NCT03296774

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
Last Updated

November 18, 2023

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

September 18, 2017

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of eligible participants who consent and complete study intervention

    Assess the feasibility of a larger randomized controlled trial

    1-4 days postpartum

Secondary Outcomes (1)

  • Adherence with postpartum visit- number of participants who return for postpartum visit.

    21-56 days after delivery

Study Arms (2)

Usual Care

PLACEBO COMPARATOR

Usual postpartum care

Behavioral: Usual Care

Healthy Beyond Pregnancy

EXPERIMENTAL

Web-based program for postpartum care and education and scheduling. Incentive for committing and returning for postpartum care.

Behavioral: Healthy Beyond Pregnancy

Interventions

Web-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care.

Healthy Beyond Pregnancy
Usual CareBEHAVIORAL
Usual Care

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy based study
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 28, 2017

Study Start

November 1, 2016

Primary Completion

February 15, 2017

Study Completion

May 30, 2017

Last Updated

November 18, 2023

Record last verified: 2017-09