Baby2Home (B2H) Mobile Health Application: A Randomized-Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Usual Care
- Conditions
- COVID-19 Pandemic
- Sponsor
- Women and Infants Hospital of Rhode Island
- Enrollment
- 642
- Locations
- 2
- Primary Endpoint
- Completion of preventive health services utilization for all family members (birthing, non-birthing, and infant)
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, 2) improves maternal and paternal patient reported outcomes, and 3) reduces racial/ethnic and income-based disparities in preventive health services utilization and parental patient reported outcomes.
Detailed Description
The transition to new parenthood is marked by dramatic changes in social roles and responsibilities. To support new parents, obstetric and pediatric healthcare surrounding this transition is designed with a supportive focus to facilitate new parents' navigation of the attendant life changes. The COVID-19 pandemic has altered healthcare delivery in ways that have limited these supportive obstetrics and pediatric services provided at the beginning of new parenthood. Consequently, aspects of preventative healthcare, such as monitoring for symptoms of postpartum depression, discussing optimal birth control options, educating parents on recommended adult and pediatric vaccinations, and providing anticipatory guidance on infant wellness, are less robust. In addition, without professional guidance and support, outcomes of foundational importance to new parents, such as perceived stress, depressive and anxiety symptoms, or parenting and breast-feeding self-efficacy, are worse. Moreover, the COVID-19 pandemic has underscored the impact of the social determinants of health on new family wellness, with racial/ethnic minority and low-income families being differentially impacted by COVID-19 pandemic driven healthcare delivery changes. Recognizing the potential for longitudinal changes in healthcare delivery engendered by the COVID-19 pandemic, a scalable, patient-centered, equity-focused intervention designed to bridge gaps in healthcare services around the transition to new parenthood is needed. "Bridging gaps in healthcare delivery to COVID-19 for parent and infants from birth through the first year of life" aims to evaluate Baby2Home (B2H) a patient-informed digital healthcare intervention that s is specifically responsive to the COVID-19 pandemic's impact on new families, with a focus on health equity for racial/ethnic minority and low-income families. B2H builds upon previous digital health successes while incorporating the evidence-based collaborative care model for mental health support. B2H is designed to mitigate the adverse effects of healthcare delivery changes in response to the COVID-19 pandemic and to improve health for mothers, fathers, and infants over the first year of life. Developed from feedback given by new parents who delivered during the COVID-19 pandemic, B2H provides 1) parental education about their own physical and mental health, 2) infant wellness resources and tracking of recommended healthcare services, 3) parental mental health screening and support, and 4) systematic case review to optimize the health of new families. The investigators will test the efficacy of B2H via a randomized control trial. In total, 640 diverse families will be randomly to either usual care or B2H intervention arm to evaluate whether, compared to usual care, B2H health services utilization and patient reported outcomes of foundational important to new families. addition, the investigators will evaluate the impact of B2H on racial/ethnic and income-based disparities observed in both services utilization and patient reported outcomes.
Investigators
Emily Miller
Associate Professor
Women and Infants Hospital of Rhode Island
Eligibility Criteria
Inclusion Criteria
- •Delivery at Prentice Women's Hospital or Women and Infants Hospital of Rhode Island
- •Viable term infant (≥ 37 weeks)
- •First live born child
- •English speaking
- •Age 18 years old or greater
- •Access to a smartphone
- •Access to a working email address
Exclusion Criteria
- •No smartphone access
- •Infant death
- •Infant requires NICU admission
- •Known severe mental illness of either parent (e.g., bipolar disorder, schizophrenia)
- •SARS-CoV-2 infection without clinical clearance
- •History of IPV (intimate partner violence) with current partner (would exclude partner)
- •Concurrent enrollment in studies that may affect the outcome of the trial (or vice versa)
Arms & Interventions
Usual Care
As a pragmatic trial, usual care will be defined by contemporary clinical standards. For maternal care, this includes a comprehensive medical visit between 4-12 weeks postpartum. This visit includes utilization of a validated screen for postpartum depression and, if that screen is positive, a clinical assessment and initiation of treatment (e.g. pharmacotherapy or referral for psychotherapy). In addition, this visit includes a discussion of contraception as well as supportive education on breastfeeding. For paternal care, clinical standards are gleaned from the AAP, ACOG, and USPSTF reports outlining mental health screening, reproductive health, and vaccine uptake. For infant care, standard pediatric care from the AAP and Bright Futures periodicity timeline and guidelines will be used. In addition, assignment in this arm will be given surveys at baseline, 1M, 2M, 4M, 6M, and 12M.
