Anushree Agarwal

Background: Patients with adult congenital heart disease (ACHD) experience significant gaps in guideline-recommended care, associated with higher morbidity and mortality compared to those without care gaps. We evaluated barriers and facilitators to specialized care to inform patient-centered solutions. Methods: We purposively sampled ACHD patients and clinicians from UCSF and across the United States and conducted semi-structured interviews in 2023-2024. Patients were ≥18 years, spoke English or Spanish, and could provide informed consent; clinicians were cardiologists or other staff involved in ACHD care. Zoom interviews were conducted using Capability, Opportunity, Motivation, and Behavior (COM-B)-informed guides and were recorded, professionally transcribed, and translated when applicable. Data were analyzed using inductive coding and rapid qualitative analysis, with independent dual coding, consensus resolution, concurrent analysis, and member checking. Identified categories were subsequently mapped to the Theoretical Domains Framework and COM-B. Results: We interviewed 54 participants (37 patients, 17 clinicians). For patients, the median age was 32 years; 57% were women, 62% were people of color, and 35% had gaps in care of ≥3 years. Findings were organized into six interdependent categories: healthcare system and institutional structure; knowledge and education; sources of support; personal development; identity and personal resources; and ACHD’s placement in one's life. Two novel findings emerged: a paradoxical facilitating role of parental language barriers and the complex impact of caregiver support on patients' independent care skills. We developed the ACHD Care Wheel, a theory-guided framework to support the design and evaluation of future interventions. Conclusions: The ACHD Care Wheel is a stakeholder-derived, theory-grounded framework for developing and evaluating interventions to improve ACHD care. Interventions targeting the three priority categories (healthcare system and institutional structure, knowledge and education, and sources of support) are likely to produce effects across multiple domains simultaneously, offering a theoretically grounded path forward for this growing population.

Background: Adults with congenital heart disease frequently experience gaps in lifelong adult congenital heart disease (ACHD) specialty care, leading to preventable complications, hospitalizations, and premature mortality. However, effective, scalable, accessible, and sustainable strategies to reduce these gaps are lacking. Digital health offers potential solutions but requires a rigorous scientific approach in its design to address the needs of the target population. Objective: This study aims to describe the development of a theory-based, community co-designed digital health intervention to improve lifelong ACHD care. Methods: We integrated theory-based behavioral frameworks, semistructured qualitative interviews with patients and clinicians, and a community-engaged approach to develop a digital health intervention for ACHD. The primary behavioral target was completing an ACHD specialist appointment. We conducted Capability, Opportunity, Motivation, and Behavior (COM-B)–guided semistructured interviews with patients with ACHD and clinicians to identify barriers to specialized care amenable to a digital intervention, and patient-centered goals for the digital tool. The community partners helped develop key intervention objectives, create a theory-driven framework, and specify how each intervention component targets specific COM-B barriers. Results: We interviewed 54 participants (n=37 patients with ACHD, and n=17 clinicians) and engaged 21 community partners representing 4 advocacy organizations. Design objectives emphasized addressing patient loneliness, ensuring accessibility and credibility, and enabling scalability while centering patient perspectives. Participants identified 4 priorities: providing credible resources, uplifting patient voices, customizing to patient needs, and centering positivity and joy. The digital tool, named by community partners as Empower My Congenital Heart (EMCH), was designed within the web- and mobile-based, Apple- and Android-compatible, Eureka Digital Research platform (University of California, San Francisco). Key intervention components included educational modules, peer support, appointment planning nudges, and a digital medical passport. The EMCH’s theory-driven framework specifies how each intervention component targets specific COM-B barriers to specialized ACHD care. Conclusions: The theory-driven, community co-designed EMCH digital tool provides a scalable approach to promote lifelong ACHD specialist care. Ongoing process evaluation and a planned randomized controlled trial will assess acceptability, engagement, and effectiveness in reducing care gaps. If proven effective, EMCH has the potential to prevent complications, emergency hospitalizations, and mortality affecting the majority of adults with congenital heart disease.

Background: The Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult-Centered Care (CHI-RON) study is a unique collaboration between the PCORnet and Congenital Heart Initiative (CHI), the first patient powered registry for adult congenital heart disease (ACHD) patients. The CHI-RON study examines the effects of gaps in recommended care in ACHD. Objective: Recruitment of racially diverse, younger, out-of-care, and male participants has been challenging in ACHD studies. Our goal was to design patient engagement and recruitment strategies to improve representation. Research Design: Launched in December 2020, patients from any location can self-enroll in the CHI registry, while the CHI-RON study (5/2022 – 10/2023) recruited ACHD patients at 12 sites participating in PCORnet. CHI-RON Recruitment methodology included a patient partner engagement toolkit and a recruitment algorithm using the PCORnet ^® Common Data Model designed specifically to improve diversity and reduce self-enrollment biases in comparison to the CHI registry. Subjects: ACHD patients, age 18 years or older, with the ability to complete PROs independently. Measures: Demographic/Recruitment Statistics for study participants and Patient Engagement in Research Scale (PEIRS-22) for the study team partners. Results: As of October 2023, a total of 2652 participants were recruited through CHI-RON recruitment methodology while 1326 were self-enrolled in the CHI. CHI-RON recruitment methodologies have increased representation when compared with self-enrolled CHI participants in terms of ethnicity (10.9% vs. 7.4% Hispanic, P P P P P <0.001). Most study team patient partners (n=12, 86%) reported a very to extremely high degree of engagement (PEIRS-22 average score 101.6), especially in the subdomains of contributions, support, feeling valued, and benefits. Conclusions: Patient engagement and novel recruitment strategies are critical to improving the inclusion of under-represented populations in clinical research and ensuring alignment with the needs of ACHD patients.

BACKGROUND There is a critical need to support patients with congenital heart disease (CHD), especially during their young adulthood, to help maintain lifelong care with adult CHD specialists. To achieve this, effective, scalable, accessible, and sustainable strategies are needed. Digital health offers potential solutions but require a rigorous scientific approach in its design to address the needs of the target population. OBJECTIVE To use a theory-based and person-centered approach to developing and adapting a digital intervention that improves lifelong CHD care. METHODS The intervention planning included the combination of theory-based behavioral framework, semi-structured qualitative interviews with patients and clinicians, and community-based participatory research (CBPR). The primary behavioral target was patients’ activation skills; skills that promote patient engagement with CHD care. We used the Capability, Opportunity, and Motivation (COM) and Theoretical Domains Framework (TDF) of the Behavior Change Wheel (BCW) theoretical model to identify determinants of the target behavior and design intervention components. To make the interventions equitable and relevant to diverse patients, we incorporated the principles of digital health equity, diffusion of innovation, and behavioral economics. RESULTS We interviewed 54 participants (37 diverse patients with CHD and 17 clinicians) and engaged 21 community partners representing 4 advocacy organizations. The COM- and TDF-guided CHD patient engagement framework identified the design objectives and key features of the digital intervention to address challenges uniquely faced by patients with CHD. Four emerging hopes for the digital tool included providing easy access to credible resources, uplifting patient voices, customizing to patient needs, and centering positivity and joy. The digital tool, named by community partners as Empower My Congenital Heart (EmpowerMyCH), was implemented within the web- and mobile-based, Apple- and Android-compatible, Eureka Digital Research platform (University of California, San Francisco). Key intervention components include a digital medical passport, expert and peer guidance, and peer connections and support. Six intervention functions from the BCW (education, training, modeling, enablement, persuasion, and environmental restructuring) were mapped to the intervention components. “Empowerment” and “Peer Empowerment” quotes are used as motivational, confidence-building messages from clinicians and patients, respectively, to reinforce the patient’s role as an active participant in their care. CONCLUSIONS The EmpowerMyCH digital tool, developed using behavior change theories and CBPR approaches, offers rapidly scalable intervention components (digital medical passport, education on managing CHD, and community support) that can be delivered outside the clinic visits. EmpowerMyCH redefines how we support adults with chronic conditions, such as CHD, to be actively involved in their care and could potentially improve outcomes. CLINICALTRIAL The National Clinical Trial number for this study is NCT06581484.

Background: Patients with adult congenital heart disease (ACHD) experience significant gaps in guideline-recommended specialized care, leading to higher morbidity and mortality. We evaluated barriers and facilitators to specialized care, with particular focus on understanding how to design and evaluate holistic, patient-centered solutions. Methods: We purposely sampled demographically and geographically diverse group of ACHD patients and clinicians in the United States. We conducted semi-structured interviews guided by the Capability, Opportunity, Motivation, and Behavior (COM-B) model and Theoretical Domains Framework (TDF) and analyzed using rapid qualitative analysis. Results: We interviewed 54 participants (37 patients and 17 clinicians). The patient median age was 32 years; 57% were women, 62% were people of color, and 35% had gaps in care of ≥3 years. Findings were organized into six interdependent categories: healthcare system and institutional structure; knowledge and education; sources of support; personal development; identity and personal resources; and ACHD’s placement in one’s life. Two novel findings emerged: a paradoxical facilitating role of parental language barriers and the complex impact of caregiver support on patients’ independent care skills. We developed the ACHD Care Wheel, a theory-guided framework to support the design and evaluation of future interventions. Conclusion: The ACHD Care Wheel is a stakeholder-derived, theory-grounded framework to develop and evaluate interventions to improve specialized ACHD care. Interventions targeting the three priority categories (healthcare system and institutional structure, knowledge and education, and sources of support) are likely to produce effects across multiple domains simultaneously, offering an efficient and theoretically grounded path forward for this growing population.

