REJUVENATE: an interactive, child-centred approach to managing autoimmune rare diseases (e.g. ITP)

doctHERs

According to the NIH, between 1.9 to 6.4 children per 100,000 children have immune thrombocytopenia (ITP) a rare condition that exemplifies the impact and burden of autoimmune diseases in children. Extrapolating this data to the US and the world, it is estimated that there are between 4000 and 12000 cases of pediatric ITP in the US (~50% undiagnosed) and between 160,000 and 480,000 cases worldwide.  

The incidence and prevalence of this disease are under-reported in the US as both parents, primary caregivers and primary healthcare providers (PCPs) are unaware of the disease or have not diagnosed it (even if they are aware that ITP is a rare disease that exists in children). In addition to a lack of awareness of ITP, the following factors contribute to the under-reporting and/or under-treatment of this condition in children:

Patient Compliance & Burden of Care: Rare diseases such as ITP impose a significant burden of care on caregivers of children with ITP.  Kids require rigorous, weekly blood testing and follow-up with PCPs and hematologists – given their time constraints, the treating physicians are often unable to delve into the psychosocial dimensions of this disease and the adverse impact it can have on children and parents/caregivers, leading to poor adherence to therapy and/or patient attrition/lack of follow-up. This impact is especially burdensome on those single parents who can't take time off from work every week.

Affordability & Expensive Treatments: Families may have inadequate (or no) insurance coverage (e.g. undocumented workers and their families) for the specific types of treatments required to manage ITP, which can often exceed $1000 per week. Families may be unaware of Patient Assistance Programs and foundations that support the management of ITP in kids (e.g. ITP foundation

As children are asymptomatic between nosebleeds (which are one of the major signs of ITP) parents who can’t afford the exorbitant cost of treatment forego weekly treatment for their child and pray that the next nosebleed doesn’t require another visit to the ER with emergency IVIG or steroidal therapy.  In the ER, the treating physician will usually administer first-line therapy but not address the underlying issue (a low platelet count).  

Environmental Toxins such as polyurethane (PUR) are known to trigger ITP - these toxins are present in common products such as bed/pillow foam, 

Fear/Stress are also known risk factors for triggering auto-immune diseases in children (via the epigenetic activation of hereditary genes). Children exposed to extreme stress in their lived environment (e.g. domestic violence) may manifest signs of ITP.   

REJUVENATE is an interactive, digitally-integrated, child-centred program that addresses the major challenges children, parents, caregivers and providers face along the child’s therapeutic journey.  

Child-Centred Design Thinking: Comprehensive, digitally integrated journey that curates the journey that children and their parents undertake in the management of ITP. Using the Japanese philosophies of ‘kaizen’ and ‘ikigai’, a family journey has been co-created with patients (both children and parents, separately and together) to address identifiable needs. The journey is continuously iterated on, based on very tight patient-family feedback loops.  

Gamified Mobile App for Kids with ITP: kids with ITP and other kid can participate in an online, interactive game that educates children on living a vibrant life with ITP. By connecting kids with ITP, their sense of isolation and ‘other-ness’ is diminished.

Access to a monthly subscription plan for unlimited access to PCPs, (occupational) therapists and nutritionists (via telemedicine): A visiting home nurse (VNS), visiting school nurse or paramedic can draw blood for platelet testing (phlebotomy) and administer weekly treatment guided by a remotely located PCP. The school-based solution obviates the need for a parent to take time off from work. During the visit, the nurse can also sensitize available teachers on what to do if their student with ITP has a massive, uncontrolled nosebleed.  

Both family therapy and individual child therapy is available online via telepsychology to help cope with the impact of ITP on the mental health of the child and their parents/caregivers.  

Patient, Parent, Teacher & Provider Education: (i) monthly, online and in-person, parent support group meetings are conducted (iii) parent/teacher education on the potential side effects of therapies for ITP (e.g. petechiae, bruising/contusions, fever, etc.) will help alleviate concerns if these side-effects are observed and (iv) quarterly group PTMs are hosted (parent-teacher meetings) in which a visiting nurse or PCP provides patient-teacher education

Evaluation of Lived Environment: an occupational therapist (OT) conducts an in-person evaluation of the lived environment of the child’s home and school/classroom to identify any environmental risk factors that can  

Patient Support & Research Advocacy groups -  e.g. Platelet Disorder Support Association provides access to a plethora of resources – clinical trials, support groups, community events, access to tools to alleviate fear of injections and injection pain (e.g. Buzzy)

Affordability: we can offer our solution for a monthly subscription fee of just $49/family/month – the reason why we can offer such a low price is because our providers are all women who work flexi-time from home and are themselves caregivers of elderly parents or children (i.e. they are not actively participating in the mainstream workforce). PCPs are compensated on a capitation fee basis.

