Kardamom

Cardiovascular disease is the leading cause of death amongst women both in the United States and world-wide, but there are sex-specific differences in women that suggest a need for a more targeted risk assessment approach, such as attempts to develop risk scores for women with a documented history of cardiovascular disease prior to pregnancy, CARPREG and the modified WHO, but little research has been done in risk assessment in the postpartum period and beyond for women without a prior history of CVD. Pregnancy history is a significant risk factor for development of cardiovascular disease in the postpartum period and later in life, with adverse pregnancy outcomes such as hypertensive disorders of pregnancy (HDP) and gestational diabetes contributing to the development of ischemic heart disease, heart failure, stroke, and arrythmias such as atrial fibrillation. While the overall global trend in maternal mortality has decreased over the last 30 years, the trends for HDP, late, and indirect maternal mortality have all been stagnant. In the United States, Black person and American Indian/Alaskan Native populations have the highest rate of HDP as well as worse cardiovascular disease outcomes in pregnancy. Nearly 75% of underserved women are lost in the year after delivery, with the biggest drop off being in those women who suffered adverse pregnancy outcomes. The CDC estimates over 80% of pregnancy-related deaths are preventable, and over half of pregnancy-related mortality occurred in the post-partum period. Additionally, trans people carry a heightened risk of cardiovascular disease due to the usage of hormone therapy. Efforts to establish multi-modal risk assessments, expand educational initiatives, and address fragmentation in care are just now beginning to be proposed by medical groups but transitioning patients from the puerperium period back to general medicine are multifactorial and continue to pose challenges for the continuity of cardiovascular screening.

Kardamom is a platform developed to focus on refining pregnant people's cardiovascular risk assessment and provide continuity of care from the antepartum period to postpartum and later in life. Kardamom takes known risk factors, demographics, and social determinant characteristics and provides a first-step screening for people who are planning to become pregnant, are pregnant, or post-pregnancy who may be at risk of developing cardiovascular disease. The risk assessment is communicated back to the patient in graphical form with additional details about the specific factors contributing to the risk assessment and will allow for a AI-backed chatbot to engage in an additional conversation with the patient to help reinforce understanding and next steps. The data collected on the platform will be used in machine-learning prediction modeling to further refine the risk assessment across varied patient demographics.

Kardamom is being developed for people of childbearing age through post-menopause, also considered the working age of 18-64. Kardamom would like to pilot in the state of Ohio, which reported nearly 130,000 births in 2021, and about half of which were covered by Medicaid. Ohio represents a diverse geographical location, with core urban centers, such as Cleveland and Columbus, and rural areas such as Defiance and Crawford County which provide a robust population with which to pilot Kardamom. 

Importantly, Kardamom is designed as a patient-first platform with health literacy and access as core design pillars. Only about 10% of Americans are considered proficient in health literacy skills, but studies have shown home blood pressure monitoring and digital health interventions can be effective in low literacy and low socioeconomic status patient populations. Ohio had over 1,000,000 enrollees in the internet affordable connectivity program and as this program ends the efforts to address the digital health divide will slow or reverse. 

The Kardamom team has been developing the platform with health equity in mind and believes a pilot in a city with significant inequities is an important part of the development process. Our team has diversity of thought, with one product design engineer, one interdisciplinary engineer with experience in business incubation, and two clinical experts. Our clinical team member Ana has been exposed to the maternal health care gaps during her medical training in Brazil and in South Florida, and she has learned first hand about impact these cardiovascular events can have as her mother experienced pre-eclampsia while carrying her. Our other clinical team member Chris worked on identifying predictors as his Master's thesis with Harvard T.H. Chan School of Public Health. He also has relationships with obstetric and gynecology, maternal-fetal medicine, and cardiology providers within Cleveland, Ohio and believe these relationships would help facilitate a pilot within a community that has significant racial inequities rooted in structural racism. Our engineer Tanya has a degree in product innovation from Carnegie Mellon University and is experienced in leading data-informed product development. Finally, our engineer Ash has a Master's from Stanford University and built a career managing technology development and business incubation global programs in Accelerated Computing Systems, Health IOT, and Edge AI domains.

• We have built out a prototype for demonstration and feedback that is not yet published our available.
• We are still exploring the generalizability of our product globally.
• We have not formally established a company structure or filed articles of incorporation.

Kardamom is applying to Solve to address financial, cultural, and market barriers. We are looking to network and bring broader diversity of thought and expertise into the development of Kardamom so we can better develop the platform for American Indian/Alaskan Native, Black, and ex-US populations. We would also like to connect with partners who will help us navigate the financial considerations and build out a financially viable platform that does not leave underserved communities behind.