Background: Adults with congenital heart disease (ACHD) frequently experience gaps in lifelong ACHD specialty care, leading to preventable complications, hospitalizations, and premature mortality. However, effective, scalable, accessible, and sustainable strategies to reduce these gaps are lacking. Digital health offers potential solutions but requires a rigorous scientific approach in its design to address the needs of the target population. Objective: To describe the development of a theory-based, community co-designed digital health intervention to improve lifelong ACHD care. Methods: We integrated theory-based behavioral frameworks, semi-structured qualitative interviews with patients and clinicians, and a community-engaged approach to develop a digital health intervention for ACHD. The primary behavioral target was completing an ACHD specialist appointment. We conducted Capability, Opportunity, Motivation, and Behavior (COM-B)-guided semi-structured interviews with ACHD patients and clinicians to identify barriers to specialized care amenable to a digital intervention and patient-centered goals for the digital tool. The community partners helped develop key intervention objectives, create a theory-driven framework, and specify how each intervention component targets specific COM-B barriers. Results: We interviewed 54 participants (37 ACHD patients and 17 clinicians) and engaged 21 community partners representing 4 advocacy organizations. Design objectives emphasized addressing patient loneliness, ensuring accessibility and credibility, and enabling scalability while centering patient perspectives. Participants identified four priorities: providing credible resources, uplifting patient voices, customizing to patient needs, and centering positivity and joy. The digital tool, named by community partners as Empower My Congenital Heart (EMCH), was designed within the web- and mobile-based, Apple- and Android-compatible, Eureka Digital Research platform (University of California, San Francisco). Key intervention components included educational modules, peer support, appointment planning nudges, and a digital medical passport. The EMCH’s theory-driven framework specifies how each intervention component targets specific COM-B barriers to specialized ACHD care. Conclusions: The theory-driven, community co-designed EMCH digital tool is a rapidly scalable approach to improve guideline-recommended specialized ACHD care. Future studies will evaluate the acceptability, feasibility, effectiveness, and implementation outcomes to provide insight into a novel tool to reduce preventable morbidity and mortality in ACHD. Trial Registration: The National Clinical Trial number for this study is NCT06581484 .

Background: In the United States, there are over 1.5 million adults living with congenital heart disease (CHD). The Congenital Heart Initiative (CHI) is a digital, online patient empowered registry that was created to advance multicenter research and improve clinical care by gathering patient-reported outcomes (PROs) in adults with CHD. Methods: After a two year design process, the CHI was created and launched nationally on December 7, 2020 using a human centered design approach. Demographics and validated survey tools on quality of life, mental health, physical activity and health care utilization were collected at baseline and every 4 months. Data were collected virtually and stored on Health Insurance Portability and Accountability Act (HIPAA)–compliant cloud-based servers with restricted access. Results: By December 31, 2023, the CHI had enrolled 4558 participants (56% female) with an average age of 39 years ± 14, representing all 50 states. Approximately 88% of participants have completed at least one e-Visit as of December 31, 2023. The most prevalent CHD anatomy included tetralogy of Fallot (883, 22%), transposition of great arteries (452, 11%), and coarctation of the aorta (429, 11%). Approximately 88% of participants reported at least one co-morbidity, with arrhythmia (1310, 29%) and mood disorder (1339, 29%) as the most common cardiac and non-cardiac co-morbidity, respectively. Among female participants, 45% (n=1147) reported having had a pregnancy with 38% (n=967) resulting in biological children. Participants with complex CHD were less likely to meet recommended physical activity guidelines (X ² (2, n = 917) = 15.9, p < 0.001), a factor that was more pronounced amongst female participants. Overall health-related quality of life was rated as good or better by 84% of participants with no difference by CHD complexity. Conclusion: CHI is the largest ongoing registry of adults living with congenital heart disease in the US and includes patients with a wide variety of CHD subtypes. Many patients report mood disorders, but most report good or very good health-reported quality of life. The CHI is poised to facilitate multicenter research with the goal of improving clinical outcomes for all adults with CHD.