Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Hip Osteoarthritis

• Registration Number: NCT02729831
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study is a 2X2 factorial randomized trial that will the examine the comparative effectiveness of two patient decision aids for hip and knee osteoarthritis (OA) as well as the impact of a surgeon-focused intervention.

Detailed Description

This study is a 2X2 factorial randomized trial that will examine the comparative effectiveness of different decision support strategies for patients making treatment decisions about hip or knee osteoarthritis (OA). Eligible patient subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating orthopedic specialist. Participating providers are randomly assigned to either usual care or an intervention (a report that includes patients' goals and treatment preferences). Patient participants will complete three surveys at different time points: before their orthopedic visit, one week after the clinic visit, and 12 months later. Providers will complete a short survey for a subset of patient participants. The study is titled the DECIDE-OA study.

Study Timeline

• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-03-31
• Study Start: 2016-04
• Study First Posted: 2016-04-06
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Results First Submitted: 2019-08-29
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Results First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1220

Inclusion Criteria

• Diagnosis of either hip or knee osteoarthritis
• Scheduled visit with participating orthopedic surgeon

Exclusion Criteria

• prior partial or total knee or hip joint replacement within last 5 years
• hip fracture or asceptic necrosis (AVN) in last 12 months
• Rheumatoid arthritis
• Psoriatic arthritis
• Unable to read English or Spanish
• Unable to consent for self due to cognitive or medical issue
• Hip or knee decision aid provided by Partners Healthcare clinician within 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Patients Knowledge	before orthopedic visit	Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge.
Percentage of Patients Who Received Preferred Treatment	1 week after visit with orthopedic surgeon	Patient preferred treatment item from the Hip or Knee Decision Quality Instrument will be compared with the treatment received to determine percentage of patients who received treatment that matched their preferences.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Used the Decision Aid	before orthopedic visit	1 item asking patients how much they reviewed the program (none, some, most, all). The percentage who report viewing most or all will be calculated.
Change in Quality of Life	before orthopedic visit; 12 months from date of orthopedic visit	Overall quality of life (EQ-5D) scores will be calculated and the impact of decision support strategies on change in quality of life will be examined. Scale ranges from -0.11 to 1.00, with higher (positive) values meaning better overall health. The minimum important change is 0.10 points.
Surgical Rates	6 months after the initial visit	Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit.

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

New England Baptist Hospital; 🇺🇸 Boston, Massachusetts, United States

Newton Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States