Take A Break - Rural

Not Applicable

Recruiting

• Conditions: Smoking; Smoking Behaviors; Smoking Cessation
• Interventions: Other: Community Paramedicine Standard Plus Enhanced Implementation Program; Other: Community Paramedicine Standard Implementation Program; Behavioral: The Comparison; Behavioral: Take a Break plus Nicotine replacement therapy (NRT) Sampling

• Registration Number: NCT05790486
• Lead Sponsor: Wake Forest University Health Sciences

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

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-30
• Study Start: 2023-07-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program	Community Paramedicine Standard Plus Enhanced Implementation Program	The Enhanced Program will include strategies described in the Standard Program plus training of local champions.
The Standard Program: Community Paramedicine Standard Implementation Program	Community Paramedicine Standard Implementation Program	The standard program will include training, resources, and access to the e-refer tool.
The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break	The Comparison	Nicotine lozenges will be given to all participants in both randomized groups. The goal of the comparison group is to isolate the effect of the Take a Break experience.
The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling	Take a Break plus Nicotine replacement therapy (NRT) Sampling	Motivational text messages, challenge quizzes, goal-setting, coping mini-games, and recognition \& rewards. Nicotine lozenges will be given to all participants in both randomized groups.

Primary Outcome Measures

Name	Time	Method
Number of participants engaged	Monthly from initial training to end of referral period year 1 to year 4 longitudinally	Referral rate of participants by EMS personnel
Follow-up smoking cessation	6 months	Point prevalent cessation is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States