Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 5, 2021
Date Accepted: Mar 8, 2021
Development and Implementation of a Mobile Technology for High-Risk Pregnant Women to Deliver Effective Caregiving for Neonatal Abstinence Syndrome: Mixed Methods Study Protocol
ABSTRACT
Background:
The United States continues to experience an alarming rise in opioid use that includes women who become pregnant and related Neonatal Abstinence Syndrome (NAS). Most newborns experiencing NAS require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no education, training or otherwise interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS.
Objective:
This protocol describes a mixed method, multi-stage study to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled trial.
Methods:
Stage 1 will include n=20 semi-structured interviews with a panel of neonatology experts, NAS care providers, and mothers with experience caring for NAS-affected infants to gather their recommendations on management of NAS and explore their perspectives on the care of these newborns. Findings will guide the adaptation of the existing mobile NAS tool for high-risk pregnant women. In stage 2, we will test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with n=10 pregnant women receiving Opioid Agonist Therapy (OAT). Finally, in stage 3 we will randomize n=30 high-risk pregnant women receiving OAT to either get the adapted mobile NAS caregiving tool or usual care. We will compare these women on primary outcomes: maternal drug relapse and OAT continuation, and secondary outcomes: maternal-newborn bonding, length of newborn hospital stays, readmissions rates, breastfeeding initiation and duration, and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum.
Results:
This project (https://grantome.com/grant/NIH/K01-DA051780-01) was funded in July 2020 and approved by the Institutional Review Board in April 2020. Data collection for Stage 1 began in December 2020 and as of January 2021 we completed n=18 semi-structured interviews (n=10 with NAS providers; n=8 with perinatal women receiving OAT). Common themes from all interviews will be analyzed in spring 2021 to inform the adaptation of the NAS caregiving tool. Results from stage 1 are expected to be published in summer 2021. Stage 2 data collection will commence in fall 2021.
Conclusions:
Findings have the potential to improve NAS care and maternal-newborn outcomes, as well as lead to commercialized product development. If effective, our new tool will be well-suited to tailoring for other high-risk perinatal women. Clinical Trial: NCT04783558
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