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Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized
Karen M Benzies1, Vibhuti Shah2, Khalid Aziz3
1Faculty of Nursing, Department of Paediatrics, University of Calgary, PF 2278, 2500 University Drive, NW, Calgary, AB, T2N 1N4, Canada. benzies@ucalgary.ca.
Insights
Family Integrated Care (FICare) in neonatal intensive care units (NICUs) improves infant and maternal outcomes. This study evaluates FICare
Area of Science:
- Neonatal care and developmental pediatrics.
- Family-centered care models.
- Health services research and health economics.
Background:
- Preterm birth affects 15 million infants globally, with Alberta having a high rate.
- Neonatal intensive care unit (NICU) stays disrupt parent-infant bonding and cause parental distress.
- Family Integrated Care (FICare) shows promise in improving outcomes for infants in Level III NICUs.
Purpose of the Study:
- To evaluate the clinical effectiveness and costs of implementing Family Integrated Care (FICare) in Level II NICUs.
- To assess the impact of FICare on infant length of stay, clinical outcomes, and maternal psychosocial distress.
- To explore the utility, acceptability, and impact of FICare from multiple stakeholder perspectives.
Main Methods:
- A pragmatic, cluster randomized controlled trial (cRCT) involving ten Alberta Level II NICUs.
- Comparison between the FICare model (information sharing, parenting education, family support) and standard care.
- Sample size of 181 mother-infant dyads per group, with data collection at admission, discharge, and 2 months corrected age.
Main Results:
- The study is designed to provide evidence on the clinical effectiveness and costs of FICare in Level II NICUs.
- Secondary outcomes include infant clinical outcomes and maternal psychosocial distress.
- Economic analysis will be conducted from both healthcare payer and societal perspectives.
Conclusions:
- Results will inform policy decisions regarding the implementation of FICare in Level II NICUs.
- Evidence on clinical effectiveness and cost-effectiveness will guide future healthcare practices.
- Qualitative data will provide insights into the utility and acceptability of FICare.
Background:
Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs.
Methods:
We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study.
Discussion:
Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare.
Trial Registration:
ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.
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