Take A Break - Rural

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05790486
Status
Recruiting
Apply to this trial

Conditions

  • Smoking
  • Smoking Behaviors
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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
    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
    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.

Study Details

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.

Key Dates

Start date
Jul 11, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: The Intervention: 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.
  • Active Comparator: The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break
    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.
  • Experimental: The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program
    The Enhanced Program will include strategies described in the Standard Program plus training of local champions.
  • Active Comparator: The Standard Program: Community Paramedicine Standard Implementation Program
    The standard program will include training, resources, and access to the e-refer tool.

Primary Outcome Measure

Number of participants engaged [ Time Frame: Monthly from initial training to end of referral period year 1 to year 4 longitudinally ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Anna M Thorpe
[email protected]
336-716-3028
Thomas K Houston, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Wake Forest University Health Sciences· Winston-Salem, NC

Related Studies