Educational Intervention for Knee Pain

NCT00324857 | Completed Results

• 1 other identifier: IIR 05-234
• Study Type: interventional
• Target: 663
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Knee; race; ethnicity; knee replacement

Outcome Measures

Primary Outcomes (1)

• Change in Willingness.

  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.

  Follow-Up

Secondary Outcomes (1)

• 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

Study Arms (4)

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

Other: Attention control

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.

Behavioral: Decision Aid Video

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

Behavioral: Motivational Interviewing

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

Behavioral: MI plus Decision aid

Interventions

Decision Aid Video BEHAVIORAL

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.

Also known as: DA

Arm 2/Decision Aid (DA)

Motivational Interviewing BEHAVIORAL

The research intervention will conduct the fact-to-face MI session with the participant. The MI session will do the following things: 1) Assessing Readiness, Importance, and Confidence; 2) Eliciting Barriers, Concerns and Positive Motivational; 3) Summarizing Pros and Cons; 4) Assess Patient Values and Goals; 5) Provide a Menu of Options.

Also known as: MI

Arm 3/ Motivational Interview (MI)

MI plus Decision aid BEHAVIORAL

Patient viewed the video and then underwent MI.

Arm 4/ DA and MI

Attention control OTHER

patients received a booklet.

Arm 1/Attention Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106-3800, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Division of General Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• 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.

  PMID: 21132110 BACKGROUND

• 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.

  PMID: 18021506 BACKGROUND

• 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.

  PMID: 28657869 RESULT

• 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.

  PMID: 23613362 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Motivational Interviewing; Decision Support Techniques

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Investigative Techniques

Results Point of Contact

• Title: Said A. Ibrahim, MD, MPH
• Organization: VA

Said.Ibrahim2@va.gov

215 823 5800

Study Officials

• Said A. Ibrahim, MD MPH

  VA Medical Center, Philadelphia

  PRINCIPAL INVESTIGATOR

• C. Kent Kwoh, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: September 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 10, 2018
• Results First Posted: January 22, 2016

Record last verified: 2018-09

Locations

US (3)