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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12009 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-20

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electronic Quitline Referral With Enhanced Academic Detailing for the Promotion of Smoking Cessation

NCT04969978

ACTIVE_NOT_RECRUITING NA

Support Person Intervention to Promote a Smoking Helpline Among Under Resourced Smokers

NCT03096145

Tobacco Cessation

COMPLETED NA

Interventions to Help More Low-income Smokers Quit

NCT04311983

Tobacco Use Cessation Smoking Behaviors Health Disparity

COMPLETED NA

Salvation Army Tobacco Quit Line Referral Implementation Trial

NCT06689774

Tobacco Use Smoking Smoking Cessation

ENROLLING_BY_INVITATION NA

Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes

NCT03575468

Smoking Cessation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Current Smoker Tobacco Smoking Tobacco Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Intervention Type BEHAVIORAL

Receive text messages

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No