Improving Infant Outcomes with a New Level of Care: NASCEND Seeks to Transform the Care and Medical Outcomes of Opioid-Exposed Infants with Its Innovative Clinical Solution, and Certification Program

As one of the most significant medical and social problems in the U.S., the numbers on neonatal abstinence syndrome (NAS) are sobering with 6.6% of women reporting prescription opiate use in pregnancy of which 1 in 5 reports Opioid Use Disorder (OUD), according to the Centers for Disease Control and Prevention (CDC), and 1 infant is born every 19 minutes with NAS.²

Making matters worse is the societal stigma commonly associated with addiction.

One forward-thinking company, NASCEND, is seeking to transform the quality of care and medical outcomes of opioid-exposed infants (OEI) and their families affected by maternal substance use disorder (SUD)

Toward that end, NASCEND, (https://nascend.com/ ), an innovative clinical solution, education, and certification company enhanced by technology, has developed a new Continuum of Care from pregnancy to pediatrics for OEI and has already trained thousands of healthcare providers in more than 35 states.

The company's nationwide training has so far impacted the lives of more than 1.6 million infants and their families.

Founded by a neonatologist, and based in Louisville, KY, NASCEND is a Certified B-Corporation featuring a team of highly experienced professionals dedicated to changing the experience of NAS.

"Addiction is a devastating disease changing the face of our society, depleting our limited healthcare resources, and forever altering the potential of generations of children," said K. Dawn Forbes, MD, founder and CEO of NASCEND. "The time to act is now to change the trajectory of this disease. Through innovation, education, certification, and technology we will inspire and equip healthcare communities to follow new paths that decrease the impact of drug abuse, improve outcomes for families, and restore the potential for every affected child. It's all about helping babies and families for us..."

In addition, the daunting scope of the problem includes:

• 7% of pregnancies are affected by opioid use.¹

• The average hospital cost for a newborn with NAS is eight times higher than for an infant without the NAS diagnosis.⁶

• The total cost of care for infants with NAS is more than half a billion dollars each year ($572.7M) ²²

• State Medicaid programs cover the cost for 60% of pregnant women with substance use and 80% of opioid-exposed infants.^7-9

• The average length of stay for a newborn with NAS was nearly six times longer when compared to infants without NAS.⁹

• The national incidence of NAS in 2018 was between 6.8 to 7.1 infants per 1000 births.^3,20 In rural areas, the incidence of NAS was disproportionately higher with up to 56 infants for 1,000 births in areas such as West Virginia.²¹

Dr. Forbes added that pregnancy is a motivator for change, and with support, it can be a pivotal point for women to seek treatment for substance use disorder.

"Opioid use in pregnancy can lead to fetal growth restriction, low birth weight, and prematurity. It can also result in newborn withdrawal with a constellation of neurological, gastrointestinal, respiratory, and autonomic symptoms. These symptoms can impact an infant's nutrition and growth, prolong newborn hospital stay, and increase healthcare costs," said Dr. Forbes.

Along with the societal shame that comes with addiction there are common misconceptions involved in the treatment for SUD and NAS.

"Newborns are NOT addicts. They are NOT addicted. When infants are exposed to opioids in utero, they can develop a dependency. After birth, when exposure stops, they are at risk of going through a self-limited withdrawal which can be treated with comfort measures and, as needed, opiate medication," explained Dr. Forbes.

She added, "substance use disorder or addiction is a disease, not a weakness or a human failing.

SUD is a disease with a significant genetic predisposition that affects the brain, specifically the dopamine reward system (DRS). Once the DRS is affected, because of the importance of dopamine in our daily functioning, one can experience alterations in motivation, memory, movement, joy, perception, impulse control, judgment, and even parenting and infant bonding."

Dr. Forbes describes NASCEND as unique in their healthcare space.

"There are others who provide limited education; online, recorded, self-directed modules, or a manual assessment approach," she said. "NASCEND is the only company/organization offering a comprehensive third-party certification for hospitals and providers that is supported by the only app-based music program for providers and parents (NASCEND Lullaby), and the only app-based assessment and treatment tool for infants (AssessPro). All delivery hospitals will benefit from our training and certification. We want to initially target hospitals with Level 1 and Level 2 NICUs/Nurseries in rural areas. This is where we feel we can make the greatest initial impact."

The top benefits of NASCEND's NAS/NOWS Certification Program (NNCP) which incorporates the Continuum of Care include:

• LESS TIME IN THE HOSPITAL -- The length of stay for infants requiring medication treatment was decreased from 45 to 12 days due to a significant reduction in the length of treatment from 39 to 7 days.

• REDUCED TREATMENT -- Better assessment with their AssessPro App and focusing on comfort first led to a 39% reduction in the number of infants requiring opiate medication.

• SAVES MONEY -- NASCEND's Continuum of Care significantly reduces the cost of care for substance-exposed infants. Decreasing the number of infants admitted to the NICU and the length of hospital stay for those treated resulted in a per-patient savings of nearly $40,000 - a 74% reduction in the cost of patient care ($52.3K to $13.6K).

• TRAINING HEALTH PROVIDERS EVERYWHERE - So far, NASCEND has trained more than 7,000 Healthcare Providers.

