Clinical trial NCT04257552: Care After Pregnancy Study (CAPS): Engaging Women in Postpartum Care
Official title: Care After Pregnancy Study (CAPS): Randomized Controlled Trial of Patient Engagement After Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Care
Keywords: contraception
postpartum care
breast feeding
interconception care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-02-06
Enrollment: 128
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overarching hypothesis of our research agenda is that an intervention that engages economically disadvantaged women in personalized postpartum care will promote equality in maternal child health. As a first step to test our hypothesis the investigators propose the following aims:

Specific Aim 1: Measure the impact of Healthy Beyond Pregnancy on key components of postpartum care, including use of effective contraception at three and six months postpartum and breastfeeding duration at three and six months.

Specific Aim 2: Determine if Healthy Beyond Pregnancy improves adherence to health screening and linkage to follow-up care for women with cardio-metabolic complications of pregnancy.

Detailed description: There are profound economic inequalities in a wide range of important maternal and child health outcomes ranging from neonatal death to maternal morbidity and mortality. The overarching scientific premise for our proposal is that these inequalities stem in part from poor engagement in postpartum care by economically disadvantaged women. The investigators hypothesize that an innovative intervention grounded in empirically derived tenets of behavioral economics that includes the critical components of the American College of Obstetricians and Gynecologists (ACOG) new vision for postpartum care will narrow gaps in important maternal child health outcomes.

Women of lower socioeconomic status are at significantly increased risk of unintended pregnancies, short inter-pregnancy interval and short duration of breastfeeding. The consequences of untimed pregnancies and short duration of breastfeeding for the health of mothers, infants and children are well documented. In addition to significant health implications, these inequalities have important economic ramifications. The cost of births from unintended pregnancies in 2006 was estimated at $11 billion in maternity and infant care. This does not include cost of abortion care, lost productivity, and government assistance.

Providers have effective postpartum strategies to reduce the risk of poorly timed pregnancies and low breastfeeding rates.

Short interval or poorly timed pregnancies: Women have a range of effective contraceptive options, however, not initiating contraception postpartum remains common. The provision of long-acting reversible contraception (LARC) including intrauterine devices (IUDs) and hormonal implants has been shown to decrease short interval pregnancies and the associated risk of preterm birth. Importantly, given the array of contraceptive options available to women, it is important to make LARC accessible while empowering women to choose a method that is effective and acceptable to them. This highlights the need for solutions to engage women in patient centered comprehensive contraceptive decision-making in the postpartum period.

Short Breastfeeding Duration: A number of strategies have been shown to increase breastfeeding success. Most relevant to our proposal is that efforts to educate women about the benefits of breastfeeding, weekly text reminders in the immediate postpartum period, and access to a lactation consultant have all improved both duration and exclusivity of breastfeeding. Importantly, three recent trials demonstrated significant increases in exclusive breastfeeding from eight weeks to six months postpartum among women who received weekly-automated text message breastfeeding support. These interventions may be particularly relevant to our target population, as low-income, non-Hispanic Black women between 18-29 years send and receive text messages more frequently than any other demographic.

There are important high-risk subgroups of women who benefit uniquely from postpartum care given the need to link these women to primary or specialty health care providers in postpartum period.

Gestational diabetes (GDM): GDM complicates roughly 6-9% of pregnancies, but disproportionately burdens those with lower socio-economic status. Women with GDM are at increased risk of type 2 diabetes, metabolic syndrome, and cardiovascular disease after delivery. These findings are present as early as 3 months postpartum with the absolute risk of Type 2 diabetes approaching 5% a year postpartum. Professional societies recommend screening women for diabetes 4-12 weeks after delivery and linking women to primary care to improve long-term maternal health. In 2016, only 14% of economically disadvantaged women who received prenatal care at the Magee-Womens Hospital outpatient clinic returned for their postpartum screening. This is slightly better than national trends, which suggest roughly 6% of women with GDM had recommend postpartum screening and 13.8% had a primary care visit within a year.

Hypertensive disorders of pregnancy: Hypertensive disorders of pregnancy occur in roughly 6-8% of pregnancies and low SES is an independent risk factor. Women with hypertensive disorders of pregnancy, either gestational hypertension or preeclampsia, are more than twice as likely to develop hypertension or prehypertension in the 12 months after delivery. They are also at increased risk for cardiovascular disease. Given this, women with a hypertensive disorder of pregnancy should have early postpartum follow up for a blood pressure and establish care with a primary care physician within a year of delivery.

Recognizing the importance of the postpartum period for the health of women and children across their lifespans, ACOG recently proposed a new paradigm for postpartum care. In their new vision for postpartum care ACOG emphasized the following: 1) Postpartum care should be an on-going process rather than a single encounter 2) The content of postpartum care should be tailored to a woman's individual needs 3) The timing of the postpartum visit should be individualized for a woman. How to implement and scale this model of postpartum care and whether it will improve health outcomes for women and children has not been investigated.

Despite considerable maternal morbidity and mortality in the postpartum period, attendance rates for the postpartum visit are markedly lower for women with limited resources contributing to economic health disparities. While women with Medicaid receive excellent prenatal care, only 50% of them return for their postpartum visit. These parallel national trends, where 60% of women with Medicaid insurance return for a postpartum checkup compared with over 82% of women with private insurance. Medicaid programs serve pregnant women who are particularly vulnerable to poor health outcomes and thus this gap is critical. These data demonstrate that our current care model does not engage all women in quality postpartum care and is disproportionately failing our most vulnerable moms and babies.

Existing interventions to improve adherence with the postpartum visit have not been rigorously evaluated, would be difficult to scale, and do not reflect the new vision for postpartum care outlined by ACOG.

Empirically derived concepts from behavioral economics can be leveraged to design interventions that support patient's engagement in their health. The field of behavioral economics acknowledges that people do not make exclusively rational choices. In fact, immediate (rather than future) needs, cognitive and psychological biases, and social norms profoundly influence decision-making. Insights from the field of behavioral economics have begun to influence the health sciences as researchers seek more effective health interventions and health policy.

Healthy Beyond Pregnancy incorporates tenets of behavioral economics that address two powerful drivers of behavioral change-- awareness and willingness. Awareness has three parts: 1) an awareness of how one's behavior affects oneself 2) an awareness of how one's actions impact others and 3) an awareness of social norms around the given behavior. Awareness alone, however, is insufficient to alter behavior. People must be willing to change their behavior. Designing health interventions that address both awareness and willingness are more likely to lead to behavior change.

In the current proposal the investigators focus on four tenets of behavioral economics-bounded rationality (information overload), status quo bias (valuing the present self over the future self), hovering (limited attention), and framed incentives-- that address both awareness and willingness and have been successfully used to tackle stubborn health problems such as smoking and obesity. Both bounded rationality and hovering address awareness, while status quo bias and framed incentives address willingness.

In summary, this proposal is significant because it will evaluate the impact of an innovative program built on empirically derived concepts of behavioral economics on health decision-making in the postpartum period- a critical window for maternal child health. Our program directly mirrors the new vision for postpartum care outlined by ACOG. Additionally, it targets low-income women who are at risk for not participating in postpartum care to promote equality in maternal child health.

Eligibility criteria: Inclusion Criteria:

* Insured by a PA Medicaid insurance
* Pregnancy care in the Magee Womens Hospital Outpatient Clinic

Exclusion Criteria:

* Delivery less than 24 weeks
* Fetal or neonatal demise
* Women who had a postpartum tubal ligation
* Women less than 18 year of age

Primary outcomes:
measure: Number of Participants Using a Non-barrier Method of Contraception
timeFrame: 3 months after delivery
measure: Number of Participants Using a Non-barrier Method of Contraception
timeFrame: 6 months after delivery
measure: Adherence of Postpartum Visit
timeFrame: 12 weeks after deliery
Secondary outcomes:
measure: The Number of Participants Who Given Their Infant Breast Milk
timeFrame: 1 week after delivery
measure: The Number of Participants Who Given Their Infant Breast Milk
timeFrame: 1 month after delivery
measure: The Number of Participants Who Given Their Infant Breast Milk
timeFrame: 3 months after delivery
measure: The Number of Participants Who Given Their Infant Breast Milk
timeFrame: 6 months after delivery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Francesca Facco, MD
role: PRINCIPAL_INVESTIGATOR
References: