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Completed

NCT Number: NCT03900767

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ask-Advise-Connect (AAC)

Other

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.

Other names: eReferral

Text Messaging (TM)

Behavioral

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)

Behavioral

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.

Quitline

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Impact

    Time frame: At 12 months

    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.

  2. Abstinence From Tobacco

    Time frame: At 12 months

    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.

  3. Health-related Quality of Life

    Time frame: At 12 months

    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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2019
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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