Novel Decision Aid for Carpal Tunnel Patients

NCT04693273 | Completed

• 1 other identifier: 13583
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A questionnaire will be given to patients who are considering undergoing hand surgery as a treatment for Carpal Tunnel Syndrome to help participants decide between two surgical options- Wide-Awake-Local-Anesthesia-no-Tourniquet (WALANT) and traditional open hand surgery. These patients will be asked to complete a pre-questionnaire knowledge test and a post-questionnaire knowledge test. the primary objective is to validate this questionnaire to be used by other orthopedic surgeons. This study will also reveal patient preference between these two surgical treatments for carpal tunnel syndrome.

Conditions

Carpal Tunnel Syndrome

Keywords

WALANT; Wide-Awake-Local-Anesthesia-no-Tourniquet

Outcome Measures

Primary Outcomes (1)

• Surgical Modality preference for CTR through questionnaire answers

  Investigators will reveal participants' preferences regarding the preferred surgical modality between WALANT and traditional tourniquet by having a questionnaire question after participants read the decision aid whereby such participants are asked whether their preference is WALANT or traditional tourniquet carpal tunnel release after having learned about both.

  Feb, 2020- Feb, 2021

Secondary Outcomes (3)

• Patient Knowledge scores Before the decision aid use

  Feb, 2020- Feb, 2021

• Patient knowledge scores after the decision aid use

  Feb, 2020- Feb, 2021

• Decisional Conflict Score

  Feb, 2020- Feb, 2021

Study Arms (1)

Carpal Tunnel Release surgical patients

This is the group the investigators survey who are candidates for carpal tunnel release (CTR) surgery: patients should be 18 years or older, comprehend and read English, and patients who consent to do the survey.

Other: Decision Aid for Surgical Modality Choice

Interventions

Decision Aid for Surgical Modality Choice OTHER

A novel decision aid that helps surgical patients choose between Wide-Awake carpal tunnel release and traditional tourniquet surgery. It involves an orientation-memory-concentration test to test if patients are cognitively capable of making decisions, then the decision aid table that has similarities and differences between the two modalities, and a few survey questions that help the investigators know what the patients prefer. Finally, patients finish the decision conflict test to see how confident these patients are about their preference.

Carpal Tunnel Release surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are CTR candidates will be asked to participate in this study considering such patients are 18 years or older, comprehend and read English, and considering the participation depends on passing the orientation, concentration, and memory test.

You may qualify if:

• years of older,
• CTS patients who are CTR candidates,
• Comprehend and understand English,
• Passed the Orientation-memory-concentration test done before the decision aid

You may not qualify if:

• Younger than 18 years of age,
• Non-CTS patients,
• Not CTR candidates,
• Do not comprehend or read English,
• Failed the Orientation-memory-concentration test done before the decision aid

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Decision Support Techniques

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Charles S Day, M.D., M.B.A.

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Executive Vice Chair of the Orthopaedic Service Line

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 5, 2021
• Study Start: February 12, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)