Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05226624 |
| Other study ID # |
Pro00111771 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
University of Alberta |
| Contact |
Matt Hicks, MD, PhD |
| Phone |
780-492-1772 |
| Email |
mhicks1[@]ualberta.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Neonatal Abstinence Syndrome (NAS), is a common and costly problem in Alberta that affects
approximately 250 babies per year exposed to drugs during pregnancy. Unfortunately, this has
become more common in the last 10 years. Babies with NAS can be very difficult to care for
with poor feeding, diarrhea, and extreme irritability. These babies often receive specialized
care and medications in the Neonatal Intensive Care Unit (NICU), which leads to separation of
mothers and babies at a time when it is most important that they be together. This separation
is traumatic for families and expensive for the health and foster care systems, as babies
often end up being cared for by governmental agencies. Recent research has shown that keeping
mothers and babies together in a quiet, supportive environment in hospital, called 'rooming
in', leads to a decreased need for NICU admission, decreased amount of time spent in the
NICU, increased rates of breastfeeding, and an increase in babies going home with their
mothers. This project will systematically introduce a program of 'rooming-in' to hospitals in
Alberta to determine if the investigators can improve NAS care provided to babies and
mothers. The goal is to decrease NICU admission and length of stay, increase the number of
babies going home with mothers, increase breastfeeding rates, and increase the number of
women enrolled in supportive programs for substance use. The investigators will also
determine if this rooming-in model of care decreases health and societal costs associated
with caring for babies with NAS.
Description:
This is a Stepped Wedge-Cluster Randomized Controlled Trial (SW-cRCT) of 8 hospitals with
NICUs and post-partum/pediatric units. The SW-cRCT is ideally suited to interventions that
require implementation by multiple team members in which there is an impact on workflow and
the structure of care delivery. There is randomized sequential roll-out of the intervention
to all sites over time. Baseline data acts as the pre-intervention control comparisons and in
addition, there is some ability to account for secular trends due to concurrent control
groups for most periods. The analysis can also assess whether the impact of the intervention
changes over time.
Primary Research Question: Does an evidence-based implementation project to apply a NAS care
bundle for infants born at >36 weeks gestation to mothers who report opiate use during
pregnancy and are admitted to hospital lead to a reduction in NICU Length of Stay (LOS)?
Secondary outcomes that will be assessed include:
- rates of child apprehension, NAS pharmacological management, breastfeeding at discharge,
and maternal participation in an Opioid Dependancy Program/ Virtual Opioid Dependancy
Program (ODP/VODP);
- satisfaction of stakeholders;
- costs associated with intervention versus current care;
- maternal mental health, parenting self-efficacy, and quality of life at discharge and at
6 months follow-up; and
- short-term developmental outcomes as determined at 6 months using the Ages and Stages
Questionnaire: Social-Emotional Second Edition (ASQ:SE-2).
Hospitals will implement the intervention following a computer-generated stratified random
allocation sequence created by the independent study statistician. Stratification will be
based on 'readiness'. The goal is to recruit participants prior to hospital admission for
delivery but potential participants will also be approached if their delivery presentation is
the first recruitment opportunity.
Data will be collected from consenting participants using standardized data collection forms.
Anonymous LOS data will also be collected from administrative data for NAS admissions at all
sites pre-initiation and at each step for patients that do not consent. The following
databases will be used to collect baseline LOS, perinatal characteristics, and data to inform
the economic analysis: Alberta Perinatal Health Program; Canadian Institute for Human
Information (CIHI) Costing Database; Discharge Abstract Database; ConnectCare; and Alberta
Health Services (AHS) Finance and Data Enterprise Warehouse. Data linkage will be through
unique identifiers and probabilistic linkage.
Sample Size/Feasibility - Conservatively, mean NICU LOS was set at 15 days and standard
deviation (SD) at 3 days based on local and national data to provide adequate power to detect
small differences in LOS. Intra-cluster correlation (ICC) was conservatively estimated at
0.1. With 8 centres, 8 initiation steps and 1 centre initiated per step over the course of 3
years, a mean LOS of 15 days (SD 3 days), and an ICC of 0.1 the study will have at least 80%
power with a two-sided 5% significance level to detect a 19% difference (2.75 days) in NICU
LOS.
Statistical Analysis - The primary outcome of NICU LOS was chosen as NICU admission may occur
for several medical reasons unrelated to NAS and a difference in LOS may be more meaningful
in understanding NAS severity. Cases in which there is no NICU admission will be assigned a
NICU LOS value of 0 days. Generalized Linear Mixed Models and Estimating Equations will be
used in analyzing the primary and secondary outcomes.
Barriers and Facilitators The investigators have connected directly with patients and
families in identifying gaps and solutions. The MMUNA and EMBRACE programs receive feedback
from families and staff related to the care provided and iteratively improve the programs
based on lessons learned. The drive to change current practice is directly informed by our
ongoing interactions with these organizations and their clients, as well as by our patients.
NASCENT Team Members completed the Comprehensive Accessible care for Infants with Neonatal
abstinence (CAIN) study funded by the Addiction and Mental Health (AMH) (Strategic Clinical
Network) SCN. This project was a first step in identifying appropriate and safe care of NAS
newborns across all Alberta regions. The strategies used in the NASCENT study will be
directly informed by themes identified in the CAIN study. Through focus groups and individual
interviews with care-providers in hospital and community settings as well as with parents who
had experienced care of an infant with NAS the investigators explored:
- existing gaps in the care of babies with NAS in hospital and in the community;
- how to improve communication between existing hospital and community networks;
- attitudes, perceptions and experiences regarding NAS;
- facilitators and barriers to changing NAS care;
- challenges and experiences of providing care to newborns with NAS; and
- strategies and existing resources to enhance support program interconnectedness to
improve health services for newborns with NAS.
