Current SmokerNCT03900767
Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment
A study testing Ask-Advise-Connect (AAC), Text Messaging (TM) and Motivation And Problem-Solving (MAPS) in people with Current Smoker and Tobacco Smoking, run by University of Utah at 1 site in United States.
Trial summary
This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Current Smoker, Tobacco Smoking, Tobacco Use
- What is being tested?
- Ask-Advise-Connect (AAC), Text Messaging (TM) and Motivation And Problem-Solving (MAPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,009 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants will be current tobacco users.
- Participants who speak English or Spanish.
- Participants will have a working cellphone that can accept texts and calls.
- Participants who present at participating community health center (CHC) clinics.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)
This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. The trial will evaluate multiple strategies, that target both clinics and for patients, to increase the number of patients who enroll in Utah Tobacco Quit Line treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate clinic and patient level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline).
II. To evaluate clinic and patient level interventions with respect to increasing the impact of Quitline treatment. Impact is defined as Reach X Efficacy. In calculating impact, efficacy is defined as the proportion of smokers who enroll in Quitline delivered treatment that successfully quit.
III. To evaluate characteristics of both clinics and patients that may influence tobacco use outcomes.
OUTLINE:
CLINIC-LEVEL INTERVENTION
All clinics will receive a clinic-level intervention of Ask Advise Connect (AAC). AAC consists of an electronic health record (EHR) intervention that utilizes the EHR to facilitate clinic staff to Ask patients about tobacco use, Advise patients to quit using tobacco, and directly and electronically Connect patients to the Utah Tobacco Quit Line.
PHASE I (PATIENT-LEVEL): Patients who do not enroll in the Quit Line following the clinic visit will be eligible for Phase 1 randomization to receive either TM or continue with the EHR Condition Only (CO).
GROUP I: Patients receive a Text Message (TM) weekly for one month followed by a monthly text message with a one-touch response to connect to the Quit Line over the next 5 months (i.e., 6 months of text messages following the clinic visit).
GROUP II: Patients receive continued clinic level EHR intervention only (CO).
PHASE II (Patient-level): Nonresponders (i.e., did not enroll in Quit Line treatment at 6 months) in Group 1 of Phase I (TM/CO) will be randomized to 1 of 2 groups:
GROUP I: Patients will continue to receive text messages (motivational messaging with simple touch response to connect directly to the Quit Line) plus 2 brief telephone calls from health coaches for 6-12 months following the clinic visit. Brief telephone coaching calls will be conducted using Motivation and Problem Solving (MAPS) for a TM+MAPS condition.
GROUP II: Patients continue to receive a monthly text message with a one-touch response to directly connect to the Quit Line during months 6-12 following the clinic visit, i.e., text message continued (TM-Cont).
Roughly twelve months after the clinic visit, eligible patients will be invited to complete a 12-month survey on quality of life and abstinence assessments.
A saliva kit will be sent to 300 randomly selected patients who indicate abstinence at the 12-month follow-up and agree to the saliva sample.
- Conditions
- Current Smoker, Tobacco Smoking, Tobacco Use
- Being tested
- Ask-Advise-Connect (AAC), Text Messaging (TM), Motivation And Problem-Solving (MAPS), Quitline
- Keywords
- Text Messaging, Underserved Population, Underserved, Utah, Tobacco Cessation
- Medical subject headings
- Tobacco Smoking, Tobacco Use, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ask-Advise-Connect (AAC)Other
Also called eReferral
AAC utilizes EHR capabilities to prompt clinic practice team members to assess patients' tobacco use status, advise them to quit, and directly and electronically connect interested patients w/ Quitline treatment. Patients were then called by the Quitline to enroll w/in 48 hours.
Text Messaging (TM)Behavioural
Patients received text messages that offer opportunities to enroll in the Quitline. Text messages were sent on behalf of each patient's CHC system included a brief motivational message, the Quit Line website/phone number, and response options to opt-out (stop receiving study interventions) or connect to Quitline.
