883. Qualitative Patient-Participant Perspectives on Implementation of Monthly Cabotegravir and Rilpivirine Long Acting (CAB+RPV LA) Injectable in the United States (CUSTOMIZE)

Background CAB+RPV LA administered monthly for HIV treatment is non-inferior to daily oral ART at maintaining viral suppression and preferred by most participants in clinical trials over daily ART. CUSTOMIZE, an implementation-effectiveness study, evaluated facilitators and barriers to clinic implementation of CAB+RPV LA from the patient perspective. Methods 115 participants were enrolled across 8 HIV clinics. Semi-structured phone interviews were conducted with a randomized subgroup of 3-6 participants per site, prior to the 1st (Baseline [BL], N=34) and 12th CAB+RPV LA injections (Month 12 [M12], N=31). Consolidated Framework for Implementation Research-guided interviews were recorded, transcribed, and coded using ATLAS.ti. Results At BL, 97% (n=33) of those interviewed indicated ≥1 challenge taking daily oral ART, including concerns about adherence (n=19; 56%), dosing frequency (n=13; 38%) and side effects (n=12; 35%). Twenty-seven (79%) reported anticipated challenges of CAB+RPV LA such as worry about side effects (n=15; 44%) and discomfort from injections (n=14; 41%). Participants reported at BL that CAB+RPV LA may help with adherence (n=17; 50%) or reduce fears of HIV status disclosure (n=10; 29%). At M12, 35% (n=11) reported some pain/discomfort from injections, but 87% (n=27) reported satisfaction with CAB+RPV LA, most commonly due to preferring the monthly regimen over the daily pill (n=15; 48%). Facilitators reported by participants as most helpful during early implementation were verbal education by clinic staff (14%), reminder texts/calls (13%), and an educational video about the regimen (6%). Most (n=25; 81%) indicated clinic hours were not a barrier, but 19% (n=6) noted taking time off work for the visits. Many participants (n=21; 68%) described positive aspects of going to the clinic each month, none complained about visit length, and 94% (n=29) reported intent to continue CAB+RPV LA after the study. Conclusion Interviewed participants reported several challenges with daily oral ART that monthly CAB+RPV LA may help overcome. Some initial concerns about receiving CAB+RPV LA were reported at BL, but most participants were satisfied with the regimen after one year and plan to continue receiving CAB+RPV LA following the study. Disclosures Cindy Garris, MS, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Larissa Stassek, MPH, GlaxoSmithKline (Consultant, Other Financial or Material Support, My company (Evidera) received funding from GSK to conduct this research. We did not receive funding for work on this abstract.) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Marybeth Dalessandro, BS, ViiV Healthcare (Employee, Shareholder) Sheila Adkins, BS, GSK (Employee)GSK (Employee, Stock) Maggie Czarnogorski, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

How Informative were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov

Background Early in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic. Methods We created a cohort of SARS-CoV-2 treatment and prevention efficacy trials that were initiated from 2020-01-01 to 2020-06-30 using ClinicalTrials.gov registration records. We evaluated trials on 3 criteria of informativeness: potential redundancy, design quality and feasibility of patient-participant recruitment. The study protocol was prospectively registered with the Open Science Framework (https://osf.io/fp726/). Results We included 500 trials in our cohort, 58% of which were Phase 2 and 84.8% were directed towards the treatment of SARS-CoV-2. Close to one third of trials met all three criteria and were deemed informative (29.0% (95% Confidence Interval 23.7-36.9)). The proportion of potentially redundant trials in our cohort was 4.1%. Over half of the trials in our cohort (56.2%) did not meet our criteria for high quality trial design. The proportion of trials with infeasible patient-participant recruitment was 22.6%. Conclusions Less than one third of COVID-19 trials registered on ClinicalTrials.gov during the first six months met all three criteria for informativeness. Shortcomings in trial design, recruitment feasibility and redundancy reflect longstanding weaknesses in the clinical research enterprise that were likely amplified by the exceptional circumstances of a pandemic.

