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 and others.

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 smoking is the leading cause of preventable death in the United States. Quitting smoking can help people live longer, healthier lives.

In this study, the research team is comparing three ways to help people quit smoking:

  • iCanQuit is a mobile phone app with self-paced modules that help people accept the urge to smoke without trying to make it go away. The app also helps people make behavior changes based on their personal values.
  • iCanQuit plus Motiv8 combines the mobile phone app with a breath smoke monitor connected to a smartphone. People breathe into the monitor to verify that they aren’t smoking. To encourage quitting, Motiv8 provides financial rewards when people pass the breath test.
  • The Florida Quitline provides free phone counseling with a trained coach who helps people assess their addiction and create a plan to quit smoking.

Who can this research help?

Results may help clinic administrators and doctors when considering ways to help patients quit smoking.

What is the research team doing?

The research team is recruiting 1,332 adults who smoke from primary care clinics in Florida. The clinics are in urban and rural neighborhoods with few resources. The team is assigning patients by chance to use iCanQuit, iCanQuit plus Motiv8, or the Florida Quitline.

The research team is using a breath test to check if patients have quit smoking 2, 6, and 12 months after the start of the study. The team is also surveying patients about their:

  • Quality of life
  • Self-confidence to quit
  • Motivation to quit
  • Commitment to personal values
  • Acceptance of urges and smoking triggers
  • Treatment satisfaction

The research team is looking at how well the programs work for different groups of people, such as those from different races and genders.

Patients who used to smoke, community members, doctors, and health insurers are helping to design and conduct this study.

Research methods at a glance

Design ElementDescription
DesignRandomized controlled trial
Population1,332 adults ages 21 and older who smoke and were referred by a provider at a participating clinic
  • iCanQuit
  • iCanQuit plus Motiv8
  • Florida Quitline

Primary: smoking point-prevalence abstinence (negative breath sample ≤5 parts per million using a carbon monoxide monitor and self-reported abstinence from smoking in the last 7 days)

Secondary: 2- and 12-month smoking abstinence; treatment satisfaction; quality of life and well-being; self-efficacy; acceptance of cravings and urges to smoke; commitment to values; motivation to quit smoking; self-reported prolonged post-quit abstinence

Timeframe  Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 6-month follow-up for primary outcome

*Increase Diversity and Advance Health Equity Funding Supplement
This study received supplemental funding to build on existing PCORI-funded comparative clinical effectiveness research (CER) studies to leverage meaningful engagement of affected/relevant communities to ensure that a diverse and inclusive study population can be achieved.

Project Information

Jesse Dallery, PhD
Ramzi Salloum, PhD
University of Florida
Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care

Key Dates

December 2021
April 2028

Study Registration Information


Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 27, 2024