Tobacco Use CessationNCT05671380
A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
A study testing Longitudinal Proactive Outreach (LPO). and Ask-Advice-Connect (AAC) in people with Tobacco Use Cessation and Cardiovascular Diseases, run by University of Minnesota at 3 sites in United States.
Trial summary
This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Cardiovascular Diseases, Tobacco Use
- What is being tested?
- Longitudinal Proactive Outreach (LPO). and Ask-Advice-Connect (AAC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 May 2023to 31 Mar 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey.
- Currently smoke >1 cigarette over the past 30 days
- Must have address or telephone number in the electronic health record
Who cannot join
- Electronic health record documented cognitive impairment or legal guardianship
- Patients who have opted out of reserach studies
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hennepin Healthcare
Minneapolis, Minnesota, 55415
University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic Health System
Rochester, Minnesota, 55902
About this study
This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.
- Being tested
- Longitudinal Proactive Outreach (LPO)., Ask-Advice-Connect (AAC)
- Medical subject headings
- Tobacco Use Cessation, Cardiovascular Diseases, Tobacco Use, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal Proactive Outreach (LPO).Behavioural
All participants will receive personalized invitation materials (in their preferred language) with messages culturally and linguistically tailored to BIPOC communities, guided by the literature on culturally adapting evidence-based interventions. The study team will tailor these resources in collaboration with the CE core. The tailored mailed packet will include an invitation letter and a brochure describing the types of tobacco treatment services available from their health system and from Quit Partner. One week after the written materials are sent, participants assigned to this condition will receive LPO by a MI-trained coach. The MI outreach call protocol will consist of 6 contact attempts over two weeks.The MI outreach call protocol will be repeated at 3, 6, and 9 months for a total of four outreach cycles because participants may not have quit or may have relapsed.
Ask-Advice-Connect (AAC)Behavioural
Licensed Practical Nurses will be trained to ask all patients if they smoke, document smoking status in the EHR, advise patients to stop smoking, and complete an electronic referral to Quit Partner or the smoking cessation clinic. AAC will be designed to connect participants to Quit Partner Minnesota to receive tobacco cessation counseling. Quit Partner™ is a family of programs available to help Minnesota residents quit commercial tobacco, administered by the Minnesota Department of Health (MDH). Quit Partner programs are provided by National Jewish Health (NJH). Any Minnesota resident can access a free 2-week supply of Nicotine Replacement Therapy (NRT). Uninsured and underinsured residents can access the full Quit Partner programs, including free one-on- one coaching, more NRT, and additional supports. Quit Partner also offers four population- specific programs and calls are available in several languages.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care: Ask-Advice-Connect (AAC) | Active comparator | AAC participants will receive care through their primary care provider as usual (with the caveat that providers in the clinics will be trained to provide AAC). AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy. Receives: Behavioral: Ask-Advice-Connect (AAC) |
| AAC + Longitudinal Proactive Outreach (LPO) | Experimental | AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment. AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy. Receives: Behavioral: Longitudinal Proactive Outreach (LPO).; Behavioral: Ask-Advice-Connect (AAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point-prevalence smoking abstinence at 18 months
7-day point prevalence abstinence from combustible tobacco will be verified at 18 months post-enrollment. Surveys to self-report abstinence will be provided at 6, 12, and 18 months.
Self-reported smoking abstinence will be verified using expired carbon monoxide as the primary method with salivary cotinine as an alternative method at the 18-month follow-up. Participants with a CO of < 6 ppm will be considered abstinent. Participants with a salivary cotinine < 10 ng/ml will be considered abstinent.
Measured: 18 months
Secondary outcomes (3)
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
The TPB-Q is a commonly used and thoroughly validated instrument that maps onto the three predictors of health behavior change in the Theory of Planned Behavior: attitudes about the behavior, perceived subjective norms about the behavior, and perceived control over the behavior. The TPB-Q items have common wording tapping into those three domains, but the scale was developed such that the items are customized to the specific behavioral goal of an intervention, and thus still comparable across behaviors.
Measured: 0, 6, 12, and 18 months
Change in Treatment utilization.
Self-reported utilization of evidence-based cessation treatment (EBCT) will be assessed during the 18-month follow-up from any source. The main treatment outcome will be initiation of counseling with Quit Partner or the participant's healthcare provider, combined with medication treatment utilization. Initiation of counseling treatment with the Quit Partner will be defined as completion of a warm transfer or electronic referral to the quitline. Initiation of medication treatment will be defined as using one or more tobacco dependence medications (e.g., NRT, bupropion or varenicline) in the 18-month follow-up period. Additional treatment utilization outcomes include individual use of counseling or medication and use of any form of EBCT.
Measured: 6, 12, and 18 months
Change in Overall Quality of Life
Overall quality of life will be assessed using a single-item numerical linear analogue self-assessment from 0 (as bad as it can be) to 10 (as good as it can be) via survey through 18 months post-enrollment.
