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

Status

Completed

Intervention / Treatment

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
      • Austin, Texas, United States, 78751
        • Orthopedic Specialists of Austin
      • Austin, Texas, United States, 78705
        • Texas Orthopedics
      • Austin, Texas, United States, 78731
        • Seton Institute for Plastic and Reconstructive Surgery
      • 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

14 years to 85 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.

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

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.

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