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

September 18, 2018 updated by: Karen Sepucha, Massachusetts General Hospital
This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Newton, Massachusetts, United States, 02462
        • Newton Wellesley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive decision aid
Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise
Behavioral: Brief interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Experimental: 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
Behavioral: Long video decision aid
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
Time Frame: 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.
In clinic, immediately before the first visit with surgeon

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Used the Decision Aid
Time Frame: 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.
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
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.
In clinic, immediately before the first visit with surgeon

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Newton-Wellesley Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P001794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Outcome measure
    Information comments: Hip Osteoarthritis Decision Quality Instrument
  2. Outcome measure
    Information comments: Knee Osteoarthritis Decision Quality Instrument

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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