Project Summary
PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Tobacco use is the leading cause of preventable death and disability in the United States. Quitting tobacco can lower the risk of cancer, heart disease, and other health problems. More than half of tobacco users try to quit each year, but few are successful. Tobacco users with low incomes may have less access than others to treatments that work well.
Tobacco quitlines, available in every state, offer a variety of services to help tobacco users quit. Quitlines are a telephone-based service that offers counseling on quitting tobacco, information about medicines that can help, and referrals to other resources for quitting. Quitlines often include access to free or discounted medicines. However, only about 1 to 2 percent of tobacco users use quitlines annually.
This study is looking at how to connect adults who use tobacco with a quitline.
Who can this research help?
Information from this study can help clinics plan services for adults who want to stop using tobacco.
What is the research team doing?
The research team is working with about 30 health clinics that offer primary care to patients with low incomes. The team is enrolling about 6,000 adult English or Spanish speakers who get care at these clinics and use tobacco. Clinics can send patient information electronically to a quitline if a patient wants to receive treatment.
The research team is conducting the study in three phases. In phase 1, the team is assigning clinics to one of two groups by chance. In both of these groups, the electronic health record, or EHR, alerts clinic staff to ask about tobacco use. In one group, clinicians such as doctors and nurses receive an automatic notice if the patient uses tobacco and a prompt to connect the patient to the quitline. The prompt requires the clinician to offer treatment to the patient or to opt out of doing so. In the other group, clinicians receive an automatic notice but are not prompted to connect the patient to the quitline; however, they can choose to do so.
In phase 2, the research team is assigning patients who were identified during phase 1 but who didn’t enroll in the quitline treatment program to one of two groups by chance. In the first group, patients receive monthly text messages for six months after each clinic visit. The text message includes a one-touch response option that directly connects the patient to the quitline. In the second group, patients receive continued clinic care only.
In phase 3, the research team is assigning patients who received text messages in phase 2 but didn’t enroll in the quitline treatment program to one of two groups by chance. In the first group, patients continue to receive monthly text messages for six more months. In the second group, patients receive a monthly text message for six more months plus two telephone calls from a health educator. The health educator provides information about quitline services. The educator also helps patients identify and learn how to overcome problems that keep them from stopping smoking.
At the end of 12 months, the research team is looking at the proportion of tobacco users who began a quitline treatment program and the proportion of quitline users who quit using tobacco. The team is picking a group of participants, by chance, who reported quitting tobacco to test for indicators of tobacco use. The team is also collecting information about each patient’s health-related quality of life.
Adults who use tobacco are working with the research team to plan the study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Current tobacco users age 18 and older who speak English or Spanish, who have a working cell phone that can receive text messages and calls, and who present at a participating community health center clinic |
| Interventions/ Comparators |
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| Outcomes |
Primary: quitline reach, quitline impact, abstinence from tobacco use, health-related quality of life Secondary: biochemical validation of abstinence |
| 1-year follow-up for primary outcomes |