Clinical trial NCT06292130: Health-Kit Enabled Mobile App for Tobacco Cessation
Official title: FHIR-ed Up for Tobacco Cessation: Health-Kit Enabled Mobile App for Tobacco Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: smoking
app
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-03-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, repeated measures (2 timepoints)
Primary purpose: TREATMENT

Brief summary: Tobacco use is 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 Small Business Innovation Research (SBIR) explored the effects of one such innovative health IT solution. refresh is a highly individualized tobacco cessation HealthKit enabled app that 1) implemented a full range of best practices in tailored health behavior change communications based on readiness to change; 2) provided individualized behavior change guidance based on Health app data; and 3) concisely provided data and documentation of key actionable insights in the EHR on the patient's smoking status, app usage, and brief micro-message delivered by clinicians to reinforce and accelerate a patient's behavior change progress. This interoperability provided value to both patients and clinicians; empowered and supported successful and lasting behavior change; and enabled the implementation and evaluation of a best-in-class approach to tobacco and nicotine treatment.

Extensive end user and stakeholder input ensured that refresh was designed for rapid dissemination. Patients of an integrated delivery system with an upcoming appointment (n=51) were recruited to participate in a 30-day pilot test. Pre-post comparisons of Patient-Reported Outcomes Measurement Information System (PROMIS) measure for tobacco (psychosocial expectancies) and confidence for quitting provided preliminary data on the effects of the program. The hypothesis was that the patients who utilize refresh will have significantly higher psychosocial expectancies regarding tobacco at follow-up and greater confidence to quit smoking.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Current cigarette smoker
* Having an iPhone 6s or higher
* Willing and able to download a mobile app
* Able to read and speak English
* Having an upcoming appointment with a participating clinician in the next 42 days

Exclusion Criteria:

* Younger than 18
* Non-smoker
* Unable to read and speak English
* Not having an iPhone 6s or higher
* Not having an appointment with a participating clinician in the next 42 days

Primary outcomes:
measure: Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome
timeFrame: Pretest (baseline) and Posttest (30 day follow-up)
Secondary outcomes:
measure: Confidence
timeFrame: Pretest (baseline) and Posttest (30 day follow-up)
Other outcomes:
Locations:
city: South Kingstown
country: United States
facility: Pro-Change Behavior Systems, Inc
state: Rhode Island
Study officials:
affiliation: Pro-Change Behavior Systems, Inc.
name: Sara Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: