Clinical trial NCT03532373: Testing of a Tool to Elicit Patient Preferences for CTS
Official title: Testing of a Tool to Elicit Patient Preferences for CTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel
Carpal Tunnel Syndrome
Carpal Tunnel Syndrome Left
Carpal Tunnel Syndrome Right
Carpal Tunnel Syndrome Bilateral
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Brown University
name: University of Texas at Austin
name: Mayo Clinic
name: Harvard University
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2018-05-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the intervention or control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: Immediately after using tool (up to 5 minutes to complete survey)
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Robin N Kamal, MD
role: PRINCIPAL_INVESTIGATOR
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