- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03900767
Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment
Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chelsey Schlechter, PhD, MPH
- Phone Number: 801-213-5704
- Email: chelsey.schlechter@hci.utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute/University of Utah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clinic-Level
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 |
AAC
|
Experimental: Phase I Group I (Continued EHR and text messages)
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.
|
Receive phone calls
Receive text messages
AAC
Receive standard Utah Quitline treatment
Other Names:
|
Experimental: Phase I Group II (Continued clinic-level EHR intervention only)
Patients receive continued clinic level EHR intervention only (CO).
|
AAC
Receive standard Utah Quitline treatment
Other Names:
|
Experimental: Phase II Group I (Text messages, Counseling call)
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.
|
Receive phone calls
Receive text messages
AAC
Receive standard Utah Quitline treatment
Other Names:
|
Experimental: Phase II Group II (Text messages continued)
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.
|
Receive phone calls
Receive text messages
AAC
Receive standard Utah Quitline treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reach
Time Frame: Up to 12 months
|
Defined as the proportion of tobacco users who enter Quitline treatment.
|
Up to 12 months
|
Impact
Time Frame: 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).
|
At 12 months
|
Abstinence from tobacco use
Time Frame: At 12 months
|
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
Time Frame: At 12 months
|
Assessed with the Short Form Health Survey (SF-12)
|
At 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abstinence from tobacco use (biochemical validation)
Time Frame: 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.
|
At 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Wetter, Huntsman Cancer Institute/ University of Utah
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HCI111985 (Other Identifier: Huntsman Cancer Institute/University of Utah)
- NCI-2019-00502 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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