Trial Outcomes & Findings for AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid (NCT NCT04463719)

Last Updated: 2025-11-10

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

107 participants

Primary outcome timeframe

at 6 months of follow up

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Patient Intervention Group Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Patient Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid	Clinicians Clinicians enrolled in the study counseled patients with or without the use of the conversation aid, per patient randomization assigment
Overall Study STARTED	45	45	17
Overall Study COMPLETED	43	43	17
Overall Study NOT COMPLETED	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Patient Intervention Group Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Patient Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid	Clinicians Clinicians enrolled in the study counseled patients with or without the use of the conversation aid, per patient randomization assigment
Overall Study Exclusion criteria identified during clinical visit	2	2	0

Baseline Characteristics

No additional information was collected for clinicians.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: at 6 months of follow up

Population: Number of patients that were screened for inclusion in the study

Outcome measures

Outcome measures
Measure	Intervention Group n=531 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Proportion of Eligible Patients for Feasibility Eligible Patients Based on Chart Review	213 Participants	—
Proportion of Eligible Patients for Feasibility Patients not eligible based on chart review	318 Participants	—

SECONDARY outcome

Timeframe: first visit

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

Outcome measures

Outcome measures
Measure	Intervention Group n=120 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Patient's Acceptance to Participate in the Study Patients that agree to participate	90 Participants	—
Patient's Acceptance to Participate in the Study Patients that refused participation	30 Participants	—

SECONDARY outcome

Timeframe: initial clinical visit

Proportion of patients that were randomized and completed the study

Outcome measures

Outcome measures
Measure	Intervention Group n=90 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Adequate Randomization Adequate randomization	86 Participants	—
Adequate Randomization Post Randomization exclusion	4 Participants	—

SECONDARY outcome

Timeframe: baseline

Proportion of patients that completed the baseline survey

Outcome measures

Outcome measures
Measure	Intervention Group n=86 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Completeness of Baseline Survey (Patients) Completed baseline survey	84 Participants	—
Completeness of Baseline Survey (Patients) Did not complete baseline survey	2 Participants	—

SECONDARY outcome

Timeframe: 6 months

Population: From the initial group of 86 patients, 6 were diagnosed with cancer and not eligible for the follow up survey.

Proportion of patients that completed the 6 month survey

Outcome measures

Outcome measures
Measure	Intervention Group n=80 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Patient Survey (6 Months) Completed the survey	50 Participants	—
Patient Survey (6 Months) Did not complete the survey	30 Participants	—

SECONDARY outcome

Timeframe: baseline

Population: 17 clinicians care for the patients in the study and were asked to complete a baseline survey

Outcome measures

Outcome measures
Measure	Intervention Group n=17 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Clinician Baseline Survey Completed	17 Participants	—
Clinician Baseline Survey Not Completed	0 Participants	—

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were included in each arm, completion of survey items related to knowledge were available for 40 patients in the intervention group and 41 patients in the control group.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=40 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=41 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Knowledge	72.1 correct response Standard Deviation 18.1	65.0 correct response Standard Deviation 22.4

SECONDARY outcome

Timeframe: baseline

Population: 43 were randomized in each arm in the study, and for 31 in the intervention group items related the decisional conflict scale in the survey were completed and 23 for those in the control group.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=31 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=23 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Decisional Conflict	10.9 score on a scale Interval 0.8 to 42.8	20.3 score on a scale Interval 0.0 to 29.7

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.

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

Outcome measures

Outcome measures
Measure	Intervention Group n=42 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=43 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
OPTION Score	35.4 score on a scale Interval 31.3 to 38.5	27.1 score on a scale Interval 20.8 to 30.3

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.

Length of the clinical visit

Outcome measures

Outcome measures
Measure	Intervention Group n=42 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=43 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Visit Duration	21.5 minutes Standard Deviation 9.3	22.1 minutes Standard Deviation 9.3

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were randomized in the study, the outcome of next diagnostic test (undergoing thyroid biopsy) was assessed from clinical chart review which was available for all patients.

Proportion of patients undergoing thyroid biopsy

Outcome measures

Outcome measures
Measure	Intervention Group n=43 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=43 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Diagnostic Decision Thyroid Biopsy	17 Participants	22 Participants
Diagnostic Decision Other	26 Participants	21 Participants

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=42 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=43 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Fidelity	78.6 percentage of items of the conversation Standard Error 16.5	59.6 percentage of items of the conversation Standard Error 17.9

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.

Proportion of visits in which thyroid cancer risk was communicated evaluated through review of clinical visit, as yes/no outcome.

