AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

Not Applicable

Completed

• Conditions: Thyroid Cancer; Thyroid Nodules
• Interventions: Behavioral: counseling by routine care; Behavioral: Counseling using the electronic conversation aid

• Registration Number: NCT04463719
• Lead Sponsor: University of Florida

Brief Summary

There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Study Start: 2022-02-20
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adults >18 years old presenting for evaluation of a thyroid nodule

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Exclusion Criteria

• Patients with hyperthyroidism
• Patients with previous biopsy of the nodule of interest
• Pregnant patients
• Prisoners

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	counseling by routine care	Routine counseling only
Intervention group	Counseling using the electronic conversation aid	Counseling using the electronic conversation aid

Primary Outcome Measures

Name	Time	Method
Proportion of eligible patients for feasibility	at 6 months of follow up	Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States