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Strengthen the Evidence for Maternal and Child Health Programs

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Displaying records 1 through 20 (42 total).

Abroms LC, Chiang S, Macherelli L, Leavitt L, Montgomery M. Assessing the National Cancer Institute's SmokefreeMOM Text-Messaging Program for Pregnant Smokers: Pilot Randomized Trial. Journal of Medical Internet Research 2017a;19:e333.

Link: https://www.ncbi.nlm.nih.gov/pubmed/28974483

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PARENT/FAMILY, Notification/Information Materials (Online Resources, Information Guide), PATIENT/CONSUMER, Educational Material, Telephone Support, Parent Engagement, Patient Reminder/Invitation

Intervention Results:

Results indicate that SmokefreeMOM was rated highly and more favorably than a control condition that consisted of a single text message in its helpfulness at 3-month follow-up and in its frequency of messaging at both time points. Among the intervention group participants, messages were read at high rates and participants unsubscribed from the program at low rates. Nonetheless, almost 30% of participants experienced some technical problems with the program during the study period, largely related to not being able to get responses from the automated system after replying to queries or sending in keywords. There were no significant differences between groups on use of extra treatment resources or on smoking-related outcomes, though some outcomes favored the intervention group at 3-month follow-up. Some participants felt the program was a trigger for smoking.

Abroms LC, Johnson PR, Leavitt LE, Cleary SD, Bushar J, Brandon TH, et al. A randomized trial of text messaging for smoking cessation in pregnant women. American Journal of Preventive Medicine 2017b;53:781-90.

Link: https://www.ncbi.nlm.nih.gov/pubmed/28982527

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PARENT/FAMILY, Notification/Information Materials (Online Resources, Information Guide), PATIENT/CONSUMER, Patient Reminder/Invitation, Educational Material, Parent Engagement, Telephone Support

Intervention Results:

For the primary outcome, biochemically confirmed 7-day PPA at the 3-month follow-up, there was no overall effect of the intervention, although effects were found among two subgroups: those who enrolled in the study in their second or third trimester and those who were aged ≥26 years. Additionally, for secondary outcomes based on self-report, an effect of Quit4baby on 7-day PPA at 1 and 3 months and in late pregnancy was observed. However, no effects were observed on self-reported 7-day PPA at 6 months or in the postpartum period. Results provide limited support of the efficacy of the Quit4baby text messaging program in the short term and late in pregnancy, but not in the postpartum period.

Abroms LC, Johnson PR, Heminger CL, Van Alstyne JM, Leavitt LE, Schindler-Ruwisch JM, Bushar JA. Quit4baby: results from a pilot test of a mobile smoking cessation program for pregnant women. Journal of Medical Internet Research Mhealth Uhealth. 2015 Jan 23;3(1):e10. doi: 10.2196/mhealth.3846.

Link: https://www.ncbi.nlm.nih.gov/pubmed/25650765

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PARENT/FAMILY, Notification/Information Materials (Online Resources, Information Guide), PATIENT/CONSUMER, Patient Reminder/Invitation, Educational Material, Telephone Support, Parent Engagement, Incentives

Intervention Results:

The pilot test provides support for the feasibility and acceptability of Quit4baby. Participants gave overall high ratings to the Quit4baby text-messaging program. Participants agreed that the program was helpful in quitting, gave good ideas on quitting, and they would recommend the program to a friend. At baseline, participants smoked an average of 7.6 cigarettes per day. At the 2-week follow-up, the average number of cigarettes smoked had decreased to 4.7. At the 4-week follow-up, this number had decreased to 2.4 cigarettes per day. At the 2-week-follow-up, 5 participants out of 13 (38%) had reported abstaining for the past week, and 7 participants out of 13 (54%) reported abstaining for the past week at the 4-week follow-up.

Bailey SR, Heintzman JD, Marino M, Jacob RL, Puro JE, DeVoe JE, Burdick TE, Hazlehurst BL, Cohen DJ, Fortmann SP. Smoking-Cessation Assistance: Before and After Stage 1 Meaningful Use Implementation. American Journal of Preventive Medicine 2017 Aug;53(2):192-200. doi: 10.1016/j.amepre.2017.02.006. Epub 2017 Mar 29.

Link: https://www.ncbi.nlm.nih.gov/pubmed/28365090

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Educational Material, Incentives

Intervention Results:

Non-pregnant patients had decreased odds of current smoking over time, odds for all other outcomes increased except for medication orders from 2010 to 2012. Among pregnant patients, odds of assessment and counseling increased across all years. Odds of discussing or ordering cessation medications increased from 2010 compared with the other 2 study years; however, medication orders did not change over time, and current smoking only decreased from 2010 to 2012. Though the overall decrease in current smoking was small, 30.3% in 2010 versus 27.2% in 2014, given the public healthcare costs and comorbidities associated with smoking, this change is highly significant from a public health perspective. Current smoking did not decrease over time, despite the increase in receipt of counseling. Given that medication plus counseling substantially increases cessation rates compared with counseling alone and only a little more than half of pregnant women received counseling, the insignificant change in smoking rates is not surprising, albeit it is concerning.

Bailey BA. Effectiveness of a pregnancy smoking intervention: The Tennessee Intervention for Pregnant Smokers program. Health Education and Behavior 2015;42:824-31.

Link: https://journals.sagepub.com/doi/full/10.1177/1090198115590780

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Educational Material, Other Person-to-Person Education, Peer Counselor, Motivational Interviewing, Telephone Support, PARENT/FAMILY, Notification/Information Materials (Online Resources, Information Guide), Consultation (Parent/Family)

Intervention Results:

Of those offered the intervention, 28.1% quit smoking by the end of the second trimester and remained smoking-free to delivery as verified biochemically. In contrast, only 9.8% of the control group, who received usual care only, quit smoking prior to the third trimester and remained smoking free to delivery. Birth outcomes also showed positive outcomes compared to controls. Having educated health educators with knowledge of social needs was important to outcomes and increased usage of prenatal services.

Bartholomew KS, Abouk R. The effect of local smokefree regulations on birth outcomes and prenatal smoking. Maternal and Child Health Journal 2016;20:1526-38.

Link: https://link.springer.com/article/10.1007%2Fs10995-016-1952-x

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): STATE, Policy/Guideline (State)

Intervention Results:

None of the regulations had any effect on prenatal smoking in the full sample. Prenatal smoking showed very limited effect, with a small decrease in married women with the more comprehensive smoke free regulations. With regard to birth outcomes, only more comprehensive smoke free regulations were associated with statistically significant favorable effects on birth outcomes in the full sample: Comprehensive (workplace/restaurant/bar ban) demonstrated increased birthweight and preterm birth. Restrictive (workplace/restaurant ban) demonstrated a small decrease in very low birthweight. Among less restrictive regulations: Moderate (workplace ban) was associated with a 23g decrease in birthweight; Limited (partial ban) had no effect. Comprehensive's improvements extended to most maternal groups, and were broadest among mothers 21+ years, non-smokers, and unmarried mothers. Regulation restrictiveness is a determining factor in the impact of smoke free regulations on birth outcomes, with comprehensive smoke free regulations showing promise in improving birth outcomes. Favorable effects on birth outcomes appear to stem from reduced second hand smoke exposure rather than reduced prenatal smoking prevalence.

Bell R, Glinianaia SV, van der Waal Z, Close A, Moloney E, Jones S et al. Evaluation of a complex healthcare intervention to increase smoking cessation in pregnant women: Interrupted time series analysis with economic evaluation. Tobacco Control: An International Journal 2018;27:90-8.

Link: https://www.ncbi.nlm.nih.gov/pubmed/28202783

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PROVIDER/PRACTICE, Quality Improvement/Practice-Wide Intervention, Provider Training/Education, Assessment (Provider)

Intervention Results:

The introduction of a system-wide intervention to promote smoking cessation during pregnancy increased referrals to smoking cessation by 2.5 times and the proportion of women quitting by delivery by nearly twofold. Quitting smoking during pregnancy was associated with a clinically important increase in birth weight. The referral rate increased progressively in the first 3 months after the intervention was introduced. The intervention was associated with a significant increase in referrals. Additional training sessions were associated with an increase in referrals in the month of, as was availability of a system for enhanced initial contact with smokers. Introduction of the intervention was associated with a significant increase in quitting by delivery. The odds of quitting were higher) for deliveries with a recorded referral to smoking cessation services, and if there was a record of a quit date. The odds of quitting were significantly higher following additional training. Mothers resident in the most deprived areas were less likely to quit as were younger mothers and those of white ethnicity. Additional findings: Babies born to women who did not smoke during pregnancy were significantly heavier than those born to women who smoked throughout pregnancy and the incremental cost per additional quitter was £952 and the number needed to treat for each additional quitter was 31 pregnant women.

Berlin I, Grangé G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. British Medical Journal (Clinical Research Ed) 2014;348:g1622.