The target population is children living with rare diseases such as ITP. These children come from families with different ethnicities, faiths, income levels, and parent education levels.

ITP Disrupts/Impairs the Quality of Life: Children with rare diseases such as ITP require rigorous diagnostic and therapeutic follow-up. This can impose a major burden on their primary caregivers (including parents). The children (and their caregivers) often have to take time off from school (and work) to consult a doctor (such as a hematologist) and/or have weekly blood work done (tracking the child's platelet count). This disrupts the child, their parents, caregivers and school teachers.  

Rare Disease Impact on Mental Health & Continuity-of-Care: Psychologically speaking, children with ITP feel ‘different’ or excluded from groups of ‘regular’ kids, especially when it comes to team-based contact sports such as football (soccer), American football, rugby and basketball (all of which put kids with ITP at risk of injury such as lacerations, potentially leading to heavy internal or external bleeding). This social exclusion and ‘otherness’ can place a heavy toll on the child’s mental health & wellbeing.

Within the children with ITP target population, there is a small subset of children whose parents are Jehovah’s Witnesses and who prohibit doctors from transfusing their kids with platelets or fresh frozen plasma (FFP). For these children, early intervention following a bleed is vital.    

The REJUVENATE program addresses the unmet needs described above in the following ways: 

Convenient Home/School Health Visits & Nurse-Assisted Telepsychology:  nurses visit the child’s home or school, administer  IV therapies (e.g. IVIG or second-line therapies) and draw blood to track the platelet count. The nurses can conduct a real-time, virtual office visit via 3-way video consultation between the child’s parents, the child’s treating physician and themselves.

Improved Quality of Life: the diagnostic and therapeutic journey of the child and their parent(s)/caregiver(s) is significantly enhanced by the REJUVENATE program, based on the feedback sought by doctHERs during the (prototype) iterative, design thinking phase of the program.

Reduced Opportunity Costs: parent(s)/caregiver(s) do not need to take time off from work and the child with ITP does not need to take a day off from school or commute to the doctor’s clinic, resulting in much less disruption in the lives of the entire family. This saves money, resources, and time and is also environmentally friendly (less GHG emissions from reduced carbon-fueled transport).   

doctHERs has already launched the REJUVENATE program in South Asia (starting in Pakistan) and has initial clinical experience with the digitally integrated management of ITP that will prove very useful as we replicate our model in the US/Canadian context. We have already identified and enlisted the supply side of our model (HealthgCare Providers) and now plan to do the same on the child-beneficiary (demand side; hopefully in collaboration with Amgen & MIT SOLVE)

Our solution approaches the problem in a new or significantly improved way via the following digitally-enabled, interventions:

Innovation - Child-Centered Clinical Journey: as far as we are aware, this is the first example of a holistic, digitally integrated, continuity-of-care program focused on BIPOC that accompanies the child-patient and their parent(s)/caregiver(s) along the entire diagnostic and therapeutic continuum (from A to Z). While many programs are ‘vertical’ and focus on one aspect or component of the solution, our solution is ‘diagonal’ – it provides expertise on both vertical and lateral axes.

Innovation - Women PCPs: Another unique feature of our solution is that all of our primary care physicians (PCPs) are women of colour who reflect the skin tone and/or culture of the child being treated with ITP.  These PCPs work flexi-time and have been reintegrated into the workforce by doctHERs. Most of these PCPs work from home as they have care responsibilities themselves (either for elderly parents or children).

Catalyzing Ecosystem Development:  one of doctHERs’ key functions in the health marketplace is to help build an ecosystem of digitally integrated healthcare providers (HCPs), patient/care-provider support groups, clinical research advocacy groups, school systems and non-profits/NGOs that work at the grass-roots, under-resourced, community level (i.e. in low-income, disadvantaged communities). Other public-sector agencies, medical associations, social enterprises and private-sector organizations (such as pharmaceutical and biotech companies) can join this ‘Coalition of the Coagulants’.

