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

Alberta FICare Level II NICU Study Team

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish (US)
Article number467
JournalTrials
Volume18
Issue number1
DOIs
StatePublished - Oct 10 2017

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Neonatal Intensive Care Units
Randomized Controlled Trials
Alberta
Mothers
Premature Birth
Premature Infants
Nonprofessional Education
Length of Stay
Hospital Administrators
Costs and Cost Analysis
Pregnancy
Information Dissemination
Birth Rate
Standard of Care
Health Personnel
Sample Size
Economics
Interviews
Delivery of Health Care

Keywords

  • Cost-effectiveness
  • Family integrated care
  • Infant
  • Nursing
  • Parenting education
  • Patient engagement
  • Premature
  • Randomized controlled trial

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units : Study protocol for a cluster randomized controlled trial. / Alberta FICare Level II NICU Study Team.

In: Trials, Vol. 18, No. 1, 467, 10.10.2017.

Research output: Contribution to journalArticle

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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.",
keywords = "Cost-effectiveness, Family integrated care, Infant, Nursing, Parenting education, Patient engagement, Premature, Randomized controlled trial",
author = "{Alberta FICare Level II NICU Study Team} and Benzies, {Karen M.} and Vibhuti Shah and Khalid Aziz and Wanrudee Isaranuwatchai and Luz Palacio-Derflingher and Jeanne Scotland and Jill Larocque and Kelly Mrklas and Esther Suter and Christopher Naugler and Stelfox, {Henry T.} and Radha Chari and Abhay Lodha and Pilar Zanoni and Amy Fowler and Maxine Scringer and Jana Kurilova and Meredith Brockway and Samantha Delhenty and Albert Akierman and Harish Amin and Hoch, {Jeffrey S} and Ernest Phillipos and Amuchou Soraicham and Katharina Staub and Sandra Walker-Kendall",
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T2 - Study protocol for a cluster randomized controlled trial

AU - Alberta FICare Level II NICU Study Team

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 - Zanoni, Pilar

AU - Fowler, Amy

AU - Scringer, Maxine

AU - Kurilova, Jana

AU - Brockway, Meredith

AU - Delhenty, Samantha

AU - Akierman, Albert

AU - Amin, Harish

AU - Hoch, Jeffrey S

AU - Phillipos, Ernest

AU - Soraicham, Amuchou

AU - Staub, Katharina

AU - Walker-Kendall, Sandra

PY - 2017/10/10

Y1 - 2017/10/10

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.

AB - 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.

KW - Cost-effectiveness

KW - Family integrated care

KW - Infant

KW - Nursing

KW - Parenting education

KW - Patient engagement

KW - Premature

KW - Randomized controlled trial

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