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Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.
Trials. 2017 Oct 10; 18(1):467.T

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.

Authors+Show Affiliations

Faculty of Nursing, Department of Paediatrics, University of Calgary, PF 2278, 2500 University Drive, NW, Calgary, AB, T2N 1N4, Canada. benzies@ucalgary.ca.Mount Sinai Hospital, Department of Paediatrics and Institute of Health Policy, Management and Evaluation, University of Toronto, Rm 19-231N, Mount Sinai Hospital, 600 University Avenue, Toronto, ON, M5G 1X5, Canada.Edmonton Neonatal Program, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, DTC 5027, Royal Alexandra Hospital, 10240 Kingsway NW, Edmonton, AB, T5H 3V9, Canada.Centre for Excellence in Economic Analysis Research (CLEAR), Li Ka Shing Knowledge Institute, St. Michael's Hospital, Institute of Health Policy, Management and Evaluation, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.Faculty of Kinesiology, Sport Injury Prevention Research Center, Department of Community Health Sciences, University of Calgary, 2500 University Drive NW, PF2250G, Calgary, AB, T2N 1N4, Canada.Rockyview General Hospital, Unit 63, 7007 14th Street SW, Calgary, AB, T2V 1P9, Canada.DTC 5027, Royal Alexandra Hospital, 10240 Kingsway NW, Edmonton, AB, T5H 3V9, Canada.Knowledge for Change Unit, Research Innovation and Analytics, Alberta Health Services, 1103 South Tower, Foothills Medical Centre, 1403 29th Street NW, Calgary, AB, T2N 2T9, Canada.Faculty of Social Work, University of Calgary, Calgary, AB, T2N 1N4, Canada.Pathology and Laboratory Medicine, Faculty of Medicine, University of Calgary, Calgary, AB, T2L 2K8, Canada. General Pathology, Calgary Zone, Alberta Health Services; Calgary Laboratory Services, Alberta Health Services Laboratory Utilization Office, 9-3535 Research Road NW, Calgary, AB, T2L 2K8, Canada.Critical Care Strategic Clinical Network, Departments of Critical Care Medicine, Medicine and Community Health Sciences, University of Calgary, 3E18D, TRW Building, 3280 Hospital Drive NW, Calgary, AB, T2N 4Z6, Canada.Department of Obstetrics and Gynecology, Edmonton Zone, Alberta Health Services, University of Alberta, 5S131 -10240 Kingsway NW, Edmonton, AB, T5H 3V9, Canada.Alberta Health Services, Department of Pediatrics and Community Health Sciences, University of Calgary, C211-1403 29th Street NW, Calgary, AB, T2N 2T9, Canada.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial

Language

eng

PubMed ID

29017578

Citation

Benzies, Karen M., et al. "Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: Study Protocol for a Cluster Randomized Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 467.
Benzies KM, Shah V, Aziz K, et al. Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial. Trials. 2017;18(1):467.
Benzies, K. M., Shah, V., Aziz, K., Isaranuwatchai, W., Palacio-Derflingher, L., Scotland, J., Larocque, J., Mrklas, K., Suter, E., Naugler, C., Stelfox, H. T., Chari, R., & Lodha, A. (2017). Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial. Trials, 18(1), 467. https://doi.org/10.1186/s13063-017-2181-3
Benzies KM, et al. Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: Study Protocol for a Cluster Randomized Controlled Trial. Trials. 2017 Oct 10;18(1):467. PubMed PMID: 29017578.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial. AU - Benzies,Karen M, AU - Shah,Vibhuti, AU - Aziz,Khalid, AU - Isaranuwatchai,Wanrudee, AU - Palacio-Derflingher,Luz, AU - Scotland,Jeanne, AU - Larocque,Jill, AU - Mrklas,Kelly, AU - Suter,Esther, AU - Naugler,Christopher, AU - Stelfox,Henry T, AU - Chari,Radha, AU - Lodha,Abhay, AU - ,, Y1 - 2017/10/10/ PY - 2017/04/02/received PY - 2017/09/08/accepted PY - 2017/10/12/entrez PY - 2017/10/12/pubmed PY - 2018/7/18/medline KW - Cost-effectiveness KW - Family integrated care KW - Infant KW - Nursing KW - Parenting education KW - Patient engagement KW - Premature KW - Randomized controlled trial SP - 467 EP - 467 JF - Trials JO - Trials VL - 18 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29017578/Family_Integrated_Care__FICare__in_Level_II_Neonatal_Intensive_Care_Units:_study_protocol_for_a_cluster_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2181-3 DB - PRIME DP - Unbound Medicine ER -