Clinical trial NCT05790486: Take A Break - Rural
Official title: Using Rural Community Paramedicine to Engage Lower-Motivated Smokers: Spreading an Effective mHealth-Assisted Intervention to Motivate Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Smoking Behaviors
Smoking Cessation
Keywords: smoking rates
public health tobacco control services
smoking cessation service
Rural Health
Implementation Science
Community Paramedicine
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Massachusetts, Worcester
First posted: 2023-03-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study team proposes a multi-level trial to test 1) novel implementation programs in rural counties designed to increase access to 2) recent advances in tobacco control services for people who are not-yet-ready-to-quit smoking. In this field, most trials have focused only on those already ready-to-quit. Thus, the proposed trial addresses an important knowledge gap critical to advance tobacco control in rural areas.

Detailed description: The study team 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 the 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, the study team 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. The team 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, the team seeks 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. The team recently published the first TAB effectiveness trial in Journal of American Medical Association 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, the team 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, the team will study pathways to cessation. To inform sustainment and dissemination, the team 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, the team will track the cost of the implementation strategies and the intervention

Eligibility criteria: Inclusion Criteria:

* Current Smoker
* at least 18 years old
* speaks English
* Able to receive texts and read text (literate)
* Have a text-enabled phone or receive one from the study team
* Not yet ready to quit smoking

Exclusion Criteria:

* actively quitting smoking
* preparing to quit smoking within 30 days
* prisoners
* FDA- defined NRT contraindications
* unable or unwilling to provide informed consent

Primary outcomes:
measure: Number of participants engaged
timeFrame: Monthly from initial training to end of referral period year 1 to year 4 longitudinally
measure: Follow-up smoking cessation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas K Houston, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Chan Medical School
name: Rajani Sadasivam, PhD
role: PRINCIPAL_INVESTIGATOR
References: