Healthy Beyond Pregnancy: Improving Postpartum Care

Healthy Beyond Pregnancy: A Pilot Usability and Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Care
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Healthy Beyond Pregnancy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care; Usual postpartum care	Behavioral: Usual Care
Experimental: Healthy Beyond Pregnancy; Web-based program for postpartum care and education and scheduling. Incentive for committing and returning for postpartum care.	Behavioral: Healthy Beyond Pregnancy; Web-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eligible participants who consent and complete study intervention	Assess the feasibility of a larger randomized controlled trial	1-4 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence with postpartum visit- number of participants who return for postpartum visit.	Did participant come for postpartum visit	21-56 days after delivery

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PRO16090292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No