This type of consortium has the potential to significantly amplify the impact of the REJUVENATE program and exponentially transform the landscape of ITP (rare disease) management. 

Changing the Market/landscape:  The REJUVENATE approach to building a consortium of partners has the potential to (i) amplify the impact of the program by linking complementary services between partners (i.e. not vertically duplicating them which would lead to systemic inefficiencies), (ii) transcend market-barriers (e.g. price barriers) and (iii) exponentially transform the landscape of ITP (rare disease) management in the US (and many developing nations in South Asia, ASEAN, MENA and Sub-Saharan Africa).      

We hope The Amgen Prize will enable us to overcome the following challenges and barriers:

Financial: we need access to early-stage, patient capital (grants, recoverable grants or quasi-equity) to scale our solution in the US in early 2025. Our pilot program will be complete by the end of 2024. Accordingly, we are actively engaging prospective funders with a target close date of 31 December 2024.

Technical: Amgen & MIT SOLVE have access to partners who can provide essential technical knowledge (especially on generative AI-enabled technology).

Legal: doctHERs is fiscally sponsored as a non-profit in the US by 501c3 non-profit Tides Foundation (based in San Francisco, CA). Following IRS rules,  doctHERs can legally receive tax-exempt grants from donors, foundations, etc. However, it is better (and more cost-effective) for doctHERs to register as a 501c3 in the US, independent of the Tides Foundation. Legal Assistance to doctHERs that can be channelled via Amgen or MIT SOLVE will be invaluable to achieving this objective by the end of 2024.    

Cultural: The initial market segment for REJUVENATE  will be Black, Indigenous and People of Colour (BIPOC). Both providers and patient-beneficiary families will initially be people of colour. Cultural sensitivity will be important for the successful implementation of the REJUVENATE program. Accordingly, any DEI initiatives, campaigns or in-kind resources that Amgen and/or MIT SOLVE can share with doctHERs would be invaluable. 

MARKET BARRIERS: Access to Relevant & Retainable Human Talent: doctHERs has already launched the REJUVENATE program in South Asia (starting in Pakistan) and has initial clinical experience with the digitally integrated management of ITP in children that will prove very very useful as we replicate our model in the US. We’ve already identified and enlisted the supply side of our model (American women HealthCare Providers - HCPs) and plan to do the same on the demand side; hopefully in collaboration with Amgen & MIT SOLVE). We will leverage registries of children with ITP’ and with informed consent, reach out to the child’s parents and primary caregivers. Additionally, we plan to collaborate with academic and clinical research faculty at Harvard-MIT, Brigham-MGH, BUMC and Tufts-NEMC to identify and enroll additional child-beneficiaries and their parents(s)/caregiver(s) into the REJUVENATE program. Roxbury and Jamaica Plain will be one of our key target populations.

doctHER’s core team is a multidisciplinary group of entrepreneurs, doctors, nurses, MBAs, design thinkers and project managers. One Co-Founder (Sabeen) is a Canadian-American former VP of Sales at Thomson Reuters with expertise in online education – Sabeen has also accelerated over 200 women-led businesses as part of a World Bank Women X accelerator program. 

The other Co-Founder is a British-American, US-trained Medical Doctor (MD)-cum-MBA with over 20 years of healthcare systems experience in the healthcare, biotech and pharmaceutical industries worldwide.

The REJUVENATE program has been co-created by families whose children have ITP (an example of a rare disease), along with frontline workers (nurses and paramedics) and (remotely located) female HCPs who can deliver services to these families via nurse-assisted telemedicine. The REJUVENATE pilot has already been launched in South Asia, and with The Amgen Prize, we hope to launch the US pilot by Q1 2025.  

Both team co-leads are People of Color (PoC) and are intimately familiar with the culture of their current market (South Asia; they are also fluent in the local languages - Hindi and Urdu).  The initial target market segment for the US pilot of REJUVENATE is families living in the South Asian diaspora (US). As doctHERs continues to expand its market footprint across the US, it will recruit human talent representative of the population enrolled in the REJUVENATE program (e.g. Caucasian, East Asian, Latin-American, Native-American, etc.).

