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Efficacy of First Time Anterior Shoulder Decision Tool

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Tool
Information on Shoulder Dislocation
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Dislocation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Shoulder dislocation

Exclusion Criteria:

  • Prior surgery for shoulder stabilization
  • Inability to complete enrollment forms

Sites / Locations

  • Duke Sports Science Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision tool

Information on Shoulder Dislocation

Arm Description

The 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.

Subjects in this arm will receive the standard of care information available to patients to make this treatment decision.

Outcomes

Primary Outcome Measures

Patient Preference Survey
patient-voiced preferences guiding solution

Secondary Outcome Measures

Full Information

First Posted
January 12, 2016
Last Updated
January 30, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02656277
Brief Title
Efficacy of First Time Anterior Shoulder Decision Tool
Official Title
Efficacy of First Time Anterior Shoulder Decision Tool in a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
An anterior shoulder dislocation is a common problem for people between the ages of 15 to 35. Recurrent instability is common and dependent on age and gender. Treatment options include surgical intervention and repair or non-surgical options that include intensive rehabilitation. Level I evidence suggests early surgical repair can significantly reduce the risk of recurrent instability. The risk of arthritis is increased with multiple dislocation episodes. Traditionally, the combination of 1) history and physical exam performed by the provider, 2) clinical and diagnostic tools to assess the extent of injury and impact on physical activity, and 3) patient-voiced preference has guided the selection of an optimal solution for an individual patient. When providing a recommendation to individual patients and their unique circumstances, the health care provider may gather patient preferences on factors such as desire to avoid pain, chance of recurrent shoulder dislocation, time needed for rehabilitation and physical therapy, and operative versus non-operative costs. Surgical and non-surgical options have distinct differences in these outcomes. When combined, the interaction between these variables creates important tradeoffs of risks and benefits for each option. No studies have been conducted to determine the objective weight of these different dimensions of patient preferences and how they might guide the provider-patient conversation. Conjoint analysis is a statistical method that seeks to quantify the relative importance of various aspects of the decision-making process, such as cost or probability of repeat injury as described above. Combined with a validated survey tool, conjoint analysis of patient preferences in shoulder repair can assist the physician in recommending a patient-centered option.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision tool
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Information on Shoulder Dislocation
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive the standard of care information available to patients to make this treatment decision.
Intervention Type
Other
Intervention Name(s)
Decision Tool
Intervention Type
Other
Intervention Name(s)
Information on Shoulder Dislocation
Primary Outcome Measure Information:
Title
Patient Preference Survey
Description
patient-voiced preferences guiding solution
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Shoulder dislocation Exclusion Criteria: Prior surgery for shoulder stabilization Inability to complete enrollment forms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Mather, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Sports Science Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30834817
Citation
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.
Results Reference
derived

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Efficacy of First Time Anterior Shoulder Decision Tool

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