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

Inadequate selection of patients for thyroid biopsy contributes and precedes thyroid cancer overdiagnosis. To assess the feasibility of a multicenter randomized trial evaluating a conversation aid for patients with thyroid nodules. Pilot encounter level randomized trial. Two US academic centers. 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. Encounters were randomized to either usual care alone or usual care plus a conversation aid. 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. 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). 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. NCT04463719. Question How feasible are study procedures for a multicenter randomized trial evaluating a conversation aid for patients with thyroid nodules? Preliminarily, what are the effects on shared decision making of this aid? Findings In this feasibility randomized trial, we documented high participation rates from patients and clinicians and successful completion of study procedures. Preliminary evidence suggests the conversation aid promotes shared decision making and influences testing decisions without lengthening the encounter. Meaning Our finding documents both the feasibility of a trial to evaluate the effectiveness of a conversation aid and its efficacy in supporting diagnostic conversations in patients with thyroid nodules.