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

Primary Purpose

Hip Osteoarthritis, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief interactive decision aid
Long video decision aid
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hip Osteoarthritis focused on measuring decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 replacement surgery
  • Hip fracture or aseptic necrosis in the last 12 months
  • Rheumatoid arthritis or psoriatic arthritis
  • Unable to read or speak English

Sites / Locations

  • Massachusetts General Hospital
  • Newton Wellesley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Interactive decision aid

Video decision aid

Arm Description

Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise

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

Outcomes

Primary Outcome Measures

Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
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

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.
Percentage of Participants With a Clear Treatment Preference
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.

Full Information

First Posted
December 4, 2015
Last Updated
September 18, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Newton-Wellesley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02625402
Brief Title
Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
Official Title
Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Newton-Wellesley Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis
Keywords
decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interactive decision aid
Arm Type
Experimental
Arm Description
Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise
Arm Title
Video decision aid
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Brief interactive decision aid
Intervention Description
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Intervention Type
Behavioral
Intervention Name(s)
Long video decision aid
Intervention Description
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Primary Outcome Measure Information:
Title
Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
Description
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.
Time Frame
In clinic, immediately before the first visit with surgeon
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Used the Decision Aid
Description
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.
Time Frame
In clinic, immediately before the first visit with surgeon
Title
Percentage of Participants With a Clear Treatment Preference
Description
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.
Time Frame
In clinic, immediately before the first visit with surgeon

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen R Sepucha, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Newton Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23891070
Citation
Sepucha K, Feibelmann S, Chang Y, Clay CF, Kearing SA, Tomek I, Yang T, Katz JN. Factors associated with the quality of patients' surgical decisions for treatment of hip and knee osteoarthritis. J Am Coll Surg. 2013 Oct;217(4):694-701. doi: 10.1016/j.jamcollsurg.2013.06.002. Epub 2013 Jul 25.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Outcome measure
Available IPD/Information URL
https://mghdecisionsciences.org/tools-training/decision-quality-instruments/
Available IPD/Information Comments
Hip Osteoarthritis Decision Quality Instrument
Available IPD/Information Type
Outcome measure
Available IPD/Information URL
https://mghdecisionsciences.org/tools-training/decision-quality-instruments/
Available IPD/Information Comments
Knee Osteoarthritis Decision Quality Instrument

Learn more about this trial

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

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