Our Impact goals for 2025 are as follows:

·      Conduct 600 (monthly) video consultations between HCPs and children/parents/caregivers for management of ITP (an OUTPUT)

·      Enroll ~50 cases of children with ITP into Rejuvenate program [i.e. demonstrate Proof-of-Concept (PoC) of the model] – an OUTPUT

·      Reduce child School Absences due to ITP diagnosis/treatment by 30% (measured via a prospective, case-control study) – a short-to-intermediate-term OUTCOME

·      Reduce Employee absenteeism by 20% (parent(s) and/or primary caregiver(s) of children with ITP; measured via a prospective, case-control study) – a short-to-intermediate-term OUTCOME

·      Enable at least 5% of children with ITP (between 200-600 cases) to be effectively managed via the Rejuvenate program, as assessed by a normal platelet count – an intermediate-to-long-term outcome OUTCOME

·      (Relatively) Reduce the prevalence of mood disorders (anxiety and depression) in children with ITP by 20% – a long-term OUTCOME

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Our 5-year impact goals for 2030 are as follows:

·      Conduct 12,000 (monthly) video consultations between HCPs and children/parents/caregivers for management of ITP (an OUTPUT)

·      Enroll ~1000 cases of children with ITP into the Rejuvenate program [i.e. demonstrate Proof-of-Concept (PoC) of the model] – (an OUTPUT)

·      Reduce child School Absences due to ITP diagnosis/treatment by 60% (measured via a prospective, case-control study) – a short-to-intermediate-term OUTCOME

·      Reduce Employee absenteeism by 50% (parent(s) and/or primary caregiver(s) of children with ITP; measured via a prospective, case-control study) – a short-to-intermediate-term OUTCOME

·      Enable at least 25% of American children with ITP (between 1000-3000 cases) to be effectively managed via the Rejuvenate program, as assessed by a normal platelet count – an intermediate-to-long-term OUTCOME

·      (Relatively) Reduce the prevalence of mood disorders (anxiety and depression) in children with ITP by 50% – a long-term OUTCOME

Our Theory of Change

We believe that:

(1) the enrolment of children with rare diseases (such as ITP) into affordable, child-centred, Coordinated & Curated, Continuity-of-Care for Children (C5) programs such as Rejuvenate (OUTPUTs) and

(2) the re-integration of women healthcare providers (HCPs such as doctors, therapists and pharmacists, etc.; ‘another OUTPUT’)

(3) using a climate-smart strategy, clean technology and clinical human talent (collectively, the ‘INPUTs’)

will help generate:

(4) a better diagnostic & therapeutic child-beneficiary journey (short-term OUTCOME)

leading to:

(5) increased number of children with (chronic) ITP who have better management of their disease (i.e. a higher percentage of kids with normal platelet count – an intermediate-to-long-term outcome),  

(6) improved mental health & well-being of children with ITP and their parents/caregivers (a positive, long-term ‘outcome’) and

(7) affordable access to high-quality healthcare (management of ITP in children) for underserved populations (a positive health ‘outcome’).

The above outcomes will ultimately lead to:

Improved Quality of Life (QoL, measured via a QoL index) for the child-patient, the parent(s), the primary caregivers(s) and female HealthCare Providers (HCPs) in the clinical management of the child – collectively the long-term Impact of this intervention.

This theory of change is based on compelling evidence cited byChild’s et al and Higa-McMillan C.K., et al who respectively demonstrate the benefits of telepsychology and telehealth (INPUTs) [1] enable families to attend many more scheduled psychiatric appointments (OUTPUTs)[2], with better mental health outcomes for children (OUTCOMES)[3].

[1] Childs A.W., Bacon S.M., Klingensmith K., Li L., Unger A., Wing A.M., Fortunati F. Showing Up Is Half the Battle: The Impact of Telehealth on Psychiatric Appointment Attendance for Hospital-Based Intensive Outpatient Services During COVID-19. Telemedicine and E-Health. 2021;27(8):835–842. doi: 10.1089/tmj.2021.0028

[2] Childs A.W., Bacon S.M., Klingensmith K., Li L., Unger A., Wing A.M., Fortunati F. Showing Up Is Half the Battle: The Impact of Telehealth on Psychiatric Appointment Attendance for Hospital-Based Intensive Outpatient Services During COVID-19. Telemedicine and E-Health. 2021;27(8):835–842. doi: 10.1089/tmj.2021.0028

