Take A Break - Rural
TABR
Using Rural Community Paramedicine to Engage Lower-Motivated Smokers: Spreading an Effective mHealth-Assisted Intervention to Motivate Cessation
2 other identifiers
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 11, 2026
February 1, 2026
3.4 years
March 8, 2023
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants engaged
Referral rate of participants by EMS personnel
Monthly from initial training to end of referral period year 1 to year 4 longitudinally
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.
6 months
Study Arms (4)
The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling
EXPERIMENTALMotivational text messages, challenge quizzes, goal-setting, coping mini-games, and recognition \& rewards. Nicotine lozenges will be given to all participants in both randomized groups.
The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break
ACTIVE COMPARATORNicotine 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 Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program
EXPERIMENTALThe Enhanced Program will include strategies described in the Standard Program plus training of local champions.
The Standard Program: Community Paramedicine Standard Implementation Program
ACTIVE COMPARATORThe standard program will include training, resources, and access to the e-refer tool.
Interventions
The comparison group will receive Nicotine Replacement Therapy sampling and will be balanced in all variables except the Take a Break 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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- actively quitting smoking
- preparing to quit smoking within 30 days
- prisoners
- FDA- defined NRT contraindications
- unable or unwilling to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- National Cancer Institute (NCI)collaborator
- University of Massachusetts, Worcestercollaborator
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas K Houston, MD, MPH
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Rajani Sadasivam, PhD
UMass Chan Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 30, 2023
Study Start
July 11, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share