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Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Benzies KM

PROVIDER: S-EPMC5634877 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

Benzies Karen M KM Shah Vibhuti V Aziz Khalid K Isaranuwatchai Wanrudee W Palacio-Derflingher Luz L Scotland Jeanne J Larocque Jill J Mrklas Kelly K Suter Esther E Naugler Christopher C Stelfox Henry T HT Chari Radha R Lodha Abhay A

Trials 20171010 1

<h4>Background</h4>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 [32<sup>0/7</sup>] to 33<sup>6/7</sup> weeks) and late preterm (34<sup>0/7</sup> ...[more]

PMID: 29017578

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Project description:BACKGROUND:Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. METHODS:In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n =?5) or standard care (n =?5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2?months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. RESULTS:We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96?days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55?days shorter (95% CI, -?4.44 to -?0.66) in the Alberta FICare™ group than standard care group, P =?.02. Secondary outcomes were not significantly different between groups. CONCLUSIONS:Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.

Project description:ObjectiveTo evaluate the barriers and facilitators to implementing Alberta Family Integrated Care (AB-FICare [2019 Benzies]), a model of care for integrating parents into level II neonatal intensive care units (NICUs) care teams, from the perspective of healthcare providers (HCP) and hospital administrators.DesignQualitative process evaluation substudy.SettingTen level II NICUs in six cities across Alberta, Canada.ParticipantsHCP and hospital administrators (n=32) who were involved in the cluster-randomised controlled trial of AB-FICare in level II NICUs.MethodsPost-implementation semi-structured interviews were conducted via phone or in-person. The Consolidated Framework for Implementation Research was used to develop interview guides, code transcripts and analyse data.ResultsKey facilitators to implementation of AB-FICare included (1) a receptive implementation climate, (2) compatibility of the intervention with individual and organisational practices, (3) available resources and access to knowledge and information for HCP and hospital administrators, (4) engagement of key stakeholders across the organisation, (5) engagement of and outcomes for intervention participants, and (6) reflecting and evaluating on implementation progress and patient and family outcomes. Barriers were (1) design quality and packaging of the intervention, (2) relative priority of AB-FICare in relation to other initiatives, and (3) learning climate within the organisation. Mixed influences on implementation depending on contextual factors were coded to eight constructs: intervention source, cost, peer pressure, external policy and incentives, staff needs and resources, structural characteristics, organisational incentives and rewards, and knowledge, beliefs and attitudes.ConclusionsThe characteristics of an organisation and the implementation process had largely positive influences, which can be leveraged for implementation of AB-FICare in the NICU. We recommend site-specific consultations to mitigate barriers and assess how swing factors might impact implementation given the local context, with the goal that strategies can be put in place to manage their influence on implementation.Trial registration numberNCT02879799.

Project description:Admission 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.FICare 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.By evaluating the impact of integrating parents into the care of their infant in the NICU, this trial may transform the delivery of neonatal care.NCT01852695 , registered December 19, 2012.

Project description:BackgroundHealthcare organisations differ in performance even if they are located in the same country or region. Suitable managerial practices and organisational processes can lead to better health outcomes. As a result, hospitals are constantly looking for managerial arrangements that can improve outcomes and keep costs down. This study aims to identify different managerial models in neonatal intensive care units (NICUs) and their impact on a large number of outcomes.MethodsThe research was conducted in Italy, within the SONAR project. SONAR's aim was to identify the characteristics of NICUs, monitor outcomes and promote best practices. This study includes 51 of the 63 NICUs that took part in the SONAR project. Questionnaires on the activities and managerial features were administered to doctors and nurses working in NICUs. A total of 643 questionnaires were analysed from doctors and a total of 1601 from nurses. A cluster analysis was performed to identify managerial models of NICUs.ResultsThree managerial models emerged from cluster analysis: traditional, collaborative and individualistic. In the "traditional" model the doctor is above the nurse in the hierarchy, and the nurse therefore has exclusively operational autonomy. The "collaborative" model has as key elements professional specialisation and functional coordination. The "individualistic" model considers only individual professional skills and does not concern the organisational conditions necessary to generate organisational effectiveness. The results also showed that there is an association between managerial model and neonatal outcomes. The collaborative model shows best results in almost all outcomes considered, and the traditional model has the worst. The individualistic model is in the middle, although its values are very close to those of traditional model.ConclusionsHealth management needs to assess NICU strategically in order to develop models to improve outcomes. This study provides insights for management useful for designing managerial characteristics of NICUs in order to achieve better results. NICUs characterised by a collaborative model in fact show better neonatal outcomes.

Project description:BackgroundFamily members of critically ill patients face considerable uncertainty and distress during their close others' intensive care unit (ICU) stay. About 20-60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.MethodsTo test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, we will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. It will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 h or longer. Families in the intervention arm will receive a family support intervention in addition to usual care. The intervention consists of specialist nurse support that is mapped to the patient pathway with follow-up care and includes psycho-educational and relationship-focused family interventions, and structured, interprofessional communication, and shared decision-making with families. Families in the control arm will receive usual care. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after 3, 6, and 12 months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.DiscussionThis trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and could be scaled up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.Trial registrationClinicalTrials.gov NCT05280691 . Prospectively registered on 20 February 2022.

Dataset Information

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

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Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

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