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Completed

NCT Number: NCT04693273

Novel Decision Aid for Carpal Tunnel Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Surgical Modality preference for CTR through questionnaire answers

    Time frame: 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 outcomes

  1. Patient Knowledge scores Before the decision aid use

    Time frame: 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.

  2. Patient knowledge scores after the decision aid use

    Time frame: 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.

  3. Decisional Conflict Score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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