Baby2Home Intervention
Families randomized to the intervention arm will receive the B2H services. B2H is a novel digitized CC-based intervention delivered via a smartphone app available on iOS or Android phones, built by combining two successful programs: NICU2Home+ app and CC services. Using the UCD methodologies, AI-based communication within the app will include education for mothers and fathers on the standard of care regarding self-care and newborn care after hospital discharge as well as education, reminders and scheduling for recommended preventative healthcare services for themselves and their new infant.
Intervention: Baby2Home Mobile Application
Outcomes
Primary Outcomes
Completion of preventive health services utilization for all family members (birthing, non-birthing, and infant)
Time Frame: Baseline through 1 year postpartum
The primary outcome defined as positive if all of the items below are met for all family members: 1. optimal maternal preventive health services utilization over the 1st year postpartum (including attendance at the comprehensive postpartum visit, receives chosen contraceptive method, and undergoes postpartum depression screening) 2. optimal paternal/co-parental preventive health services utilization over the 1st year postpartum (including receiving recommended vaccinations for new parents, if desires a male-driven contraceptive option, receives chosen method, and undergoes screening for depression) 3. optimal infant preventive health services utilization over the 1st year postpartum (including attending all AAP recommended wellness visits, receiving all AAP recommended vaccines, and receiving breast milk for 6 months of life)
Secondary Outcomes
- Number of participants who attend comprehensive postpartum visit (birthing parent)(At least once between 4 and 12 weeks postpartum)
- Completion of postpartum depression screening (birthing parent)(Through study completion, up to 12 months)
- Number of participants who received contraception (birthing and non-birthing parent)(Through study completion, up to 12 months)
- Number of participants who received the recommended vaccinations (non-birthing parent)(Through study completion, up to 12 months)
- Completion of postnatal depression screening for non-birthing parent(Through study completion, up to 12 months)
- Number of participants who attended well-child visits for the infant(Through study completion, up to 12 months)
- Number of participants who received the recommended vaccinations for infant(Through study completion, up to 12 months)
- Continued breastfeeding for infants until 6 months(Through study completion, up to 6 months)
- Duration of breastfeeding (birthing parent)(Through study completion, up to 6 months)
- Patient reported outcomes: stress symptoms (for birthing and non-birthing parent)(Month 1, 2, 4, 6, and 12)
- Patient reported outcomes: depressive symptoms (for birthing and non-birthing parent)(Month 1, 2, 4, 6, and 12)
- Patient reported outcomes: anxiety symptoms (for birthing and non-birthing parent)(Month 1, 2, 4, 6, and 12)
- Patient reported outcomes: global health status (for birthing and non-birthing parent)(Month 1, 2, 4, 6, and 12)
- Patient reported outcomes: relationship assessment (for birthing and non-birthing parent)(Month 1, 2, 4, 6, and 12)
- Patient reported outcomes: self-efficacy (for birthing and non-birthing parent)(Month 1, 2, 4, 6, and 12)
- Patient reported outcomes: parenting self-efficacy (for birthing and non-birthing parent)(Month 12)
- Patient reported outcomes: breastfeeding self-efficacy (for birthing parent)(Month 1, 2, 4, 6, and 12)