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Recruitment of Pregnant Smokers to a Contingency Management (CM) Intervention Study Indiana University School of Public Health – Bloomington Indiana State Department of Health (sponsor)
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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
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Carolyn Runge Theresa Hunter Katelin Ryan Brain Busching ISDH Partners Maternal and Child Health Division
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Eskenazi Southside OB/GYN Obstetrics and Gynecology of Indiana IU Health Southern Indiana Physicians Northshore Health Centers Parkview Health (coming soon) Clinic Partners
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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
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Education Information and self-help materials Counseling from cessation professionals Biochemical monitoring and feedback Contingency Management Intervention Strategies
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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
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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
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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
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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
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Recruitment to date far below benchmarks: Recruitment Obstacles
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Initial inclusion criteria changes: current smoking at entry into prenatal care (within 7 30 days) at least 18 years of age less than 17 25 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
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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
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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
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