Virtual disclosure of preclinical Alzheimer's biomarkers: Preliminary experiences.

"PRELIMINARY FINDINGS: IS Aβ PET DISCLOSURE VIA TELEVIDEO FEASIBLE? Our study design originally included three in‐person visits comprising an education session, disclosure of Aβ PET scan results, and counseling session on reducing modifiable risk factors for dementia (Figure 1). With COVID‐19 changing the landscape of clinical care and research, our group discussed the risks and benefits of conducting in‐person masked visits as compared to virtual unmasked visits. FIGURE 1Study flow with virtual adaptations. Figure depicts each of the study visits and adaptations to study modality While the in‐person masked visits facilitated easier interpretation of body language, they presented a risk of viral transmission and hindered facial expression. Further, while visits were in‐person they did not feel as intimate as visits prior to COVID‐19 due to physical distance between the participant and clinician and inability to provide physical comfort during disclosure. The virtual unmasked visits allowed participants and clinicians to see each other's faces but reduced body language cues and required more competence and familiarity with technology by staff and participants. To continue the accessibility of our study for participants without necessary technology (e.g., internet bandwidth or device), we adapted the visits to all occur virtually either from home or at the research center (Figure 1). In the at‐home televideo visit, the clinician and participant complete a virtual visit using a platform that is compliant with the Health Insurance Portability & Accountability Act (HIPAA‐compliant platform). The modified in‐person visit looks nearly identical to virtual at‐home visits. The clinician and participant complete a virtual visit over research computers and campus internet from separate rooms within the research center. We believe the adaptations to onsite “in‐person” visits mitigate virus transmission, are more consistent with the at‐home virtual option, and address technological challenges. To center participant preference, participants can choose modified in‐person or at‐home virtual disclosure. Currently, as many participants are choosing the at‐home virtual visit as in‐person (Table 1). Twenty participants have gone through the disclosure visit, 10 at‐home and 10 onsite. Three participants were not disclosed to following clinician assessment during the onsite disclosure visit (see the following text). Of those electing at‐home disclosure, reasons include ease of access, particularly time and stress saved in not driving to the research center. Additionally, participants have shared being in their homes instead of the research center provides them comfort and a sense of safety when learning their Aβ PET results. TABLE 1Study visit completionVisit 1: Education and informed consentVisit 2: Disclosure of Aβ resultsVisit 3: Lifestyle counselingParticipants enrolleda (n)2120 (n = 3 not disclosed to)17Completed in‐person (n)010 (n = 3 not disclosed to)0Completed at home virtually (n)211017Experienced technological issues requiring study modality adaptationb (n)314Note: The table reflects data collected as of March 19, 2021. Data collection is ongoing.aNumber of people who have completed the visit.bFor Visit 2, study modality adaptation refers to converting from an at‐home televideo visit to onsite televideo visit. For Visit 1 and 3, study modality adaptation refers to converting from televideo to telephone. On the whole, technology has worked with minimal issues. We identify people with technological issues at the first study visit to assess feasibility of conducting the disclosure visit at home. Technological issues include not having access to a device or difficulty connecting to the televideo platform. So far, one participant opted for and was unable to complete the disclosure visit at home because of difficulty connecting to the televideo platform. Even though technology worked without issue for this participant at the first visit, their disclosure visit was rescheduled onsite at the research center. Despite some frustration in rescheduling, the onsite disclosure went well. KEY TAKEAWAYS IN CONDUCTING TELEVIDEO Aβ PET DISCLOSURE Our primary objectives to develop a safe and effective disclosure process and study postdisclosure outcomes remain consistent despite the COVID‐19 pandemic. We have not yet identified any clinically significant changes in symptoms of depression, anxiety, suicidality, or distress following disclosure. In conducting Aβ PET disclosure via televideo, we have learned a considerable amount about disclosure processes. First, remote visits can be made more personal through intentional emotive facial expressions and gestures. While engagement via a computer presents challenges in expressing the full range of nonverbal communication, clinicians can cultivate a more personal experience for participants by using hand gestures and facial expressions to convey support and understanding. Participants have reported “feeling heard” during the postdisclosure conversation as well as commented on the “empathetic care” of the clinicians. Second, our experience demonstrates the feasibility of healthcare professionals delivering sensitive health‐related information in‐person and remotely. Nurse practitioners and physicians have effectively conducted disclosure such that participant safety and understanding of results are prioritized. Our clinical study team of nurse practitioners and a geriatrician was trained on the role of Aβ in AD and research. They role‐played potential disclosure visit scenarios to practice. The clinicians developed a frequently asked questions document to ensure standardization and completeness of responses. In preliminary assessment of competency in Aβ disclosure, the clinicians have exceeded pre‐established study metrics for visit effectiveness. Third, full team meetings are imperative. Including clinical and nonclinical research members in debriefs regarding cases and overall progress has been essential for study cohesion and understanding. For the clinicians, learning the scientific rationale behind each visit component provides important context. Understanding the scientific rationale can inform the clinicians to approach visits from both a clinical and research perspective, improving participant experience and ensuring adequate data collection. For the nonclinical team members, understanding the critical “on‐the‐ground” components to actualizing study visits provides valuable insight into the impact of biomedical research on individuals. Last, the clinical judgment of the study clinician is fundamental in fully determining participant preparedness to learn their Aβ PET result. Despite passing psychological screeners and reporting readiness to learn their results to study coordinators, select research participants were identified as “high risk” for disclosure during the predisclosure clinician interview. In this section of the visit, the clinician asks a set of open‐ended questions and assesses the participant's responses for readiness to learn results and potential negative psychological impact following disclosure. The predisclosure clinician interview provides a nonjudgmental space for participants to share their experience with Alzheimer's disease and thoughts about how learning their Aβ PET results may impact their lives. This structured interview has been invaluable in identifying risk for negative consequences the validated questionnaires for depression, anxiety, and suicidality symptoms are not sensitive enough to detect. To date, three individuals passed screening questionnaires and were ultimately not disclosed to following the clinician interview. After an explanation was provided, the participants thanked the study team for not disclosing their Aβ PET results, expressed relief, and continue to support the efforts of the research program. CONFLICT OF INTEREST Sterling C. Johnson has participated on an advisory panel for and received an equipment grant from Roche Diagnostics, and he has received support (sponsoring of an observational study and provision of precursor for tau imaging) from Cerveau Technologies. No other disclosures were reported."

"Funding information National Institute of Aging, Grant/Award Numbers: R01 AG02115, R01 AG027161"