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Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment

Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03900767
Enrollment
12009
Registered
2019-04-03
Start date
2021-07-20
Completion date
2023-03-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Current Smoker, Tobacco Smoking, Tobacco Use

Keywords

Text Messaging, Underserved Population, Underserved, Utah, Tobacco Cessation

Brief 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. 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: I. 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.

Interventions

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.

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.

BEHAVIORALMotivation 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.

BEHAVIORALQuitline

Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g. Nicotine Replacement Therapy).

Sponsors

University of Utah
Lead SponsorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
ReachUp to 12 monthsDefined 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.

Secondary

MeasureTime frameDescription
ImpactAt 12 monthsImpact 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.
Abstinence From TobaccoAt 12 monthsAbstinence 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.
Health-related Quality of LifeAt 12 monthsHealth-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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid Wetter

Huntsman Cancer Institute

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
152 Participants
Age, Categorical
>=65 years
784 Participants
Age, Categorical
Between 18 and 65 years
10669 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3250 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6871 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1484 Participants
Insurance Status
Private
3070 Participants
Insurance Status
Public
4483 Participants
Insurance Status
Uninsured
4052 Participants
Language
English
9431 Participants
Language
Missing/ Declined
95 Participants
Language
Other
11 Participants
Language
Spanish
2068 Participants
Race (NIH/OMB)
American Indian or Alaska Native
249 Participants
Race (NIH/OMB)
Asian
47 Participants
Race (NIH/OMB)
Black or African American
186 Participants
Race (NIH/OMB)
More than one race
847 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
53 Participants
Race (NIH/OMB)
Unknown or Not Reported
675 Participants
Race (NIH/OMB)
White
9548 Participants
Region of Enrollment
United States
11605 participants
Sex: Female, Male
Female
5297 Participants
Sex: Female, Male
Male
6279 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026