Outcome measures

Outcome measures
Measure	Intervention Group n=42 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=43 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Risk Communication Risk communicated yes	39 Participants	38 Participants
Risk Communication Risk communicated no	3 Participants	5 Participants

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were randomized in each arm, for all patients in the intervention group items related to satisfaction were completed in the survey and for 41 in the control group these items were completed in the survey.

Likert score, lower number more satisfied, 1-7

Outcome measures

Outcome measures
Measure	Intervention Group n=43 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=41 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Satisfaction With the Communication (Patient)	1.3 units on a scale Standard Deviation 0.8	1.4 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: baseline

Population: Clinicians expressed satisfaction with the clinical visit through a survey, that was completed for all patients in the intervention group (43) and (42) in the control group.

Likert score, higher numbers better, 1-5 options

Outcome measures

Outcome measures
Measure	Intervention Group n=43 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=42 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Satisfaction With the Visit (Clinician)	4.5 units on a scale Standard Deviation 0.7	4.4 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: baseline

Population: 43 patients were randomized in each arm, survey responses for this outcome were available for 43 participants in the intervention group and 41 participants in the control group.

Worry about thyroid cancer diagnosis assessed through a survey item, including the options Not at all, rarely/a little or somewhat or a lot

Outcome measures

Outcome measures
Measure	Intervention Group n=43 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=41 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Worry About Thyroid Cancer Not at all	14 Participants	8 Participants
Worry About Thyroid Cancer Rarely/ a litte	16 Participants	18 Participants
Worry About Thyroid Cancer Somewhat or a lot	13 Participants	15 Participants

SECONDARY outcome

Timeframe: 6 months

Population: From the initial population of 86 participants (43 in each group), 6 were diagnosed with thyroid cancer and were not eligible for evaluation of outcomes at 6 months of follow up. Leaving 42 eligible patients in the intervention group (1 cancer diagnosis) of which 29 completed the follow up survey and 38 in the control group (5 cancer diagnoses) of which 21 completed the follow up survey.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=29 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Control Group n=21 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid
Distress Due to Thyroid Nodule (6 Months)	1.1 units on a scale Standard Deviation 2.1	3.0 units on a scale Standard Deviation 3.1

