Atrial Fibrillation (AF), Cardiovascular Diseases
Conditions
Keywords
Veterans, Clinical Trial Recruitment, Cardiovascular Disease, Artificial Intelligence, Patient Engagement, Health Literacy, Virtual Outreach
Brief summary
Cardiovascular disease is the leading cause of death among Veterans. Clinical trials are essential for developing better treatments, but Veterans remain underrepresented in these studies due to barriers including limited health literacy, lack of awareness, and mistrust. Current outreach approaches rely on either in-person physician conversations, which are limited by workforce constraints, or mailed letter invitations, which often fail to engage Veterans with limited health literacy. This study tests whether AI-generated video avatars can improve Veteran engagement in cardiovascular clinical trials.
Detailed description
Recent advances in artificial intelligence now enable the creation of personalized video avatars at negligible cost and time. These computer-generated videos can be rapidly adapted to describe any clinical trial and tailored to individual patient preferences in both speaker appearance and content. The EVERYVET Study (Empowering VEterans in Research effectivelY using Virtual Engagement Tools) will evaluate whether these AI-supported tools can increase Veteran engagement in cardiovascular clinical trials compared to standard mailed letter invitations. The avatar invitations will be randomly embedded into outgoing invitations for existing VA clinical studies. Veterans will be able to choose their preferred avatar speaker from a diverse set of computer-generated avatars and self-select the content topics most important to them. The study is co-designed with the Veterans and Family Research Engagement Council (VFREC) and a Veteran Co-Investigator to ensure the approach centers Veteran priorities and preferences throughout.
Interventions
BEHAVIORALAI-Generated Avatar Videos for Clinical Trial Outreach
Veterans randomized to the intervention arm will receive the website link where they can select their preferred avatar speaker(s) from a diverse set of options and self-select content topics of interest. They may watch the self-directed tailored video to guide their decision to participate in the parent trial.
Sponsors
VA Office of Research and Development
Palo Alto Veterans Institute for Research
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Participants in the control arm receive a standard mailed letter and are not aware of the avatar video intervention being received by the intervention arm. Study coordinators and investigators are aware of group assignment for operational purposes. Full blinding is not possible given the nature of the communication intervention.
Intervention model description
Veterans are randomized 1:1 to two concurrent arms with no crossover. The control arm receives a standard mailed letter invitation to the parent VA Cooperative Studies cardiovascular trial. The intervention arm receives the identical letter enhanced with a QR code and URL linking to AI-generated avatar videos and a chatbot, deployed across both the screening and treatment components of the parent trial. An adaptive design allows refinement of avatar options at pre-specified interim analyses without altering the parallel group structure or primary endpoint analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria: \- Veteran receiving a mailed invitation to participate in the parent VA Cooperative Studies cardiovascular trial (therefore meeting inclusion criteria of the parent VA Cooperative Studies trial) Inclusion Criteria (Aim 1 Qualitative Interviews): * Veteran receiving care at VAPAHCS * Recently invited (within 3 months) to participate in an existing cardiovascular clinical trial at VAPAHCS * Able to provide informed consent in English Inclusion Criteria (Aim 1 Beta-Testing and Aim 3): * Veteran receiving care at VAPAHCS or a participating VA-CTC site * Able to view a brief video and complete a short survey in English Inclusion Criteria (Focus Groups): * VA study coordinator or trial investigator actively engaged in cardiovascular clinical trial recruitment at VAPAHCS or a VA-CTC site * Willing to participate in a 60-90 minute virtual focus group
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Veterans who enroll in the parent VA Cooperative Studies cardiovascular trial within 6 months of receiving the invitation | Baseline through 6 months | Superiority of enrollment rate in the intervention arm (AI-supported avatar invitation) compared to the control arm (routine letter invitation alone), assessed using an intention-to-treat approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Veterans accessing the intervention website | Baseline through 6 months | Process measure assessing engagement with the QR code and URL among Veterans randomized to the intervention arm. |
| Proportion of Veterans viewing avatar videos | Baseline through 6 months | Process measure assessing video viewing behavior tracked through unique de-identified research numbers. |
| Avatar preferences | Baseline through 6 months | Frequency distribution of avatar speaker selections among Veterans who accessed the website |
Countries
United States
Contacts
CONTACTNicholas Vesom, MPH CCRP
PRINCIPAL_INVESTIGATORCelina M. Yong, MD MBA MSc
VA Palo Alto Health Care System, Palo Alto, CA
Outcome results
None listed