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

Knee Osteoarthritis Clinical Trial

— REPAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413411
• Other study ID #: 1-RO1-AR-054474-5
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: April 8, 2015
• Start date: May 2010
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• 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.
• an educational program (an NIH-developed booklet)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12-months post-intervention	No
Secondary	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	12-months post-intervention	No