The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT (NASCENT) Program: A Stepped Wedge Cluster Randomized Trial of a Hospital-level Neonatal Abstinence Syndrome Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Length of stay (LOS) in NICU (days)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infants born at >36 weeks gestation to mothers who report opiate use during pregnancy (or who are in an ODP/VODP program) and who are admitted to a participating implementation project hospital.
排除标准
- •Infants born at less than 36 weeks and/or birth weight less than 2000 grams and infants with congenital anomalies will be excluded as these infants would be expected to be admitted to NICU.
结局指标
主要结局
Length of stay (LOS) in NICU (days)
时间窗: 6-24 months
It is expected that care will switch to a post-partum/pediatric private room with a resultant change in associated NICU days and associated costs. Data will be collected from consenting participants using standardized data collection forms. Anonymous LOS data will be collected from administrative data for NAS admissions at all sites pre-initiation and at each step for patients that do not consent.
次要结局
- Rate of NAS pharmacological management(6-24 months)
- Rate of breastfeeding at discharge(6-24 months)
- Rate of maternal participation in an ODP/VODP(6-24 months)
- Cost of care(6-24 months)
- Rate of child apprehension(6-24 months)