Take A Break - Rural

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Current Smoker

at least 18 years old

speaks English

Able to receive texts and read text (literate)

Disqualifiers

actively quitting smoking

preparing to quit smoking within 30 days

prisoners

FDA- defined NRT contraindications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Take a Break plus Nicotine replacement therapy (NRT) Sampling

    Behavioral

    Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At week 1 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and facilitate an abstinence goal.

  • The Comparison

    Behavioral

    The comparison group will receive Nicotine Replacement Therapy sampling and will be balanced in all variables except the Take a Break Intervention.

  • Community Paramedicine Standard Plus Enhanced Implementation Program

    Other intervention

    Counties randomized to the enhanced program will receive the standard implementation program plus the following enhancements. We will engage and train local implementation champions. The EMS Implementation Champion will go through the Take a Break Intervention but will not receive NRT sampling. The local implementation champions are internal facilitators with additional knowledge and experience related to the electronic referral process. The champions will also be leaders in their county by trying to improve referrals, remind EMS personnel, and distribute feedback on the performance of the county.

  • Community Paramedicine Standard Implementation Program

    Other intervention

    In counties randomized to the standard program, we will engage EMS leaders and train local personnel. The training will be applying the Ask-Advise-Refer model and the use of an eRefer tool in EMS situations and conditions. The EMS will then engage smokers in the field or community to use the Ask-Advise-Refer training to submit electronic referrals with the eRefer tool.

Treatment groups

800 Participants
are divided into 4 treatment groups
Group A: The Intervention: Take a Break plus Nicotine replacement therapy (NRT) SamplingExperimental treatment 1 intervention
Group B: The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a BreakActive comparator 1 intervention
Group C: The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation ProgramExperimental treatment 1 intervention
Group D: The Standard Program: Community Paramedicine Standard Implementation ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants engaged

Referral rate of participants by EMS personnel

Time frame
Monthly from initial training to end of referral period year 1 to year 4 longitudinally
2

Follow-up smoking cessation

Point prevalent cessation is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Wake Forest University Health Sciences

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Massachusetts, Worcester

Collaborator