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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

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE September 24, 2018
Actual Primary Completion Date December 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
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").
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cost Information on Carpal Tunnel Syndrome Treatment Decisions
Official Title  ICMJE Does Societal Cost Information Affect Patient Decision-Making in Carpal Tunnel Syndrome: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE Other: Societal cost
Annual societal cost information to the US for carpal tunnel release surgery was displayed.
Study Arms  ICMJE
  • Experimental: Cost group
    These patients reviewed total societal costs associated with carpal tunnel release.
    Intervention: Other: Societal cost
  • No Intervention: No cost group
    These patients did not review total societal costs associated with carpal tunnel release.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2019)
184
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 26, 2018
Actual Primary Completion Date December 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English speaking upper extremity patients
  • Nontraumatic condition

Exclusion Criteria:

  • Traumatic condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880812
Other Study ID Numbers  ICMJE 2018-09-0067
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Ring, University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE Stanford University
Investigators  ICMJE Not Provided
PRS Account University of Texas at Austin
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP