Novel Decision Aid for Carpal Tunnel Patients

Novel Decision Aid for Carpal Tunnel Patients: Exploring Patient Preferences Between WALANT and Traditional Surgery

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Decision Aid for Surgical Modality Choice

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Knowledge scores Before the decision aid use	This is achieved through 4 multiple-choice questions (the score is out of 4) that are completed by the patient before reading the decision aid. The questions revolve around concepts relevant to wide-awake and traditional-tourniquet carpal tunnel release surgical modalities. These questions assess the patient's prior knowledge.	Feb, 2020- Feb, 2021
Patient knowledge scores after the decision aid use	This is achieved through 4 multiple-choice questions (the score is out of 4) that are completed by the patient after reading the decision aid. They are the same questions as those done before the decision aid but aim to test if the patient truly understood and learned from the decision tool. This knowledge score along with the score of the questions done before the decision aid will help assess if a significant enhancement of the knowledge scores happened which reflects a useful decision aid.	Feb, 2020- Feb, 2021
Decisional Conflict Score	A previously validated scale was used which involves several questions assessing how confident the patient is about the decision/preference declared and how much it resembles their values. Patients are asked to assess their agreement/disagreement on several factors on the scale using a Likert scale between 0 (confident) and 4 (not confident ). The lower the aggregate score, the more confident the participant is. Per the scale's manual, a score of 25 or lower reflects a confident patient while any score over 36 reflects decisional hesitation or conflict. (This is the reference for the decisional scale's manual that is used in the study: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf)	Feb, 2020- Feb, 2021

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Charles S Day, M.D., M.B.A., Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: WALANT; Wide-Awake-Local-Anesthesia-no-Tourniquet
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 13583 (Other Grant/Funding Number: Stand up to Cancer (Kom op tegen Kanker))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Patient information will be de-identified and then will be deleted after completion of the study. Patient information will not be shared with others.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No