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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD075669-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best practices for pregnant smokers | Experimental | Five As plus referral to pregnancy-specific tobacco quit line |
|
| Best practices plus financial incentives | Experimental | Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. |
|
| Never-smoker comparison condition | No Intervention | We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best practices | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria for two intervention arms:
Inclusion Criteria for never-smoker comparison condition:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen T Higgins, PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont, University Health Center Campus | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22227223 | Background | 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. | |
| 35533885 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Best Practices for Pregnant Smokers | Five As plus referral to pregnancy-specific tobacco quit line Best practices |
| FG001 | Best Practices Plus Financial Incentives | Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. Best practices financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence |
| FG002 | Never-smoker Comparison Condition | We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Women who aborted were removed from the study as per convention in this research area. A total of 8 women were removed for this reason, 3, 4, and 1 in Best practices for pregnant smokers, Best practices plus financial incentives, and Never-smoker comparison conditions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Best Practices for Pregnant Smokers | Five As plus referral to pregnancy-specific tobacco quit line Best practices |
| BG001 | Best Practices Plus Financial Incentives | Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. Best practices financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Comparison of women in two smoking-cessation arms | Posted | Count of Participants | Participants | collected once per women at approximately 28-weeks gestation in each of the two smoking arms |
|
On average women were followed for 1 year, 6 months (end of 1st trimester of pregnancy through 1 year postpartum).
We report the number of instances of pregnancy termination/fetal demise per treatment condition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Best Practices for Pregnant Smokers | Five As plus referral to pregnancy-specific tobacco quit line Best practices |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy termination/fetal demise | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen T. Higgins | University of Vermont | 802-735-6267 | stephen.higgins@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2021 | May 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| financial incentives | Behavioral | financial incentives provided contingent on biochemically confirmed smoking abstinence |
|
|
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries) | Compared the three trials conditions on preterm deliveries. | at delivery |
| Birth Outcomes (NICU Admissions) | Compared three trial conditions on percent of NICU admissions | at delivery |
| 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 |
| Birth Outcome: Gestational Age at Delivery | Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks. | at delivery |
| 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). |
| 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 |
| 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 |
| 35248683 | Derived | 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. |
| BG002 | Never-smoker Comparison Condition | We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cigarettes smoked per day pre-pregnancy | Mean | Standard Deviation | cigarettes/day |
|
| Cigarettes smoked per day at 1st antepartum visit | Mean | Standard Deviation | cigarettes/day |
|
| Age started smoking (yrs) | Mean | Standard Deviation | years |
|
| % living with other smokers | Count of Participants | Participants |
|
| % with no smoking allowed in home | Count of Participants | Participants |
|
| % with none or few family who smoke | Count of Participants | Participants |
|
| % attempted to quit prepregnancy | Count of Participants | Participants |
|
| # quit attempts during pregnancy | Mean | Standard Deviation | attempts |
|
| Minnesota Nicotine Withdrawal Scale total score; scale: 0 (none) to 4 (severe);average item scores | Minnesota Nicotine Withdrawal Scale We report mean Total Scores (minimum = 0 [no discomfort], maximum = 4 [severe discomfort]) There are 8 scale items, each is scored 0 to 4. Total Scores reflect the average of the eight items. We report the average the average Total Score and standard deviation in each treatment condition. | Mean | Standard Deviation | scores on a scale |
|
| Fagerstrom Test for Nicotine Dependence | The Fagerstrom Test for Nicotine Dependence is a 6-item scale Four items are scored Yes-No with Yes = 1 and No = 0. Two items have four response options each scored 1-4 with lower scores indicating less dependence Items are summed for each test taker to get a total score with a range of 0 (no dependence) to 10 (intense dependence). We report the average participant score and standard deviation for each treatment condition. | Mean | Standard Deviation | 0-10 scale |
|
| % endorsing that smoking will greatly harm baby | Item is scored on 0 (not at all) to 4 (a lot); there is a "don't know" item that is recoded as missing. Scale is dichotomized by collapsing items 1-3 vs. 4. We report the number of participants indicating a score of 4. | Count of Participants | Participants |
|
| Stress rating scale for past week from 0 (none) to 10 (extreme) | This is a single item scale on which each participant rates their past week's stress as 0 (none) to 10 (extreme). We report the mean score and standard deviation for each treatment condition. | Mean | Standard Deviation | Scores on a scale |
|
