Family Integrated Care (FICare) in Level II NICUs

NCT02879799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2019-09-26

No results posted yet for this study

Summary

In Alberta, nearly one in every twelve babies is born too soon (preterm). Preterm babies are at greater risk for breathing and feeding problems, as well as infections, than babies born on their due date (full term). As a result, parents must leave their preterm babies in the hospital to fully develop and become healthy enough to take home. When it is time for discharge, parents are often not ready to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The purpose of this project is to test a new way to integrate parents into the care of their baby through a program called Family Integrated Care (FICare). In FICare, parents are educated and supported by nurses to provide care for their baby; nurses and doctors still provide intravenous medications and medical procedures. FICare has been tested in Ontario and shows promise as a better model of care for the small percentage of babies born more than 8 weeks early, who have to spend a long time in hospital.

Now the investigators want to test FICare with the greater percentage of preterm babies who are born 4 to 8 weeks early to see if parents are able to take their baby home sooner, and if their babies are healthier. The investigators also want to know if FICare can reduce distress for parents. The investigators propose to test FICare in Level II Neonatal Intensive Care Units (NICUs) in Alberta by implementing FICare in half the Level II NICUs and comparing the outcomes with the other Level II NICUs who do not use FICare. If FICare improves outcomes for preterm babies and their parents, the investigators will implement it in all Level II NICUs. In Alberta, the investigators want the best quality care for our most vulnerable babies and their parents. This project is aligned with Alberta's Health Research and Innovation Strategy priority of wellness at every age (child and maternal health), and with Alberta Health Services' quality of care goals to increase efficiency, effectiveness, appropriateness, and acceptability of health care services delivery.

Conditions

  • Premature Birth

Interventions

OTHER

Implement Family Integrated Care

Specially trained FICare nurses will provide education and support for families to provide care for the baby while they are present in the NICU. Study mothers will meet with veteran parents for additional support. Families will keep a log of their activities and costs.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Karen Benzies, PhD · University of Calgary

  • Abhay Lodha, MD · University of Calgary

  • Khalid Aziz, MD · University of Alberta

  • Vibhuti Shah, MD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-07-26
Completion
2018-12-10

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02879799 on ClinicalTrials.gov