Cost Information on Carpal Tunnel Syndrome Treatment Decisions

NCT03880812 | Completed

• 1 other identifier: 2018-09-0067
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 6

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cost group

EXPERIMENTAL

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

Other: Societal cost

No cost group

NO INTERVENTION

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

Interventions

Societal cost OTHER

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

Cost group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking upper extremity patients
• Nontraumatic condition

You may not qualify if:

• Traumatic condition

Sponsors & Collaborators

• University of Texas at Austin: lead
• Stanford University: collaborator

Study Sites (6)

Austin Regional Clinic

Austin, Texas, 78705, United States

Location

Texas Orthopedics

Austin, Texas, 78705, United States

Location

HTB Musculoskeletal Institute

Austin, Texas, 78712, United States

Location

Seton Institute for Plastic and Reconstructive Surgery

Austin, Texas, 78731, United States

Location

Orthopedic Specialists of Austin

Austin, Texas, 78751, United States

Location

ATX Ortho

Austin, Texas, 78756, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Comprehensive Care and Professor, Department of Surgery and Perioperative Care

Model Details: Patients were randomized in an intervention group that reviewed societal costs associated with carpal tunnel release and a control group that did not.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: September 24, 2018
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)