7. Project Summary/Abstract
We will conduct a multi-level “hybrid type 2” study (i.e.: implementation and effectiveness outcomes) to test
1) a novel implementation program in rural counties and 2) a mHealth (mobile health)-assisted brief abstinence
experience (Take a Break, TAB) for rural adults who smoke and are not-yet-ready to quit. In our network of rural
counties, the implementation trial will use a novel, multi-strategy implementation program centered on county
employees engaged in ‘community paramedicine.’ Emergency Medical Services personnel (EMS) are evolving
into this more expansive role (e.g.: non-emergent healthcare delivery, monitoring of chronic disease, and
preventive medicine). To test the implementation, we will randomize rural counties with EMS serving
geographically complex and ethnically varied areas (the mountainous region of Appalachia and plains of eastern
North Carolina). These counties have some of the highest smoking rates in the U.S. We will compare a well-
tested (standard) implementation program versus a novel enhanced program. The standard program uses
evidence-based external facilitation – providing training and technical support to EMS services to support the
integration of enhanced tobacco control practices (including recommending and referring people who smoke and
not-yet-ready-to-quit to the mHealth-assisted population health intervention. The novel enhanced
implementation program will include the standard program an EMS Champion program. EMS who currently
smoke will be offered participation in TAB themselves. Those who participate, Champions, will then use their
TAB experience to support implementation as internal facilitators. They will encourage other EMS to experience
TAB, longitudinally encourage use of the tobacco control practices in routine workflow for all EMS, and will be
able to use their personal experience with TAB to engage in a richer dialog with patients who smoke. Using these
strategies, we seek to engage individuals living in harder-to-reach rural areas with less access to clinical services.
Engaging these individuals is possible with brief, low intensity, palatable interventions that target self-efficacy
and facilitate skills building to support future abstinence. The TAB intervention addresses the challenge of
engaging lower motivated individuals using a novel format, a brief abstinence game, supported using mHealth
and building upon 10 years of research. We recently published the first TAB effectiveness trial in JAMA Internal
Medicine. This preliminary data supports the current application and does not include a large number of
individuals living in rural areas. In this project, we will randomize to TAB versus an active comparison designed
to isolate the effect of TAB and balance the participant contact across the two groups. In addition to evaluating
implementation success and effectiveness outcomes, we will study pathways to cessation. To inform
sustainment and dissemination, we will collect data on implementation fidelity, county-level adaptations,
variations in referrals, and patient-level engagement across the counties, and at the EMS and patient-level. To
evaluate budget impact, we will track the cost of the implementation strategies and the intervention.
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