Measured: 0, 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start5 May 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Fu, MD, MSCE, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671380
- Sponsor's protocol ID
- STUDY00013870
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu SS, Hammett P, Nelson D, Busch A, McKinney W, Sharma P, Patten CA, Gutierrez Sacasa N, Andreae L, Japuntich S. Evaluating chronic disease approaches to ameliorate tobacco-related health disparities: Study protocol of a hybrid type 1 implementation-effectiveness trial. Contemp Clin Trials Commun. 2024 Oct 16;42:101380. doi: 10.1016/j.conctc.2024.101380. eCollection 2024 Dec.
PubMed 39498443
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
- ClinicalTrials.gov ID
- NCT05671380
- Acronym / sponsor ID
- STUDY00013870
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 4 Jan 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.
This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care: Ask-Advice-Connect (AAC) | Active comparator | Behavioral: Ask-Advice-Connect (AAC)AAC participants will receive care through their primary care provider as usual (with the caveat that providers in the clinics will be trained to provide AAC). AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy. |
| AAC + Longitudinal Proactive Outreach (LPO) | Experimental | Behavioral: Longitudinal Proactive Outreach (LPO)., Behavioral: Ask-Advice-Connect (AAC)AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment. AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey.
- Currently smoke >1 cigarette over the past 30 days
- Must have address or telephone number in the electronic health record
Key exclusion criteria (2 listed)
- Electronic health record documented cognitive impairment or legal guardianship
- Patients who have opted out of reserach studies
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 |
|---|---|---|
| Longitudinal Proactive Outreach (LPO).All participants will receive personalized invitation materials (in their preferred language) with messages culturally and linguistically tailored to BIPOC communities, guided by the literature on culturally adapting evidence-based interventions. The study team will tailor these resources in collaboration with the CE core. The tailored mailed packet will include an invitation letter and a brochure describing the types of tobacco treatment services available from their health system and from Quit Partner. One week after the written materials are sent, participants assigned to this condition will receive LPO by a MI-trained coach. The MI outreach call protocol will consist of 6 contact attempts over two weeks.The MI outreach call protocol will be repeated at 3, 6, and 9 months for a total of four outreach cycles because participants may not have quit or may have relapsed. | Behavioural | AAC + Longitudinal Proactive Outreach (LPO) |
| Ask-Advice-Connect (AAC)Licensed Practical Nurses will be trained to ask all patients if they smoke, document smoking status in the EHR, advise patients to stop smoking, and complete an electronic referral to Quit Partner or the smoking cessation clinic. AAC will be designed to connect participants to Quit Partner Minnesota to receive tobacco cessation counseling. Quit Partner™ is a family of programs available to help Minnesota residents quit commercial tobacco, administered by the Minnesota Department of Health (MDH). Quit Partner programs are provided by National Jewish Health (NJH). Any Minnesota resident can access a free 2-week supply of Nicotine Replacement Therapy (NRT). Uninsured and underinsured residents can access the full Quit Partner programs, including free one-on- one coaching, more NRT, and additional supports. Quit Partner also offers four population- specific programs and calls are available in several languages. | Behavioural | AAC + Longitudinal Proactive Outreach (LPO), Enhanced Usual Care: Ask-Advice-Connect (AAC) |
Primary outcome
7-day point-prevalence smoking abstinence at 18 months
Time frame: 18 months
7-day point prevalence abstinence from combustible tobacco will be verified at 18 months post-enrollment. Surveys to self-report abstinence will be provided at 6, 12, and 18 months. Self-reported smoking abstinence will be verified using expired carbon monoxide as the primary method with salivary cotinine as an alternative method at the 18-month follow-up. Participants with a CO of < 6 ppm will be considered abstinent. Participants with a salivary cotinine < 10 ng/ml will be considered abstinent.
3 secondary outcomes
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
Time frame: 0, 6, 12, and 18 months
Change in Treatment utilization.
Time frame: 6, 12, and 18 months
Change in Overall Quality of Life
Time frame: 0, 6, 12, and 18 months
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 13 Apr 2026.
- Derived from this study: PubMed 39498443Fu SS, Hammett P, Nelson D, Busch A, McKinney W, Sharma P, Patten CA, Gutierrez Sacasa N, Andreae L, Japuntich S. Evaluating chronic disease approaches to ameliorate tobacco-related health disparities: Study protocol of a hybrid type 1 implementation-effectiveness trial. Contemp Clin Trials Commun. 2024 Oct 16;42:101380. doi: 10.1016/j.conctc.2024.101380. eCollection 2024 Dec.
- 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. This study is not recruiting at the moment.
Steven Fu, MD, MSCE principal investigator
Minneapolis Veterans Affairs Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal Proactive Outreach (LPO). and Ask-Advice-Connect (AAC) in people with Tobacco Use Cessation and Cardiovascular Diseases, run by University of Minnesota at 3 sites 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point-prevalence smoking abstinence at 18 months (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671380, which also lists 1 linked publication.
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 13 Apr 2026.