Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women

Cigarette Smoking Clinical Trial

Official title:

Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210832
• Other study ID #: 1R01HD075669-01
• Secondary ID: R01HD075669-01
• Status: Completed
• Phase: N/A
• Start date: January 31, 2014
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Best practices

• financial incentives
financial incentives provided contingent on biochemically confirmed smoking abstinence

Locations

Country	Name	City	State
United States	University of Vermont, University Health Center Campus	Burlington	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional Birth Outcome: Mean Birth Weight	Birth weight was obtained for each infant from the birth record and expressed in grams. We report the group mean and standard error for each treatment condition.	at delivery
Primary	7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment	Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing	collected once per women at approximately 28-weeks gestation in each of the two smoking arms
Secondary	7-day Point Prevalence Abstinence Postpartum	Compare two treatment arms on 7-day point-prevalence abstinence assessed at 2-, 4-, 8-, 12-, 24- and 48-weeks postpartum. Abstinence was defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing	Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Secondary	Breastfeeding in the Three Trial Arms	Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments	Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Secondary	Breastfeeding While Abstinent From Smoking	We compared the three trial arms on the percent of women who reported breastfeeding and were biochemically confirmed to be abstinent from smoking at each postpartum assessment.	Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Secondary	Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).	The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.	Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
Secondary	Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.	Reporting mean total scores and SEM from the Minnesota Nicotine Withdrawal Scale (MNWS). Total score is an average of 7 items, with each item on a 0 (none) to 4 (severe) scale.	Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
Secondary	Infant Growth in First Year of Life	Infant growth (length & weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.	delivery, 24-week, and 50-week postpartum assessments
Secondary	Birth Outcomes (% Small for Gestational Age Deliveries)	Birth outcomes were compared between the three study arms. Small for gestational age was defined as <10th percentile using INTERGROWTH-21st [2021] https://intergrowth21.tghn.org/about/about-us/.	delivery
Secondary	Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)	Compared the three trials conditions on preterm deliveries.	at delivery
Secondary	Birth Outcomes (NICU Admissions)	Compared three trial conditions on percent of NICU admissions	at delivery
Secondary	Ages & Stages Questionnaire (ASQ)	The ASQ assesses infant development in five areas (communication [Comm], gross motor [GM], fine motor [FM], problem solving [PrbSlv], personal-social [PerSoc]); Each area includes six items, each with a possible value of 0, 5, 10, along with a cutoff to dichotomize infants into typical/normal vs. monitor/potential delay categories for an area. Scores in each area are compared to norms; scores with 1 standard deviation of the norm mean are categorized as typical/normal and those greater than one standard deviation below the norm mean are categorized as monitor/potential delay. We report the dichotomized outcomes for each of the six areas at the 24-week and 48-week assessments noting the number of infants in each treatment condition in the monitor/potential delay category.	24- and 48-weeks postpartum
Secondary	Birth Outcome: Gestational Age at Delivery	Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.	at delivery
Secondary	Cost Per Participant	Cost per participant for BP+FI and BP interventions. These costs per participant are used in calculation of the Incremental Cost Effectiveness Ratio (ICER). This ICER measure is the added healthcare sector cost per participant for BP+FI compared to BP relative to estimated net health gain per participant (QALY). Maternal net health gains in QALYs from cessation difference between treatment conditions at 24 weeks postpartum were based on Stapleton & West, 2012, Nicotine Tob Res; 14: 463-71.	Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).
Secondary	Quality of Life Years Gained (QALYs)	Smoking abstinence at the 24-week assessment was converted into quality of life years gained using standardized tables reported in Stapleton & West, 2012, Nicotine Tob Res; 14: 463-71.	24 weeks postpartum
Secondary	Incremental Cost Effectiveness Ratio (ICER)	A summary measure representing the economic value of an intervention (BP+FI) compared with an alternative (BP). The measure type used below is 'number' due to the fact that this measure is simply a ratio of mean dollars divided by mean years gained between the treatment conditions. Thus there was no alternative measure type that could be used or measure of dispersion available.	24 weeks postpartum