Smart Wearables in the Lens of Aging: Results From the ROAMM Study

Continuous, long-term monitoring with remote capabilities using wearable technology is ideal for capturing information about patient/participant symptoms synced to sensor-based information. The Real-time Online Assessment and Mobility Monitor (ROAMM) is a smartwatch framework configured to collect data in free-living settings from both sensor-based (location and movement) and responses to symptom notifications through a visual display. The symposium presents the overall framework and preliminary findings from a demonstration study in older adults with knee osteoarthritis. Karnati will present the general framework of ROAMM explaining the data flow from the smartwatch to end users (clinicians and research). He will highlight components in the design that makes the framework unique and highly flexible to serve different studies with different research questions. Rouzaud evaluated satisfaction, usability and compliance wearing a smartwatch and using the ROAMM app. Participants were compliant to ecological prompts about pain, fatigue and mood three times a day (82.5% compliance rate). Additionally, > 70% reported being satisfied with the function/usability and comfort with using ROAMM and wearing the smartwatch. Mardini examined the temporal relationship between ecological pain and derived life-space mobility features from Global Positioning System coordinates. Results suggested that higher level of knee pain in older adults was associated with lower life-space mobility. Manini examined physician perception towards an electronic health record (EHR) graphical interface of top ranked patient attributes of pain, falls, hydration and mobility patterns. Results indicated a relatively high level of usability of the EHR interface depicting smartwatch data.

Perceptions of Risk of Attending Hospital During the COVID-19 Pandemic: A UK Public Opinion Survey

Background: To inform clinical and research practice in secondary care in the COVID-19 pandemic we consulted patients and the public on their feelings of safety, factors affecting feelings of safety, intention to participate in research, attitudes to research and comfort with new ways of working in order to inform secondary care policy on restarting research and some clinical activity. Method: An online survey was used to collect public opinions on attending hospitals. The survey link was circulated via the National Institute for Health Research (NIHR) Public Involvement (PPI) Leads network and social media.Results: 402 people completed the survey. Participants age ranged from the 18-85+, with the majority (337 (84%)) aged between 35 to 74 years. There were a higher number of women (77%) compared to men (23%); and were mainly White European (91%) compared to Black, Asian and Minority Ethnic (BAME) (6%), or other (2%).Results for feelings of safety scales show bi-polarity with few respondents in the middle ground. Implementation of COVID-19 related safety measures such as social distancing, use of personal protective equipment (PPE) and cleaning were strongly supported by most respondents. There was ambivalence around less certain measures such as staff antigen and antibody testing. Respondents were most likely to participate in research related to their own condition, COVID-19 and vaccine, but less likely to participate as healthy volunteers, especially if suffering from a pre-existing comorbidity identified with increased risk or were female. There was general agreement that participants are comfortable with new ways of working, such as remote consultation, though women and BAME respondents were less comfortable.Conclusions: Findings raise concerns for health inequalities already impacting some groups in the pandemic. The role of clinical necessity and personal benefit support the reopening of services in line with clinical necessity. Moderate caution in respect of vaccine research relative to patient-participant research presents a challenge for pending recruitment demands, and would benefit from qualitative research to explore themes and concerns in more depth and support development and targeting of key messaging.

Perceptions of Risk of Attending Hospital during the COVID-19 Pandemic: a UK public opinion survey

