Current Smoker, Tobacco Smoking, Tobacco Use
Conditions
Keywords
Text Messaging, Underserved Population, Underserved, Utah, Tobacco Cessation
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.
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.
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.
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.
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g. Nicotine Replacement Therapy).
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact | 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. |
| Abstinence From Tobacco | 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. |
| Health-related Quality of Life | 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 |
Countries
United States
Contacts
Huntsman Cancer Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 152 Participants |
| Age, Categorical >=65 years | 784 Participants |
| Age, Categorical Between 18 and 65 years | 10669 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3250 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6871 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1484 Participants |
| Insurance Status Private | 3070 Participants |
| Insurance Status Public | 4483 Participants |
| Insurance Status Uninsured | 4052 Participants |
| Language English | 9431 Participants |
| Language Missing/ Declined | 95 Participants |
| Language Other | 11 Participants |
| Language Spanish | 2068 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 249 Participants |
| Race (NIH/OMB) Asian | 47 Participants |
| Race (NIH/OMB) Black or African American | 186 Participants |
| Race (NIH/OMB) More than one race | 847 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 53 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 675 Participants |
| Race (NIH/OMB) White | 9548 Participants |
| Region of Enrollment United States | 11605 participants |
| Sex: Female, Male Female | 5297 Participants |
| Sex: Female, Male Male | 6279 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |