Clinical trial NCT03296774: Healthy Beyond Pregnancy: Improving Postpartum Care
Official title: Healthy Beyond Pregnancy: A Pilot Usability and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Minority women and 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 poorly timed pregnancies and short duration of breastfeeding for the health of mothers, infants and children are well documented.

To decrease rates of poorly timed pregnancies, increase breastfeeding duration and address other postpartum concerns women must be engaged in their postpartum care outside of the traditional postpartum visit. In addition to contraceptive counseling and breastfeeding support, providers discuss a number of important maternal and child health issues at the postpartum visit. These include (1) screening and referral for postpartum mood disorders (2) screening for cardiometabolic consequences of pregnancy complications, (3) discussing inter-conception care and (4) connecting women with a primary care provider. Thus, as recommended by numerous professional societies, the standard postpartum visit at 4 to 6 weeks after delivery has considerable value to women's postpartum care.

Attendance rates for the postpartum visit are markedly lower for women with limited resources contributing to racial and economic health disparities. Despite receiving excellent prenatal care, only 40% of the economically disadvantaged women who receive prenatal care at the Magee outpatient clinic 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. Additionally, minority women disproportionally receive Medicaid and thus interventions that focus on Medicaid recipients have the potential to address racial as well as economic disparities. These data demonstrate that the current care model does not engage all women to make good health care decision postpartum and is disproportionately failing our most vulnerable moms and babies.

Empirically derived concepts from behavioral economics can be leveraged to design interventions that support participants to make better health decisions and may be particularly useful for postpartum care.

The feasibility trial will focus on four tenants of behavioral economics-bounded rationality (information overload), status quo bias (lack of self-control), hovering (limited attention), and framed incentives-- that have been successfully used to tackle stubborn health problems such as smoking and obesity. Importantly, unlike tobacco cessation or weight loss, many aspects of postpartum care such as compliance with the visit or uptake of LARC, do not require on-going action on part of the patient and thus may be particularly amenable to the lessons of behavioral economics.

Specific Aim 1: To conduct a pilot trial evaluating the feasibility and acceptability of a future randomized trial to determine the efficacy of Healthy Beyond Pregnancy on adherence with the postpartum visit.

Specific Aim 2: To determine the impact of Healthy Beyond Pregnancy on adherence with the postpartum visit.


Eligibility criteria: Inclusion Criteria:

* Postpartum 6-72 hours from delivery, aged 18-50, receipt of prenatal care through the Magee-Womens Hospital outpatient clinic and UPMC for You Medicaid insurance.

Exclusion Criteria:

* Delivery less than 24 weeks, fetal or neonatal death, non-English speaking, no text-enabled phone

Primary outcomes:
measure: Number of eligible participants who consent and complete study intervention
timeFrame: 1-4 days postpartum
Secondary outcomes:
measure: Adherence with postpartum visit- number of participants who return for postpartum visit.
timeFrame: 21-56 days after delivery
Other outcomes:
Locations:
Study officials:
References:
citation: Himes KP, Donovan H, Wang S, Weaver C, Grove JR, Facco FL. Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial. JMIR Hum Factors. 2017 Oct 10;4(4):e26. doi: 10.2196/humanfactors.7964.