protocolSection identificationModule nctId: NCT06292130, orgStudyIdInfo id: 156588-01, briefTitle: Health-Kit Enabled Mobile App for Tobacco Cessation, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-21, primaryCompletionDateStruct date: 2023-09-21, completionDateStruct date: 2023-09-21, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Pro-Change Behavior Systems, class: OTHER, descriptionModule briefSummary: Tobacco use remains the leading preventable cause of death in the US, contributing to more than 480,000 premature deaths each year. The Tobacco Treatment Guidelines underscore the need to offer patients who use tobacco products brief interventions that include prescriptions for proven pharmacological smoking cessation aids and proactive connections to evidence-based behavioral support. The rapid expansion of smart phone capabilities enhances the potential for tobacco cessation apps to personalize behavior change guidance and to send contextually relevant tailored behavior change nudges based on readiness to quit and electronic heath record (EHR) data. Rich data from EHRs are now available to third-party apps from the Health app (iOS) via Fast Healthcare Interoperability Resources standard Application Programming Interface (API).This Phase I SBIR will explore the acceptability and effects of one such innovative health IT solution. Refresh is a highly individualized tobacco cessation HealthKit enabled app that will 1) implement a full range of best practices in tailored health behavior change communications based on readiness to change; 2) individualize behavior change guidance based on Health app data; and 3) concisely provide data and documentation of key actionable insights in the EHR on the patient's smoking status, app usage, and brief micro-message clinicians can deliver to reinforce and accelerate a patient's behavior change progress. This interoperability will provide value to both patients and clinicians; empower and support successful and lasting behavior change; and enable the implementation and evaluation of a best-in-class approach to tobacco and nicotine treatment.Extensive end user and stakeholder input will ensure refresh is designed for rapid dissemination. Patients of an integrated delivery system with an upcoming appointment (n=100) will be recruited to participate in a 30-day pilot test. Pilot participants will provide quantitative and qualitative data, and utilization and acceptability data will be examined. Pre-post comparisons of PROMIS measure for tobacco (psychosocial expectancies) will provide preliminary data on the effects of the program. Acceptability data from participating clinicians (n=10) who receive and deliver EHR prompts will also be gathered. The hypothesis is that the patients who utilize refresh will have significantly higher psychosocial expectancies regarding tobacco at follow-up. Secondary outcomes will be examined., conditionsModule conditions: Cigarette Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group, repeated measures (2 timepoints), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 51, type: ACTUAL, armsInterventionsModule interventions name: refresh, outcomesModule primaryOutcomes measure: Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome, secondaryOutcomes measure: Confidence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pro-Change Behavior Systems, Inc, city: South Kingstown, state: Rhode Island, zip: 02879, country: United States, geoPoint lat: 41.44718, lon: -71.52494, hasResults: False