Medicaid Interventions + Doula Care for Maternal Health

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-Medicaid, Non-Black, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

10000000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug varenicline for maternal health?

The research shows that varenicline is effective as an aid to smoking cessation, which can lead to health benefits by reducing smoking-related diseases. However, there is no direct evidence in the provided research about its effectiveness for maternal health specifically. ^{1 2 3 4 5}

Is the combination of Medicaid interventions and doula care safe for maternal health?

The safety data available primarily concerns varenicline, a medication used for smoking cessation, which has been associated with neuropsychiatric side effects like depression and suicidal thoughts. However, this information is not directly related to Medicaid interventions or doula care for maternal health. ^{2 4 5 6 7}

How does the treatment Medicaid Interventions + Doula Care for Maternal Health differ from other treatments for maternal health?

This treatment is unique because it combines Medicaid interventions with doula care, which provides continuous labor support and focuses on childbirth education, breastfeeding, and newborn care. Unlike standard medical care, this approach aims to improve maternal and infant health outcomes by addressing both medical and psychosocial needs, potentially reducing health disparities and unnecessary medical interventions. ^{8 9 10 11 12}

What is the purpose of this trial?

The goal of this study is to learn about the effects of structural inventions, such as equity-focused Medicaid polices, on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are: 1. What is the effect of Medicaid healthcare quality interventions on SMM? 2. What is the effect of Medicaid healthcare quality interventions + doula care? 3. What are Medicaid beneficiaries' experiences in receiving services and the potential impact of integration of doula services and equity practices? Participants will be asked to describe experiences as a result of structural interventions and focused Medicaid policies.

Eligibility Criteria

This trial is for Black Medicaid beneficiaries in PA Health Equity Zones, doulas caring for them, and Medicaid MCO administrators in Pennsylvania. It's also open to pregnant and postpartum Medicaid beneficiaries across the US. The study will use healthcare records to assess severe maternal morbidity and mortality outcomes.

Inclusion Criteria

Doulas who provide care to Medicaid beneficiaries in Pennsylvania

Pregnant and postpartum Medicaid beneficiaries across the US

Medicaid beneficiaries who self-identify as Black and/or live in PA Health Equity Zones

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants experience Medicaid healthcare quality interventions and doula care to assess effects on severe maternal morbidity and racial equity

20 weeks gestation through 42 days postpartum

Follow-up

Participants are monitored for chronic conditions and receive guideline concordant care for up to 1 year postpartum

43 days through 1 year after delivery

Qualitative Assessment

Qualitative data collection from Medicaid beneficiaries, doula care providers, and MCO leadership to assess experiences and perspectives

Years 2, 3, and 4

Treatment Details

Interventions

• Doula
• Medicaid healthcare quality interventions (equity payment and obstetric bundled payment)
• Standard Care

Trial Overview The study examines the impact of equity-focused Medicaid policies on severe maternal morbidity (SMM) and mortality. It compares standard care with two interventions: quality interventions alone, or combined with doula care. Participants' experiences with these services are also evaluated.

Participant Groups

Group I: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) Only Experimental Treatment 2 Interventions

The investigators will employ a quasi-experimental study design to test two hypotheses: H1: SMM rates among Black people will decline after the interventions (equity payment and obstetric bundled payment), relative to people of other race groups within Pennsylvania (PA); and H2: Racial inequities in SMM will decline among those exposed to the interventions in PA, relative to those in similar states. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare interventions on beneficiaries' experiences.

Group II: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) + Doula Experimental Treatment 3 Interventions

Group III: Doula Only Experimental Treatment 2 Interventions

The investigators will test two hypotheses: H1: SMM rates among Black people will decline more after the addition of doula care in PA, relative to healthcare quality interventions alone. H2: Racial inequities in SMM will decline more among those exposed to both healthcare quality and doula care interventions in PA, relative to states implementing doula care only. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare and service interventions on beneficiaries' experiences.

Group IV: Standard Care Active Control 1 Intervention

Standard Care is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Varenicline for:

• Smoking cessation

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in Japan as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

In 2006, 39 state Medicaid programs provided some form of tobacco-dependence treatment, indicating a significant increase in support for smoking cessation among Medicaid recipients.

Despite progress, substantial increases in Medicaid coverage for tobacco-dependence treatments are still needed to meet the Healthy People 2010 objective for comprehensive coverage across all states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State Medicaid coverage for tobacco-dependence treatments--United States, 2006. [2008]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

Varenicline is an effective and generally well-tolerated medication for smoking cessation, acting as a partial agonist at nicotinic acetylcholine receptors, although further research is needed on its potential neuropsychiatric side effects.

Pharmacoeconomic analyses indicate that varenicline is a cost-effective treatment for smoking cessation, outperforming other therapies like bupropion and nicotine replacement in terms of cost per quality-adjusted life-year gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacoeconomic spotlight on varenicline as an aid to smoking cessation. Keating, GM., Lyseng-Williamson, KA.[2021]

In a study of 70 patients with brain lesions, those who quit smoking after their injury (Quitters) did not show higher rates of depression compared to those who continued smoking (Non-Quitters), indicating that smoking cessation itself is not linked to increased depression in this population.

The findings suggest that the neuropsychiatric side effects associated with varenicline, such as depression, are likely due to the medication rather than the act of quitting smoking, as both groups exhibited similar levels of depression and related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation after brain damage does not lead to increased depression: implications for understanding the psychiatric complications of varenicline. Tranel, D., McNutt, A., Bechara, A.[2021]

Varenicline is an effective smoking cessation aid that works as a partial agonist at nicotinic acetylcholine receptors, with a standard dosage of 1 mg twice daily for 12 weeks, showing a linear pharmacokinetic profile across various populations including smokers and nonsmokers.

The drug is primarily excreted unchanged in urine and does not significantly interact with other medications, making it safe for use alongside common drugs; however, nausea is the most common side effect, particularly at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the clinical pharmacokinetics and pharmacodynamics of varenicline for smoking cessation. Faessel, HM., Obach, RS., Rollema, H., et al.[2022]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

A study involving 885,185 infants found that exposure to varenicline during pregnancy did not significantly increase the risk of major congenital malformations, with 3.6% of exposed infants showing such malformations compared to 4.3% in the unexposed group.

The research suggests that using varenicline during pregnancy is not associated with higher rates of adverse birth outcomes, including stillbirth and preterm delivery, indicating it may be a safer option for pregnant women trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of adverse birth outcomes after maternal varenicline use: A population-based observational study in Denmark and Sweden. Pedersen, L., Petronis, KR., Nørgaard, M., et al.[2020]

The doula-home-visiting program significantly increased attendance in childbirth-preparation classes and improved infant-care behaviors, such as placing infants on their backs to sleep and using car seats, compared to standard case management.

Mothers in the intervention group were less likely to use epidurals or pain medication during labor and more likely to initiate breastfeeding, although the latter effect did not last over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Hans, SL., Edwards, RC., Zhang, Y.[2019]

A survey of 51 Title V Maternal and Child Health agency officials in 1986 revealed that while nearly all states offered prenatal care programs for uninsured women, restrictive eligibility and limited access meant that only a small fraction of those in need could benefit from these services.

Most states had pediatric outpatient programs, but many were limited to 'well-child' care, with only a few providing comprehensive services, highlighting significant gaps in healthcare access for low-income children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal and child health services for medically indigent children and pregnant women. Rosenbaum, S., Hughes, DC., Johnson, K.[2019]

Continuous labor support from trained doulas significantly improves maternal and infant health outcomes, enhances satisfaction with maternity care, and can reduce healthcare costs.

To increase access to doula services, especially for at-risk women, eliminating cost barriers through Medicaid and private insurance coverage is essential, with various pathways identified for reimbursement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdue: Medicaid and Private Insurance Coverage of Doula Care to Strengthen Maternal and Infant Health. Strauss, N., Sakala, C., Corry, MP.[2020]

Women covered by Medicaid or CHIP reported that the Strong Start initiative significantly improved their maternity care experience by focusing more on psychosocial factors and providing better education and support compared to typical care.

Participants appreciated the longer appointments and community referrals, but some expressed concerns about continuity of care and challenges attending visits due to childcare issues, highlighting areas for improvement in enhanced prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do women in Medicaid say about enhanced prenatal care? Findings from the national Strong Start evaluation. Hill, I., Cross-Barnet, C., Courtot, B., et al.[2020]

Doula care can improve health outcomes, enhance the experience of care, and lower healthcare costs by reducing unnecessary medical interventions, aligning with the goals of the Affordable Care Act.

Increasing reimbursement for doula services through private insurance and Medicaid could enhance access to doulas, potentially lowering cesarean rates and addressing health disparities in maternal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Doula Care Can Advance the Goals of the Affordable Care Act: A Snapshot From New York City. Strauss, N., Giessler, K., McAllister, E.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

State Medicaid coverage for tobacco-dependence treatments--United States, 2006. [2008]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacoeconomic spotlight on varenicline as an aid to smoking cessation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation after brain damage does not lead to increased depression: implications for understanding the psychiatric complications of varenicline. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A review of the clinical pharmacokinetics and pharmacodynamics of varenicline for smoking cessation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Risk of adverse birth outcomes after maternal varenicline use: A population-based observational study in Denmark and Sweden. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Maternal and child health services for medically indigent children and pregnant women. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Overdue: Medicaid and Private Insurance Coverage of Doula Care to Strengthen Maternal and Infant Health. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

What do women in Medicaid say about enhanced prenatal care? Findings from the national Strong Start evaluation. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

How Doula Care Can Advance the Goals of the Affordable Care Act: A Snapshot From New York City. [2020]