Link: https://www.bmj.com/content/348/bmj.g1622

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Nicotine Patches

Intervention Results:

The nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses. Even a relatively high daily dose of nicotine, adjusted for baseline saliva cotinine levels and administered with a relatively high self-reported compliance rate for a median of 105 days during the second and third trimester did not increase abstinence rates. The complete abstinence rate from quit date up to end of pregnancy was low (5.5% and 5.1%), and this was lower than the 21% and 19% (relative risk 1.1%, 95% confidence interval 0.7% to 1.8%) found in the most similarly designed previous study, but with a substantially shorter exposure. The nicotine substitution rate in the nicotine patch group showed that abstinence was unrelated to the level of nicotine substitution, suggesting that factors other than nicotine replacement may determine abstinence in pregnant smokers. The nicotine patch did not significantly reduce craving for tobacco, withdrawal symptoms, and number of cigarettes smoked. Diastolic blood pressure increased significantly in the nicotine patch group compared with placebo patch group.

Brown QL, Hasin DS, Keyes KM, Fink DS, Ravenell O, Martins SS. Health insurance, alcohol and tobacco use among pregnant and non-pregnant women of reproductive age. Drug and Alcohol Dependence 2016;166:116-24.

Link: https://www.ncbi.nlm.nih.gov/pubmed/27422762

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Health Insurance Coverage

Intervention Results:

Among pregnant women there were no significant differences in the relationship between insurance status, alcohol and tobacco use in the first two trimesters. However, in the third trimester, 3.18% of insured pregnant women used alcohol in the past month versus 0.15% of uninsured pregnant women. The relationship between insurance status and tobacco use was not significant in the third trimester. Despite health insurance coverage, tobacco use persisted during pregnancy.

Buchanan C, Nahhas GJ, Guille C, Cummings KM, Wheeler C, McClure EA. Tobacco use prevalence and outcomes among perinatal patients assessed through an "opt-out" cessation and follow-up clinical program. Maternal and Child Health Journal 2017;21:1790-7.

Link: https://europepmc.org/article/med/28702864

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Educational Material, Other Person-to-Person Education, Motivational Interviewing, Other Education, Intensive Therapy, Peer Counselor

Intervention Results:

This real-world, hospital-based, opt-out tobacco assessment and cessation program was able to reach 198 perinatal smokers during their inpatient stay and another 83 patients not seen at the bedside by phone after discharge, yielding an overall reach rate of 67% (281/421). Those counseled in the hospital were twice as likely to be abstinent from smoking at any time during the 30 days post-discharge. This opt-out service reached a highly nicotine-dependent perinatal population, many of whom were receptive to the service, and it appeared to improve abstinence rates post-discharge.

Campbell KA, Cooper S, Fahy SJ, Bowker K, LeonardiBee J, McEwen A et al. 'Opt-out' referrals after identifying pregnant smokers using exhaled air carbon monoxide: Impact on engagement with smoking cessation support. Tobacco Control: An International Journal 2017;26:300-6.

Link: https://tobaccocontrol.bmj.com/content/26/3/300.long

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Referrals

Intervention Results:

In a hospital with an ‘opt-in’ referral system, adding CO screening with ‘opt-out’ referrals as women attended ultrasound examinations doubled the numbers of pregnant smokers setting quit dates and reporting smoking cessation. Approximately 2300 women attended antenatal care in each period. Before the implementation, 536 (23.4%) women reported smoking at ‘booking’ and 290 (12.7%) were referred to SSS. After the implementation, 524 (22.9%) women reported smoking at ‘booking’, an additional 156 smokers (6.8%) were identified via the ‘opt-out’ referrals and, in total, 421 (18.4%) were referred to SSS. Over twice as many women set a quit date with the SSS after ‘opt-out’ referrals were implemented (121 (5.3%, 95% CI 4.4% to 6.3%) compared to 57 (2.5%, 95% CI 1.9% to 3.2%) before implementation) and reported being abstinent 4 weeks later (93 (4.1%, 95% CI 3.3% to 4.9%) compared to 46 (2.0%, 1.5% to 2.7%) before implementation).

Chertok IRA, Archer SH. Evaluation of a midwife- and nurse-delivered 5 A's prenatal smoking cessation program. Journal of Midwifery & Womens Health 2015;60:175-81.

Link: https://www.ncbi.nlm.nih.gov/pubmed/25782851

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Motivational Interviewing, Telephone Support, Peer Counselor, Midwife, PROVIDER/PRACTICE, Nurse/Nurse Practitioner

Intervention Results:

Over the course of the intervention, there was a significant reduction in cigarette smoking during pregnancy. Also women expressed a higher level of confidence in feeling able to reduce smoking during pregnancy compared to quitting smoking. The reported average number of cigarettes smoked in a day showed a significant effect in reduction over time, from 9.9 (4.9) at baseline to 8.1 (4.9) at time 1, to 7.0 (4.7) by time 2, and 6.0 (5.6) by the end of pregnancy, for an overall reduction of 43.5% over time.

Coleman-Cowger VH, Mark KS, Rosenberry ZR, Koszowski B, Terplan M. A Pilot Randomized Controlled Trial of a Phone-based Intervention for Smoking Cessation and Relapse Prevention in the Postpartum Period. Journal of Addictive Medicine 2018 May/Jun;12(3):193-200. doi: 10.1097/ADM.0000000000000385.

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5970014/

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Telephone Support, Enabling Services, Access to Provider through Hotline

Intervention Results:

Limited benefits of including phone-based continuing care to standard care for smoking cessation during pregnancy were found. There were no significant differences in average cotinine levels between the Experimental and Control group at any of the time points. There were no statistically significant differences in the number of tobacco products used per day between the Experimental and Control groups. More participants in the Experimental group were abstinent at 6 weeks postpartum (39% vs 25%; p=0.18) and 3 months postpartum (25% vs 14%; p=0.21) but the percentage of smoking abstinent women was similar for the Experimental and Control groups at 6 months postpartum.

Cummins SE, Tedeschi GJ, Anderson CM, Zhu S. Telephone intervention for pregnant smokers: A randomized controlled trial. American Journal of Preventive Medicine 2016;51:318-26.

Link: https://www.ncbi.nlm.nih.gov/pubmed/27056131

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Peer Counselor, Telephone Support

Intervention Results:

The study demonstrated that a telephone-based, pregnancy-specific protocol without financial incentives can increase smoking cessation during pregnancy, with a sustained effect postpartum. At the end of pregnancy, women in the intervention were 1.5 times more likely to be abstinent than those in the control group. Abstinence was higher for the intervention than the control group at the end of pregnancy (30-day abstinence, 29.6% vs 20.1%; p<0.001), 2 months postpartum (90-day abstinence, 22.1% vs 14.8%; p<0.001), and 6 months postpartum (180-day abstinence, 14.4% vs 8.2%; p<0.001). 2 months post-partum (90-day abstinence, 22.2% vs. 14.8%); and 6 months postpartum (180-day abstinence, 14.4% vs. 8.2%). Cotinine-corrected 7-day abstinence rates at the end of pregnancy supported the intervention effect (35.8% vs. 22.5%).

Eddy, A, Prileszky, G, Nicoll, K, Barker, R, Anisy, J. ABC by LMC midwives: an innovative intervention to support women to become smoke-free in pregnancy. New Zealand College of Midwives Journal 2015; Issue 51.

Link: https://www.midwife.org.nz/wp-content/uploads/2018/09/Jnl-51-article-6.pdf

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Home Visits, Midwife, Referrals

Intervention Results:

Over the course of the project, the six midwives delivered a total of 1086 ABC interventions to the 101 women. This total is comprised of 438 reported incidences of asking about smoking behavior, 358 incidences of offering brief advice and 290 incidences of offering referral to specialist cessation support to women. Sixteen women accepted referral to the dedicated pregnancy smoking cessation service—all of whom had a least one reported contact with the provider. Partners and other adults in the household received fewer ABC interventions than did the women, as they were not present every time the midwife visited. Thirty-two women became smoke-free during the course of the project following the midwives' intervention. 16 (50%) of the 32 women who became smoke-free recommenced smoking, nine during pregnancy, and seven posnatally. Ten partners (15%) became smoke-free following the LMC midwives’ intervention; in five of these cases the woman also became smoke-free. Three other adults (2.7%) also became smoke-free and in two of these cases the woman herself also became smoke-free.

England L, Tong VT, Rockhill K, Hsia J, McAfee T, Patel D, Rupp K, Conrey EJ, Valdivieso C, Davis KC. Evaluation of a federally funded mass media campaign and smoking cessation in pregnant women: a population-based study in three states. British Medical Journal Open 2017 Dec 19;7(12):e016826. doi: 10.1136/bmjopen-2017-016826.

