SBIR-STTR Award

Implementation of support tools to promote safety in the prescribing of oral contraceptives
Award last edited on: 2/14/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$268,754
Award Phase
1
Solicitation Topic Code
865
Principal Investigator
Mary Kucek

Company Information

Ovaryit LLC

519 E Call Street
Tallahassee, FL 32301
   (850) 570-7920
   N/A
   www.ovaryit.com
Location: Single
Congr. District: 02
County: Leon

Phase I

Contract Number: 1R43HD110346-01
Start Date: 9/5/2022    Completed: 8/31/2023
Phase I year
2022
Phase I Amount
$214,719
Nearly half of the pregnancies in the United States are unintended despite the discovery of the first combination hormonal contraceptive in the 1960s. Hormonal contraceptives are an efficacious and cost-effective strategy to decrease the rate of unintended pregnancy. Lack of access to contraceptive services, especially for adolescents, minority women, and women of lower socioeconomic status creates significant health and financial inequities and leads to significant US government expenditures. Pharmacist-prescribed contraceptive services have the potential to increase access to care, decreasing the number of unintended pregnancies in the US. Pharmacists have expressed interest in providing contraceptive services but have cited several barriers that currently serve to hinder their expansion. For the widespread growth of pharmacist-prescribed contraceptive services, an implementation package is needed that addresses the barriers that currently exist. A contraceptive-specific Electronic Health Record system that increases efficiency, incorporates point-of-care tools, and is affordable will be the foundation of a successful implementation package. OvaryIt, a Florida-based small business, has developed a proprietary HIPAA-compliant contraceptive-specific platform for the provision of direct-to-consumer telehealth services. We propose to adapt this platform to serve as the foundation of a comprehensive implementation package to expand in-person pharmacist-prescribed contraceptive services. Phase I will support studies to investigate the feasibility and establish a proof-of-concept of such a solution. Aim 1: Conduct a needs assessment to determine operational requirements. This will result in project documentation and the roadmap needed to integrate contraceptive functionality within existing Pharmacy Management Systems. Aim 2: Completion of a study of 20 pharmacist end-users comparing the OvaryIt platform to the current standard paper charting process. Each pharmacist will complete two standardized contraceptive patient encounters, one utilizing each process. Outcomes will include time to completion of the encounter, compliance with the USMEC guidelines, appropriate prescription selection, and quantitative survey data. Aim 3: Conduct a focus group with pharmacist end-users and administrative stakeholders to discuss the perceived strength and quality of the proposed project solutions for each of the identified barriers or pain points to implementation success. At the end of Phase I, OvaryIt, LLC will have a roadmap for a comprehensive implementation package with vetted solutions for the many barriers that currently prevent the adoption of pharmacist-prescribed contraceptive services. Phase II efforts will allow for the creation of a comprehensive implementation package ready for widespread commercialization to independent, large chain, and health system-based pharmacies. A tremendous market opportunity exists for OvaryIt, LLC and participating pharmacies to create new revenue opportunities while significantly expanding access to contraceptives in the US.

Public Health Relevance Statement:
Narrative Pharmacist-prescribed contraceptive services have the potential to lower the rate of unplanned pregnancy in the US, however several barriers must be addressed to incentivize widespread adoption. OvaryIt, LLC has created a proprietary contraceptive-specific Electronic Health Records system with point-of-care clinical decision support tools and safety features that can be adapted to pharmacist end-users and serve as part of a comprehensive implementation package to address the current barriers and expedite the adoption and availability of pharmacist-prescribed contraceptive services.

Project Terms:
Adoption; Affect; Birth Intervals; Birth Spacing; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Contraceptive Agents; Contraceptives; Oral Contraceptives; birth control pill; Counseling; District of Columbia; D.C. Washington; DC Washington; Economics; Education; Educational aspects; Expenditure; Family; Florida; Focus Groups; Foundations; Government; Growth; Generalized Growth; Tissue Growth; ontogeny; Health; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Health Services Accessibility; Access to Care; access to health services; access to services; access to treatment; accessibility to health services; availability of services; care access; health service access; health services availability; service availability; treatment access; Incentives; Leadership; Maternal Mortality; maternal death; Medicaid; Medicine; Mental Health; Mental Hygiene; Psychological Health; Mothers; Persons; Painful; Pain; Paper; Patients; Pharmacies; Pharmacy facility; Pharmacists; Gestation; Pregnancy; Privatization; QOL; Quality of life; Risk; Safety; Societies; Standardization; Survey Instrument; Surveys; Medical Technology; Time; Transportation; United States; Woman; Gender; Businesses; Health Benefit; Caring; Guidelines; base; Clinical; Phase; Medical; Training; Policies; Reproductive Health; tool; System; physical health; physical conditioning; interest; Services; Needs Assessment; empowered; success; HIPAA; Kennedy Kassebaum Act; PL 104-191; PL104-191; Public Law 104-191; United States Health Insurance Portability and Accountability Act; Health Insurance Portability and Accountability Act; payment; social; Documentation; preventing; prevent; low SES; low socio-economic position; low socio-economic status; low socioeconomic position; low socioeconomic status; telehealth; Address; Health system; Data; Process; point of care; Electronic Health Record; electronic health care record; electronic healthcare record; hormonal contraception; hormonal contraceptive; unintended pregnancy; Unplanned pregnancy; cost; design; designing; Outcome; cost effective; commercialization; maternal morbidity; support tools; minority children; adolescent minority; minority youth; pediatric minority; young minority; health care availability; access to health care; access to healthcare; accessibility of health care; accessibility to health care; accessibility to healthcare; health care access; health care service access; health care service availability; healthcare access; healthcare accessibility; healthcare availability; healthcare service access; healthcare service availability; clinical decision support; Financial Hardship; financial burden; financial distress; financial strain; financial stress; Minority Women; Minority Female

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
$54,035