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Efficacy of First Time Anterior Shoulder Decision Tool

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ClinicalTrials.gov Identifier: NCT02656277
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

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


Condition or disease Intervention/treatment Phase
Shoulder Dislocation Other: Decision Tool Other: Information on Shoulder Dislocation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Efficacy of First Time Anterior Shoulder Decision Tool in a Randomized Control Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Decision tool
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.
Other: Decision Tool
Active Comparator: Information on Shoulder Dislocation
Subjects in this arm will receive the standard of care information available to patients to make this treatment decision.
Other: Information on Shoulder Dislocation



Primary Outcome Measures :
  1. Patient Preference Survey [ Time Frame: 2 months ]
    patient-voiced preferences guiding solution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Shoulder dislocation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656277


Locations
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United States, North Carolina
Duke Sports Science Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Richard Mather, MD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02656277     History of Changes
Other Study ID Numbers: Pro00066738
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Shoulder Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries