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

NCT03900767 | Unknown DMC

• 2 other identifiers: HCI111985NCI-2019-00502
• Study Type: interventional
• Target: 12,009
• Locations: 1 country
• Sites: 1

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.

Conditions

Current Smoker; Tobacco Smoking; Tobacco Use

Keywords

Text Messaging; Underserved Population; Underserved; Utah; Tobacco Cessation

Outcome Measures

Primary Outcomes (4)

• Reach

  Defined as the proportion of tobacco users who enter Quitline treatment.

  Up to 12 months

• 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

• 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

• Health-related quality of life

  Assessed with the Short Form Health Survey (SF-12)

  At 12 months

Secondary Outcomes (1)

• Abstinence from tobacco use (biochemical validation)

  At 12 months

Study Arms (5)

Clinic-Level

EXPERIMENTAL

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

Other: Electronic Health Record intervention

Phase I Group I (Continued EHR and text messages)

EXPERIMENTAL

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.

Other: Electronic Health Record intervention; Behavioral: Smoking Cessation Intervention; Behavioral: Telephone-Based Intervention

Phase I Group II (Continued clinic-level EHR intervention only)

EXPERIMENTAL

Patients receive continued clinic level EHR intervention only (CO).

Other: Electronic Health Record intervention; Behavioral: Smoking Cessation Intervention

Phase II Group I (Text messages, Counseling call)

EXPERIMENTAL

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.

Other: Electronic Health Record intervention; Behavioral: Smoking Cessation Intervention; Behavioral: Telephone-Based Intervention

Phase II Group II (Text messages continued)

EXPERIMENTAL

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.

Other: Electronic Health Record intervention; Behavioral: Smoking Cessation Intervention; Behavioral: Telephone-Based Intervention

Interventions

Electronic Health Record intervention OTHER

AAC

Clinic-Level; Phase I Group I (Continued EHR and text messages); Phase I Group II (Continued clinic-level EHR intervention only); Phase II Group I (Text messages, Counseling call); Phase II Group II (Text messages continued)

Smoking Cessation Intervention BEHAVIORAL

Receive standard Utah Quitline treatment

Also known as: Smoking and Tobacco Use Cessation Interventions

Phase I Group I (Continued EHR and text messages); Phase I Group II (Continued clinic-level EHR intervention only); Phase II Group I (Text messages, Counseling call); Phase II Group II (Text messages continued)

Telephone-Based Intervention BEHAVIORAL

Receive text messages

Phase I Group I (Continued EHR and text messages); Phase II Group I (Text messages, Counseling call); Phase II Group II (Text messages continued)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• University of Utah: lead
• Patient-Centered Outcomes Research Institute: collaborator

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: 32000812 DERIVED

MeSH Terms

Conditions

Tobacco Smoking; Tobacco Use; Tobacco Use Cessation

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Smoking; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• David Wetter

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: April 3, 2019
• Study Start: July 20, 2021
• Primary Completion: September 1, 2024
• Study Completion: October 31, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)