跳至主要内容
临床试验/NCT00324857
NCT00324857已完成不适用

Knee Replacement Disparity: A Randomized, Controlled Intervention

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 663 人开始时间: 2006年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
663
试验地点
6
主要终点
Change in Willingness.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Arm 1/Attention Control

Placebo Comparator

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

干预措施: Attention control (Other)

Arm 2/Decision Aid (DA)

Active Comparator

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.

干预措施: Decision Aid Video (Behavioral)

Arm 3/ Motivational Interview (MI)

Active Comparator

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

干预措施: Motivational Interviewing (Behavioral)

Arm 4/ DA and MI

Active Comparator

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

干预措施: MI plus Decision aid (Behavioral)

结局指标

主要结局

Change in Willingness.

时间窗: Follow-Up

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.

次要结局

  • 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.(12 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验