Evaluation of a conversation aid for patients with thyroid nodules considering a biopsy: pilot multicenter randomized control trial.

IMPORTANCE: Inadequate selection of patients for thyroid biopsy contributes and precedes thyroid cancer overdiagnosis. OBJECTIVE: To assess the feasibility of a multicenter randomized trial evaluating a conversation aid for patients with thyroid nodules. DESIGN: Pilot encounter level randomized trial. SETTING: Two US academic centers. PARTICIPANTS: Clinicians who routinely engaged in discussions with patients about thyroid nodules and their eligible patients, i.e., English-speaking adults (aged ≥ 18 years) presenting for initial evaluation of a thyroid nodule. Patients were excluded if they had hyperthyroidism, were pregnant, had already undergone a biopsy of the nodule of interest, or had received counseling for thyroid nodule management within the year before their visit. INTERVENTION: Encounters were randomized to either usual care alone or usual care plus a conversation aid. MAIN OUTCOME(S) AND MEASURE(S): The primary outcome was feasibility of implementing study procedures. Secondarily, we assessed the aids’ impact on shared decision-making and clinical outcomes. We used the Observing Patient Involvement in Decision Making (OPTION-12) scale to assess the observed extent to which clinicians sought to involve patients in decision making. RESULTS: During the study, we screened 531 patients scheduled for thyroid nodule evaluation and found 213 (40%) eligible; of these, 120 (56%) attended their clinic visit and were invited to participate. Of those, 90 (75%) agreed to participate. Post-visit surveys were completed by 98% of patients, and clinical visit recordings obtained for 99% of encounters. The trial included 43 patients in each arm, most of whom were women (80%), mean age 57 years (SD 16). Encounter duration averaged 22 min, in both groups. Compared to usual care alone, usual care plus conversation aid yielded higher OPTION-12 scores (34 vs. 21, p < 0.001), more frequent discussion of alternative approaches (91 vs. 65% p = 0.008), and fewer decisions to pursue nodule biopsy (40 vs. 51%, p = 0.386). CONCLUSIONS AND RELEVANCE: This study demonstrates the feasibility of procedures needed to conduct a multicenter randomized trial assessing the efficacy of a conversation aid. Preliminary outcomes suggest that the aid may favorably affect the care of patients with thyroid nodules. TRIAL REGISTRATION: NCT04463719.