SmokingTABRNCT05790486
Take A Break - Rural
A study testing Take a Break plus Nicotine replacement therapy (NRT) Sampling, The Comparison and Community Paramedicine Standard Plus Enhanced Implementation Program in people with Smoking and Smoking Behaviors, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Behaviors, Smoking Cessation
- What is being tested?
- Take a Break plus Nicotine replacement therapy (NRT) Sampling, The Comparison and Community Paramedicine Standard Plus Enhanced Implementation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- actively quitting smoking
- preparing to quit smoking within 30 days
- prisoners
- FDA- defined NRT contraindications
- unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Anna M Thorpe, 336-716-3028, Anna.Thorpe@advocatehealth.org
Thomas K Houston, MD, MPH
About this study
Official title: Using Rural Community Paramedicine to Engage Lower-Motivated Smokers: Spreading an Effective mHealth-Assisted Intervention to Motivate Cessation
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.
Read the detailed description
The study team will conduct a multi-level "hybrid type 2" study (i.e.: implementation and effectiveness outcomes) to test
- a novel implementation program in rural counties and 2) a mHealth (mobile health)-assisted brief abstinence experience (Take a Break, TAB) for rural adults who smoke and are not-yet-ready to quit. In the network of rural counties, the implementation trial will use a novel, multi-strategy implementation program centered on county employees engaged in 'community paramedicine.' Emergency Medical Services personnel (EMS) are evolving into this more expansive role (e.g.: non-emergent healthcare delivery, monitoring of chronic disease, and preventive medicine). To test the implementation, the study team will randomize rural counties with EMS serving geographically complex and ethnically varied areas (the mountainous region of Appalachia and plains of eastern North Carolina). These counties have some of the highest smoking rates in the U.S. The team will compare a well tested (standard) implementation program versus a novel enhanced program. The standard program uses evidence-based external facilitation - providing training and technical support to EMS services to support the integration of enhanced tobacco control practices (including recommending and referring people who smoke and not-yet-ready-to-quit to the mHealth-assisted population health intervention. The novel enhanced implementation program will include the standard program an EMS Champion program. EMS who currently smoke will be offered participation in TAB themselves. Those who participate, Champions, will then use their TAB experience to support implementation as internal facilitators. They will encourage other EMS to experience TAB, longitudinally encourage use of the tobacco control practices in routine workflow for all EMS, and will be able to use their personal experience with TAB to engage in a richer dialog with patients who smoke. Using these strategies, the team seeks to engage individuals living in harder-to-reach rural areas with less access to clinical services.
Engaging these individuals is possible with brief, low intensity, palatable interventions that target self-efficacy and facilitate skills building to support future abstinence. The TAB intervention addresses the challenge of engaging lower motivated individuals using a novel format, a brief abstinence game, supported using mHealth and building upon 10 years of research. The team recently published the first TAB effectiveness trial in Journal of American Medical Association Internal Medicine. This preliminary data supports the current application and does not include a large number of individuals living in rural areas. In this project, the team will randomize to TAB versus an active comparison designed to isolate the effect of TAB and balance the participant contact across the two groups. In addition to evaluating implementation success and effectiveness outcomes, the team will study pathways to cessation. To inform sustainment and dissemination, the team will collect data on implementation fidelity, county-level adaptations, variations in referrals, and patient-level engagement across the counties, and at the EMS and patient-level. To evaluate budget impact, the team will track the cost of the implementation strategies and the intervention
- Conditions
- Smoking, Smoking Behaviors, Smoking Cessation
- Being tested
- Take a Break plus Nicotine replacement therapy (NRT) Sampling, The Comparison, Community Paramedicine Standard Plus Enhanced Implementation Program, Community Paramedicine Standard Implementation Program
- Keywords
- smoking rates, public health tobacco control services, smoking cessation service, Rural Health, Implementation Science, Community Paramedicine
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take a Break plus Nicotine replacement therapy (NRT) SamplingBehavioural
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 ComparisonBehavioural
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 ProgramOther
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 ProgramOther
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 group | Role | What they receive |
|---|---|---|
| The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling | Experimental | 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. Receives: Behavioral: Take a Break plus Nicotine replacement therapy (NRT) Sampling |
| The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break | Active comparator | 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. Receives: Behavioral: The Comparison |
| The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program | Experimental | The Enhanced Program will include strategies described in the Standard Program plus training of local champions. Receives: Other: Community Paramedicine Standard Plus Enhanced Implementation Program |
| The Standard Program: Community Paramedicine Standard Implementation Program | Active comparator | The standard program will include training, resources, and access to the e-refer tool. Receives: Other: Community Paramedicine Standard Implementation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants engaged
Referral rate of participants by EMS personnel
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start11 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Thomas K Houston, MD, MPH, Principal investigator, Wake Forest University Health SciencesRajani Sadasivam, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790486
- Sponsor's protocol ID
- IRB00087067
- Other IDs
- 1R01CA268041-01A1
- Acronym
- TABR
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Rural Community Paramedicine to Engage Lower-Motivated Smokers: Spreading an Effective mHealth-Assisted Intervention to Motivate Cessation
- ClinicalTrials.gov ID
- NCT05790486
- Acronym / sponsor ID
- TABR / IRB00087067
- Conditions
- Smoking, Smoking Behaviors, Smoking Cessation
- Keywords
- smoking rates, public health tobacco control services, smoking cessation service, Rural Health, Implementation Science, Community Paramedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Massachusetts, Worcester
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study team will conduct a multi-level "hybrid type 2" study (i.e.: implementation and effectiveness outcomes) to test
- a novel implementation program in rural counties and 2) a mHealth (mobile health)-assisted brief abstinence experience (Take a Break, TAB) for rural adults who smoke and are not-yet-ready to quit. In the network of rural counties, the implementation trial will use a novel, multi-strategy implementation program centered on county employees engaged in 'community paramedicine.' Emergency Medical Services personnel (EMS) are evolving into this more expansive role (e.g.: non-emergent healthcare delivery, monitoring of chronic disease, and preventive medicine). To test the implementation, the study team will randomize rural counties with EMS serving geographically complex and ethnically varied areas (the mountainous region of Appalachia and plains of eastern North Carolina). These counties have some of the highest smoking rates in the U.S. The team will compare a well tested (standard) implementation program versus a novel enhanced program. The standard program uses evidence-based external facilitation - providing training and technical support to EMS services to support the integration of enhanced tobacco control practices (including recommending and referring people who smoke and not-yet-ready-to-quit to the mHealth-assisted population health intervention. The novel enhanced implementation program will include the standard program an EMS Champion program. EMS who currently smoke will be offered participation in TAB themselves. Those who participate, Champions, will then use their TAB experience to support implementation as internal facilitators. They will encourage other EMS to experience TAB, longitudinally encourage use of the tobacco control practices in routine workflow for all EMS, and will be able to use their personal experience with TAB to engage in a richer dialog with patients who smoke. Using these strategies, the team seeks to engage individuals living in harder-to-reach rural areas with less access to clinical services.
Engaging these individuals is possible with brief, low intensity, palatable interventions that target self-efficacy and facilitate skills building to support future abstinence. The TAB intervention addresses the challenge of engaging lower motivated individuals using a novel format, a brief abstinence game, supported using mHealth and building upon 10 years of research. The team recently published the first TAB effectiveness trial in Journal of American Medical Association Internal Medicine. This preliminary data supports the current application and does not include a large number of individuals living in rural areas. In this project, the team will randomize to TAB versus an active comparison designed to isolate the effect of TAB and balance the participant contact across the two groups. In addition to evaluating implementation success and effectiveness outcomes, the team will study pathways to cessation. To inform sustainment and dissemination, the team will collect data on implementation fidelity, county-level adaptations, variations in referrals, and patient-level engagement across the counties, and at the EMS and patient-level. To evaluate budget impact, the team will track the cost of the implementation strategies and the intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling | Experimental | Behavioral: Take a Break plus Nicotine replacement therapy (NRT) SamplingMotivational 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 comparator | Behavioral: The ComparisonNicotine 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 | Experimental | Other: Community Paramedicine Standard Plus Enhanced Implementation ProgramThe Enhanced Program will include strategies described in the Standard Program plus training of local champions. |
| The Standard Program: Community Paramedicine Standard Implementation Program | Active comparator | Other: Community Paramedicine Standard Implementation ProgramThe standard program will include training, resources, and access to the e-refer tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- actively quitting smoking
- preparing to quit smoking within 30 days
- prisoners
- FDA- defined NRT contraindications
- unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take a Break plus Nicotine replacement therapy (NRT) SamplingTake 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. | Behavioural | The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling |
| The ComparisonThe comparison group will receive Nicotine Replacement Therapy sampling and will be balanced in all variables except the Take a Break Intervention. | Behavioural | The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break |
| Community Paramedicine Standard Plus Enhanced Implementation ProgramCounties 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 | The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program |
| Community Paramedicine Standard Implementation ProgramIn 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. | Other | The Standard Program: Community Paramedicine Standard Implementation Program |
Primary outcome
Number of participants engaged
Time frame: Monthly from initial training to end of referral period year 1 to year 4 longitudinally
Referral rate of participants by EMS personnel
Follow-up smoking cessation
Time frame: 6 months
Point prevalent cessation is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas K Houston, MD, MPH principal investigator
Wake Forest University Health Sciences
Rajani Sadasivam, PhD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take a Break plus Nicotine replacement therapy (NRT) Sampling, The Comparison and Community Paramedicine Standard Plus Enhanced Implementation Program in people with Smoking and Smoking Behaviors, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna M Thorpe (336-716-3028, Anna.Thorpe@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants engaged (time frame: Monthly from initial training to end of referral period year 1 to year 4 longitudinally). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.