Testing of a Tool to Elicit Patient Preferences for CTS

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome Left; Carpal Tunnel Syndrome Right; Carpal Tunnel; Carpal Tunnel Syndrome; Carpal Tunnel Syndrome Bilateral
• Interventions: Other: Preference Elicitation tool

• Registration Number: NCT03532373
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Study Start: 2021-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-06
• Results First Submitted: 2024-06-10
• Results First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Preference Elicitation tool	Patients will use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS

Primary Outcome Measures

Name	Time	Method
Decisional Conflict Scale	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

Trial Locations

Locations (1)

Stanford Health Care; 🇺🇸 Redwood City, California, United States