Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
765 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-09-30
Study Completion Date
2018-12-10
Brief Summary
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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.
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.
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Detailed Description
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Every year, about 15 million of the world's infants are born at \<37 weeks gestation (preterm). In Alberta, the preterm birth rate was 8.43% in 2015, representing 4,749 infants. Alberta has the highest rate of preterm birth in Canada, which can be attributed, in part, to delayed child bearing and assisted reproductive technology. Approximately 20% of the earliest (\< 32 weeks gestation) and usually the sickest preterm infants require care in a Level III neonatal intensive care unit (NICU). Approximately 80% are moderate to late preterm (32 weeks and zero days \[32 0/7\] and 36 weeks and six days \[36 6/7\] gestation; comprising 6.6% of all live births) and require care in a Level II NICU. Compared to their full term counterparts, moderate and late preterm infants are at higher risk for poor health (e.g., increased hospitalizations, respiratory morbidities, and growth and feeding problems) and developmental outcomes, including neurodevelopmental disabilities and cognitive delays, communication and language impairments,\] and school-related problems. As gestational age (GA) decreases, the risk of chronic health problems and developmental delays increases. In 2010, care of preterm infants represented the largest category of Alberta's expenditures for pediatric health care at 8.45%, with a total cost of approximately $35 million. The costs associated with preterm infants are greater than for term infants because of increased hospital length of stay (LOS), resource utilization, readmissions, and need for health, education, and social services. Financial consequences for parents of preterm infants are associated with reduced workforce participation and lost earnings, and developmental supports for the infant. Unquantifiable costs are associated with psychological distress, marital distress, and social isolation. Although effective interventions for parents of preterm infants exist, evidence is generally limited to the earliest preterm infants, and cost effectiveness data is lacking. Implementing a new model of care, Family Integrated Care (FICare), in Level II NICUs for moderate to late preterm infants has great potential to improve outcomes of infants and parents, and reduce costs to the health care system and families.
Level II NICUs are a highly technological, critical care environment where healthcare providers (i.e., nurses, physicians, trainees, respiratory therapists, social workers, and others) often unintentionally marginalize parents in the pursuit of optimal care of preterm infants. The unexpected birth of a tiny infant leaves parents in shock, feeling anxious, depressed, isolated, and unprepared to interact with, and care for, their infant. Preterm birth and experiences in the NICU disrupt breastfeeding and the early parent-infant relationship, which is critical for early brain and biological development. The goal of FICare is a change in culture and practice that permits, encourages, and supports parents in their parenting role while their infant is in a Level II NICU. FICare is, in essence, a dynamic educational intervention, with learners (parents), coaches (healthcare providers and veteran NICU parents), curriculum content, and implementation strategies. Veteran parents are those who have had previous experience with their own preterm infant in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill, and confidence so that the family is well-prepared to care for their infant long before discharge. This model is dynamic, whereby parents and healthcare providers openly and mutually negotiate equitable roles during the infant's NICU stay. Thus, roles will change as parents learn to care for their infant.
Philosophically, efforts to keep parents closer to their infant in NICU started in the 1950s with parental presence that permitted visitation in the NICU. Later, family-centred care articulated respect for family in decisions about care. Despite a comprehensive understanding of family-centred care and recognition of its importance, family-centred approaches remain fraught with challenges, including non-facilitative physical space, restrictive access, limited parental involvement in direct infant care, and lack of consistent information. These challenges result in confusion about the parental role in NICU, and leave parents feeling dissatisfied and more like detached visitors than parents. Integrating parents as central to the care of their infant is the next logical step in the evolution of approaches to NICU care.
Existing interventions include skin-to-skin care, psychological support for the parent (primarily mothers), education about the care of a preterm infant, and education of parents as providers of supportive therapy for their infant. A systematic review suggested that psychological support and parenting education showed the greatest effect over the short- (\<1 year) and longer- (≥1 year) term. While parenting education can take many forms from simple leaflets with information to self-modeled video interaction guidance, parenting education that actively engages parents with their infant had the greatest impact on parental and infant outcomes. Education that is consistent across care providers is critical to ensure parental belief in the competence of care providers. A positive relationship between parents and providers contributes to increased satisfaction with care, and greater willingness by parents to seek further support for the care of their infant. Further, health care should be individualized to accommodate sequential clinical phases from admission to post-discharge care of the infant.
Adapted from existing family-centred care interventions, the Family Integrated Care (FICare) model was developed and pilot tested with preterm infants ≤ 35 weeks GA in a Level III NICU at Mount Sinai Hospital, Toronto. The pilot study indicates that FICare is feasible and safe in Canada. Compared to 31 matched controls, the 42 infants who received FICare showed increased weight gain and breastfeeding at discharge. FICare reduced LOS by approximately 10% (personal communication, Dr. S. Lee) and mothers reported less stress. Based on these promising results, FICare in Level III NICUs is currently being evaluated in a 19-centre, cRCT; Calgary is a control site. With success in Level III NICUs, Dr. V. Shah (co-investigator) is implementing FICare in four Ontario Level II NICUs. However, the Ontario study is limited by a pre-test/post-test design. Without a randomized controlled train (RCT), evidence of the effectiveness of FICare in Level II NICUs will continue to be plagued by methodological and contextual limitations. The aim of this study is to refine and implement FICare in Level II NICUs across Alberta and evaluate it using a cluster RCT (cRCT).
