NCT03900767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,009

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 8, 2026

Completed
Last Updated

September 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

March 11, 2019

Results QC Date

March 20, 2026

Last Update Submit

July 7, 2026

Conditions

Current SmokerTobacco SmokingTobacco Use

Keywords

Text MessagingUnderserved PopulationUnderservedUtahTobacco Cessation

Outcome Measures

Primary Outcomes (1)

  • Reach

    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.

    Up to 12 months

Secondary Outcomes (3)

  • Impact

    At 12 months

  • Abstinence From Tobacco

    At 12 months

  • Health-related Quality of Life

    At 12 months

Study Arms (5)

Ask-Advise-Connect (AAC)

EXPERIMENTAL

Subjects who enrolled in Quitline within 2 weeks of the AAC intervention were not randomized to other interventions.

Other: Ask-Advise-Connect (AAC)Behavioral: Quitline

AAC, Text Messaging (TM)

EXPERIMENTAL

Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who enrolled in Quitline within 6 months of TM were not randomized to other interventions. TM: weekly text message for one month, followed by a monthly text message over the next 5 months.

Other: Ask-Advise-Connect (AAC)Behavioral: Text Messaging (TM)Behavioral: Quitline

AAC, Clinic Only (CO)

EXPERIMENTAL

Subjects who did not enroll in Quitline within 2 weeks of the AAC intervention were randomized to CO. Patients receive continued clinic-level EHR intervention only.

Other: Ask-Advise-Connect (AAC)Behavioral: Quitline

AAC, TM, Motivation And Problem-Solving (TM+MAPS)

EXPERIMENTAL

Subjects who did not enroll in Quitline w/in 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline w/in 6 months of TM were randomized to MAPS. TM: weekly text message for one month, then a monthly text message for 5 months MAPS: monthly text message plus up to 2 phone calls for 6-12 months after their clinic visit

Other: Ask-Advise-Connect (AAC)Behavioral: Text Messaging (TM)Behavioral: Motivation And Problem-Solving (MAPS)Behavioral: Quitline

AAC, TM, Text Messaging Continued (TM-Cont)

EXPERIMENTAL

Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline within 6 months of TM were randomized to TM-Cont. TM: weekly text message for one month, followed by a monthly text message over the next 5 months. TM-Cont: monthly text message for 6-12 months following each tobacco user's clinic visit

Other: Ask-Advise-Connect (AAC)Behavioral: Text Messaging (TM)Behavioral: Quitline

Interventions

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.

Also known as: eReferral
AAC, Clinic Only (CO)AAC, TM, Motivation And Problem-Solving (TM+MAPS)AAC, TM, Text Messaging Continued (TM-Cont)AAC, Text Messaging (TM)Ask-Advise-Connect (AAC)
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.

AAC, TM, Motivation And Problem-Solving (TM+MAPS)AAC, TM, Text Messaging Continued (TM-Cont)AAC, Text Messaging (TM)
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.

AAC, TM, Motivation And Problem-Solving (TM+MAPS)
QuitlineBEHAVIORAL

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

AAC, Clinic Only (CO)AAC, TM, Motivation And Problem-Solving (TM+MAPS)AAC, TM, Text Messaging Continued (TM-Cont)AAC, Text Messaging (TM)Ask-Advise-Connect (AAC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • Fernandez ME, Schlechter CR, Del Fiol G, Gibson B, Kawamoto K, Siaperas T, Pruhs A, Greene T, Nahum-Shani I, Schulthies S, Nelson M, Bohner C, Kramer H, Borbolla D, Austin S, Weir C, Walker TW, Lam CY, Wetter DW. QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers. Implement Sci. 2020 Jan 30;15(1):9. doi: 10.1186/s13012-020-0967-2.

    PMID: 32000812DERIVED

MeSH Terms

Conditions

Tobacco SmokingTobacco UseTobacco Use Cessation

Condition Hierarchy (Ancestors)

SmokingBehaviorHealth Behavior

Results Point of Contact

Title
IIT Data Management Team
Organization
Research Compliance Office, Huntsman Cancer Institute
IITDataManagement@hci.utah.edu
801-213-6215

Study Officials

  • David Wetter

    Huntsman Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

April 3, 2019

Study Start

July 20, 2021

Primary Completion

January 2, 2023

Study Completion

March 31, 2023

Last Updated

September 8, 2026

Results First Posted

September 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)