Interviews were with leaders, care-providers, and parents with experience with the MMUNA
program. The overarching theme identified in the CAIN study was 'hope'. Fostering hope was
key for families and care-providers in working with mother-infant dyads with NAS. In
addition, patients who went through the MMUNA program and care-providers who are directly
involved with MMUNA have provided feedback through the CAIN study as well as through direct
feedback to the MMUNA program. The success of both MMUNA and EMBRACE is an indication of
their engagement with families.
Despite the successes seen with the MMUNA program there are still significant challenges
related to cultural barriers in providing care to families impacted by NAS. From previous
work in CAIN it is evident that there is trepidation, discomfort, and judgement related to
providing care to infants and families who require support for NAS. Care-providers experience
moral distress related to uncertainty and discomfort with addictions. Tailored implementation
strategies targeting physician, nursing, and social work barriers and leveraging existing
facilitators can be effective in changing practice. The NASCENT Project will be designed to
bring about provider and unit-level behaviour and culture change. This will be explored
during Pre-Implementation at each site using focus groups and a theory-based survey and
addressed through the use of a behaviour change management framework; the
Capability-Opportunity-Motivation-Behaviour Framework and Behaviour Change Wheel . Part of
the planned intervention is to access existing resources developed to assist caregivers to
examine their behaviors and identify unconscious bias. The NASCENT model of intervention is
ideally suited to understanding and changing hospital culture and individual behaviour
related to NAS care. This behaviour change framework is already being used successfully in
Alberta by NASCENT co-investigators in the REDUCED Trial.
Implementation Study Outcomes Through prospective data collection, including surveys of
stakeholder satisfaction, during each phase of the project the NASCENT team will be able to
respond to risks as they arise. The experiences and lessons learned from each Site
Implementation Team will be shared across sites to inform risk-mitigation strategies. Sites
that have successfully implemented the intervention will share their stories with sites that
are getting ready for implementation.
There will be three phases at each site during which Implementation, Service, and Client
outcomes will be measured including Pre-Implementation, Implementation and
Post-Implementation. During all phases, stakeholder satisfaction with current infant care for
NAS will be assessed. Stakeholders to be surveyed include hospital and community health care
providers, social workers, managers, families, and clinical and operational leaders. Surveys
will have common elements across sites but will also include site-specific items that address
identified facilitators, barriers, and contextual influences. Data related to costs, safety,
and adverse events will be collected during all phases.
NASCENT is as an evidence-based intervention to bring about provider, unit, and
community-level behaviour and culture change. Physician, nursing, social work, patient, and
management facilitators and barriers as well as contextual influences on implementation will
be explored using theory-based surveys, stakeholder interviews, and focus groups at
participant sites prior to site initiation. Transcripts from surveys, interviews, and focus
groups will be analyzed thematically by the investigative team with representation from
leadership, nursing, physicians, social work, patients, and families to identify
site-specific facilitators and barriers as well as contextual influences within and across
sites. Findings from this process will be mapped to the
Capability-Opportunity-Motivation-Behaviour Framework (COM-B) and then used to generate
Behaviour Change Wheel interventions to introduce the 'rooming in' model of care. This
methodological approach is already being used successfully in Alberta by NASCENT
co-investigators in the REDUCED Trial which introduced new obstetrical guidelines related to
identifying poor progress in labor. The NASCENT team will guide evidence- and local
experience-based identification of appropriate adaptations to the core NAS-interventions
including, recent national and provincial guidelines, and lessons learned from existing
programs like MMUNA and EMBRACE.
With NASCENT there will be sequential roll-out of the intervention to all participant
hospitals, with a new hospital initiated every 3 months following an initial minimum 6 months
of baseline data collection.
There will be three phases during implementation: Pre-Implementation, Implementation and
Post-Implementation. During all phases, stakeholder satisfaction with current infant care for
NAS will be assessed including site-specific items that address identified facilitators,
barriers, and contextual influences. The focus of each implementation phase is as follows:
A) Pre-implementation
- Identification of site-specific facilitators and barriers;
- Identification of site operational, medical, nursing, and social work champions and
formation of Site Implementation Team;
- Creation of site-specific interventions and plan to prepare for NAS care, e.g.,
identification of units and commencement dates where rooming-in will take place and
contingency plans for when census reaches 100% occupancy; development of site-specific
mechanisms to refer to the ODP/VODP program; development of additional staff resources
to address specific learning needs such as (Frequently Asked Questions) FAQs;
development of mechanisms for prenatal recruitment of opioid dependent women through
community agencies; and
- Completion of staff education on MyLearningLink related to NASCENT interventions.
B) Implementation
-With each step (3-month period) in the trial, data related to the intervention will be
collected. These data will be shared with stakeholders in feedback sessions as a mechanism to
iteratively explore facilitators and barriers, modify interventions based on feedback, and
provide ongoing staff education .
C) Post-Implementation
- NASCENT results, experience at each site and between sites, lessons learned,
satisfaction from stakeholder groups, and economic analysis will be shared in feedback
sessions with stakeholders at each site; and
- The NASCENT Project is being designed to become the 'new normal' standard of care for
infants with NAS and their mothers. The elements related to stakeholder education will
become part of routine training and orientation for care providers.
