Evidence map›Paper›PMID 29017578›Full record

Trial reportTrials2017

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

Karen M Benzies, Vibhuti Shah, Khalid Aziz, Wanrudee Isaranuwatchai, Luz Palacio-Derflingher, Jeanne Scotland, Jill Larocque, Kelly Mrklas, Esther Suter, Christopher Naugler and 4 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02879799 (Family Integrated Care), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02879799 nacompletednot on this map

Family Integrated Care (FICare) in Level II NICUs: An Innovative Program for Alberta

TypeinterventionalSponsorUniversity of CalgaryRan2015 to 2018Enrolled765ConditionsPremature BirthArmsImplement Family Integrated Care
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  9. Observational
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  20. Maternal, Newborn, Child and Youth Strategic Clinical Network: Improving health outcomes and system efficiency through partnerships.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2019
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Karen M BenziesFaculty of Nursing, Department of Paediatrics, University of Calgary, PF 2278, 2500 University Drive, NW, Calgary, AB, T2N 1N4, Canada. benzies@ucalgary.ca.
Vibhuti ShahMount 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.
Khalid AzizEdmonton 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.
Wanrudee IsaranuwatchaiCentre 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.
Luz Palacio-DerflingherFaculty 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.
Jeanne ScotlandRockyview General Hospital, Unit 63, 7007 14th Street SW, Calgary, AB, T2V 1P9, Canada.
Jill LarocqueDTC 5027, Royal Alexandra Hospital, 10240 Kingsway NW, Edmonton, AB, T5H 3V9, Canada.
Kelly MrklasKnowledge 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.
Esther SuterFaculty of Social Work, University of Calgary, Calgary, AB, T2N 1N4, Canada.
Christopher NauglerPathology and Laboratory Medicine, Faculty of Medicine, University of Calgary, Calgary, AB, T2L 2K8, Canada.
Henry T StelfoxCritical 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.
Radha ChariDepartment of Obstetrics and Gynecology, Edmonton Zone, Alberta Health Services, University of Alberta, 5S131 -10240 Kingsway NW, Edmonton, AB, T5H 3V9, Canada.
Abhay LodhaAlberta Health Services, Department of Pediatrics and Community Health Sciences, University of Calgary, C211-1403 29th Street NW, Calgary, AB, T2N 2T9, Canada.
Alberta FICare Level II NICU Study Team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvery 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

methodsWe 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 registrationClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

Indexed as

Delivery of Health Care, IntegratedInfant, PrematureIntensive Care Units, NeonatalAlbertaClinical ProtocolsCost-Benefit AnalysisFamily TherapyGestational AgeHealth Care CostsHealth Knowledge, Attitudes, PracticeHumansInformation DisseminationIntensive Care, NeonatalMother-Child RelationsMothersPremature BirthCost-effectivenessFamily integrated careInfantNursingParenting educationPatient engagementPrematureRandomized controlled trial

Identifiers

PMID29017578
PMCPMC5634877

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.