Testing of a Tool to Elicit Patient Preferences for CTS

June 10, 2024 updated by: Robin Kamal, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94061
        • Stanford Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after using tool (up to 5 minutes to complete survey)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

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

Investigators

  • Principal Investigator: Robin N Kamal, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46107
  • K23AR073307 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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