Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Osteoarthritis, Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Interactive decision aid
* Behavioral: Video decision aid
* Behavioral: Provider Report


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive Decision Aid and Usual Care<br>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. | Behavioral: Interactive decision aid<br>* The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis<br>|
| Experimental: Video decision aid and usual care<br>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. | Behavioral: Video decision aid<br>* Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis<br>|
| Experimental: Interactive Decision Aid and Provider Report<br>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. | Behavioral: Interactive decision aid<br>* The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis<br>Behavioral: Provider Report<br>* A short report that includes the patients' goals and treatment preferences<br>|
| Experimental: Video decision aid and Provider report<br>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. | Behavioral: Interactive decision aid<br>* The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis<br>Behavioral: Provider Report<br>* A short report that includes the patients' goals and treatment preferences<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Knowledge | 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. | before orthopedic visit | 
| Percentage of Patients Who Received Preferred Treatment | 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. | 1 week after visit with orthopedic surgeon | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Used the Decision Aid | 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. | before orthopedic visit | 
| Change in Quality of Life | 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. | before orthopedic visit; 12 months from date of orthopedic visit | 
| Surgical Rates | Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit. | 6 months after the initial visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making