Take A Break - Rural

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.

Conditions

• Smoking
• Smoking Behaviors
• Smoking Cessation

Interventions

BEHAVIORAL

Take 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.

BEHAVIORAL

The Comparison

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

OTHER

Community 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.

OTHER

Community 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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Massachusetts, Worcester

  collaborator OTHER

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Thomas K Houston, MD, MPH · Wake Forest University Health Sciences

• Rajani Sadasivam, PhD · UMass Chan Medical School

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-11

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations