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Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

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Mass General Brigham

Status

Completed

Conditions

Hip Osteoarthritis
Knee Osteoarthritis

Treatments

Behavioral: Video decision aid
Behavioral: Interactive decision aid
Behavioral: Provider Report

Study type

Interventional

Funder types

Other

Identifiers

NCT02729831
2016P000229

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,220 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

1,220 participants in 4 patient groups

Interactive Decision Aid and Usual Care
Experimental group
Description:
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Treatment:
Behavioral: Interactive decision aid
Video decision aid and usual care
Experimental group
Description:
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Treatment:
Behavioral: Video decision aid
Interactive Decision Aid and Provider Report
Experimental group
Description:
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Treatment:
Behavioral: Interactive decision aid
Behavioral: Provider Report
Video decision aid and Provider report
Experimental group
Description:
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Treatment:
Behavioral: Interactive decision aid
Behavioral: Provider Report

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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