Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia

Abstract

BackgroundAdmission to the neonatal intensive care unit (NICU) may disrupt parent-infant interaction with adverse consequences for infants and their families. Several family-centered care programs promote parent-infant interaction in the NICU; however, all of these retain the premise that health-care professionals should provide most of the infant’s care. Parents play a mainly supportive role in the NICU and continue to feel anxious and unprepared to care for their infant after discharge. In the Family Integrated Care (FICare) model, parents provide all except the most advanced medical care for their infants with support from the medical team. Our hypothesis is that infants whose families complete the FICare program will have greater weight gain and better clinical and parental outcomes compared with infants provided with standard NICU care.Methods/DesignFICare is being evaluated in a cluster randomized controlled trial among infants born at ≤ 33 weeks’ gestation admitted to 19 Canadian, 6 Australian, and 1 New Zealand tertiary-level NICU. Trial enrollment began in April, 2013, with a target sample size of 675 infants in each arm, to be completed by August, 2015. Participating sites were stratified by country, and by NICU size within Canada, for randomization to either the FICare intervention or control arm. In intervention sites, parents are taught how to provide most of their infant’s care and supported by nursing staff, veteran parents, a program coordinator, and education sessions. In control sites standard NICU care is provided. The primary outcome is infants’ weight gain at 21 days after enrollment, which will be compared between the FICare and control groups using Student’s t-test adjusted for site-level clustering, and multi-level hierarchical models accounting for both clustering and potential confounders. Similar analyses will examine secondary outcomes including breastfeeding, clinical outcomes, safety, parental stress and anxiety, and resource use. The trial was designed, is being conducted, and will be reported according to the CONSORT 2010 guidelines for cluster randomized controlled trials.DiscussionBy evaluating the impact of integrating parents into the care of their infant in the NICU, this trial may transform the delivery of neonatal care.Trial registrationNCT01852695, registered December 19, 2012

Evaluation of the Multidisciplinary Assistance provided in a Public Neonatal Care Unit from mothers` perception

“…6 Thus, the insertion of the family, especially of the parents, in the care of the NB is essential, since they play a fundamental role in the recovery of the baby. 12 The results of this study corroborate this idea, since they demonstrated that the majority of mothers evaluated in a positive way the item on the incentive of professionals for them to take care of their own children.…”

“…[10][11] Other researches have also shown that the care centralized in the family promotes a better integration of parents with the newborn, which can reduce this abrupt distancing caused by hospitalization in the neonatal environment. 6,12 However, studies have shown that there are still many aspects related to the humanization of care that need to be improved, and there are many obstacles encountered by professionals in offering this kind of assistance, such as lack of infrastructure, flexibilization of visiting hours so as to meet not only the needs of the sector, among others. [13][14] In this way, mothers need a more frequent and closer assistance before this new phase of their life: the experience of hospitalization of their baby in a Neonatal Unit.…”

The evolution of family‐centered care: From supporting parent‐delivered interventions to a model of family integrated care

“…FICare incorporates evidence‐based practices with strong evidence including parent education and psychosocial support, peer‐to‐peer support, clinical team education (with special emphasis around communication with families), and environmental supports including physical and procedural supports for prolonged parental presence. A key tenet of the implementation of FICare is that FICare's implementation needs to be co‐led by parents and the clinical team, making FICare adaptable to the needs of different environments, while maintaining fidelity to its core pillars (Bracht et al, ; O'Brien et al, ). Different strategies and tools may need to be used for different environments depending on their structure and the available resources.…”

Family Integrated Care for very preterm infants: evidence for a practice that seems self-evident?

“…Parents are resident in the neonatal intensive care unit for extended periods, learn to provide all care (except intravenous fluid and medications), record observations in medical charts, and participate in ward rounds, with their involvement underpinned by peer support and education. 2 FICare has been in use since the late 1980s in Estonia 3 and low-resource settings; 4 however, there has been a paucity of robust evidence to support it.…”