Novel Decision Aid for Carpal Tunnel Patients

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693273
• Other study ID #: 13583
• Status: Completed
• Start date: February 12, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: August 2021
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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