SBIR/STTR Research Award

A patient self-assessment software combining compliance protocols to improve prescriber confidence, reduce liability, and improve patient outcomes.

Award identifier 95145f9db5e897608b36adcdb18310e8f98e832376f78c473d66be4edfe3723cAwarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$1,656,458

Program and phase

SBIR · Phase II – Direct to Phase II

Award year

2020

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
Clarity, LLC
Proposal award date
2020-08-01
Contract end date
2022-07-31
UEI
P8LGKUV1MMK5
Solicitation number
DA19-019
Topic code
NIDA

Research abstract

PROJECT ABSTRACT The current overdose epidemic is being fueled by widespread, non-medical use of opioids prescribed by mostly well-meaning physicians with inadequate training on how to properly initiate, monitor and discontinue opioid therapy. Many patients being initiated on chronic opioid therapy have factors putting them at higher risk for substance misuse and possible future overdose, however the typical primary care visit for a new patient is too short for a thorough evaluation. This puts patients at risk by perpetuating a substandard level of care, and puts prescribers at risk by lacking substantiated documentation to support the legal standard “legitimate medical purpose”. Most current measures aimed at solving the opioid epidemic have not considered the biggest obstacle to appropriate patient care and good medicolegal documentation, which is time. To complicate the matter, many physicians are simply refusing to prescribe opioids for fear of criminal, civil or regulatory intervention. This is compounding the issue by inundating clinics that do prescribe opioids with new, unverified patients that are often almost out of medication or already in withdrawal. This common scenario is contributing to the steady rise of fentanyl and other synthetic opioid related overdose deaths by pushing patients with pain, dependence and addiction to seek help through illegal means. The Care Continuity Program (CCP), a product of Sure Med Compliance, is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. This tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance driven protocol developed by analyzing case law against physicians in mis-prescribing opioid cases. Results, in the form of a date and time stamped legal report, are instantly transmitted to the prescriber’s electronic health records, mitigating the prescriber’s civil and criminal risk. A brief of findings is displayed within the software through a dashboard and on the summary page of the report. This software offering includes a mobile and standard web-based application. The objective of the proposed research is to validate the protocols and delivery system of the CCP by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings, pre and post implementation of the CCP.PUBLIC HEALTH RELEVANCE STATEMENT Inadequate opioid prescribing protocols and insufficient chart documentation have led to low confidence in managing chronic opioid therapy patients and increased civil and criminal risk for prescribers. Already being used in 13 states and over 50 clinical settings, the Care Continuity Program (CCP) has demonstrated its ability to increase prescriber confidence, decrease prescriber liability, and improve patient outcomes by automating compliance protocols and providing substantial chart documentation.

Technology keywords

Not reported

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Agency intelligence

Department of Health and Human Services

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