Motivation And Problem-Solving (MAPS)Behavioural
Patients received MAPS calls from Community health workers (CHWs) trained in MAPS. MAPS is designed to help patients address the larger context in which tobacco use occurs, motivate patients towards a long-term goal of quitting tobacco, and identify and address barriers to quitting and engaging in treatment.
QuitlineBehavioural
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g. Nicotine Replacement Therapy).
| Study group | Role | What they receive |
|---|---|---|
| Ask-Advise-Connect (AAC) | Experimental | Subjects who enrolled in Quitline within 2 weeks of the AAC intervention were not randomized to other interventions. Receives: Other: Ask-Advise-Connect (AAC); Behavioral: Quitline |
| AAC, Text Messaging (TM) | Experimental | Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who enrolled in Quitline within 6 months of TM were not randomized to other interventions.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months. Receives: Other: Ask-Advise-Connect (AAC); Behavioral: Text Messaging (TM); Behavioral: Quitline |
| AAC, Clinic Only (CO) | Experimental | Subjects who did not enroll in Quitline within 2 weeks of the AAC intervention were randomized to CO.
Patients receive continued clinic-level EHR intervention only. Receives: Other: Ask-Advise-Connect (AAC); Behavioral: Quitline |
| AAC, TM, Motivation And Problem-Solving (TM+MAPS) | Experimental | Subjects who did not enroll in Quitline w/in 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline w/in 6 months of TM were randomized to MAPS.
TM: weekly text message for one month, then a monthly text message for 5 months MAPS: monthly text message plus up to 2 phone calls for 6-12 months after their clinic visit Receives: Other: Ask-Advise-Connect (AAC); Behavioral: Text Messaging (TM); Behavioral: Motivation And Problem-Solving (MAPS); Behavioral: Quitline |
| AAC, TM, Text Messaging Continued (TM-Cont) | Experimental | Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline within 6 months of TM were randomized to TM-Cont.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months.
TM-Cont: monthly text message for 6-12 months following each tobacco user's clinic visit Receives: Other: Ask-Advise-Connect (AAC); Behavioral: Text Messaging (TM); Behavioral: Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Defined as the count of tobacco users who enter Quitline treatment. This outcome measure will report the number of participants in each group who enrolled in Quitline treatment.
Measured: Up to 12 months
Secondary outcomes (3)
Impact
Impact is defined as reach x efficacy. Reach is defined as the count of tobacco users who enter Quitline treatment. Efficacy is defined as the proportion of tobacco users entering Quitline treatment who quit (i.e., achieve abstinence).
This outcome measure will report 7-day point prevalence and 30-day point prevalence impact. This is the proportion of patients who enroll in the Quitline and are abstinent from any tobacco/nicotine product for the past 7 or 30 days at 12 months after study enrollment.
Measured: At 12 months
Abstinence From Tobacco
Abstinence assessments are based on recommendations for cessation induction trials. This outcome measure will report the count of participants who achieved abstinence. This outcome measure will report the count of participants who achieved 7-Day Point Prevalence Abstinence and 30--Day Point Prevalence Abstinence.
This outcome measure will report 7-day point prevalence and 30-day point prevalence abstinence. This is the count of people who report not using any tobacco/nicotine product for the past 7 or 30 days at 12 months after study enrollment.
Results of abstinence analyses where people who had missing abstinence outcomes were considered as using tobacco are provided.
Measured: At 12 months
Health-related Quality of Life
Health-related quality of life will be measured with the Short Form Health Survey (SF-12). SF-12 is a 12-item questionnaire assessing both physical (6 items) and mental (6 items) health-related quality of life.
Scores from the SF-12 survey range from 0-100, with lower scores indicating worse health-related quality of life and higher scores indicating better health-related quality of life. This assessment provides two subscores: SF-12 Physical Component Score and SF-12 Menta lComponent Score.
