Best Beginnings for Babies Birth Sister Program Evaluation
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Peer support during labor, birth and the perinatal period (also known as "doula" support) has
      been shown in some studies to reduce cesarean rates, postpartum depression and increase
      breastfeeding rates. The purpose of this program evaluation is to prospectively assess the
      clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the
      few established, hospital-based programs in the United States. To enhance the capability of
      the Birth Sisters Program to impact social determinants of perinatal health in a low-income
      population, the program evaluation will include the addition of Medical Legal Partnership for
      Children's (MLP) training and referral services. This program will be described as the Birth
      Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB
      compared with no Birth Sister support for women receiving maternity care at Boston Medical
      Center. Eligible women will be randomly assigned either BBB services or usual care. All women
      will be consented and interviewed in the mid-second trimester of pregnancy and interviewed
      again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8 prenatal Birth
      Sister visits in the home or at Boston Medical Center starting at 6 months of pregnancy,
      continuous support through labor and birth, and up to 4 postpartum Birth Sister visits in the
      home or at Boston Medical Center. The usual care group will receive no birth sister support
      but does have access to standard interdisciplinary maternity care services. The primary
      outcomes will be reduction in cesarean rate. Secondary outcomes will include cost, labor
      interventions, infant outcomes, satisfaction with care and psychosocial outcomes, including
      depression, social functioning and self-efficacy.
    

Detailed description: 
      Racial and income disparities in maternal and perinatal outcomes in the United States are
      large and persistent. Maternal and infant morbidity and mortality alike are 2-3 times higher
      in the black population than in the white population. Poor women in general are more likely
      to have babies born prematurely or with low birth weight compared with women from a higher
      socio economic strata. Infants born either too early or too small are at risk for a lifetime
      of disabilities, perpetuating the cycle of poverty and poor health. Low-income and minority
      populations are also less likely to breastfeed, putting children and mothers at higher risk
      for a variety of health problems, including obesity, diabetes, and some cancers.

      In addition to income and racial disparities, the nation as a whole struggles with inferior
      maternity care outcomes when compared with other developed countries. This is true despite
      considerably higher rates of maternity care expenditures. The unnecessarily high rate of
      cesarean birth is one factor that contributes to both high cost and poor outcomes. The
      Society of Maternal and Fetal Medicine and the American Congress of Obstetricians and
      Gynecologists have both called for innovations and strategies to reduce the high rate of
      cesarean birth.

      Community "doulas", or peer support during pregnancy, labor and birth, is one intervention
      that may both improve outcomes for low-income populations and lower the cost of maternity
      care. A culturally competent peer who provides caring support during a crucial life
      transition may lower stress and improve engagement in healthcare, therefore improving health
      status during pregnancy and lowering the need for costly medical care. Low income and
      minority women are more likely to desire a doula during labor and less likely to have access
      to their services.

      The Birth Sisters Program One of the few hospital-based community doula programs in the
      country, Boston Medical Center's Birth Sisters Program has provided multicultural doula
      support to childbearing women since 1999. The approximately 20 per diem Birth Sisters
      together speak over 10 languages. Birth Sisters are recruited from the communities served by
      the BMC maternity service and provide peer support throughout the perinatal period. Prenatal
      home visits focus on creating a relationship, identifying psychosocial needs and providing
      childbirth and breastfeeding education. The Birth Sister also assesses whether the woman is
      lacking in essential resources such as housing, food and baby care items. She then refers her
      client to social service agencies and helps her navigate those services as needed. During
      labor, the Birth Sister offers physical and emotional comfort measures, advocacy for the
      mother, and help with the first breastfeeding. Postpartum home visits provide assistance in
      the transition to motherhood, help around the house so that the mother can rest, education on
      breastfeeding, parenting and infant care, and connections to needed medical and social
      services.

      The Birth Sisters Program does not have resources to serve all women who would like a Birth
      Sister. investigators are currently able to meet approximately 20 percent of the demand.
      Prenatal providers have traditionally been the primary referral source for the program, with
      some providers referring often and others rarely referring. This has created inequities in
      whether women have a chance to receive a Birth Sister. investigators are now changing the
      referral process to systematically screen all potentially eligible women and allow eligible
      women to self-refer to the Birth Sister pool. A limited number of Birth Sister assignments
      are made from this pool each month. Women are informed about the Birth Sister pool through
      flyers placed in the obstetrical ultrasound unit and, if they would like to be in the pool,
      they fill out a form with their contact information and place it in the "Birth Sister pool"
      box. Due to the budget limitations, investigators restrict referrals to women who benefit
      most, including first time mothers with public insurance.

      Because investigators only have resources to serve a small portion of women who want a Birth
      Sister, investigators have designed an evaluation to provide rigorous evidence about the
      health and economic outcomes of our program. Prospective, high-quality data is needed to
      inform policy questions about the benefits of billable community doulas for Medicaid
      recipients. This is our justification for randomization in a study testing a standard care
      program.

      Purpose The primary objective of the proposed project is to determine the effectiveness of
      the Birth Sisters Program, in reducing cesarean birth rates and cost of care in a safety net
      population. The associated objectives are, by the end of the project, to demonstrate
      significant reductions in: depressive symptoms, low birth weight and preterm birth; and
      significant increases in breastfeeding rates in women accessing enhanced Birth Sisters as
      compared to women who are not supported by Birth Sisters. Effective interventions must be
      sustainable. Cost of care analyses will evaluate whether the incremental costs of the Birth
      Sisters Program services are justified by the savings brought about by lower rates of labor
      complications, cesarean sections, emergency room visits and NICU days.

      Of note, to improve the ability of the Birth Sisters to address social determinants of
      health, this evaluation will add training and consultations for Birth Sisters and their
      clients by Medical Legal Partnership (MLP). MLP is a team of legal experts who integrate
      legal assistance into the medical setting as a vital component of patient care to ensure that
      low-income patients are able to meet legal needs that impact on health. They will provide
      trainings for Birth Sisters on key legal issues, such as housing and benefits. They will also
      be available for consultation when the mother requires additional resources and information.

      Investigators hypothesize that women receiving the BBB intervention will:

        1. exhibit lower rates of cesarean sections, low birth weight and preterm birth, and
           neonatal intensive care unit days; and

        2. exhibit the highest rates of breastfeeding initiation, exclusivity, and continuation;

        3. experience reductions in depressive symptoms;

        4. incur lower health care costs than incremental program costs, providing evidence for
           long-term sustainability.
    

Intervention name(s): Birth Sisters Best Beginnings for Babies; Usual maternity care
Intervention type(s): Behavioral; Other
Intervention description(s): Birth Sisters Best Beginnings for Babies support during Pregnancy, Labor and Delivery and six weeks postpartum. Participants assigned to the Birth Sister group receive community doula services with consultation from the Medical Legal Partnership when indicated beginning at 24 weeks. Participants receive up to 8 two-hour prenatal home visits; continuous support through labor and birth, and up to 4 two-hour postpartum home visits through 6-8 weeks postpartum.; Usual prenatal, intrapartum and postpartum maternity care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care