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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03900767
• Other study ID #: HCI111985
• Secondary ID: NCI-2019-00502HC
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12009
• Est. completion date: October 31, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Current Smoker
• Tobacco Smoking
• Tobacco Use

Intervention

Other:
• Electronic Health Record intervention
AAC

Behavioral:
• Smoking Cessation Intervention
Receive standard Utah Quitline treatment
• Telephone-Based Intervention
Receive text messages
• Telephone-Based Intervention
Receive phone calls

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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