The mean component score by group was used to assess the quality of life impact on the patients, up to 12 months after study enrollment
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start20 Jul 2021
- Primary completion2 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Current SmokerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- David Wetter, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900767
- Sponsor's protocol ID
- 111985
- Other IDs
- NCI-2019-00502, HCI111985
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2019
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez ME, Schlechter CR, Del Fiol G, Gibson B, Kawamoto K, Siaperas T, Pruhs A, Greene T, Nahum-Shani I, Schulthies S, Nelson M, Bohner C, Kramer H, Borbolla D, Austin S, Weir C, Walker TW, Lam CY, Wetter DW. QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers. Implement Sci. 2020 Jan 30;15(1):9. doi: 10.1186/s13012-020-0967-2.
PubMed 32000812
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)
- ClinicalTrials.gov ID
- NCT03900767
- Acronym / sponsor ID
- 111985
- Conditions
- Current Smoker, Tobacco Smoking, Tobacco Use
- Keywords
- Text Messaging, Underserved Population, Underserved, Utah, Tobacco Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,009 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 8 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. The trial will evaluate multiple strategies, that target both clinics and for patients, to increase the number of patients who enroll in Utah Tobacco Quit Line treatment.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate clinic and patient level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline).
II. To evaluate clinic and patient level interventions with respect to increasing the impact of Quitline treatment. Impact is defined as Reach X Efficacy. In calculating impact, efficacy is defined as the proportion of smokers who enroll in Quitline delivered treatment that successfully quit.
III. To evaluate characteristics of both clinics and patients that may influence tobacco use outcomes.
OUTLINE:
CLINIC-LEVEL INTERVENTION
All clinics will receive a clinic-level intervention of Ask Advise Connect (AAC). AAC consists of an electronic health record (EHR) intervention that utilizes the EHR to facilitate clinic staff to Ask patients about tobacco use, Advise patients to quit using tobacco, and directly and electronically Connect patients to the Utah Tobacco Quit Line.
PHASE I (PATIENT-LEVEL): Patients who do not enroll in the Quit Line following the clinic visit will be eligible for Phase 1 randomization to receive either TM or continue with the EHR Condition Only (CO).
GROUP I: Patients receive a Text Message (TM) weekly for one month followed by a monthly text message with a one-touch response to connect to the Quit Line over the next 5 months (i.e., 6 months of text messages following the clinic visit).
GROUP II: Patients receive continued clinic level EHR intervention only (CO).
PHASE II (Patient-level): Nonresponders (i.e., did not enroll in Quit Line treatment at 6 months) in Group 1 of Phase I (TM/CO) will be randomized to 1 of 2 groups:
GROUP I: Patients will continue to receive text messages (motivational messaging with simple touch response to connect directly to the Quit Line) plus 2 brief telephone calls from health coaches for 6-12 months following the clinic visit. Brief telephone coaching calls will be conducted using Motivation and Problem Solving (MAPS) for a TM+MAPS condition.
GROUP II: Patients continue to receive a monthly text message with a one-touch response to directly connect to the Quit Line during months 6-12 following the clinic visit, i.e., text message continued (TM-Cont).
Roughly twelve months after the clinic visit, eligible patients will be invited to complete a 12-month survey on quality of life and abstinence assessments.
A saliva kit will be sent to 300 randomly selected patients who indicate abstinence at the 12-month follow-up and agree to the saliva sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ask-Advise-Connect (AAC) | Experimental | Other: Ask-Advise-Connect (AAC), Behavioral: QuitlineSubjects who enrolled in Quitline within 2 weeks of the AAC intervention were not randomized to other interventions. |
| AAC, Text Messaging (TM) | Experimental | Other: Ask-Advise-Connect (AAC), Behavioral: Text Messaging (TM), Behavioral: QuitlineSubjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who enrolled in Quitline within 6 months of TM were not randomized to other interventions. TM: weekly text message for one month, followed by a monthly text message over the next 5 months. |
| AAC, Clinic Only (CO) | Experimental | Other: Ask-Advise-Connect (AAC), Behavioral: QuitlineSubjects who did not enroll in Quitline within 2 weeks of the AAC intervention were randomized to CO. Patients receive continued clinic-level EHR intervention only. |
| AAC, TM, Motivation And Problem-Solving (TM+MAPS) | Experimental | Other: Ask-Advise-Connect (AAC), Behavioral: Text Messaging (TM), Behavioral: Motivation And Problem-Solving (MAPS), Behavioral: QuitlineSubjects who did not enroll in Quitline w/in 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline w/in 6 months of TM were randomized to MAPS. TM: weekly text message for one month, then a monthly text message for 5 months MAPS: monthly text message plus up to 2 phone calls for 6-12 months after their clinic visit |
| AAC, TM, Text Messaging Continued (TM-Cont) | Experimental | Other: Ask-Advise-Connect (AAC), Behavioral: Text Messaging (TM), Behavioral: QuitlineSubjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline within 6 months of TM were randomized to TM-Cont. TM: weekly text message for one month, followed by a monthly text message over the next 5 months. TM-Cont: monthly text message for 6-12 months following each tobacco user's clinic visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be current tobacco users.
