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 Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute/University of Utah
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-
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.
Exclusion Criteria:
- None
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: Ask-Advise-Connect (AAC)
Subjects who enrolled in Quitline within 2 weeks of the AAC intervention were not randomized to other interventions.
|
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.
Other Names:
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
|
|
Experimental: AAC, Text Messaging (TM)
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. |
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.
Other Names:
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
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.
|
|
Experimental: AAC, Clinic Only (CO)
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. |
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.
Other Names:
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
|
|
Experimental: AAC, TM, Motivation And Problem-Solving (TM+MAPS)
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 |
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.
Other Names:
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
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.
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.
|
|
Experimental: AAC, TM, Text Messaging Continued (TM-Cont)
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 |
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.
Other Names:
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach
Time Frame: Up to 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact
Time Frame: At 12 months
|
Impact is defined as reach x efficacy. Reach is defined as the count of tobacco users who enter Quitline treatment. Efficacy is defined as the proportion of tobacco users entering Quitline treatment who quit (i.e., achieve abstinence). This outcome measure will report 7-day point prevalence and 30-day point prevalence impact. This is the proportion of patients who enroll in the Quitline and are abstinent from any tobacco/nicotine product for the past 7 or 30 days at 12 months after study enrollment. |
At 12 months
|
|
Abstinence From Tobacco
Time Frame: At 12 months
|
Abstinence assessments are based on recommendations for cessation induction trials. This outcome measure will report the count of participants who achieved abstinence. This outcome measure will report the count of participants who achieved 7-Day Point Prevalence Abstinence and 30--Day Point Prevalence Abstinence. This outcome measure will report 7-day point prevalence and 30-day point prevalence abstinence. This is the count of people who report not using any tobacco/nicotine product for the past 7 or 30 days at 12 months after study enrollment. Results of abstinence analyses where people who had missing abstinence outcomes were considered as using tobacco are provided. |
At 12 months
|
|
Health-related Quality of Life
Time Frame: At 12 months
|
Health-related quality of life will be measured with the Short Form Health Survey (SF-12). SF-12 is a 12-item questionnaire assessing both physical (6 items) and mental (6 items) health-related quality of life. Scores from the SF-12 survey range from 0-100, with lower scores indicating worse health-related quality of life and higher scores indicating better health-related quality of life. This assessment provides two subscores: SF-12 Physical Component Score and SF-12 Menta lComponent Score. The mean component score by group was used to assess the quality of life impact on the patients, up to 12 months after study enrollment |
At 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Wetter, Huntsman Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111985
- 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.
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