NCT04463719

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

Completed NA Results posted Last updated 10 November 2025

What this trial tests

NA trial testing Counseling using the electronic conversation aid in Thyroid Nodules in 107 participants. Completed in 30 September 2024.

Timeline

20 February 2022

Primary endpoint
30 September 2024

30 September 2024

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	107
Start date	20 February 2022
Primary completion	30 September 2024
Estimated completion	30 September 2024
Sites	2 locations across United States

Drugs / interventions tested

• Counseling using the electronic conversation aid
• counseling by routine care

Conditions studied

• Thyroid Nodules — all drugs for Thyroid Nodules →
• Thyroid Cancer — all drugs for Thyroid Cancer →

Sponsor

University of Florida

Who can join

Adults 18 to 99, any sex, with Thyroid Nodules or Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Eligible Patients for Feasibility Primary · 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).

Group	Value	95% CI
Eligible Patient for the Study	213
Eligible Patient for the Study	318

Patient's Acceptance to Participate in the Study Secondary · first visit

From eligible patients that were invited to participate, the proportion of patients that agreed to enter the study

Group	Value	95% CI
Eligible Patients Invited to Participate in the Study	90
Eligible Patients Invited to Participate in the Study	30

Adequate Randomization Secondary · initial clinical visit

Proportion of patients that were randomized and completed the study

Group	Value	95% CI
Adequate Randomization	86
Adequate Randomization	4

Completeness of Baseline Survey (Patients) Secondary · baseline

Proportion of patients that completed the baseline survey

Group	Value	95% CI
Completeness of Baseline Survey (Patients)	84
Completeness of Baseline Survey (Patients)	2

Patient Survey (6 Months) Secondary · 6 months

Proportion of patients that completed the 6 month survey

Group	Value	95% CI
Completeness of 6-month Survey (Patients)	50
Completeness of 6-month Survey (Patients)	30

Clinician Baseline Survey Secondary · baseline

Group	Value	95% CI
Completeness of Baseline Survey (Clinicians)	17
Completeness of Baseline Survey (Clinicians)	0

Knowledge Secondary · baseline

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.

Group	Value	95% CI
Intervention Group	72.1	± 18.1
Control Group	65.0	± 22.4

Decisional Conflict Secondary · baseline

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.

Group	Value	95% CI
Intervention Group	10.9	0.8 – 42.8
Control Group	20.3	0 – 29.7

OPTION Score Secondary · baseline

Observing Patient Involvement (OPTION), evaluates the extent to which clinicians engaged patients in decision making, higher levels more engagement, range (0-100)

Group	Value	95% CI
Intervention Group	35.4	31.3 – 38.5
Control Group	27.1	20.8 – 30.3

Visit Duration Secondary · baseline

Length of the clinical visit

Group	Value	95% CI
Intervention Group	21.5	± 9.3
Control Group	22.1	± 9.3

Diagnostic Decision Secondary · baseline

Proportion of patients undergoing thyroid biopsy

Group	Value	95% CI
Intervention Group	17
Control Group	22
Intervention Group	26
Control Group	21

Fidelity Secondary · baseline

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.

Group	Value	95% CI
Intervention Group	78.6	± 16.5
Control Group	59.6	± 17.9

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development and pilot testing of a conversation aid to support the evaluation of patients with thyroid nodules.
   Singh Ospina NM, Bagautdinova D, Hargraves I, Barb D, et al · · 2022 · cited 8× · PMID 34590734 · DOI 10.1111/cen.14599
2. Patient feedback receiving care using a shared decision making tool for thyroid nodule evaluation-an observational study.
   Patel Chavez CP, Godinez Leiva E, Bagautdinova D, Hidalgo J, et al · · 2023 · cited 4× · PMID 36534326 · DOI 10.1007/s12020-022-03277-4
3. Evaluation of a conversation aid for patients with thyroid nodules considering a biopsy: pilot multicenter randomized control trial.
   Algarin Perneth S, Patel U, Ortiz Rocha A, Barb D, et al · · 2026 · PMID 41801576 · DOI 10.1007/s12020-025-04517-z