Clinical trial NCT02210832: Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women
Official title: Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: smoking
pregnancy
cessation
incentives
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Centers for Disease Control and Prevention
First posted: 2014-08-07
Enrollment: 257
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators will examine whether adding financial incentives to current best practices for smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a telephone quit line) increases cessation rates and improves infant health. While more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be economically justified by the later cost savings associated with more women quitting, having healthier babies, and needing less healthcare. It should also help to reduce the greater risk for health problems often seen among those who less well off economically.

Detailed description: Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the U.S. Most pregnant smokers continue smoking through pregnancy producing serious immediate and longer-term adverse health consequences for the infant. Smoking during pregnancy is highly associated with economic disadvantage and a substantive contributor to health disparities.

Efficacious interventions are available, but cessation rates are low (\<20%) and improvements in birth outcomes often modest or absent. Current treatments usually entail relatively brief, lower-cost interventions (e.g., pregnancy specific quit lines). There is broad consensus that more effective interventions are sorely needed. This team of investigators has developed a novel behavioral economic intervention in which women earn financial incentives contingent on smoking abstinence. In a metaanalysis of treatments for smoking during pregnancy, effect sizes achieved with financial incentives were several fold larger than those achieved with lower intensity approaches or medications. The intervention also appears to improve birth outcomes and increase breastfeeding duration. While highly promising, further research is needed in at least three areas. (1) The evidence on birth outcomes and breastfeeding is from studies that combined data across trials rather than a single prospective trial, (2) whether the intervention produces other postpartum improvements in health has not been investigated, and (3) the overall cost-effectiveness of this approach has not been examined.

To examine these unanswered questions, the investigators are proposing a randomized, controlled clinical trial comparing the efficacy and cost effectiveness through one year postpartum of current best practices for smoking cessation during pregnancy vs. best practices plus financial incentives among 230 pregnant, Medicaid recipients. A third condition of 115 pregnant nonsmokers matched to the smokers on sociodemographic and health conditions will be included as well to compare the extent to which the treatments reduce the burden of smoking and to estimate how much more might be accomplished by further improvements in this incentives intervention without exceeding cost-effectiveness.

The investigators hypothesize that best practices plus financial incentives will be more effective than usual care practices alone, that the incentives intervention will be cost effective, and that while adding the incentives reduces a greater proportion of the health and economic burden of smoking than best practices alone, more can be done while remaining cost effective.

Overall, the proposed study has the potential to substantially advance knowledge on cost-effective smoking cessation for pregnant women. Importantly, because of the strong association between smoking during pregnancy and economic disadvantage, the proposed study also has the potential to contribute new knowledge relevant to reducing the serious challenges of health disparities.

Eligibility criteria: Inclusion Criteria for two intervention arms:

* report being smokers at the time that they learned of the current pregnancy;
* report smoking in the 7 days prior to the first prenatal care visit with biochemical verification;
* \< 25 weeks gestation;
* English speaking;
* plan on remaining in the geographical area through 12months postpartum.

Inclusion Criteria for never-smoker comparison condition:

* report being nonsmokers at the time they learned of the current pregnancy;
* report no smoking in the past 6 month;
* Biochemical verification of non-smoker status;
* report smoking \< 100 cigarettes in their lifetime;

Exclusion criteria:

* \> 25 weeks gestation;
* unavailable for routine assessments through 1 year postpartum;
* opioid substitution therapy;
* untreated/unstable serious mental illness

Primary outcomes:
measure: 7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment
timeFrame: collected once per women at approximately 28-weeks gestation in each of the two smoking arms
Secondary outcomes:
measure: 7-day Point Prevalence Abstinence Postpartum
timeFrame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
measure: Breastfeeding in the Three Trial Arms
timeFrame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
measure: Breastfeeding While Abstinent From Smoking
timeFrame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
measure: Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
timeFrame: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
measure: Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
timeFrame: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
measure: Infant Growth in First Year of Life
timeFrame: delivery, 24-week, and 50-week postpartum assessments
measure: Birth Outcomes (% Small for Gestational Age Deliveries)
timeFrame: delivery
measure: Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)
timeFrame: at delivery
measure: Birth Outcomes (NICU Admissions)
timeFrame: at delivery
measure: Ages & Stages Questionnaire (ASQ)
timeFrame: 24- and 48-weeks postpartum
measure: Birth Outcome: Gestational Age at Delivery
timeFrame: at delivery
measure: Cost Per Participant
timeFrame: Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).
measure: Quality of Life Years Gained (QALYs)
timeFrame: 24 weeks postpartum
measure: Incremental Cost Effectiveness Ratio (ICER)
timeFrame: 24 weeks postpartum
Other outcomes:
measure: Additional Birth Outcome: Mean Birth Weight
timeFrame: at delivery
Locations:
city: Burlington
country: United States
facility: University of Vermont, University Health Center Campus
state: Vermont
Study officials:
affiliation: University of Vermont
name: Stephen T Higgins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higgins ST, Washio Y, Heil SH, Solomon LJ, Gaalema DE, Higgins TM, Bernstein IM. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med. 2012 Nov;55 Suppl(Suppl):S33-40. doi: 10.1016/j.ypmed.2011.12.016. Epub 2011 Dec 27.
citation: Shepard DS, Slade EP, Nighbor TD, DeSarno MJ, Roemhildt ML, Williams RK, Higgins ST. Economic analysis of financial incentives for smoking cessation during pregnancy and postpartum. Prev Med. 2022 Dec;165(Pt B):107079. doi: 10.1016/j.ypmed.2022.107079. Epub 2022 May 6.
citation: Higgins ST, Nighbor TD, Kurti AN, Heil SH, Slade EP, Shepard DS, Solomon LJ, Lynch ME, Johnson HK, Markesich C, Rippberger PL, Skelly JM, DeSarno M, Bunn J, Hammond JB, Roemhildt ML, Williams RK, O'Reilly DM, Bernstein IM. Randomized Controlled Trial Examining the Efficacy of Adding Financial Incentives to Best practices for Smoking Cessation Among pregnant and Newly postpartum Women. Prev Med. 2022 Dec;165(Pt B):107012. doi: 10.1016/j.ypmed.2022.107012. Epub 2022 Mar 3.