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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03880812
Other study ID # 2018-09-0067
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2018
Est. completion date December 26, 2018

Study information

Verified date March 2019
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date December 26, 2018
Est. primary completion date December 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- English speaking upper extremity patients

- Nontraumatic condition

Exclusion Criteria:

- Traumatic condition

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Societal cost
Annual societal cost information to the US for carpal tunnel release surgery was displayed.

Locations

Country Name City State
United States ATX Ortho Austin Texas
United States Austin Regional Clinic Austin Texas
United States HTB Musculoskeletal Institute Austin Texas
United States Orthopedic Specialists of Austin Austin Texas
United States Seton Institute for Plastic and Reconstructive Surgery Austin Texas
United States Texas Orthopedics Austin Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants choosing carpal tunnel release or splinting 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
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