Tobacco Use Clinical Trial
Official title:
Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Recruiting |
NCT06033599 -
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
|
Phase 3 | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT06105424 -
BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability
|
N/A | |
Completed |
NCT01311830 -
Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons
|
N/A | |
Completed |
NCT04566198 -
Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
|
||
Completed |
NCT04107779 -
Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS
|
N/A | |
Completed |
NCT05092919 -
The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
|
Early Phase 1 | |
Terminated |
NCT05274217 -
Journey of Transformation Curriculum for Native American Adolescents
|
N/A | |
Enrolling by invitation |
NCT06042361 -
Enhancing Equity in Smoke-free Housing
|
N/A | |
Withdrawn |
NCT03352635 -
Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core
|
N/A | |
Completed |
NCT03235713 -
EMA for Tobacco Control Policy Research
|
||
Completed |
NCT03151421 -
Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home
|
N/A | |
Completed |
NCT03446170 -
Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers
|
N/A | |
Completed |
NCT04104152 -
CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
|
N/A | |
Not yet recruiting |
NCT05999383 -
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
|
Phase 2 | |
Recruiting |
NCT04429568 -
THC Crossover Study
|
N/A | |
Completed |
NCT04632030 -
Shrinking the Size of the Tobacco Power Wall
|
N/A | |
Completed |
NCT04143256 -
Evaluating Selected Constituents in the Exhaled Breath Samples
|
N/A |