Overview

This trial is active, not recruiting.

Conditions hip osteoarthritis, knee osteoarthritis
Treatments brief interactive decision aid, long video decision aid
Sponsor Massachusetts General Hospital
Collaborator Newton-Wellesley Hospital
Start date December 2015
End date March 2016
Trial size 58 participants
Trial identifier NCT02625402, 2013P001794

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise
brief interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
(Experimental)
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
long video decision aid
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

Primary Outcomes

Measure
Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
time frame: In clinic, immediately before the first visit with surgeon

Secondary Outcomes

Measure
Percentage of participants who used the Decision Aid
time frame: In clinic, immediately before the first visit with surgeon
Percentage of Participants with a Clear Treatment Preference
time frame: In clinic, immediately before the first visit with surgeon

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
Principal investigator Karen R Sepucha, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.