Efficacy of First Time Anterior Shoulder Decision Tool
1 other identifier
interventional
210
1 country
1
Brief Summary
This study is a randomized controlled trial using Duke patients to test, compared to the standard of care, a questionnaire and statistical model used to determine how patient preference regarding shoulder pain, physical limitations, physical therapy, recovery period, prognosis, and cost impact choice of surgical versus non-surgical intervention. Phase 1 of this study is the initial testing of the instrument and involves a small group of up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized to receive either the Decision Tool or the standard Information on Shoulder Dislocation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
1 active site
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
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 31, 2017
January 1, 2017
11 months
January 12, 2016
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Preference Survey
patient-voiced preferences guiding solution
2 months
Study Arms (2)
Decision tool
EXPERIMENTALThe decision tool includes a questionnaire and statistical model used to determine how patient preference regarding shoulder pain, physical limitations, physical therapy, recovery period, prognosis, and cost impact choice of surgical versus non-surgical intervention.
Information on Shoulder Dislocation
ACTIVE COMPARATORSubjects in this arm will receive the standard of care information available to patients to make this treatment decision.
Interventions
Eligibility Criteria
You may qualify if:
- \- Shoulder dislocation
You may not qualify if:
- Prior surgery for shoulder stabilization
- Inability to complete enrollment forms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke Sports Science Institute
Durham, North Carolina, 27705, United States
Related Publications (1)
Hutyra CA, Smiley S, Taylor DC, Orlando LA, Mather RC 3rd. Efficacy of a Preference-Based Decision Tool on Treatment Decisions for a First-Time Anterior Shoulder Dislocation: A Randomized Controlled Trial of At-Risk Patients. Med Decis Making. 2019 Apr;39(3):253-263. doi: 10.1177/0272989X19832915. Epub 2019 Mar 5.
PMID: 30834817DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Mather, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 14, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 31, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share