Testing of a Tool to Elicit Patient Preferences for CTS

This study will complete a randomized controlled trial to quantitatively measure patient decisional conflict (Decisional Conflict Scale) in 150 patients treated for CTS with the tool compared to 150 patients treated with standard care. The investigators hypothesize patients treated for CTS will have lower decisional conflict with the tool.

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Key information

Conditions

Carpal Tunnel Carpal Tunnel Syndrome Carpal Tunnel Syndrome Bilateral Carpal Tunnel Syndrome Left Carpal Tunnel Syndrome Right 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

Interventional

Phase

Not applicable

Primary location

Stanford Health Care

Redwood City, California, 94061, United States

About this study

The investigators will measure decisional conflict in 150 new patients being evaluated for CTS with the tool compared to 150 patients being evaluated for CTS with standard care. Those patients randomized to receiving the tool will use it to identify their preferences for certain attributes of care. Patients will then be presented with their preference data and the surgeon will have a discussion with the patient regarding CTS. Surgeons will have their standard discussion with the patients randomized to the standard care group (no tool). The tool will be operationalized on a Health Insurance Portability and Accountability Act compliant data platform, such as Qualtrics, and no identifiable data will be collected. De-identified data will be shared from study cites with our team at Stanford. This data will be backed up on a computer encrypted by Stanford.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

New patient
English fluency and literacy
Able to take informed consent
clinical diagnosis of carpal tunnel syndrome

Exclusion criteria

Prior diagnostic testing for carpal tunnel (nerve test, ultrasound)
Prior carpal tunnel release
Diagnosis of C5/6 radiculopathy (double crush)
Peripheral neuropathy (ex: diabetic)
Worker Compensation/EMG Required
Symptoms of Cubital tunnel syndrome

Treatment and study plan

Preference Elicitation tool

Other

A preference elicitation tool for carpal tunnel syndrome

Primary outcomes

Decisional Conflict Scale

Time frame: Immediately after using tool (up to 5 minutes to complete survey)

The Decisional Conflict Scale measures uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The survey consists of 16 statements with 5 response categories. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict). Lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

Brown University
Duke University
Harvard University
Mayo Clinic
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Texas at Austin

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: May 22, 2018
Registry last updated: Jul 3, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed