Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery
1 other identifier
interventional
1,220
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
December 13, 2019
CompletedDecember 13, 2019
December 1, 2019
2.7 years
March 28, 2016
August 29, 2019
December 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Percentage of Participants Who Used the Decision Aid
before orthopedic visit
Change in Quality of Life
before orthopedic visit; 12 months from date of orthopedic visit
Surgical Rates
6 months after the initial visit
Study Arms (4)
Interactive Decision Aid and Usual Care
EXPERIMENTALGroup 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.
Video decision aid and usual care
EXPERIMENTALGroup 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.
Interactive Decision Aid and Provider Report
EXPERIMENTALGroup 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.
Video decision aid and Provider report
EXPERIMENTALGroup 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.
Interventions
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
A short report that includes the patients' goals and treatment preferences
Eligibility Criteria
You may qualify if:
- Diagnosis of either hip or knee osteoarthritis
- Scheduled visit with participating orthopedic surgeon
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Newton-Wellesley Hospitalcollaborator
- The New England Baptist Hospitalcollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
New England Baptist Hospital
Boston, Massachusetts, 02120, United States
Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
Related Publications (2)
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.
PMID: 23891070BACKGROUNDMangla M, Bedair H, Chang Y, Daggett S, Dwyer MK, Freiberg AA, Mwangi S, Talmo C, Vo H, Sepucha K. Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study). BMJ Open. 2019 Feb 24;9(2):e024906. doi: 10.1136/bmjopen-2018-024906.
PMID: 30804032BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study staff and participating surgeons not blinded to intervention; 6 months may be too short to capture full benefit of surgery on quality of life.
Results Point of Contact
- Title
- Dr. Karen R. Sepucha
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Sepucha, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Health Decision Sciences Center
Study Record Dates
First Submitted
March 28, 2016
First Posted
April 6, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
December 13, 2019
Results First Posted
December 13, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- The data will be available September 2019 and will be available for at least 7 years from that time.
- Access Criteria
- Interested investigators may consult the DECIDE-OA study page on the Massachusetts General Hospital's Health Decision Sciences Center website for information about data sharing.
A complete, cleaned, de-identified copy of the final data set that includes survey data for the primary and secondary outcomes from patient participants has been created. The PI will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH) policies for data sharing. Investigators from other sites are able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team, etc.