Developing a Core OUtcome Set and outcome measures of family-centred care In Neonatal care: COUSIN study

Hospitalisation of newborns in neonatal units (NNU) or neonatal intensive care units (NICUs) can be stressful for parents.1-3 Parent organisations, healthcare professionals, and researchers have emphasised the implementation of Newborn Individualized Developmental Care and Assessment Program (NIDCAP) and family-centred care (FCC) to support parent-infant interaction, bonding, and family involvement.4-7 The European Standards of Care for Newborn Health include a standard of infant- and family-centred care, recommending training of FCC practices, parent support and involvement in care.8

A recent review and meta analysis led by the applicant revealed a range of different FCC interventions and outcome measures in the NICU.9 FCC interventions seem to have a commonality; supporting parent engagement and involvement in delivering care to their infants in partnership with healthcare professionals. These interventions have been categorised under the multidimensional models of care and their successful implementation requires systematic strategies to change care culture.10 An important factor to support the implementation of FCC interventions is the evidence of their effectiveness.11 The review and meta-analyses by Ding et al. demonstrated difficulties in comparing parent reported outcome measures such as stress and anxiety due to not using a standardised outcome measure instrument and not measuring at standardised defined time-points.9 In addition, an integrative review, including 48 quantitative and qualitative studies, quality improvement projects, and programme evaluations, documented a wealth of different outcome measures for FCC.12

The inconsistency in reporting standardised outcome measures in neonatal clinical trials has been highlighted by the Core Outcome In Neonatology (COIN) study.13 The eDelphi study among clinicians, former patients and parents developed a set of 12 outcomes for neonatal research; most were clinically focused outcomes with only one non-clinical (quality of life).14 A standardised set of outcomes and outcome measures for clinical studies evaluating FCC practices in neonatal nursing has not been developed and can strengthen the evidence base of FCC practices and support its implementation in neonatal care.

Aim: To develop a core outcome set and a set of outcome measures and recommended time-points to evaluate family-centred care practices in neonatal care. The objectives are aligned to the COMET Handbook 4-steps to develop a core outcome set.15

Objectives:
1. To identify outcomes reported in studies evaluating family-centred models of care in neonatology. (WP1: Systematic review, Work Package 1 (WP1)
2. To identify the principles of family-centred models of care to generate a generally accepted definition of parent-engaged care. (WP2: eDelphi study and stakeholders consensus meeting)
3. To define a core outcome set for studies evaluating family-centred models of care in neonatology. (WP2)
4. To identify instruments of the core outcome set that are used in studies evaluating family-centred models of care in neonatology and define the validity and reliability of these instruments. (WP3: Systematic review)
5. To reach consensus on the final list of core outcomes and outcome measures for studies evaluating family-centred models of care in neonatology. (WP4: Stakeholders meeting with Nominal Group Technique)

Impact:
This project will identify and establish a core outcome set with recommended outcome measures and recommended time-points to measure the outcomes for clinical studies evaluating family-centred care practices in neonatal care. A core outcome set and a set of recommended outcome instruments can increase research engagement of all stakeholders, including parents and former patients, and strengthen the evidence base of family-centred care practices in neonatal care and support its implementation.

