N/A
N=107
AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Thyroid Nodules · Thyroid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04463719 ↗Enrolled (actual)
107
Serious AEs
—
Results posted
Nov 2025
Primary outcome: Primary: Proportion of Eligible Patients for Feasibility — 213; 318 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Counseling using the electronic conversation aid (Behavioral); counseling by routine care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Eligible Patients for Feasibility |
213; 318 | — |
| SECONDARY Patient's Acceptance to Participate in the Study |
90; 30 | — |
| SECONDARY Adequate Randomization |
86; 4 | — |
| SECONDARY Completeness of Baseline Survey (Patients) |
84; 2 | — |
| SECONDARY Patient Survey (6 Months) |
50; 30 | — |
| SECONDARY Clinician Baseline Survey |
17; 0 | — |
| SECONDARY Knowledge |
72.1; 65.0 | — |
| SECONDARY Decisional Conflict |
10.9; 20.3 | — |
| SECONDARY OPTION Score |
35.4; 27.1 | — |
| SECONDARY Visit Duration |
21.5; 22.1 | — |
| SECONDARY Diagnostic Decision |
17; 22; 26; 21 | — |
| SECONDARY Fidelity |
78.6; 59.6 | — |
| SECONDARY Risk Communication |
39; 38; 3; 5 | — |
| SECONDARY Satisfaction With the Communication (Patient) |
1.3; 1.4 | — |
| SECONDARY Satisfaction With the Visit (Clinician) |
4.5; 4.4 | — |
| SECONDARY Worry About Thyroid Cancer |
14; 8; 16; 18; 13; 15 | — |
| SECONDARY Distress Due to Thyroid Nodule (6 Months) |
1.1; 3.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04463719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.