In order to inform clinical and research practice in secondary care in light of the COVID-19 pandemic, an online survey was used to collect public opinions on attending hospitals. The survey link was circulated via the National Institute for Health Research (NIHR) Public Involvement (PPI) Leads network and social media. 402 people completed the survey. Participants age ranged from the 18-85+, with the majority (337 (84%)) aged between 35 to 74 years. There were a higher number of women (77%) compared to men (23%); and were mainly White European (91%) compared to BAME (6%), or other (2%). Data collection included self-identified risk status due to comorbidity or age, and 100 point Likert-type scales to measures feelings of safety, factors affecting feelings of safety, intention to participate in research, comfort with new ways of working and attitudes to research. Results for feelings of safety scales indicate two distinct groups; one of respondents who felt quite safe and one of those who did not. Implementation of COVID-19 related safety measures such as social distancing, use of PPE and cleaning were strongly supported by most respondents. There was ambivalence around less certain measures such as regular staff antigen and antibody testing. Respondents were most likely to participate in research related to their own condition, COVID-19 research and vaccine research, but less likely to participate in healthy volunteer research, especially if suffering from a pre-existing comorbidity identified with increased risk or were female. There was general agreement that participants are comfortable with new ways of working, such as remote consultation, though women and BAME respondents were less comfortable. Findings raise concerns for health inequalities already impacting some groups in the pandemic. The role of clinical necessity and personal benefit support the reopening of services in line with clinical necessity. Moderate caution in respect of vaccine research relative to patient-participant research presents a challenge for pending recruitment demands, and would benefit from qualitative research to explore themes and concerns in more depth and support development and targeting of key messaging.

Return of Results in Psychiatric Genetics Research: Perceptions of Best Practices in a Global Sample of Psychiatric Genetics Researchers

Many research sponsors and genetic researchers agree that some medically relevant genetic findings should be offered to participants. The scarcity of research specific to returning genetic results related to psychiatric disorders hinders the ability to develop ethically-justified and empirically-informed guidelines for responsible return of results for these conditions. We surveyed 407 psychiatric genetics researchers from 39 countries to examine their perceptions of challenges to returning individual results and views about best practices for the process of offering and returning results. Most researchers believed that disclosure of results should be delayed if a patient-participant is experiencing significant psychiatric symptoms. Respondents felt that there is little research on the impact of returning results to participants with psychiatric disorders and agreed that return of psychiatric genetics results to patient-participants may lead to discrimination by insurance companies or other third parties. Almost half of researchers believed results should be returned through a participant's treating psychiatrist, but many felt that clinicians lack knowledge about how to manage genetic research results. Most researchers thought results should be disclosed by genetic counselors or medical geneticists and in person, however, almost half also supported disclosure via telemedicine. This is the first global survey to examine the perspectives of researchers with experience working with this patient population and with these conditions. Their perspectives can help inform the development of much-needed guidelines to promote responsible return of results related to psychiatric conditions to patients with psychiatric disorders.

Informed Consent in Healthcare

Informed consents, either for treatment or sensitive information use/disclosure, that protect the privacy of patient/participant information subject to law that in certain circumstances may override patient wishes, are mandatory practice in healthcare. Similarly, for protecting and respecting research participants, informed consents are also prerequisite for human subjects research. Although the healthcare industry has widely adopted Electronic Medical Record (EMR) systems, consents are still obtained and stored primarily on paper or scanned electronic documents. Integrating a consent management system for different purposes into an EMR system involves various implementation challenges. A case study, informed consent for genetic services, is used to show how genetic informed consents placed new challenges on the traditional ethical standards of informed consent, and how appropriate consents can be electronically obtained and automatically enforced using a system that combines medical workflows and hierarchically, ontologically motivated rule enforcement. Finally, this chapter describes an implementation that uses the open-source software-based addition of these components to an open-source EMR system, so that existing systems do not need to be scrapped or otherwise rendered obsolete.

A Clinically Integrated mHealth App and Practice Model for Collecting Patient-Reported Outcomes between Visits for Asthma Patients: Implementation and Feasibility

