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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
107
Patients receive counseling about thyroid biopsy with the use of the conversation aid.
Patients receive counseling by routine care without the use of the conversation aid
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
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).
Time frame: at 6 months of follow up
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
Time frame: first visit
Adequate Randomization
Proportion of patients that were randomized and completed the study
Time frame: initial clinical visit
Completeness of Baseline Survey (Patients)
Proportion of patients that completed the baseline survey
Time frame: baseline
Patient Survey (6 Months)
Proportion of patients that completed the 6 month survey
Time frame: 6 months
Clinician Baseline Survey
Time frame: 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.
Time frame: baseline
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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.
Time frame: 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)
Time frame: baseline
Visit Duration
Length of the clinical visit
Time frame: baseline
Diagnostic Decision
Proportion of patients undergoing thyroid biopsy
Time frame: 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.
Time frame: baseline
Risk Communication
Proportion of visits in which thyroid cancer risk was communicated evaluated through review of clinical visit, as yes/no outcome.
Time frame: baseline
Satisfaction With the Communication (Patient)
Likert score, lower number more satisfied, 1-7
Time frame: baseline
Satisfaction With the Visit (Clinician)
Likert score, higher numbers better, 1-5 options
Time frame: 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
Time frame: 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.
Time frame: 6 months