Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 107
- Locations
- 2
- Primary Endpoint
- Proportion of Eligible Patients for Feasibility
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
Counseling using the electronic conversation aid
Intervention: Counseling using the electronic conversation aid (Behavioral)
Control Group
Routine counseling only
Intervention: counseling by routine care (Behavioral)
Outcomes
Primary Outcomes
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
- Patient's Acceptance to Participate in the Study(first visit)
- Adequate Randomization(initial clinical visit)
- Completeness of Baseline Survey (Patients)(baseline)
- Patient Survey (6 Months)(6 months)
- Clinician Baseline Survey(baseline)
- Knowledge(baseline)
- Decisional Conflict(baseline)
- OPTION Score(baseline)
- Visit Duration(baseline)
- Diagnostic Decision(baseline)
- Fidelity(baseline)
- Risk Communication(baseline)
- Satisfaction With the Communication (Patient)(baseline)
- Satisfaction With the Visit (Clinician)(baseline)
- Worry About Thyroid Cancer(baseline)
- Distress Due to Thyroid Nodule (6 Months)(6 months)