- Participants who speak English or Spanish.
- Participants will have a working cellphone that can accept texts and calls.
- Participants who present at participating community health center (CHC) clinics.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Ask-Advise-Connect (AAC)Also: eReferralAAC utilizes EHR capabilities to prompt clinic practice team members to assess patients' tobacco use status, advise them to quit, and directly and electronically connect interested patients w/ Quitline treatment. Patients were then called by the Quitline to enroll w/in 48 hours. | Other | AAC, Clinic Only (CO), AAC, TM, Motivation And Problem-Solving (TM+MAPS), AAC, TM, Text Messaging Continued (TM-Cont), AAC, Text Messaging (TM), Ask-Advise-Connect (AAC) |
| Text Messaging (TM)Patients received text messages that offer opportunities to enroll in the Quitline. Text messages were sent on behalf of each patient's CHC system included a brief motivational message, the Quit Line website/phone number, and response options to opt-out (stop receiving study interventions) or connect to Quitline. | Behavioural | AAC, TM, Motivation And Problem-Solving (TM+MAPS), AAC, TM, Text Messaging Continued (TM-Cont), AAC, Text Messaging (TM) |
| Motivation And Problem-Solving (MAPS)Patients received MAPS calls from Community health workers (CHWs) trained in MAPS. MAPS is designed to help patients address the larger context in which tobacco use occurs, motivate patients towards a long-term goal of quitting tobacco, and identify and address barriers to quitting and engaging in treatment. | Behavioural | AAC, TM, Motivation And Problem-Solving (TM+MAPS) |
| QuitlineQuitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g. Nicotine Replacement Therapy). | Behavioural | AAC, Clinic Only (CO), AAC, TM, Motivation And Problem-Solving (TM+MAPS), AAC, TM, Text Messaging Continued (TM-Cont), AAC, Text Messaging (TM), Ask-Advise-Connect (AAC) |
Primary outcome
Reach
Time frame: Up to 12 months
Defined as the count of tobacco users who enter Quitline treatment. This outcome measure will report the number of participants in each group who enrolled in Quitline treatment.
3 secondary outcomes
Impact
Time frame: At 12 months
Abstinence From Tobacco
Time frame: At 12 months
Health-related Quality of Life
Time frame: At 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32000812Fernandez ME, Schlechter CR, Del Fiol G, Gibson B, Kawamoto K, Siaperas T, Pruhs A, Greene T, Nahum-Shani I, Schulthies S, Nelson M, Bohner C, Kramer H, Borbolla D, Austin S, Weir C, Walker TW, Lam CY, Wetter DW. QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers. Implement Sci. 2020 Jan 30;15(1):9. doi: 10.1186/s13012-020-0967-2.
- 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.
David Wetter principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ask-Advise-Connect (AAC), Text Messaging (TM) and Motivation And Problem-Solving (MAPS) in people with Current Smoker and Tobacco Smoking, run by University of Utah 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 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?
Yes. Results are posted in the registry (first posted 8 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reach (time frame: Up to 12 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 NCT03900767, 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 8 Sep 2026.