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Cost Information on Carpal Tunnel Syndrome Treatment Decisions

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Societal cost
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English speaking upper extremity patients
  • Nontraumatic condition

Exclusion Criteria:

  • Traumatic condition

Sites / Locations

  • Austin Regional Clinic
  • Texas Orthopedics
  • HTB Musculoskeletal Institute
  • Seton Institute for Plastic and Reconstructive Surgery
  • Orthopedic Specialists of Austin
  • ATX Ortho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cost group

No cost group

Arm Description

These patients reviewed total societal costs associated with carpal tunnel release.

These patients did not review total societal costs associated with carpal tunnel release.

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

Full Information

First Posted
March 13, 2019
Last Updated
March 18, 2019
Sponsor
University of Texas at Austin
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03880812
Brief Title
Cost Information on Carpal Tunnel Syndrome Treatment Decisions
Official Title
Does Societal Cost Information Affect Patient Decision-Making in Carpal Tunnel Syndrome: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
December 26, 2018 (Actual)
Study Completion Date
December 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
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
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.
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.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomized in an intervention group that reviewed societal costs associated with carpal tunnel release and a control group that did not.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cost group
Arm Type
Experimental
Arm Description
These patients reviewed total societal costs associated with carpal tunnel release.
Arm Title
No cost group
Arm Type
No Intervention
Arm Description
These patients did not review total societal costs associated with carpal tunnel release.
Intervention Type
Other
Intervention Name(s)
Societal cost
Intervention Description
Annual societal cost information to the US for carpal tunnel release surgery was displayed.
Primary Outcome Measure Information:
Title
Number of participants choosing carpal tunnel release or splinting
Description
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").
Time Frame
Immediately after reading the hypothetical scenario

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking upper extremity patients Nontraumatic condition Exclusion Criteria: Traumatic condition
Facility Information:
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Orthopedics
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
HTB Musculoskeletal Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Seton Institute for Plastic and Reconstructive Surgery
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Orthopedic Specialists of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
ATX Ortho
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cost Information on Carpal Tunnel Syndrome Treatment Decisions

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