Kardamom is positioning women's cardiovascular health at the center of everything we do and is inclusive of the perinatal period, recognizing the importance of longitudinal care and follow-up in truly understanding the cardiovascular risk profile of women. Beyond that, existing cardiovascular risk assessments do not consider the impact of pregnancy on the lifelong risk of cardiovascular disease progression, and Kardamom seeks to improve upon existing models. Kardamom takes the niche specialty of cardio-obstetrics and makes it understandable and actionable for all individuals engaged in the care of pregnant persons and women, from community health workers to doulas and family members. As Kardamom continues to be developed and advances into piloting and deployment, the Kardamom team will collaborate with communities to identify cultural considerations and opportunities to further refine the user experience as well as the quality of data collected and communicated.

The goal of Kardamom is to improve cardiovascular risk screening and primary prevention amongst women. It will achieve this by refining risk prediction algorithms for women beginning in pregnancy beginning with the input of patient characteristics either by the patient or the patient's provider into the platform. Clinician coaching and patient-directed reminders based on best practices (recommendation of 12-14 prenatal visits) will coincide with updates to the patient profile and the generation of a new risk profile. The platform will use the patient characteristics and risk profile to provide education to the patient and their provider and identify individuals who may be at a high risk of developing cardiovascular disease as a result of pregnancy complications. The final outcome will be an increase in preventative care measures and timelier initiation of medical therapies to reduce the risk of cardiovascular disease in the women who engage with this platform.

-Develop a risk assessment algorithm with a validation AUC greater than 0.7, the threshold typically accepted by the medical community as clinically meaningful.

-Conduct a randomized-controlled trial comparing standard of care to the Kardamom platform and demonstrate a statistically significant improvement in time to cardiovascular screening.

Kardamom is a patient-facing app which takes both established and emerging clinical risk assessment algorithms and makes them widely available. The current prototype aims to refine the user experience as much of the data requires user input, but we hope to build upon the base app by integrating two AI elements into Kardamom. The first will be a patient-facing chatbot that can help the patient understand why certain information is needed for their profile as well as help educate on their current risk profile. The second AI integration will be on the backend and will help further refine the prediction modeling.

We have five team members on this project: 1 product design engineer, 1 interdisciplinary engineer with experience in business incubation, 1 computer engineer with public health expertise, and two clinical experts. 

We came together during a hackathon in April 2024, so we have been working on the solution for a little over 2 weeks.

To ensure our team is diverse, minimizes barriers, and provides a welcoming and inclusive environment, we embrace the unique backgrounds and perspectives of each member. Ana's firsthand experience with maternal health care gaps, Chris's population health perspective, Tanya's innovation expertise, and Ash's technology development proficiency enrich our team's diversity. We foster open communication and mutual respect, encouraging all members to contribute their viewpoints and experiences without fear of judgment. Collaboration is central to our approach, as we believe that valuing each member's input equally creates a culture of inclusivity where everyone feels empowered and respected. 

Our commitment extends to implementing inclusive policies and practices, such as flexible work arrangements to accommodate diverse needs and promote fairness. By regularly assessing our team dynamics and processes, we ensure that we're actively addressing any barriers to inclusion and continually striving to create a supportive and equitable environment for all team members.

The primary beneficiaries for this platform will be working age women and trans people between the age of 18-64 who are planning to become pregnant or are pregnant. This demographic represents a significantly higher per capita spending in healthcare dollars compared to men driven largely by maternal health spending. By offering a user-friendly and evidence-based risk assessment tool, we can empower these patients to make more informed decisions in collaboration with their family medicine, primary care, or obstetrics/gynecology providers during the pregnancy and in the years following. While we recognize trans people who are pregnant or planning to become pregnant will also be at risk of cardiovascular disease, the Kardamom risk profile may not generalize to them due to their hormone therapies, so we will require a disclaimer until the risk algorithm can be validated in this population

The app will be offered as a subscription-based service to healthcare providers, with tiered pricing based on the size of the practice and the number of users. Additional revenue streams may include:

- Partnerships with healthcare systems and insurance providers to integrate the app into their care pathways

- Licensing the risk assessment algorithm to third-party app developers or medical device manufacturers

- Offering premium features or customized solutions for high-volume users

By focusing on the unique cardiovascular needs of pregnant people and providing a robust, evidence-based risk stratification tool, our app will differentiate itself from competitors that focus either specifically on maternal health or specifically on cardiovascular health, but none of which are working on cardiovascular maternal health. 

Financial strategies proposed:

• Begin grant applications to support a pilot process in the United States (Bill & Melinda Gates Foundation, NIH, HRSA)

• Develop a licensing model for health systems and government-funded healthcare delivery services (i.e. federally qualified health centers) to integrate Kardamom within their workflows or EHRs.

• Develop collaboration with low-cost pharmaceutical suppliers such as Cost Plus Drugs or Civica Rx to partner on medication access.

• License a low-cost blood pressure monitoring device to package with Kardamom enrollment.

• Long-term financial strategy of user-facing store with curated health items demonstrated to impact cardiovascular risk on the American Heart Association Life's Essential 8s such as exercise equipment, tobacco cessation products, or sleep aids.

• Long-term financial strategy of value-based contracting with health systems and government funded healthcare delivery services once Kardamom is able to demonstrate clinical outcomes such as reductions in hospitalizations or reductions in cardiovascular disease prevalence.