| Beck Depression Inventory total score | The Beck Depression Inventory contains items 21 items each scored 0 (least) to 3 (most). Item scores are summed for a total score ranging from 0-63. We report the mean total score and standard deviation for each treatment condition. | Mean | Standard Deviation | units on a 0-63 scale |
|
|
|
|
| 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 | Hypothesized that women assigned to Best practices plus financial incentives would achieve greater smoking abstinence than women assigned to Best practices only. | Posted | Count of Participants | Participants | 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 | Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78 | Posted | Count of Participants | Participants | 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. | Comparing women in each trial condition who reported breastfeeding and were biochemically confirmed abstinent from smoking at each postpartum assessment. Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78 | Posted | Count of Participants | Participants | 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. | Comparing between women assigned to the two smoking-cessation trial conditions. | Posted | Mean | Standard Error | scores on a scale | 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. | Comparing women assigned to the two smoking-cessation trial conditions. | Posted | Mean | Standard Error | scores on a 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. | There was data available for one or more assessments for 79, 67, and 77 of infants born to mothers in the Best practices, Best practices plus financial incentives, and never-smoker conditions. We compared body mass index (BMI) percentile scores between infants from the three trial conditions at delivery, 24-weeks postpartum, and 48-weeks postpartum. | Posted | Mean | Standard Error | BMI Percentile | 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/. | Comparison of three trial conditions on SGA deliveries | Posted | Count of Participants | Participants | delivery |
|
|
|
|
| Secondary | Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries) | Compared the three trials conditions on preterm deliveries. | Posted | Count of Participants | Participants | at delivery |
|
|
|
|
| Secondary | Birth Outcomes (NICU Admissions) | Compared three trial conditions on percent of NICU admissions | Compared three trial conditions on NICU admissions. | Posted | Count of Participants | Participants | 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. | Overall number of participants analyzed represents the number of participants for whom we obtained data on this outcome at 24-weeks postpartum; at 48-weeks the overall number analyzed were 69, 56, and 72 in Best Practices, Best Practices plus financial incentives, and never-smokers, respectively. | Posted | Count of Participants | Participants | No | 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. | Birth outcomes were obtained from 88, 76, and 79 infants born to women in the best practices, best practices plus financial incentives, and never-smoker conditions. | Posted | Mean | Standard Error | gestational age (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. | All participants treated in best practices plus financial incentives and best practices trial conditions. | Posted | Mean | Standard Error | U.S. dollars | 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. | Analysis of results for this measure cannot be reported separately for each treatment arm. Thus, treatment conditions were combined because the outcome is the difference in quality of life years gained (QALYs) between conditions. | Posted | Mean | Standard Deviation | net years gained | 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. | Treatment conditions were combined because the ICER outcome is a measure of the economic benefit of the BP+FI intervention relative to the BP comparator. | Posted | Number | dollars per years gained | 24 weeks postpartum |
|
|
|
| Other Pre-specified | 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. | Birth outcomes were obtained for 88, 76, and 79 infants of mothers in best practices, best practices plus financial incentives, and never-smokers. | Posted | Mean | Standard Error | weight (grams) | at delivery |
|
|
|
|
| 0 |
| 91 |
| 3 |
| 91 |
| 0 |
| 91 |
| EG001 | Best Practices Plus Financial Incentives | Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. Best practices financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence | 0 | 85 | 4 | 85 | 0 | 85 |
| EG002 | Never-smoker Comparison Condition | We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum | 0 | 81 | 1 | 81 | 0 | 81 |
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| D017530 | Health Care Quality, Access, and Evaluation |
| 8 weeks postpartum |
|
| 12 weeks postpartum |
|
| 24 weeks postpartum |
|
| 48 weeks postpartum |
|
| Mixed Models Analysis |
Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates. |
| 0.003 |
chi square test statistic = 21.93, df=7 |
| Superiority |
| Title | Measurements |
|---|---|
|
| 8-weeks postpartum |
|
| 12-weeks postpartum |
|
| 24-weeks postpartum |
|
| 48-weeks postpartum |
|
| Title | Measurements |
|---|---|
|
| 8-weeks postpartum |
|
| 12-weeks postpartum |
|
| 24-weeks postpartum |
|
| 48-weeks postpartum |
|
Testing interaction of treatment condition and assessment time |
| Mixed Models Analysis |
| 0.89 |
chi square test statistic = 5.00, df = 10. |
| Superiority |
| 2 weeks postpartum |
|
| 4 weeks postpartum |
|
| 8 weeks postpartum |
|
| 12 weeks postpartum |
|
| 24 weeks postpartum |
|
| 48 weeks postpartum |
|
| 2-weeks postpartum |
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| 4-weeks postpartum |
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| 8-weeks postpartum |
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| 12-weeks postpartum |
|
| 24-weeks postpartum |
|
| 48-weeks postpartum |
|
| Mixed Models Analysis |
Method was mixed model repeated measures analysis of covariance. |
| <0.001 |
| Superiority |
|
| 48-weeks postpartum |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| GM at 24-weeks |
|
| GM at 48-weeks |
|
| FM at 24-weeks |
|
| FM at 48-weeks |
|
| PrbSlv at 24-weeks |
|
| PrbSlv at 48-weeks |
|
| PerSoc at 24-weeks |
|
| PerSoc at 48-weeks |
|