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OpenTrials
Completed

NCT Number: NCT04463719

AIM2: 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.

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Key information

Conditions

Thyroid Nodules Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling using the electronic conversation aid

Behavioral

Patients receive counseling about thyroid biopsy with the use of the conversation aid.

counseling by routine care

Behavioral

Patients receive counseling by routine care without the use of the conversation aid

Primary outcomes

  1. Proportion of Eligible Patients for Feasibility

    Time frame: 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).

Secondary outcomes

  1. Patient's Acceptance to Participate in the Study

    Time frame: first visit

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

  2. Adequate Randomization

    Time frame: initial clinical visit

    Proportion of patients that were randomized and completed the study

  3. Completeness of Baseline Survey (Patients)

    Time frame: baseline

    Proportion of patients that completed the baseline survey

  4. Patient Survey (6 Months)

    Time frame: 6 months

    Proportion of patients that completed the 6 month survey

  5. Clinician Baseline Survey

    Time frame: baseline

  6. Knowledge

    Time frame: 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.

  7. Decisional Conflict

    Time frame: 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.

  8. OPTION Score

    Time frame: baseline

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

  9. Visit Duration

    Time frame: baseline

    Length of the clinical visit

  10. Diagnostic Decision

    Time frame: baseline

    Proportion of patients undergoing thyroid biopsy

  11. Fidelity

    Time frame: 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.

  12. Risk Communication

    Time frame: baseline

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

  13. Satisfaction With the Communication (Patient)

    Time frame: baseline

    Likert score, lower number more satisfied, 1-7

  14. Satisfaction With the Visit (Clinician)

    Time frame: baseline

    Likert score, higher numbers better, 1-5 options

  15. Worry About Thyroid Cancer

    Time frame: baseline

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

  16. Distress Due to Thyroid Nodule (6 Months)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2020
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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