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Decision Making in Hypothetical Carpal Tunnel Syndrome

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: NCT03730376
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Robin Kamal, Stanford University

Brief Summary:
Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Cost Information Not Applicable

Detailed Description:
Participants will be randomized into 1 of 2 groups and receive a hypothetical scenario of carpal tunnel, with or without cost information, and asked to decide if that hypothetical patient should undergo a carpal tunnel release.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention.

We will use a random block generator to assign participants to their study arm.

Masking: Double (Participant, Care Provider)
Masking Description: The care provider and patient will not be informed as to which group the participant is in
Primary Purpose: Health Services Research
Official Title: Patient and Consumer Decision Making in a Hypothetical Case of Carpal Tunnel Syndrome
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : March 1, 2019


Arm Intervention/treatment
No Intervention: Control
Participants in the control group will be given a hypothetical scenario about carpal tunnel syndrome and asked to make a treatment decision for that hypothetical patient.
Experimental: Intervention
Participants in the intervetion group will be given a hypothetical scenario about carpal tunnel syndrome as well as information about the cost of treatment and asked to make a treatment decision for that hypothetical patient.
Other: Cost Information
participants will be given information on the personal and societal costs




Primary Outcome Measures :
  1. Decision to have Treatment [ Time Frame: immediately after completing survey ]
    Participants are asked to answer "Should you get surgery right now," with the options of definitely yes, probably, maybe, maybe not, probably not, and definitely not


Secondary Outcome Measures :
  1. Opinion on healthcare costs [ Time Frame: immediately after completing survey ]
    a 7 item, likert response questionnaire used to elicit participant opinions on cost in health care. This is a non-validated tool.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients presenting to hand clinic OR mturk workers
  • age 18 or older

Exclusion Criteria:

  • traumatic mechanism of injury

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): NCT03730376


Locations
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United States, California
Stanford Health Care
Redwood City, California, United States, 94063
Sponsors and Collaborators
Stanford University
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Responsible Party: Robin Kamal, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03730376    
Other Study ID Numbers: 47392, 47580
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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