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NCT Number: NCT02729831

Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive decision aid

Behavioral

The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis

video decision aid

Behavioral

Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

Provider Report

Behavioral

A short report that includes the patients' goals and treatment preferences

Primary outcomes

  1. Patients Knowledge

    Time frame: 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.

  2. Percentage of Patients Who Received Preferred Treatment

    Time frame: 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 outcomes

  1. Percentage of Participants Who Used the Decision Aid

    Time frame: 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.

  2. Change in Quality of Life

    Time frame: 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.

  3. Surgical Rates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Newton-Wellesley Hospital
  • The New England Baptist Hospital

Registry information

Official study title

Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 6, 2016
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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