Recruitment of Pregnant Smokers to a Contingency Management (CM) Intervention Study Indiana University School of Public Health – Bloomington Indiana State Department of Health (sponsor)

 Dr. Jon Macy PhD, MPH (Principal Investigator)  Rachel Dowty RN, MPH (Project Director)  Dr. Susan Middlestadt, PhD  Dr. Stephen Jay, MD, IUPUI Richard Fairbanks School of Public Health  Dr. Gregory Wilson, MD, IUPUI Richard Fairbanks School of Public Health  Dr. Alejandro Arrieta, PhD, Florida International University Research Personnel

 Carolyn Runge  Theresa Hunter  Katelin Ryan  Brain Busching ISDH Partners Maternal and Child Health Division

 Eskenazi  Southside OB/GYN  Obstetrics and Gynecology of Indiana  IU Health Southern Indiana Physicians  Northshore Health Centers  Parkview Health (coming soon) Clinic Partners

 17% of pregnant women in Indiana report smoking (2012)  In some populations, as high as 38% (Medicaid)  Increased risk of poor maternal and child health outcomes  Increased healthcare costs  Leading preventable cause of adverse pregnancy outcomes Smoking Among Pregnant Women in Indiana

 Education  Information and self-help materials  Counseling from cessation professionals  Biochemical monitoring and feedback  Contingency Management Intervention Strategies

 Higgins et al, 2010 (Vermont): CM improved cessation rates by 27%  Donatelle et al, 2000 (Oregon): CM improved cessation rates by 23%  Heil et al, 2008 (Vermont): CM improved cessation rates by 31% Prior Studies Using CM

 Research objectives:  To measure the effect of a financial incentive (contingency management, or CM, intervention) on prenatal smoking cessation  CM has been shown to improve cessation rates by as much as 24% over standard of care  To evaluate the cost-benefit of the intervention  Policymakers, insurers, and providers Study Background

 Methods:  Randomized controlled trial with a “real world approach”, recruiting 600 pregnant smokers from prenatal clinics around Indiana  Compare CM to the current standard of care  3 study conditions (by site): control, low-level financial incentive ($25) and high-level financial incentive ($50)  Self report and biochemical verification of smoking status  6 clinic sites, 100 participants each between April 2014 – June 2015 Study Background

 Initial inclusion criteria:  current smoking at entry into prenatal care (within 7 days)  at least 18 years of age  less than 17 weeks gestation  not high risk  not incarcerated  not taking antipsychotic or opioid substitution medications  no current use of illicit drugs  no current heavy alcohol use Study Background

 Recruitment to date far below benchmarks: Recruitment Obstacles

 Initial inclusion criteria changes:  current smoking at entry into prenatal care (within 7 30 days)  at least 18 years of age  less than weeks gestation  not high risk (?)  not incarcerated  not taking antipsychotic or opioid substitution medications  no current use of illicit drugs (does not include marijuana)  no current heavy alcohol use Strategies

 From initial 6 clinic sites, expanded to 10, with additional 2 to 3 sites pending (Fort Wayne)  Conference call with clinic sites led to adjustments in promotional flyer wording  Expansion of recruitment window to September 2015  Results: improvement from 25% of goal to 37% of goal… More Strategies

 We are interested in :  Input from those with experience recruiting and/or working with pregnant smokers in any setting  Suggestions, ideas, questions  Thoughts on feasibility of rolling out a CM program based on this study in prenatal clinics in Indiana Discussion