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Cost Information on Carpal Tunnel Syndrome Treatment Decisions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880812
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
David Ring, University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Societal cost Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Does Societal Cost Information Affect Patient Decision-Making in Carpal Tunnel Syndrome: A Randomized Controlled Trial
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : December 26, 2018
Actual Study Completion Date : December 26, 2018


Arm Intervention/treatment
Experimental: Cost group
These patients reviewed total societal costs associated with carpal tunnel release.
Other: Societal cost
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.



Primary Outcome Measures :
  1. 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").



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking upper extremity patients
  • Nontraumatic condition

Exclusion Criteria:

  • Traumatic condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880812


Locations
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United States, Texas
Austin Regional Clinic
Austin, Texas, United States, 78705
Texas Orthopedics
Austin, Texas, United States, 78705
HTB Musculoskeletal Institute
Austin, Texas, United States, 78712
Seton Institute for Plastic and Reconstructive Surgery
Austin, Texas, United States, 78731
Orthopedic Specialists of Austin
Austin, Texas, United States, 78751
ATX Ortho
Austin, Texas, United States, 78756
Sponsors and Collaborators
University of Texas at Austin
Stanford University
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Responsible Party: David Ring, Associate Dean for Comprehensive Care and Professor, Department of Surgery and Perioperative Care, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03880812    
Other Study ID Numbers: 2018-09-0067
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries