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

2015년 4월 8일 업데이트: University of Pennsylvania

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.

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

493

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • University of Pennsylvania

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: DA/MI Intervention
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.
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.
활성 비교기: Attention Control
Patients 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Referral to knee joint replacement
기간: 12-months post-intervention
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
12-months post-intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Receipt of knee joint replacement
기간: 12-months post-intervention
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
12-months post-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Said A Ibrahim, MD, MPH, University of Pennsylvania

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 5월 1일

기본 완료 (실제)

2013년 5월 1일

연구 완료 (실제)

2014년 5월 1일

연구 등록 날짜

최초 제출

2015년 4월 6일

QC 기준을 충족하는 최초 제출

2015년 4월 8일

처음 게시됨 (추정)

2015년 4월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 4월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 4월 8일

마지막으로 확인됨

2015년 4월 1일

추가 정보

이 연구와 관련된 용어

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

DA/MI Intervention에 대한 임상 시험

구독하다