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Testing of a Tool to Elicit Patient Preferences for CTS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532373
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2018
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
Duke University
Brown University
University of Texas at Austin
Mayo Clinic
Harvard University
Information provided by (Responsible Party):
Robin Kamal, Stanford University

Study Description
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Brief Summary:
This study will complete a randomized controlled trial to quantitatively measure patient decisional conflict (Decisional Conflict Scale) in 150 patients treated for CTS with the tool compared to 150 patients treated with standard care. The investigators hypothesize patients treated for CTS will have lower decisional conflict with the tool.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Carpal Tunnel Syndrome Carpal Tunnel Syndrome Left Carpal Tunnel Syndrome Right Carpal Tunnel Syndrome Bilateral Other: Preference Elicitation tool Not Applicable

Detailed Description:
The investigators will measure decisional conflict in 150 new patients being evaluated for CTS with the tool compared to 150 patients being evaluated for CTS with standard care. Those patients randomized to receiving the tool will use it to identify their preferences for certain attributes of care. Patients will then be presented with their preference data and the surgeon will have a discussion with the patient regarding CTS. Surgeons will have their standard discussion with the patients randomized to the standard care group (no tool). The tool will be operationalized on a Health Insurance Portability and Accountability Act compliant data platform, such as Qualtrics, and no identifiable data will be collected. De-identified data will be shared from study cites with our team at Stanford. This data will be backed up on a computer encrypted by Stanford.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to either the intervention or control group
Masking: None (Open Label)
Masking Description: No masking will occur
Primary Purpose: Other
Official Title: Testing of a Tool to Elicit Patient Preferences for CTS
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
None- normal care
Experimental: Intervention
Patients will use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS
 Other: Preference Elicitation tool
A preference elicitation tool for carpal tunnel syndrome


Outcome Measures
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Primary Outcome Measures :
  1. Decisional Conflict Scale [ Time Frame: Immediately after using tool ]

    Name: Decisional Conflict Scale Measures: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

    16 statements with 5 response categories Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict) lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool.

    Calculation: Summed, divided by # of items, multiplied by 25



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New patient
  • English fluency and literacy
  • Able to take informed consent
  • clinical diagnosis of carpal tunnel syndrome

Exclusion Criteria:

  • Prior diagnostic testing for carpal tunnel (nerve test, ultrasound)
  • Prior carpal tunnel release
  • Diagnosis of C5/6 radiculopathy (double crush)
  • Peripheral neuropathy (ex: diabetic)
  • Worker Compensation/EMG Required
  • Symptoms of Cubital tunnel syndrome
Contacts and Locations
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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): NCT03532373


Locations
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United States, California
Stanford Health Care
Redwood City, California, United States, 94061
Sponsors and Collaborators
Stanford University
Duke University
Brown University
University of Texas at Austin
Mayo Clinic
Harvard University
Investigators
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Principal Investigator: Robin N Kamal, MD Stanford University
More Information
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Publications:

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Responsible Party: Robin Kamal, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03532373    
Other Study ID Numbers: 46107
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries