Testing of a Tool to Elicit Patient Preferences for CTS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing of a Tool to Elicit Patient Preferences for CTS

Conditions
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Carpal Tunnel, Carpal Tunnel Syndrome, Carpal Tunnel Syndrome Left, Carpal Tunnel Syndrome Right, Carpal Tunnel Syndrome Bilateral

Intervention / Treatment
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* Other: Preference Elicitation tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to either the intervention or control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>None- normal care | |
| Experimental: Intervention<br>Patients will use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS | Other: Preference Elicitation tool<br>* A preference elicitation tool for carpal tunnel syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Scale | Name: 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. 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 | Immediately after using tool |