Additional benefits include:

• Standardized care
• Better family engagement
• Improved maternal education and transparency
• Optimized infant nutrition and growth
• Decreased stigma and bias among healthcare providers
• Improved nursing satisfaction, education, and resources

The idea for founding NASCEND came out of the experience of Dr. Forbes and her colleagues treating opioid-exposed infants within their practice. In 2010, they saw a four-fold increase in cases, illustrating the shortcomings in care for this population, which included a lack of standardized care guidelines, outdated and ineffective infant assessment tools, poor parental engagement, insufficient nutrition guidelines, and a lack of transparency for families.

"All of these issues resulted in infant overtreatment, long hospital stays, excessive healthcare costs, inconsistent maternal prenatal and addiction education, lack of family transparency, and significant bias and stigma within healthcare and communities," said Dr. Forbes.

Assigned the task of finding a solution to this complex problem, and given the incentive of partnership if she was successful, Dr. Forbes and her colleagues spent the next three years filling in the gaps within the care of both pregnant women with SUD and their infants from pregnancy to pediatrics. They developed a comprehensive Continuum of Care that focused on comfort over pharmacology, decreasing pharmacological treatment and NICU admission by 39%, the length of infant treatment by 82%, and the cost of care for OEI by $40K per infant. They had improved system transparency, maternal compliance, family engagement, and provider satisfaction.

"Along the way, I realized that these deficiencies in maternal and infant care were a national problem, and we had developed a multidisciplinary, comprehensive, scalable, and innovative solution that could improve outcomes and realign care with cost savings in any NICU and even provide new NICU revenue for some," she said.

After spending an additional three years working within the system and providing education via hundreds of speaking events, Dr. Forbes and several of her colleagues created the vision for NASCEND and launched the company in 2016. NASCEND achieved B-Corp Certification in 2019 and most recently became Canopy Certified in Kentucky in 2022

"NASCEND is a new kind of business that balances purpose and profit. We consistently consider the impact of our decisions on our workers, customers, suppliers, community, and the environment. We are part of a community of leaders, driving a global movement of people using business as a force for good," stressed Dr. Forbes.

NASCEND milestones in 2022:

• Partnered with a major Eastern Kentucky healthcare system in the application for KY Opioid Abatement funds for full system certification of their five delivery hospitals.

• Received a $77K TRAINS grant in partnership with Appalachian Regional Healthcare (same system as above).

• In the past six months (after being sidelined by the pandemic), they have held multiple events in 12 states with more than 600 providers trained, impacting more than 4,500 babies in the 12 months to follow.

• Celebrated three years as certified B-Corp.

• Established business from an LLC to a PBC, a public benefit corporation.

• Received Kentucky's Business for Good Canopy Certification.

• The 18-month post-certification with the company's first healthcare system had better than predicted outcomes. NNCP with the AssessPro app resulted in significant improvement in care including a 74% reduction in the need to treat, and a 37% reduction in the length of treatment when needed. Also, 18 months post certification - only 5 of the 45 infants with opioid exposure, who were evaluated utilizing AssessPro, required pharmacological treatment. This yielded an 11% treatment rate compared to the national treatment rate of 55-60%.

"NASCEND's vision is for the NNCP to be the standard of care for OEI nationally," she said.

Dr. Forbes added that NASCEND's upcoming goals for 2023 include:

• Partner with healthcare systems and community-based recovery systems to improve care for OEI and pregnant and early-parenting women with SUD.

• Join with managed care organizations to make funding available for underserved/underfunded/highest impacted healthcare systems to receive training free or for a reduced cost. Also, to align care with revenue by incentivizing systems to improve outcomes via better reimbursement rates.

• Partner with health care systems to seek funding from opioid abatement settlements nationally for NNCP.

• Complete FDA review and initiate national validation/scalability study for AssessPro.

• Launch version two of the music app, NASCEND Lullaby, which will engage parents in the care of their infants, improving infant feeding, sleep, and consolability. LULLABY will feature real-time karaoke, and the ability to record your song and create your own original lullaby.

• Launch a web-based version of AssessPro for improved access, usability, and scalability.

• Launch CareOEI, a non-profit for the improved outcomes and care of Opioid Exposed Infants, which received 501c3 status in 2022

NASCEND is planning to launch a StartEngine campaign later this month, and will be looking for investors for second-round funding to support the 2023 goals and the growth of the company.

AssessPro is currently an iOS app that is not integrated with a hospital EMR (electronic medical record). The company's version two, which is 80% complete and will launch in early 2023, is web-based with increased function, offering convenience and communication with hospital EMR without integration. Version three of the app will include FHIR integration with EPIC, one of the most commonly used EMRs in the U.S.

Dr. Forbes said AssessPro is currently undergoing FDA review and upon completion, they will launch a large-scale, multi-site, prospective validation study.

NASCEND Music is the company's first-generation music player, designed to improve infant sleep, comfort, and feeding through the use of AAP-recommended lullaby music. NASCEND Lullaby is the company's second-generation music app that will launch in the first quarter of 2023 that offers increased features for users and better support for infant feeding, sleep, and consolability. NASCEND is looking for partners to distribute LULLABY nationally.