SBIR-STTR Award

FHIR-ed Up for Tobacco Cessation
Award last edited on: 4/30/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$378,553
Award Phase
1
Solicitation Topic Code
838
Principal Investigator
Sara S Johnson

Company Information

Pro-Change Behavior Systems Inc

1174 Kingstown Road Unit 101
South Kingston, RI 02879
   (401) 360-2980
   info@prochange.com
   www.prochange.com
Location: Single
Congr. District: 02
County: Washington

Phase I

Contract Number: 1R43HL156588-01A1
Start Date: 5/1/2021    Completed: 4/30/2022
Phase I year
2021
Phase I Amount
$378,553
Tobacco use remains the leading preventable cause of death in the US, contributing to more than 480,000premature deaths each year. The well-established Tobacco Treatment Guidelines and recently releasedAmerican College of Cardiology Expert Consensus Decision Pathway for tobacco cessation treatmentunderscore the need to conceptualize tobacco use as a chronic substance use disorder and to offer any patientswho use tobacco products brief interventions that include prescriptions for proven pharmacological smokingcessation aids and proactive connections to evidence-based behavioral support. The rapid expansion of smartphone capabilities enhances the potential for tobacco cessation apps to personalize behavior change guidanceand to send contextually relevant tailored behavior change nudges based not just on readiness to quit, but alsobased on electronic heath record (EHR) data. Rich data from EHRs are now available to third-party apps fromthe Health app (iOS) via Fast Healthcare Interoperability Resources (FHIR) standard ApplicationProgramming Interface (API). The proposed research represents an innovative approach in that it will developand examine the feasibility, acceptability, and preliminary effects of FHIR-ed Up- a theoretically-grounded,highly individualized tobacco cessation Health-Kit enabled app. Unlike existing tobacco cessation apps, FHIR-ed Up will: 1) implement a full range of best practices in tailored health behavior change communications; 2)individualize messaging based on Health app data and behavior change constructs; and 3) provide data andkey insights back to electronic health records via HL7 transmissions from the server-portion of the FHIR-edUp app. Developed in collaboration with interoperability and app development experts, FHIR-ed Up willachieve sustained use by hyper-personalizing the user experience for patients and integrating actionableinsights seamlessly into the clinical workflow of their clinicians. Extensive end user and stakeholder input willensure FHIR-ed Up is designed for rapid dissemination. Potential end users (n=8 tobacco users aged 18 andolder) will be recruited via community and social media ads. Formative qualitative data will be combined withinput from four experts and five clinician stakeholders to develop a prototype of FHIR-ed Up. Iterativeusability testing (n=10) will allow the prototype to be refined before patients of an integrated delivery systemwith an upcoming appointment (n=100) are recruited to participate in a 30-day pilot test. Pilot participantswill provide quantitative and qualitative data, and utilization and acceptability data will be examined. Pre-postcomparisons of psychosocial expectancies for smoking will provide preliminary data on the effects of theprogram. Acceptability data from participating clinicians (n=5) who receive and deliver EHR prompts will alsobe gathered. The results will inform program modifications needed to proceed with the Phase II effectivenesstrial. Phase II will provide the impetus for commercialization of a cost-effective, evidence-based, interoperableapp that has the potential to address tobacco use on a population basis.

Public Health Relevance Statement:
Relevance: Effective tailored mobile applications for tobacco cessation that integrate seamlessly into patients' medical records are critical because smoking is a leading preventable cause of death and disability in the US, taking the lives of 480,000 Americans each year and contributing costs exceeding $300 billion annually. The proposed study will develop and test FHIR-ed Up, a mobile app that 1) provides truly individualized behavior change guidance to end users based on their tobacco use behaviors and pertinent medical data captured from their electronic health record (EHR); and 2) pushes actionable insights back to the patient's EHR for delivery by the clinician, who can play a key role in the patient's behavior change journey. FHIR-ed Up will take advantage of key advancements in the secure transmission of data to further tailor behavior change guidance and to create an interoperable and integrated experience that connects patients and providers in the battle against tobacco.

Project Terms:
Adult ; 21+ years old ; Adult Human ; adulthood ; Appointment ; Back ; Dorsum ; Behavior ; Biometry ; Biometrics ; Biostatistics ; Blood Pressure ; Cardiology ; Cause of Death ; Centers for Disease Control and Prevention (U.S.) ; CDC ; Centers for Disease Control ; Centers for Disease Control and Prevention ; United States Centers for Disease Control ; United States Centers for Disease Control and Prevention ; Communication ; Communities ; Cessation of life ; Death ; Goals ; Health ; Healthcare Systems ; Health Care Systems ; indexing ; Medicine ; Methods ; Occupations ; Jobs ; Professional Positions ; Patient Outcomes Assessments ; Patient Reported Measures ; Patient Reported Outcomes ; Patients ; Pharmacology ; Pilot Projects ; pilot study ; Play ; Recommendation ; Research ; Science ; Smoke ; Smoking ; Substance Use Disorder ; Surveys ; Survey Instrument ; Testing ; Time ; Tobacco ; Translating ; Friends ; smoking cessation ; cease smoking ; quit smoking ; stop smoking ; base ; Chronic ; Clinical ; premature ; prematurity ; Phase ; Medical ; Ensure ; disability ; insight ; Medical History ; Personal Medical History ; Personal Medical History Epidemiology ; Collaborations ; Integrated Delivery Systems ; Smoker ; Nature ; Consensus ; programs ; Techniques ; psychosocial ; behavior change ; Tobacco Consumption ; tobacco product use ; Tobacco use ; collegiate ; college ; American ; experience ; success ; Tobacco Cessation ; Tobacco Use Cessation ; Cigarette ; Participant ; brief therapy ; brief treatment ; brief intervention ; Documentation ; Cell Phone ; Cellular Telephone ; iPhone ; smart phone ; smartphone ; Cellular Phone ; Provider ; Preparedness ; Readiness ; Address ; Health system ; Evidence based practice ; Data ; Enrollment ; enroll ; transmission process ; Transmission ; Modification ; Development ; developmental ; electronic data ; Electronic Health Record ; electronic health care record ; electronic healthcare record ; Behavioral ; Pathway interactions ; pathway ; effectiveness trial ; cost ; design ; designing ; cost effective ; Expectancy ; Population ; aged ; innovation ; innovate ; innovative ; Health behavior change ; health application ; interoperability ; usability ; prototype ; commercialization ; clinical care ; evidence base ; data exchange ; data transfer ; data transmission ; Secure ; Healthy People 2020 ; mobile application ; mobile app ; mobile device application ; health data ; application programming interface ; application program interface ; social media ; data access ; Electronic Nicotine Delivery Systems ; Electronic Nicotine Delivery Product ; electronic nicotine delivery device ; electronic nicotine distribution system ; recruit ; smartphone Application ; Android App ; Android Application ; Cell Phone Application ; Cell phone App ; Cellular Phone App ; Cellular Phone Application ; Smart Phone App ; Smart Phone Application ; Smartphone App ; iOS app ; iOS application ; iPhone App ; iPhone Application ; tobacco user ; combustible cigarette ; conventional cigarette ; traditional cigarette ; tobacco cessation intervention ; tobacco cessation treatment ; treatment guidelines ; tobacco products ; Fast Healthcare Interoperability Resources ; FHIR ; patient health information ; patient health record ; patient medical record ; acceptability and feasibility ; Data Store ;

Phase II

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