Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Hip Osteoarthritis; Knee Osteoarthritis
• Interventions: Behavioral: Long video decision aid; Behavioral: Brief interactive decision aid

• Registration Number: NCT02625402
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.

Detailed Description

This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis. The vendors employ different design features (e.g. use of video for patient narratives, interactive values clarification exercise) and the study will examine the relative impact of the different features on decision quality. Eligible subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating provider. Immediately before the visit, participants will complete a short questionnaire about the decision aid. This pilot study will assist with determining the potential difference between these two decision aids on improving knowledge and use of decision aids.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-09
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Results First Submitted: 2017-03-21
• Results First Submitted QC: 2017-12-15
• Results First Posted: 2017-12-18
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

Exclusion Criteria

• Prior partial or total knee or hip replacement surgery
• Hip fracture or aseptic necrosis in the last 12 months
• Rheumatoid arthritis or psoriatic arthritis
• Unable to read or speak English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video decision aid	Long video decision aid	Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog
Interactive decision aid	Brief interactive decision aid	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise

Primary Outcome Measures

Name	Time	Method
Hip and Knee Decision Quality Instruments Knowledge Subscale Scores	In clinic, immediately before the first visit with surgeon	5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Used the Decision Aid	In clinic, immediately before the first visit with surgeon	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.
Percentage of Participants With a Clear Treatment Preference	In clinic, immediately before the first visit with surgeon	1 item assessing patient's treatment preference (surgery, non-surgical options, or not sure). The percentage who have a clear preference (either for surgery or non surgical options) will be calculated.

Trial Locations

Locations (2)

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

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