RecruitingNot ApplicableNCT05790486

Take A Break - Rural

Using Rural Community Paramedicine to Engage Lower-Motivated Smokers: Spreading an Effective mHealth-Assisted Intervention to Motivate Cessation


Sponsor

Wake Forest University Health Sciences

Enrollment

800 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

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

Interventions

BEHAVIORALTake a Break plus Nicotine replacement therapy (NRT) Sampling

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.

BEHAVIORALThe Comparison

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

OTHERCommunity Paramedicine Standard Plus Enhanced Implementation Program

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.

OTHERCommunity Paramedicine Standard Implementation Program

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.


Locations(1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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NCT05790486


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