- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880812
Cost Information on Carpal Tunnel Syndrome Treatment Decisions
March 18, 2019 updated by: David Ring, University of Texas at Austin
Does Societal Cost Information Affect Patient Decision-Making in Carpal Tunnel Syndrome: A Randomized Controlled Trial
The purpose of this study was to determine whether the provision of societal cost information affects patients' decisions whether or not to undergo surgical management in carpal tunnel syndrome, using a hypothetical scenario.
Study Overview
Detailed Description
Given the large societal costs of carpal tunnel surgery and existence of a relatively inexpensive treatment option, carpal tunnel release provides fertile ground for testing whether societal costs can influence patient decision-making in hand surgery.
Such work would inform future efforts to reduce societal healthcare costs by elucidating whether appeals to societal cost are effective at driving stewardship of limited healthcare resources at the patient level.
In this study, the investigators aimed to answer this question by presenting participants with a hypothetical scenario in which the participants had to choose between surgery and wrist bracing for carpal tunnel syndrome.
Participants were randomized into two cohorts and societal cost information was presented to the intervention group.
The effect of societal cost information on treatment choice is assessed, along with participants' healthcare attitudes.
Study Type
Interventional
Enrollment (Actual)
184
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
- Austin Regional Clinic
-
Austin, Texas, United States, 78712
- HTB Musculoskeletal Institute
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Austin, Texas, United States, 78751
- Orthopedic Specialists of Austin
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Austin, Texas, United States, 78705
- Texas Orthopedics
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Austin, Texas, United States, 78731
- Seton Institute for Plastic and Reconstructive Surgery
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Austin, Texas, United States, 78756
- ATX Ortho
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 87 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English speaking upper extremity patients
- Nontraumatic condition
Exclusion Criteria:
- Traumatic condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cost group
These patients reviewed total societal costs associated with carpal tunnel release.
|
Annual societal cost information to the US for carpal tunnel release surgery was displayed.
|
No Intervention: No cost group
These patients did not review total societal costs associated with carpal tunnel release.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants choosing carpal tunnel release or splinting
Time Frame: Immediately after reading the hypothetical scenario
|
Choice for carpal tunnel release over splinting.
All participants were presented a hypothetical case of mild carpal tunnel syndrome.
The scenario described (nocturnal) symptoms of numbness and tingling and two treatment choices: carpal tunnel release or wrist splinting.
In addition, participants were randomized to review total annual societal cost information for CTR procedures in the United States.
After reviewing the case, participants were asked to indicate if they would choose surgery (more expensive) or splinting (less expensive).
Scoring was measured on a 6-point ordinal Likert scale (ranging from 1="Definitely not" to 6="Definitely").
|
Immediately after reading the hypothetical scenario
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2018
Primary Completion (Actual)
December 26, 2018
Study Completion (Actual)
December 26, 2018
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 18, 2019
First Posted (Actual)
March 19, 2019
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 18, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-09-0067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome
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