African American Preference for Knee Replacement: A Patient-Centered Intervention

NCT01851785 | Completed

• 1 other identifier: 5R01AR059615-03
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled design will be utilized to examine and compare the effectiveness of the proposed educational intervention, which includes an educational decision aid with attention control on select key patient-centered and process of care outcomes. The study sample will consist of approximately 300 African-American patients with osteoarthritis (OA) of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center 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 on African American patient preferences, expectations, and the likelihood of receiving a recommendation for knee joint replacement surgery when clinically indicated. The long-term goal of this research is to implement effective strategies to improve minority patients' access to joint replacement and ultimately eliminate racial disparities in the utilization of this effective treatment for knee OA. Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis: The DA intervention will lead to higher rate of treatment recommendation within 6 months. Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will undergo knee replacement within 12 months at a higher rate than those in the attention control group.

Conditions

Knee Osteoarthritis

Keywords

Knee Arthroplasty; Knee Osteoarthritis; Osteoarthritis; disparity; joint replacement

Outcome Measures

Primary Outcomes (1)

• Recommendation of knee joint replacement

  Recommendation of knee joint replacement 6 months after intervention will be assessed for all patients by chart abstraction.

  6 months after intervention

Secondary Outcomes (1)

• Receipt of knee joint replacement

  assessed for all patients 12 months post-intervention

Study Arms (2)

Attention control

NO INTERVENTION

Subjects 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 information about OA, examples of exercises one could do to improve pain and reduce stiffness, types of non-drug pain relief such as massage, and information about various medications. The interventionist will give the participant the booklet and describe what can be found inside. They are also encouraged to ask their doctor any questions they may have about the information in the booklet or questions they may have about their OA. The purpose of this educational program is to provide a tangible clinical incentive to the control group for participating in this additional component of the study.

Decision Aid (DA) Intervention

EXPERIMENTAL

Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3." The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment. The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?

Behavioral: Decision Aid (DA) Intervention

Interventions

Decision Aid (DA) Intervention BEHAVIORAL

Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3." The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment. The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?

Decision Aid (DA) Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African-American patient referred to orthopedic doctor
• Age 50 or older
• Presence of knee OA by American College of Rheumatology as evidenced by:
• Chronic, frequent knee pain based on the NHANES questions.
• Moderate to severe knee OA based on WOMAC index score 39.
• Radiographic evidence of knee OA.

You may not qualify if:

• 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).
• Prosthetic leg
• Cognitive impairment (e.g.,dementia)
• No home telephone service.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Ibrahim SA, Blum M, Lee GC, Mooar P, Medvedeva E, Collier A, Richardson D. Effect of a Decision Aid on Access to Total Knee Replacement for Black Patients With Osteoarthritis of the Knee: A Randomized Clinical Trial. JAMA Surg. 2017 Jan 18;152(1):e164225. doi: 10.1001/jamasurg.2016.4225. Epub 2017 Jan 18.

  PMID: 27893033 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Decision Support Techniques; Methods

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Said A Ibrahim, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Gwo-Chin Lee, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: July 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: July 8, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

US (1)