[3] Higa-McMillan C.K., Francis S.E., Rith-Najarian L., Chorpita B.F. Evidence-Based Update: 50 Years of Research on Treatment for Child and Adolescent Anxiety. Journal of Clinical Child & Adolescent Psychology. 2016;45(2):91–113. doi: 10.1080/15374416.2015.1046177

12 Full-Time employees; 30 Part-Time employees (all are healthcare providers - doctors, therapists, pharmacists, etc.)  & 8 Contract workers (Total: 50)

The design thinking phase for the REJUVENATE program was conducted between Mar 2023 - Dec 2023 

We have been working on this specific program (product/service) since Jan 2013 (18 months)

As an impact organization, doctHERs nurse-assisted telemedicine model has been operational since 2017 (7 years) 

As part of its core mission doctHERs (as its brand name implies), an inclusive, gender-equal, healthtech company, reintegrates Women Healthcare Providers (HCPs such as doctors, therapists, nutritionists, etc.)  into the health workforce.  These women are excluded from the workforce due to the following reasons: (i) rigid health systems that have not adapted to the workforce 2.0 needs of contemporary women, (ii) hostile work environments where they may feel excluded and (iii) sociocultural barriers that discourage the visible, public participation of women in the workforce. 

doctHERs proactively recruits these Women Healthcare Providers (HCPs) and builds their capacity through a multitude of Continuing Medical Education (CME) & Continuing Professional Education (CPE) programs. These women HCPs also receive training on telemedicine and epidemiological data analysis (e.g. SPSS). HCPs are invited to practice 'phygitally' (Physical + Digital) or digital alone, based on the HCPs preference. doctHERs' HCPs come from all major ethnic groups, faiths and socioeconomic levels. 

By design, sixty (60%) of our board, fifty (50%) of our senior management team and eighty (80%) of our workforce are women. 3 out of 12 (25%) full-time employees have special needs and/or disabilities.

Financial Model: For every dollar that doctHERs generates from enrolment in its monthly subscription model earned income, ~40% is allocated to the primary healthcare provider (PCP, therapist, etc.), ~15% is allocated to the frontline health worker (nurse or paramedic), and 20% covers doctHERs’ operating expenses, yielding a net income surplus of ~15% which is re-invested to amplify doctHERs’ impact.   

Value Proposition (VP): the VP of the REJUVENATE program is that it:

[1] Time-efficient, cost-effective access to treating physicians/specialists, therapists, etc. using nurse-assisted technology (digital healthcare)

[2]  Leverages technology (telemedicine) while retaining the empathetic human touch of the frontline health worker (a nurse or paramedic)

[3] Decreases child absenteeism from school and parent/caregiver absenteeism from their workplace

[4] Enables a higher % of children with ITP to achieve adequate platelet levels (indicating effective management of their rare, autoimmune disease)

[5] Reduces the feelings of exclusion that children with ITP feel when they are with their peer group 

[6] Enhances the mental health and well-being of both the child (with ITP) and their parent(s)/caregiver(s)

A Cost-Benefit Analysis: a cost-benefit analysis of the REJUVENATE program in South Asia indicates an annual Cost/Impact of $240/20% relative reduction in the prevalence of mood disorders in children under 18 = $1200 per child impacted (where Impact is measured by the change in prevalence of mood disorders in children following 24 weeks of telepsychology - therapy).

 For the US pilot, we forecast an annual cost/impact of $3000 per child (with ITP).

doctHERs’ monthly subscription model has been operating in South Asia for the past 5 years and currently services over 75,000 annual subscribers (via its digital health & wellbeing plan).

 In the US context, market pricing ($49/family/month) will be kept low to enable low-income/underserved families to enroll in the REJUVENATE program.

doctHERs has worked out a US capitation model where it will be cash-flow positive and sustainable by month 24 of its US launch. US-based earned income from the monthly subscriptions will enable doctHERs to sustain and scale its non-profit inclusive business model in the US, i.e. doctHERs should be grant and donor-independent from January 2027 onwards. Any grants doctHERs receives after this date will be channelled towards R&D (program iteration) or to co-finance a Patient Assistance Program for those patients who are unable to afford the monthly subscription fee