: Pennsylvania
Study officials:
affiliation: VA Medical Center, Philadelphia
name: Said A. Ibrahim, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: C. Kent Kwoh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.