Needs Definition

Our project is designed for women living with lupus who are planning to have children and as well as to support their healthcare team. Our project intent is to provide better predictability to maternal outcomes for women with lupus.

Pregnancy while living with lupus carries a high risk for both mother and baby. Symptom flares both before and during pregnancy have a correlation to negative outcomes like miscarriage and stillbirth. Our project provides early detection of lupus symptom flareups to help improve their maternal outcomes.

Lupus is an autoimmune disease that impacts 5 million people worldwide and 1.5 million in the US. People between the ages of 18 and 34 are at greatest risk of being diagnosed with lupus. Women make up 90 percent of lupus patients. Lupus is two to three times more prevalent among women of color. The CDC estimates that there are 16000 new cases each year in the US. 5 percent of children born to women with lupus will develop the illness.

Living with an autoimmune disease can be difficult even without being pregnant. Every day feels like a roll of the dice because of symptom flareups that seem to come out of the blue bringing pain and exhaustion. While symptom flares are problematic for all autoimmune patients, flares during pregnancy can result in complications.

SLE flares during pregnancy make the difference between an uncomplicated pregnancy and pregnancy with maternal and fetal complications. Therefore, the knowledge of risk factors leads the best treatment strategies to reduce flares and fetal complications in SLE patients.

Source: Risk factors of systemic lupus erythematosus flares during pregnancy

Flare monitoring will help the patient and her doctors better plan for pregnancy by applying the data derived from the crowd. We can use the data to cluster patients with similar patterns and experiences. This allows clinicians to understand how their patient’s pregnancy might progress given the experience drawn from large numbers of other patients.

“Maternal lupus flares occurred in 57 % of pregnancies and were being best predicted by the number of flares before conception...Stillbirth [was best predicted] by the number of flares during the last year before conception”

Source: Predictors of maternal and fetal complications in SLE patients: a prospective study

Planning for pregnancy with lupus requires working with your healthcare team for a healthy outcome.

Using our technology, our persona Maria and her health care team are able to discover patterns in pregnancies of women with similar health histories. This gives the care team the ability to make better choices for Maria’s care.

“Pregnancies in women with systemic lupus erythematosus (SLE) and lupus nephritis are considered high-risk due to high rates of maternal and fetal complications. All maternal deaths in patients with SLE and lupus nephritis occurred in those with active disease, with disease activity/complications and infections (mainly opportunistic) being the two major causes. The presented evidence further supports timing of pregnancy relative to SLE activity, and the judicious use of immunosuppressive agents in pregnant patients.“

Source: Maternal deaths in women with lupus nephritis: A review of published evidence

We want to help women like Maria have a healthy pregnancy by applying a software platform to better manage and understand lupus flare-ups before, during and after pregnancy. Stakeholders in our project include patients and their care teams. We propose using a custom symptom tracking app for the patient and an analytics dashboard for the healthcare team, applying predictive analytics to patient clinical data and collected patient generated outcomes to provide early indication of flares.

Business Feasibility

In the US alone, chronic diseases affect approximately 133 million people, representing more that 40% of the total population of the country. These numbers are projected to grow to an estimated 157 million, with 81 million having multiple conditions according to National Center for Health Statistics, Centers for Disease Control and Prevention. Many chronic disease patients are Medicare or Medicaid beneficiaries.

Lupus is a lifelong incurable chronic disease often with several chronic co-morbidities.

Under new 2017 CMS chronic care management codes, Patients with two or more chronic conditions are eligible for CMS' chronic care management (CCM) program. The included services are:

  1. Use of a Certified Electronic Health Record (EHR)
  2. Continuity of Care with Designated Care Team Member
  3. Comprehensive Care Management and Care Planning
  4. Transitional Care Management
  5. Coordination with Home- and Community-Based Clinical Service Providers
  6. 24/7 Access to Address Urgent Needs
  7. Enhanced Communication (for example, email)

We believe that our patient facing app combined with clinician focused dashboard would would be reimburseable under the CMS chronic care management program.

Technical Feasibility

We use AI to predict symptom progression from patient reported outcomes and clinical data. We anticipate integrating aggregated biometric as well as environmental sensor data partnering with companies like Validic, Inflammatix and Shade.

Uniqueness

There are other startups that predict symptoms or outcomes in the areas of hospital acquired infections, mental health and readmittance. However, no other startups apply this technology in autoimmune disease.

Progress During the Hackathon

During the hackathon, we were able to gain an understanding of the pain points and perspecitive of the patients and physicians through interviews. We reviewed the clinical information for lupus which informed the development of our prototype. We also verified the likelihood of reimbursement and evaluated several business models. We developed a prototype physician facing dashboard and patent facing mobile app.

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