Novel Decision Aid for Carpal Tunnel Patients

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Decision Aid for Surgical Modality Choice

• Registration Number: NCT04693273
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carpal Tunnel Release surgical patients	Decision Aid for Surgical Modality Choice	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.

Primary Outcome Measures

Name	Time	Method
Surgical Modality preference for CTR through questionnaire answers	Feb, 2020- Feb, 2021	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.

Secondary Outcome Measures

Name	Time	Method
Patient knowledge scores after the decision aid use	Feb, 2020- Feb, 2021	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.
Decisional Conflict Score	Feb, 2020- Feb, 2021	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)
Patient Knowledge scores Before the decision aid use	Feb, 2020- Feb, 2021	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.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States