Link: https://www.ncbi.nlm.nih.gov/pubmed/29259054

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): NATIONAL, Campaign

Intervention Results:

Exposure to a national anti-smoking campaign for a general audience was associated with smoking cessation in pregnant women. Cessation rates were stable during 2009–2011 but increased at the time Tips 2012 aired and remained elevated. Overall, 32.9% of unexposed and 34.7% of exposed smokers quit by the third trimester (p<0.001). Exposure to Tips 2012 was associated with increased cessation (adjusted OR: 1.07, 95% CI 1.05 to 1.10). Cessation benefits were observed across most subgroups, including adolescents under 18 years of age, Medicaid-insured women and women with less than a high school education, and that media buy dose was positively associated with cessation rates.

Fallin-Bennett A, Rademacher K, Dye H, Elswick A, Ashford K, Goodin A. Perinatal Navigator Approach to Smoking Cessation for Women With Prevalent Opioid Dependence. Western Journal of Nursing Research 2019 Feb 6:193945918825381. doi: 10.1177/0193945918825381.

Link: https://www.ncbi.nlm.nih.gov/pubmed/30724661

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Patient Navigation, Other Person-to-Person Education, Referrals

Intervention Results:

The pilot PWN intervention enrolled a high-risk population of pregnant or early postpartum patients who smoked and demonstrated significant reductions in cigarettes smoked per day by participants, as well as decreases in postnatal depression and stress. This pilot program had minimal success with promoting total tobacco cessation. However, this program demonstrated success in reducing cigarettes per day and nicotine dependence.

Forinash AB, Yancey A, Chamness D, Koerner J, Inteso C, Miller C, Gross G, Mathews K. Smoking Cessation Following Text Message Intervention in Pregnant Women. Annals of Pharmacotherapy 2018 Nov;52(11):1109-1116. doi: 10.1177/1060028018780448. Epub 2018 Jun 1.

Link: https://journals.sagepub.com/doi/10.1177/1060028018780448

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Patient Reminder/Invitation, Telephone Support

Intervention Results:

Two-week cessation was achieved by 57.1 percent of the texting group versus 31.3 percent in the control group. No difference was found in cessation rates for cold turkey (50%), NRT patch (38.9%) or buprion cessation (50%). At follow-up, 8 women reported they successfully quit, while 7 of those were verified by eCO testing. Post analysis revealed that there were no statistical differences between black and white patients and those who lived with or without smokers in the household. However, black patients in the texting group were more likely to quit than black patients in the SOC-only group. There were no differences in birth outcomes between groups.

Glover M, Kira A, Smith C. Enlisting "Aunties" to support indigenous pregnant women to stop smoking: Feasibility study results. Nicotine & Tobacco Research 2016;18:1110-5.

Link: https://www.ncbi.nlm.nih.gov/pubmed/26253617

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Home Visits, Other Person-to-Person Education, PROVIDER/PRACTICE, Outreach (Provider)

Intervention Results:

The cultural community health workers (CHWs) were able to find women who smoked while pregnant. Although they did provide support at the initial visit, the continued level of support provided varied. Based on the medical records, 24% reported quitting. Māori CHWs are best placed to find women early in pregnancy and provide cessation information, support and referral in a way consistent with traditional Māori knowledge and practices and this study suggests such an intervention could increase abstinence from smoking while pregnant.

Griffis H, Matone M, Kellom K, Concors E, Quarshie W, French B, Rubin D, Cronholm PF. Home visiting and perinatal smoking: a mixed-methods exploration of cessation and harm reduction strategies. BioMed Central Public Health 2016 Aug 11;16(1):764. doi: 10.1186/s12889-016-3464-4.

Link: https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3464-4

NPM: 14-1: Smoking During Pregnancy
Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Home Visits, Motivational Interviewing, Referrals, Educational Material

Intervention Results:

A program effect was seen for smoking cessation among light (less than ten cigarettes during the first trimester) and heavy (20 or more cigarettes during the first trimester) baseline smoking clients. Clients who were light baseline smokers had a 45 % probability of smoking cessation compared to 38 % for comparison women (p <0.01; Table 3). Heavier baseline smoking clients also had a higher probability of smoking cessation—16 % compared to 12 % (p = 0.01). Qualitative: Four of the 19 clients who smoked described achieving cessation, with three suggesting that their behavior change was motivated primarily by their pregnancy rather than a direct program effect. There was also a program effect for smoking reduction. Using smoking to reduce stress was a frequently reported barrier to smoking reduction and cessation.
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This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U02MC31613, MCH Advanced Education Policy, $3.5 M. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.