Family Integrated Care (FICare) in Level II NICUs (FICare)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02879799|
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : September 26, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Other: Implement Family Integrated Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||765 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Family Integrated Care (FICare) in Level II NICUs: An Innovative Program for Alberta|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||July 26, 2018|
|Actual Study Completion Date :||December 10, 2018|
Experimental: Implement Family Integrated Care
Dynamic education and support intervention for families of preterm infants.
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.
No Intervention: Monitor Standard Practices
Standard nursing care of preterm infants and their families.
- Birth admission length of stay [ Time Frame: Hospital length of stay in days, expected to range between 14 and 24 days; some infants may require a longer admission ]Time in days from birth (admission) to discharge
- Nosocomial infection [ Time Frame: From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants) ]Number of nosocomial infections from birth (admission) to discharge
- Adverse events [ Time Frame: From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants) ]E.g. medication and breast milk errors
- Number of times infant NPO [ Time Frame: 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 was NPO (nothing by mouth) from birth (admission) to discharge - up to 24 days (may be longer for some infants)
- Taking breast milk [ Time Frame: On date of admission, date of discharge, and date at 2-months corrected age ]Includes time to full oral feeds from birth
- Number of re-admissions to hospital [ Time Frame: From date of discharge from hospital to date at 2-months corrected age ]
- Number of emergency room visits [ Time Frame: From date of discharge from hospital to date at 2-months corrected age ]
- Number of unplanned visits to physician or other provider [ Time Frame: From date of discharge from hospital to date at 2-months corrected age ]
- Parental confidence in caring for their infant questionnaire [ Time Frame: On date of admission, on date of discharge, and at 2-months corrected age ]
- Breastfeeding self-efficacy questionnaire [ Time Frame: On date of admission, on date of discharge, and at 2-months corrected age ]
- Parental psychosocial distress (stress, anxiety, depression) questionnaires [ Time Frame: On date of admission, date of discharge, and date at 2-months corrected age ]
- Staff satisfaction questionnaire [ Time Frame: 12 months post-implementation ]
- Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times). [ Time Frame: From birth admission date to hospital discharge date; from hospital discharge date to 2-months corrected age ]
- Indirect societal costs (out-of-pocket costs to the family including parking, transportation, lodging, food, and time off work) collected in parent journal [ Time Frame: From birth admission date to hospital discharge date - up to 24 days (may be longer for some infants) ]
- Demographics (including mother and father age; education; family income; marital status) [ Time Frame: Baseline ]
- Maternal health data (including chronic diseases; ART; antenatal steroids; pregnancy complications; mode of delivery; parity/gravida) [ Time Frame: Baseline ]
- Infant health data (including DOB; Apgar; multiple birth; admission illness severity; medications; interventions; weight gain) [ Time Frame: Date of discharge from hospital - up to 24 days post birth (may be longer for some infants) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- Mothers whose infants have serious congenital anomalies that require surgery, or are receiving palliative care.
- Mothers who are not able to communicate in English.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879799
|Peter Lougheed Centre|
|Calgary, Alberta, Canada, T1Y 6J4|
|Rockyview General Hospital|
|Calgary, Alberta, Canada, T2V 1P9|
|South Health Campus|
|Calgary, Alberta, Canada, T3M 1M4|
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|
|Misericordia Community Hospital|
|Edmonton, Alberta, Canada, T5R 4H5|
|Grey Nuns Community Hospital|
|Edmonton, Alberta, Canada, T6L 5X8|
|Queen Elizabeth II Hospital|
|Grande Prairie, Alberta, Canada, T8V 2E8|
|Chinook Regional Hospital|
|Lethbridge, Alberta, Canada, T1J 1W5|
|Medicine Hat Regional Hospital|
|Medicine Hat, Alberta, Canada, T1A 4H6|
|Red Deer Regional Hospital|
|Red Deer, Alberta, Canada, T4N 4E7|
|Principal Investigator:||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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Karen Benzies, Professor, University of Calgary|
|Other Study ID Numbers:||
|First Posted:||August 26, 2016 Key Record Dates|
|Last Update Posted:||September 26, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Negotiations are underway to reposit data with the Alberta Centre for Child, Family and Community Research, Secondary Analyses to Generate Evidence (SAGE)|
Neonatal intensive care unit
Obstetric Labor, Premature
Obstetric Labor Complications
Female Urogenital Diseases and Pregnancy Complications