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

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer; Thyroid Nodules
• Intervention / Treatment: Behavioral: Counseling using the electronic conversation aid; Behavioral: counseling by routine care

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Counseling using the electronic conversation aid	Behavioral: Counseling using the electronic conversation aid; Patients receive counseling about thyroid biopsy with the use of the conversation aid.
Active Comparator: Control Group; Routine counseling only	Behavioral: counseling by routine care; Patients receive counseling by routine care without the use of the conversation aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eligible Patients for Feasibility	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).	at 6 months of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Acceptance to Participate in the Study	From eligible patients that were invited to participate, the proportion of patients that agreed to enter the study	first visit
Adequate Randomization	Proportion of patients that were randomized and completed the study	initial clinical visit
Completeness of Baseline Survey (Patients)	Proportion of patients that completed the baseline survey	baseline
Patient Survey (6 Months)	Proportion of patients that completed the 6 month survey	6 months
Clinician Baseline Survey		baseline
Knowledge	To assess knowledge transfer related to thyroid nodules, patients completed a 12-item questionnaire with Yes/No and "I don't know" response options, related to thyroid nodule knowledge. Higher score indicate increased number of correct answers.	baseline
Decisional Conflict	Decisional conflicts reflects degree of conflict with the decision made. This construct was evaluated with a validated questionnaire that includes 16-items, with the total score transformed into a 1-100 scale, with higher scores indicating greater decisional conflict.	baseline
OPTION Score	Observing Patient Involvement (OPTION), evaluates the extent to which clinicians engaged patients in decision making, higher levels more engagement, range (0-100)	baseline
Visit Duration	Length of the clinical visit	baseline
Diagnostic Decision	Proportion of patients undergoing thyroid biopsy	baseline
Fidelity	Fidelity of use of the conversation aid during clinical visit, evaluating using 12 items during review of clinical visit. Higher percentage refers to higher number of items observed.	baseline
Risk Communication	Proportion of visits in which thyroid cancer risk was communicated evaluated through review of clinical visit, as yes/no outcome.	baseline
Satisfaction With the Communication (Patient)	Likert score, lower number more satisfied, 1-7	baseline
Satisfaction With the Visit (Clinician)	Likert score, higher numbers better, 1-5 options	baseline
Worry About Thyroid Cancer	Worry about thyroid cancer diagnosis assessed through a survey item, including the options Not at all, rarely/a little or somewhat or a lot	baseline
Distress Due to Thyroid Nodule (6 Months)	Impact of Event Scale evaluates distress with a new medical situation (new thyroid nodule in this case). The scale includes 6 items, with a score range from 0 to 24 points, with higher values indicating more distress.	6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Naykky Singh Ospina, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: shared decision making; thyroid nodules
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Nodule; Thyroid Neoplasms
• Other Study ID Numbers: IRB202000837-N; 1K08CA248972-01 (U.S. NIH Grant/Contract); 5K08CA248972-02 (U.S. NIH Grant/Contract); OCR34613 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No