Back to resultsDecision Making in Hypothetical Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cost Information
Sponsored by
About this trial
This is an interventional health services research trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- patients presenting to hand clinic OR mturk workers
- age 18 or older
Exclusion Criteria:
- traumatic mechanism of injury
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Decision to have Treatment
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
Opinion on healthcare costs
a 7 item, likert response questionnaire used to elicit participant opinions on cost in health care. This is a non-validated tool.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03730376
Brief Title
Decision Making in Hypothetical Carpal Tunnel Syndrome
Official Title
Patient and Consumer Decision Making in a Hypothetical Case of Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
The care provider and patient will not be informed as to which group the participant is in
Allocation
Randomized
Enrollment
488 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cost Information
Intervention Description
participants will be given information on the personal and societal costs
Primary Outcome Measure Information:
Title
Decision to have Treatment
Description
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
Time Frame
immediately after completing survey
Secondary Outcome Measure Information:
Title
Opinion on healthcare costs
Description
a 7 item, likert response questionnaire used to elicit participant opinions on cost in health care. This is a non-validated tool.
Time Frame
immediately after completing survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients presenting to hand clinic OR mturk workers
age 18 or older
Exclusion Criteria:
traumatic mechanism of injury
Facility Information:
Facility Name
Stanford Health Care
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Decision Making in Hypothetical Carpal Tunnel Syndrome
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