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

Not Applicable

Active, not recruiting

• Conditions: Tobacco Use; Current Smoker; Tobacco Smoking
• Interventions: Other: Electronic Health Record intervention; Behavioral: Smoking Cessation Intervention; Behavioral: Telephone-Based Intervention

• Registration Number: NCT03900767
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Study Start: 2021-07-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-09-01
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12009

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase I Group II (Continued clinic-level EHR intervention only)	Smoking Cessation Intervention	Patients receive continued clinic level EHR intervention only (CO).
Phase II Group I (Text messages, Counseling call)	Electronic Health Record intervention	Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit.
Phase II Group I (Text messages, Counseling call)	Smoking Cessation Intervention	Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit.
Phase II Group II (Text messages continued)	Smoking Cessation Intervention	Patients receive a monthly text message for 6-12 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline.
Phase II Group II (Text messages continued)	Telephone-Based Intervention	Patients receive a monthly text message for 6-12 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline.
Phase II Group I (Text messages, Counseling call)	Telephone-Based Intervention	Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit.
Phase II Group II (Text messages continued)	Electronic Health Record intervention	Patients receive a monthly text message for 6-12 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline.
Clinic-Level	Electronic Health Record intervention	Clinics will receive the AAC intervention consisting of an EHR-based point of care alert that prompts clinic staff to Ask every patient about tobacco use, Advise tobacco using patients to quit, and Connect interested tobacco users to the Utah Tobacco Quit Line Assigned Interventions = Electronic Health Record intervention AAC
Phase I Group I (Continued EHR and text messages)	Electronic Health Record intervention	Patients receive a weekly text message for one month followed by a monthly text message over the next 5 months (i.e., 6 months of text messages following each tobacco users' clinic visit). All messages will include a motivational message, the Quit Line website, the Quit Line phone number, and simple two-touch response that directly connects interested tobacco users to the Quit Line.
Phase I Group I (Continued EHR and text messages)	Smoking Cessation Intervention	Patients receive a weekly text message for one month followed by a monthly text message over the next 5 months (i.e., 6 months of text messages following each tobacco users' clinic visit). All messages will include a motivational message, the Quit Line website, the Quit Line phone number, and simple two-touch response that directly connects interested tobacco users to the Quit Line.
Phase I Group I (Continued EHR and text messages)	Telephone-Based Intervention	Patients receive a weekly text message for one month followed by a monthly text message over the next 5 months (i.e., 6 months of text messages following each tobacco users' clinic visit). All messages will include a motivational message, the Quit Line website, the Quit Line phone number, and simple two-touch response that directly connects interested tobacco users to the Quit Line.
Phase I Group II (Continued clinic-level EHR intervention only)	Electronic Health Record intervention	Patients receive continued clinic level EHR intervention only (CO).

Primary Outcome Measures

Name	Time	Method
Reach	Up to 12 months	Defined as the proportion of tobacco users who enter Quitline treatment.
Impact	At 12 months	Defined as reach x efficacy. Efficacy is defined as the proportion of tobacco users entering Quitline treatment who quit (i.e., achieve abstinence).
Abstinence from tobacco use	At 12 months	Abstinence assessments are based on recommendations for cessation induction trials (i.e., 7 and 30 day point prevalence abstinence).
Health-related quality of life	At 12 months	Assessed with the Short Form Health Survey (SF-12)

Secondary Outcome Measures

Name	Time	Method
Abstinence from tobacco use (biochemical validation)	At 12 months	We will randomly select a subset of participants who report abstinence at 12 months follow-up survey to complete biochemical validation of abstinence via saliva samples. The saliva sample will be used to test for cotinine, a metabolite of nicotine.

Trial Locations

Locations (1)

Huntsman Cancer Institute/University of Utah; 🇺🇸 Salt Lake City, Utah, United States