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Family Integrated Care (FICare) in Level II NICUs (FICare)

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ClinicalTrials.gov Identifier: NCT02879799
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Karen Benzies, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Premature Birth Other: Implement Family Integrated Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 824 participants
Allocation: Randomized
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
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2019

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. Number of re-admissions to hospital [ Time Frame: From date of discharge from hospital to date at 2-months corrected age ]
  6. Number of emergency room visits [ Time Frame: From date of discharge from hospital to date at 2-months corrected age ]
  7. Number of unplanned visits to physician or other provider [ Time Frame: From date of discharge from hospital to date at 2-months corrected age ]

Other Outcome Measures:
  1. Parental confidence in caring for their infant questionnaire [ Time Frame: On date of admission, on date of discharge, and at 2-months corrected age ]
  2. Breastfeeding self-efficacy questionnaire [ Time Frame: On date of admission, on date of discharge, and at 2-months corrected age ]
  3. Parental psychosocial distress (stress, anxiety, depression) questionnaires [ Time Frame: On date of admission, date of discharge, and date at 2-months corrected age ]
  4. Staff satisfaction questionnaire [ Time Frame: 12 months post-implementation ]
  5. 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 ]
  6. 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) ]
  7. Demographics (including mother and father age; education; family income; marital status) [ Time Frame: Baseline ]
  8. Maternal health data (including chronic diseases; ART; antenatal steroids; pregnancy complications; mode of delivery; parity/gravida) [ Time Frame: Baseline ]
  9. 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) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Karen Benzies, PhD 403-220-2294 benzies@ucalgary.ca

Locations
Canada, Alberta
Peter Lougheed Centre Recruiting
Calgary, Alberta, Canada, T1Y 6J4
Contact: Irene Anderson         
Rockyview General Hospital Recruiting
Calgary, Alberta, Canada, T2V 1P9
Contact: Sandra Walker-Kendall         
South Health Campus Recruiting
Calgary, Alberta, Canada, T3M 1M4
Contact: Sandra Denis         
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Karen Pelletier         
Misericordia Community Hospital Recruiting
Edmonton, Alberta, Canada, T5R 4H5
Contact: Marnie Kumpula         
Grey Nuns Community Hospital Recruiting
Edmonton, Alberta, Canada, T6L 5X8
Contact: Valerie Harrison         
Queen Elizabeth II Hospital Recruiting
Grande Prairie, Alberta, Canada, T8V 2E8
Contact: Dianne Sweetman         
Chinook Regional Hospital Recruiting
Lethbridge, Alberta, Canada, T1J 1W5
Contact: Brenda Vandenbeld         
Medicine Hat Regional Hospital Recruiting
Medicine Hat, Alberta, Canada, T1A 4H6
Contact: Rebecca Eldridge         
Red Deer Regional Hospital Recruiting
Red Deer, Alberta, Canada, T4N 4E7
Contact: Barb Mehlhorn         
Sponsors and Collaborators
University of Calgary
Investigators
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

Additional Information:
Publications:
March of Dimes, PMNCH, Save the Children, World Health Organization. Born too soon: The global action report on preterm birth. Geneva: World Health Organization; 2012.
Alberta Health and Wellness. Interactive Health Data Application, 2015 reproductive health data set. Edmonton, AB: Alberta Health and Wellness, Government of Alberta; 2015. From http://www.ahw.gov.ab.ca/IHDA_Retrieval/selectSubCategory.do
Alberta Reproductive Health Report Working Group. Alberta reproductive health: Pregnancies and births table update 2011. Edmonton, AB: Alberta Health and Wellness, Government of Alberta; 2011.
Tough S, Tofflemire K, Newburn-Cook C, Fraser-Lee N, Benzies K. Increased risks of pregnancy complications and adverse infant outcomes associated with assisted reproduction. International Congress Series; 2004: Elsevier. p. 376-9.
Alberta Perinatal Health Program: Provincial Perinatal Report. Alberta Health Services; 2013.
Dean S. Reporting and analytics. Child Health Strategic Clinical Network meeting. Calgary, AB: Alberta Health Services; 2012, October 12.
Knowles M. The adult learner: A neglected species. Houston, TX: Gulf Publishing Company; 1973
Prochaska JO, DiClemente CC. Transtheoretical therapy: Toward a more integrative model of change. Psychotherapy: Theory, Research & Practice 1982;19:276-88.
Ludington-Hoe SM, Morgan K, Abouelfettoh A. A clinical guideline for implementation of kangaroo care with premature infants of 30 or more weeks' postmenstrual age. Adv. Neonatal Care. 2008;8(3S):S3-S23.
Teti DM, Black MM, Viscardi R, et al. Intervention with African American premature infants: Four-month results of an early intervention program. Journal of Early Intervention. 2009;31(2):146-66.
Beck SA, Weis J, Greisen G, Andersen M, Vibeke Z. Room for family-centered care - A qualitative evaluation of a neonatal intensive care unit remodeling project. J. Neonatal Nurs. 2009;15(3):88-99.
Cockcroft S. How can family centred care be improved to meet the needs of parents with a premature baby in neonatal intensive care? J. Neonatal Nurs. 2011;18(3):105-10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Benzies, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02879799     History of Changes
Other Study ID Numbers: AIHS-PRIHS 201400399
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
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)

Keywords provided by Karen Benzies, University of Calgary:
Family-centered care
Family-integrated care
Neonatal intensive care unit
Premature
Infant

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications