Periodic Reporting for period 1 - RISEinFAMILY (Alliance for Family Integrated Care (FICare) Implementation in Neonatal Intensive Care Units)
Reporting period: 2021-09-01 to 2023-12-31
Preterm births are the major cause of infant mortality in both developed and developing worldwide countries and one of the main concerns of public health systems. Very low birth weight infants and new-borns who suffer severe acquired diseases, congenital malformations or rare diseases face similar burdens and challenges. Altogether can be referred to as “high-risk neonates”. These neonates have to spend long periods at Neonatal Intensive Care Units (NICUs) and, even so, they are at risk of developing short- and long-term health problems. This fact provokes suffering (e.g. anxiety, stress or trauma) to high-risk neonates’ parents and stressful situations, including burn-out, to NICU clinical staff. To overcome this, a Family Integrated Care (FICare) model that involves parents as primary caregivers in NICU teams has been recently developed with very promising results.
RISEinFAMILY, a 52-months research project, aims to undertake an implementation study of the FICare model to make it suitable to all environments (no matter the country or the NICU) and set it as the new international standard of neonatal and family care.
A geographical, social and cultural diverse consortium composed of 12 partners from 4 high- (ES, NL, UK and CA), 2 middle- (RO and TR) and 1 low-income (ZM) countries will scale-up and adapt the FICare model for the first time in Europe, Africa and Asia. About 2800 infants will be assessed and clinical staff and families from at least 1600 high-risk neonates trained and educated for enrolling in 7 pilots worldwide (5 in non-FICare and 2 in FICare NICUs).
Using mixed-methods research, the project will assess the impact of RISEinFAMILY in infants’ health (during NICU admission and after discharge), families and healthcare professionals experience from a psychological perspective and the socio-economic sustainability. Project outcomes will be promoted for stakeholders’ engagement and an appropriate strategy for exploitation of results will be defined.
RISEinFAMILY, a 52-months research project, aims to undertake an implementation study of the FICare model to make it suitable to all environments (no matter the country or the NICU) and set it as the new international standard of neonatal and family care.
A geographical, social and cultural diverse consortium composed of 12 partners from 4 high- (ES, NL, UK and CA), 2 middle- (RO and TR) and 1 low-income (ZM) countries will scale-up and adapt the FICare model for the first time in Europe, Africa and Asia. About 2800 infants will be assessed and clinical staff and families from at least 1600 high-risk neonates trained and educated for enrolling in 7 pilots worldwide (5 in non-FICare and 2 in FICare NICUs).
Using mixed-methods research, the project will assess the impact of RISEinFAMILY in infants’ health (during NICU admission and after discharge), families and healthcare professionals experience from a psychological perspective and the socio-economic sustainability. Project outcomes will be promoted for stakeholders’ engagement and an appropriate strategy for exploitation of results will be defined.
The study protocol to address the scientific questions, adapted to all socio-economic, cultural and health contexts of the consortium members, has been developed. Families, healthcare professionals, economists, psychologists, sociologists, and relevant stakeholders had participated in the process. The terms of the study protocol such as study participants and entry/exclusion criteria, study objectives and endpoints, as well as the research tools used (participants source data and specific questionnaires for parents and professionals) have been developed and are available online. Prospective data gathering will be done electronically using a REDCap-based database. Standard Operational Procedures have been developed for the different study procedures. All this study support material can be foun at the project’s website, https://riseinfamily.eu/ translated into the consortium languages.
The study is already open, and subject enrolment has started in two non-FICare centres (UNZA and AMC), and in one FICare center (SERMAS).
Dissemination activities had been carried out throughout this time, related to the co-creation process, the benefits of FICare implementation, and the RISEinFAMILY study protocol.
The work developed up to know has been extremely facilitated by the exchange of professionals from FICare centres to non-FICare centres and vice -versa by means of secondments. In addition, several dissemination activities at the different clinical sites about the FICare method and study-related topics have been accomplished.
The study is already open, and subject enrolment has started in two non-FICare centres (UNZA and AMC), and in one FICare center (SERMAS).
Dissemination activities had been carried out throughout this time, related to the co-creation process, the benefits of FICare implementation, and the RISEinFAMILY study protocol.
The work developed up to know has been extremely facilitated by the exchange of professionals from FICare centres to non-FICare centres and vice -versa by means of secondments. In addition, several dissemination activities at the different clinical sites about the FICare method and study-related topics have been accomplished.
RISEinFAMILY is the first coordinated multicontinental effort to implement FICare. For doing so, we have carried a thorough co-design process to fully understand the social-economic-cultural context of the different implementing sites. FICare is not a "one size fit all" system and RISEinFAMILY aimed to tailor the training programme to the needs of the families. Pilots are just being deployed, meaning our major results are yet to come but we have already produced new and inclusive training materials (like video turorials and infographics) and we have established the baselines to test the programme on the health of the babies, the wellbeing of families and NICU staff and its economic worthiness.
The RISEinFAMILY project has gone to the target: the co-creation of an uniformed protocol to implement FICare model that fits the expectations, needs and diversity of a wide variety of cultural and economic background clinical sites conforming the consortium has been successfully achieved. The study is already open and prospective data gathering has started. Over the next months the remaining partners will start enrolment until the expected sample size for primary outcome is reached.
Our secondary and exploratory outcomes include, among others, a 3-6 months-period follow up of the infant-family dyads to gather information on project’s impact on infant’s general and family’s mental health. Further actions planned, as a longer follow up period (up to 2 years), are beyond the scope of the project’s lifespan, but it is the intention of the consortium to reach also this target.
All the information gathered will conform the final report that will be published in scientific journals and reported in scientific and public forums. We envisage this study will provide unique information about health outcomes (infant, parents, healthcare professionals) and heath economics to support future interplay with stakeholders.
Dissemination of results will continue, and a conference on RISEinFAMILY will be held in 2025.
The RISEinFAMILY project has gone to the target: the co-creation of an uniformed protocol to implement FICare model that fits the expectations, needs and diversity of a wide variety of cultural and economic background clinical sites conforming the consortium has been successfully achieved. The study is already open and prospective data gathering has started. Over the next months the remaining partners will start enrolment until the expected sample size for primary outcome is reached.
Our secondary and exploratory outcomes include, among others, a 3-6 months-period follow up of the infant-family dyads to gather information on project’s impact on infant’s general and family’s mental health. Further actions planned, as a longer follow up period (up to 2 years), are beyond the scope of the project’s lifespan, but it is the intention of the consortium to reach also this target.
All the information gathered will conform the final report that will be published in scientific journals and reported in scientific and public forums. We envisage this study will provide unique information about health outcomes (infant, parents, healthcare professionals) and heath economics to support future interplay with stakeholders.
Dissemination of results will continue, and a conference on RISEinFAMILY will be held in 2025.