Objective Mobile health (mHealth) apps may prove to be useful tools for supporting chronic disease management. We assessed the feasibility of implementing a clinically integrated mHealth app and practice model to facilitate between-visit asthma symptom monitoring as per guidelines and with the help of patient-reported outcomes (PRO). Methods We implemented the intervention at two pulmonary clinics and conducted a mixed-methods analysis of app usage data and semi-structured interview of patients and clinician participants over a 25-week study period. Results Five physicians, 1 physician's assistant, 1 nurse, and 26 patients participated. Twenty-four patients (92%) were still participating in the intervention at the end of the 25-week study period. On average, each patient participant completed 21 of 25 questionnaires (84% completion rate). Weekly completion rates were higher for participants who were female (88 vs. 73%, p = 0.02) and obtained a bachelor's degree level or higher (94 vs. 74%, p = 0.04). On average, of all questionnaires, including both completed and not completed (25 weekly questionnaires times 26 patient participants), 25% had results severe enough to qualify for a callback from a nurse; however, patients declined this option in roughly half of the cases in which they were offered the option. We identified 6 key themes from an analysis of 21 patients and 5 clinician interviews. From the patient's perspective, these include more awareness of asthma, more connected with provider, and app simplicity. From the clinician's perspective, these include minimal additional work required, facilitating triage, and informing conversations during visits. Conclusion Implementation of a clinically integrated mHealth app and practice model can achieve high patient retention and adherence to guideline-recommended asthma symptom monitoring, while minimally burdening clinicians. The intervention has the potential for scaling to primary care and reducing utilization of urgent and emergency care.

Patienthood and participation in the digital era

The ‘digital era’ of informatics and knowledge integration has changed the roles and experiences of patients, research participants and health consumers. No longer figured (merely) as passive recipients of healthcare services or as beneficiaries of top-down biomedical information, individuals are increasingly seen as active contributors in healthcare and research. They are positioned into multiple roles that are experienced simultaneously by those who access and co-produce digital content that can easily be transformed into data. This is contextualised by ‘big data’ technologies that have altered biomedicine, enabling collation and analysis of myriad data from digitised records to personal mobile data. Social media facilitate new formations of communities and knowledge enacted online, while novel kinds of commercial value emerge from digital networks that enable health data commodification. In this paper, we draw from exemplary digital era shifts towards participatory medicine to cast light on the rapprochements between patienthood, participation and consumption, and we explore how these rapprochements are mediated by, and materialise through, the use of participatory digital technologies and big data. We argue that there is a need to use new conceptual tools that account for the multiple roles and experiences of patient–participant–consumers that co-emerge through digital technologies. We must also ethically re-assess the rights and responsibilities of individuals in the digital era, and the implications of digital era changes for the future of biomedicine and healthcare.

Let’s chat: Piloting an approach to patient-caregiver goal discussions in a neuro-oncology clinic.

28 Background: Communication is important to fostering joint coping in patients with advanced cancer and their family caregivers. Joint goal setting has been shown to enhance relationship quality for dyads and increase interpersonal ease and connection. Often patients and caregivers indicate they wish to discuss issues together but have difficulty doing so, which can inhibit dyadic coping and achievement of treatment goals and interpersonal plans. The aim of this study was to determine the feasibility and describe the methods of a short, one-time goal communication intervention for neuro-oncology patients and their primary family caregivers. Methods: Participants were recruited from a neuro-oncology clinic at an NCI-Designated Comprehensive Cancer Center. After informed consent from both patient and caregiver, the dyad was taken to a private room to complete a demographic questionnaire, eight-minute self-directed dyadic discussion of goals, and post-discussion questionnaire. For the discussion, dyads were asked to create and discuss three goals they had for themselves, and three goals they thought their partner would list, with at least one non-cancer related goal. Results: 10 dyads (n=20) were recruited for this study. Participants were mostly white, non-Hispanic, and married spouses. Only one patient participant was unable to list three goals. Dyads reported that the discussion was not stressful and they found high levels of benefit. Analysis of questionnaire and open-ended feedback overwhelmingly indicated the discussion task was useful to participants and that the study environment encouraged open, non-confrontational communication. Conclusions: Our brief prompted dyadic discussion intervention was feasible to implement and participants reported it was useful. Communication between advanced cancer patients and caregivers is vitally important to facilitate dyadic coping and ensure dyads are better able to achieve their goals. This pilot could be easily adapted to facilitate dyadic communication longitudinally to help facilitate communication between patients and caregivers along the cancer care continuum.