Adverse Events

Patient Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Naykky Singh Ospina

University of Florida

Phone: (352) 273-8655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Patients - Intervention Group n=43 Participants Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid.	Patients - Control Group n=43 Participants Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid	Clinicians n=17 Participants Clinicians enrolled in the study counseled patients with or without the use of the conversation aid, per patient randomization assignment	Total n=103 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 16.2 • n=43 Participants • No additional information was collected for clinicians.	57.2 years STANDARD_DEVIATION 15.5 • n=43 Participants • No additional information was collected for clinicians.	—	57.2 years STANDARD_DEVIATION 15.8 • n=86 Participants • No additional information was collected for clinicians.
Sex: Female, Male Female	36 Participants n=43 Participants • No additional information was collected on clinicians	33 Participants n=43 Participants • No additional information was collected on clinicians	—	69 Participants n=86 Participants • No additional information was collected on clinicians
Sex: Female, Male Male	7 Participants n=43 Participants • No additional information was collected on clinicians	10 Participants n=43 Participants • No additional information was collected on clinicians	—	17 Participants n=86 Participants • No additional information was collected on clinicians
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=43 Participants • No additional information was collected for clinicians	0 Participants n=43 Participants • No additional information was collected for clinicians	—	2 Participants n=86 Participants • No additional information was collected for clinicians
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=43 Participants • No additional information was collected for clinicians	43 Participants n=43 Participants • No additional information was collected for clinicians	—	84 Participants n=86 Participants • No additional information was collected for clinicians
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=43 Participants • No additional information was collected for clinicians	0 Participants n=43 Participants • No additional information was collected for clinicians	—	0 Participants n=86 Participants • No additional information was collected for clinicians
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=43 Participants • No additional information was collected for clinicians.	1 Participants n=43 Participants • No additional information was collected for clinicians.	—	1 Participants n=86 Participants • No additional information was collected for clinicians.
Race (NIH/OMB) Asian	2 Participants n=43 Participants • No additional information was collected for clinicians.	0 Participants n=43 Participants • No additional information was collected for clinicians.	—	2 Participants n=86 Participants • No additional information was collected for clinicians.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=43 Participants • No additional information was collected for clinicians.	0 Participants n=43 Participants • No additional information was collected for clinicians.	—	0 Participants n=86 Participants • No additional information was collected for clinicians.
Race (NIH/OMB) Black or African American	2 Participants n=43 Participants • No additional information was collected for clinicians.	5 Participants n=43 Participants • No additional information was collected for clinicians.	—	7 Participants n=86 Participants • No additional information was collected for clinicians.
Race (NIH/OMB) White	37 Participants n=43 Participants • No additional information was collected for clinicians.	37 Participants n=43 Participants • No additional information was collected for clinicians.	—	74 Participants n=86 Participants • No additional information was collected for clinicians.
Race (NIH/OMB) More than one race	1 Participants n=43 Participants • No additional information was collected for clinicians.	0 Participants n=43 Participants • No additional information was collected for clinicians.	—	1 Participants n=86 Participants • No additional information was collected for clinicians.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=43 Participants • No additional information was collected for clinicians.	0 Participants n=43 Participants • No additional information was collected for clinicians.	—	1 Participants n=86 Participants • No additional information was collected for clinicians.
Region of Enrollment United States	43 participants n=43 Participants	43 participants n=43 Participants	17 participants n=17 Participants	86 participants n=103 Participants
General Health Excellent/Very good	20 Participants n=43 Participants • No additional information was collected for clinicians.	10 Participants n=43 Participants • No additional information was collected for clinicians.	—	30 Participants n=86 Participants • No additional information was collected for clinicians.
General Health Fair	5 Participants n=43 Participants • No additional information was collected for clinicians.	9 Participants n=43 Participants • No additional information was collected for clinicians.	—	14 Participants n=86 Participants • No additional information was collected for clinicians.
General Health Good	15 Participants n=43 Participants • No additional information was collected for clinicians.	21 Participants n=43 Participants • No additional information was collected for clinicians.	—	36 Participants n=86 Participants • No additional information was collected for clinicians.
Income Missing	2 Participants n=43 Participants • No additional information was collected for clinicians.	3 Participants n=43 Participants • No additional information was collected for clinicians.	—	5 Participants n=86 Participants • No additional information was collected for clinicians.
General Health Poor	3 Participants n=43 Participants • No additional information was collected for clinicians.	1 Participants n=43 Participants • No additional information was collected for clinicians.	—	4 Participants n=86 Participants • No additional information was collected for clinicians.
General Health Missing	0 Participants n=43 Participants • No additional information was collected for clinicians.	2 Participants n=43 Participants • No additional information was collected for clinicians.	—	2 Participants n=86 Participants • No additional information was collected for clinicians.
Education High school graduate	4 Participants n=43 Participants • No additional information was collected for clinicians.	4 Participants n=43 Participants • No additional information was collected for clinicians.	—	8 Participants n=86 Participants • No additional information was collected for clinicians.
Education Graduate or professional degree	22 Participants n=43 Participants • No additional information was collected for clinicians.	19 Participants n=43 Participants • No additional information was collected for clinicians.	—	41 Participants n=86 Participants • No additional information was collected for clinicians.
Education Less than high school	1 Participants n=43 Participants • No additional information was collected for clinicians.	0 Participants n=43 Participants • No additional information was collected for clinicians.	—	1 Participants n=86 Participants • No additional information was collected for clinicians.
Education Professional degree in health related sciences	5 Participants n=43 Participants • No additional information was collected for clinicians.	6 Participants n=43 Participants • No additional information was collected for clinicians.	—	11 Participants n=86 Participants • No additional information was collected for clinicians.
Education Some college, no degree	10 Participants n=43 Participants • No additional information was collected for clinicians.	11 Participants n=43 Participants • No additional information was collected for clinicians.	—	21 Participants n=86 Participants • No additional information was collected for clinicians.
Education Missing	1 Participants n=43 Participants • No additional information was collected for clinicians.	3 Participants n=43 Participants • No additional information was collected for clinicians.	—	4 Participants n=86 Participants • No additional information was collected for clinicians.
Income >$150,000	7 Participants n=43 Participants • No additional information was collected for clinicians.	6 Participants n=43 Participants • No additional information was collected for clinicians.	—	13 Participants n=86 Participants • No additional information was collected for clinicians.
Income $40,000 to $79,999	9 Participants n=43 Participants • No additional information was collected for clinicians.	10 Participants n=43 Participants • No additional information was collected for clinicians.	—	19 Participants n=86 Participants • No additional information was collected for clinicians.
Income $80,000 to $149,999	11 Participants n=43 Participants • No additional information was collected for clinicians.	11 Participants n=43 Participants • No additional information was collected for clinicians.	—	22 Participants n=86 Participants • No additional information was collected for clinicians.
Income < $40,000	14 Participants n=43 Participants • No additional information was collected for clinicians.	13 Participants n=43 Participants • No additional information was collected for clinicians.	—	27 Participants n=86 Participants • No additional information was collected for clinicians.
Thyroid nodule size	1.6 cm n=43 Participants • No additional information was collected for clinicians, also variable not applicable to clincians	1.8 cm n=43 Participants • No additional information was collected for clinicians, also variable not applicable to clincians	—	1.7 cm n=86 Participants • No additional information was collected for clinicians, also variable not applicable to clincians