References:
1. Lundqvist P, Weis J, Sivberg B. Parents' journey caring for a preterm infant until discharge from hospital-based neonatal home care-A challenging process to cope with. J Clin Nurs. 2019;28(15-16):2966-78. https://doi.org/10.1111/jocn.14891
2. Oude Maatman SM, Bohlin K, Lilliesköld S, Garberg HT, Uitewaal-Poslawky I, Kars MC, van den Hoogen A. Factors Influencing Implementation of Family-Centered Care in a Neonatal Intensive Care Unit. Front Pediatr. 2020;8:222. https://doi.org/10.3389/fped.2020.00222
3. van den Hoogen A, Eijsermans R, Ockhuijsen HDL, Jenken F, Oude Maatman SM, ... Latour JM. Parents' experiences of VOICE: A novel support programme in the NICU. Nurs Crit Care. 2021;26(3):201-8. https://doi.org/10.1111/nicc.12569
4. Zhu LH, Lv, B, Gao XR, Sun J, Li TT, Liu ZY, Latour JM: Family-Centered Care Improves Clinical Outcomes of Very-Low-Birth-Weight Infants: A Quasi-Experimental Study. Front Pediatr. 2019;7:138. https://doi.org/10.3389/fped.2019.00138
5. Toivonen M, Lehtonen L, Löyttyniemi E, Ahlqvist-Björkroth S, Axelin A. Close Collaboration with Parents intervention improves family-centered care in different neonatal unit contexts: a pre-post study. Pediatr Res. 2020;88(3):421-8. https://doi.org/10.1038/s41390-020-0934-2
6. O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruzet M, et al. Evaluation of the family integrated care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015;15:210. https://doi.org/10.1186/s12887-015-0527-0
7. Aija A, Toome L, Axelin A, Raiskila S, Lehtonen L. Parents' presence and participation in medical rounds in 11 European neonatal units. Early Hum Dev. 2019;130:10-6. https://doi.org/10.1016/j.earlhumdev.2019.01.003
8. European Foundation for the Care of Newborn Infants. European Standards of Care for Newborn Health. Infant- & family-centered development care. https://newborn-health-standards.org/wp-content/uploads/2019/10/TEG_IFCDC_complete.pdf Accessed July 12, 2021.
9. Ding X, Zhu L, Zhang R, Wang L, Wang TT, Latour JM. Effects of family-centred care interventions on preterm infants and parents in neonatal intensive care units: a systematic review and meta-analysis of randomised controlled trials. Aust Crit Care. 2019;32:63-75. https://doi.org/10.1016/j.aucc.2018.10.007
10. Toivonen M, Lehtonen L, Ahlqvist-Björkroth S, Axelin A. Key factors supporting implementation of a training program for neonatal family- centered care - a qualitative study. BMC Health Serv Res. 2019;19(1):394. https://doi.org/10.1186/s12913-019-4256-1
11. Harvey, G., Kitson, A. PARIHS revisited: from heuristic to integrated framework for the successful implementation of knowledge into practice. Implementation Science 2016;11(1):33. https://doi.org/10.1186/s13012-016-0398-2
12. Vetchoa S, Cooke M, Ullman AJ. Family-Centred Care in Dedicated Neonatal Units: An Integrative Review of International Perspectives. J Neonatal Nurs. 2020;26(2):73-92. https://doi.org/10.1016/j.jnn.2019.09.004
13. Webbe J, Brunton G, Afonso E, Latour JM, Gale C: The importance of core outcome sets and developing one for neonatal care. Infant 2017;13(2):70-2
14. Webbe J, Duffy JMN, Afonso E, Al-Muzaffar I, Brunton G, …, Latour JM, et al. Core outcomes in neonatology: Development of a core outcome set for neonatal research. Arch Dis Child Fetal Neonatal Ed. 2020;105(4):425–31. http://dx.doi.org/10.1136/archdischild-2019-317501
15. Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET Handbook: version 1.0. Trials. 2017;18(Suppl 3):280. https://doi.org/10.1186/s13063-017-1978-4
16. Aromataris E, Munn Z (Editors). JBI Manual for Evidence Synthesis. JBI, 2020. Available from https://synthesismanual.jbi.global. https://doi.org/10.46658/JBIMES-20-01 Accessed July 15, 2021

Contributors

Professor Jos Latour. University of Plymouth, UK.
jos.latour@plymouth.ac.uk

Associate Professor Agnes van den Hoogen. Wilhelmina Children's Hospital of University Medical Centre Utrecht, Netherlands.
ahoogen@umcutrecht.nl

Associate Professor Anna Axelin. University of Turku, Finland.
anmaax@utu.fi

Dr Johanna Kostenzer. European Foundation for the Care of Newborn Infants (EFCNI), Germany.
Johanna.Kostenzer@efcni.org

Further Study Information

Current Stage: Ongoing
Date: October 2021 - October 2024
Funding source(s): Partly funded by European Society of Pediatric Research


Health Area

Disease Category: Neonatal care

Disease Name: Neonatal care

Target Population

Age Range: 0 - 1

Sex: Either

Nature of Intervention: Management of care

Stakeholders Involved

- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Nominal group technique (NGT)
- Systematic review

Methods of Work Packages
1. To identify outcomes reported in studies evaluating family-centred models of care in neonatology. (WP 1: Systematic review, Work Package 1 (WP1)
2. To identify the principles of family-centred models of care to generate a generally accepted definition of parent-engaged care. (WP2: eDelphi study and stakeholders consensus meeting)
3. To define a core outcome set for studies evaluating family-centred models of care in neonatology. (WP2)
4. To identify instruments of the core outcome set that are used in studies evaluating family-centred models of care in neonatology and define the validity and reliability of these instruments. (WP3: Systematic review)
5. To reach consensus on the final list of core outcomes and outcome measures for studies evaluating family-centred models of care in neonatology. (WP4: Stakeholders meeting with Nominal Group Technique)