Family Integrated Care (FICare) in Level II NICUs

NCT02879799 | Completed

• 1 other identifier: AIHS-PRIHS 201400399
• Study Type: interventional
• Target: 765
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Family-centered care; Family-integrated care; Neonatal intensive care unit; Premature; Infant

Outcome Measures

Primary Outcomes (1)

• Birth admission length of stay

  Time in days from birth (admission) to discharge

  Hospital length of stay in days, expected to range between 14 and 24 days; some infants may require a longer admission

Secondary Outcomes (7)

• Nosocomial infection

  From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants)

• Adverse events

  From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants)

• Number of times infant NPO

  From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants)

• Taking breast milk

  On date of admission, date of discharge, and date at 2-months corrected age

• Number of re-admissions to hospital

  From date of discharge from hospital to date at 2-months corrected age

Other Outcomes (9)

• Parental confidence in caring for their infant questionnaire

  On date of admission, on date of discharge, and at 2-months corrected age

• Breastfeeding self-efficacy questionnaire

  On date of admission, on date of discharge, and at 2-months corrected age

• Parental psychosocial distress (stress, anxiety, depression) questionnaires

  On date of admission, date of discharge, and date at 2-months corrected age

Study Arms (2)

Implement Family Integrated Care

EXPERIMENTAL

Dynamic education and support intervention for families of preterm infants.

Other: Implement Family Integrated Care

Monitor Standard Practices

NO INTERVENTION

Standard nursing care of preterm infants and their families.

Interventions

Implement Family Integrated Care OTHER

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.

Implement Family Integrated Care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers of infants born between 32 weeks and zero days and 34 weeks and 6 days gestation.
• Mothers of any age who have decision making capacity.
• Mothers who are literate, and speak, read and understand English well enough to provide informed consent, and complete surveys online or via telephone.

You may not qualify if:

• Mothers whose infants have serious congenital anomalies that require surgery, or are receiving palliative care.
• Mothers who are not able to communicate in English.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (10)

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Misericordia Community Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Queen Elizabeth II Hospital

Grande Prairie, Alberta, T8V 2E8, Canada

Location

Chinook Regional Hospital

Lethbridge, Alberta, T1J 1W5, Canada

Location

Medicine Hat Regional Hospital

Medicine Hat, Alberta, T1A 4H6, Canada

Location

Red Deer Regional Hospital

Red Deer, Alberta, T4N 4E7, Canada

Location

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  PMID: 39391887 DERIVED

• Benzies KM, Zanoni P, McNeil DA. Mobilizing strategic inflection points for sustainment of an effective intervention in an integrated learning health system: an interpretive description. Implement Sci Commun. 2024 Sep 30;5(1):106. doi: 10.1186/s43058-024-00644-2.

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• Zanoni P, Scime NV, Benzies K, McNeil DA, Mrklas K; Alberta FICare in Level II NICU Study Team; Alberta FICare in Level II NICU Study Team. Facilitators and barriers to implementation of Alberta family integrated care (FICare) in level II neonatal intensive care units: a qualitative process evaluation substudy of a multicentre cluster-randomised controlled trial using the consolidated framework for implementation research. BMJ Open. 2021 Oct 18;11(10):e054938. doi: 10.1136/bmjopen-2021-054938.

  PMID: 34663673 DERIVED

• Benzies KM, Aziz K, Shah V, Faris P, Isaranuwatchai W, Scotland J, Larocque J, Mrklas KJ, Naugler C, Stelfox HT, Chari R, Soraisham AS, Akierman AR, Phillipos E, Amin H, Hoch JS, Zanoni P, Kurilova J, Lodha A; Alberta FICare Level II NICU Study Team. Effectiveness of Alberta Family Integrated Care on infant length of stay in level II neonatal intensive care units: a cluster randomized controlled trial. BMC Pediatr. 2020 Nov 28;20(1):535. doi: 10.1186/s12887-020-02438-6.

  PMID: 33246430 DERIVED

• Brockway M, Benzies KM, Carr E, Aziz K. Breastfeeding self-efficacy and breastmilk feeding for moderate and late preterm infants in the Family Integrated Care trial: a mixed methods protocol. Int Breastfeed J. 2018 Jul 6;13:29. doi: 10.1186/s13006-018-0168-7. eCollection 2018.

  PMID: 29989087 DERIVED

• Benzies KM, Shah V, Aziz K, Isaranuwatchai W, Palacio-Derflingher L, Scotland J, Larocque J, Mrklas K, Suter E, Naugler C, Stelfox HT, Chari R, Lodha A; Alberta FICare Level II NICU Study Team. 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. doi: 10.1186/s13063-017-2181-3.

  PMID: 29017578 DERIVED

Related Links

• Study Website

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Karen Benzies, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Abhay Lodha, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Khalid Aziz, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Vibhuti Shah, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: August 26, 2016
• Study Start: September 1, 2015
• Primary Completion: July 26, 2018
• Study Completion: December 10, 2018
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (10)