Testing of a Tool to Elicit Patient Preferences for CTS

NCT ID: NCT03532373

Last Updated: 2024-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-06-01

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to either the intervention or control group
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

No masking will occur

Study Groups

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Control

None- normal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Patients will use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS

Group Type EXPERIMENTAL

Preference Elicitation tool

Intervention Type OTHER

A preference elicitation tool for carpal tunnel syndrome

Interventions

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Preference Elicitation tool

A preference elicitation tool for carpal tunnel syndrome

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Robin Kamal

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robin N Kamal, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Health Care

Redwood City, California, United States

Site Status

Countries

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United States

References

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Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: patients' preferences matter. BMJ. 2012 Nov 8;345:e6572. doi: 10.1136/bmj.e6572. No abstract available.

Reference Type BACKGROUND
PMID: 23137819 (View on PubMed)

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Reference Type BACKGROUND
PMID: 19636065 (View on PubMed)

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Reference Type BACKGROUND
PMID: 27200394 (View on PubMed)

Kamal RN; Hand Surgery Quality Consortium. Quality and Value in an Evolving Health Care Landscape. J Hand Surg Am. 2016 Jul;41(7):794-9. doi: 10.1016/j.jhsa.2016.05.016.

Reference Type BACKGROUND
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Keith MW, Masear V, Amadio PC, Andary M, Barth RW, Graham B, Chung K, Maupin K, Watters WC 3rd, Haralson RH 3rd, Turkelson CM, Wies JL, McGowan R. Treatment of carpal tunnel syndrome. J Am Acad Orthop Surg. 2009 Jun;17(6):397-405. doi: 10.5435/00124635-200906000-00008.

Reference Type BACKGROUND
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Wittink MN, Cary M, Tenhave T, Baron J, Gallo JJ. TOWARDS PATIENT-CENTERED CARE FOR DEPRESSION: CONJOINT METHODS TO TAILOR TREATMENT BASED ON PREFERENCES. Patient. 2010;3(3):145-157. doi: 10.2165/11530660.

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K23AR073307

Identifier Type: NIH

Identifier Source: secondary_id

View Link

46107

Identifier Type: -

Identifier Source: org_study_id

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