The investigators hypothesize that compared with standard care, FICare will: (1) decrease LOS (primary outcome); (2) decrease the incidence of nosocomial infections; (3) decrease adverse events (e.g., medication and donor breast milk errors); (4) reduce the number of times infants have feeding suspended (NPO) with concomitant intravenous therapy and/or sepsis workups; (5) reduce readmission and unplanned emergency room and physician visits up to 2 months corrected age (CA); (6) increase parental knowledge, skills, and confidence in caring for their infant at discharge and 2 months CA; (7) increase rates of feeding breast milk and breastfeeding self-efficacy at discharge and 2 months CA; (8) decrease parental psychosocial distress (stress, anxiety, depression) at discharge and 2 months CA, (9) improve healthcare provider satisfaction; and (10) decrease direct and indirect costs because of reduced LOS and readmission.
The FICare Alberta research study was co-developed in collaboration with Alberta Health Services operational leaders and clinicians. Nursing and medical directors at the ten Level II NICUs across Alberta embraced the idea of FICare. Buy-in is particularly notable given that sites were aware that they could be randomized to either FICare or control condition. The investigators addressed the potential for unanticipated compensatory reactions (i.e., demoralization) by offering delayed implementation of FICare at control sites. The investigators discussed development, testing, and execution of the FICare implementation plan, as well as how we can integrate changes for the new model into routine care. The investigators learned that several sites were already using some elements of FICare, albeit in an unstructured and unintegrated way. If results of FICare show improved outcomes and/or reduced costs, we will assist with implementation and provide training to staff at the control sites.
Level II NICUs are a highly technological, critical care environment where healthcare providers (i.e., nurses, physicians, trainees, respiratory therapists, social workers, and others) often unintentionally marginalize parents in the pursuit of optimal care of preterm infants. The unexpected birth of a tiny infant leaves parents in shock, feeling anxious, depressed, isolated, and unprepared to interact with, and care for, their infant. Preterm birth and experiences in the NICU disrupt breastfeeding and the early parent-infant relationship, which is critical for early brain and biological development. The goal of FICare is a change in culture and practice that permits, encourages, and supports parents in their parenting role while their infant is in a Level II NICU. FICare is, in essence, a dynamic educational intervention, with learners (parents), coaches (healthcare providers and veteran NICU parents), curriculum content, and implementation strategies. Veteran parents are those who have had previous experience with their own preterm infant in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill, and confidence so that the family is well-prepared to care for their infant long before discharge. This model is dynamic, whereby parents and healthcare providers openly and mutually negotiate equitable roles during the infant's NICU stay. Thus, roles will change as parents learn to care for their infant.
Philosophically, efforts to keep parents closer to their infant in NICU started in the 1950s with parental presence that permitted visitation in the NICU. Later, family-centred care articulated respect for family in decisions about care. Despite a comprehensive understanding of family-centred care and recognition of its importance, family-centred approaches remain fraught with challenges, including non-facilitative physical space, restrictive access, limited parental involvement in direct infant care, and lack of consistent information. These challenges result in confusion about the parental role in NICU, and leave parents feeling dissatisfied and more like detached visitors than parents. Integrating parents as central to the care of their infant is the next logical step in the evolution of approaches to NICU care.
Existing interventions include skin-to-skin care, psychological support for the parent (primarily mothers), education about the care of a preterm infant, and education of parents as providers of supportive therapy for their infant. A systematic review suggested that psychological support and parenting education showed the greatest effect over the short- (\<1 year) and longer- (≥1 year) term. While parenting education can take many forms from simple leaflets with information to self-modeled video interaction guidance, parenting education that actively engages parents with their infant had the greatest impact on parental and infant outcomes. Education that is consistent across care providers is critical to ensure parental belief in the competence of care providers. A positive relationship between parents and providers contributes to increased satisfaction with care, and greater willingness by parents to seek further support for the care of their infant. Further, health care should be individualized to accommodate sequential clinical phases from admission to post-discharge care of the infant.
Adapted from existing family-centred care interventions, the Family Integrated Care (FICare) model was developed and pilot tested with preterm infants ≤ 35 weeks GA in a Level III NICU at Mount Sinai Hospital, Toronto. The pilot study indicates that FICare is feasible and safe in Canada. Compared to 31 matched controls, the 42 infants who received FICare showed increased weight gain and breastfeeding at discharge. FICare reduced LOS by approximately 10% (personal communication, Dr. S. Lee) and mothers reported less stress. Based on these promising results, FICare in Level III NICUs is currently being evaluated in a 19-centre, cRCT; Calgary is a control site. With success in Level III NICUs, Dr. V. Shah (co-investigator) is implementing FICare in four Ontario Level II NICUs. However, the Ontario study is limited by a pre-test/post-test design. Without a randomized controlled train (RCT), evidence of the effectiveness of FICare in Level II NICUs will continue to be plagued by methodological and contextual limitations. The aim of this study is to refine and implement FICare in Level II NICUs across Alberta and evaluate it using a cluster RCT (cRCT).
The investigators hypothesize that compared with standard care, FICare will: (1) decrease LOS (primary outcome); (2) decrease the incidence of nosocomial infections; (3) decrease adverse events (e.g., medication and donor breast milk errors); (4) reduce the number of times infants have feeding suspended (NPO) with concomitant intravenous therapy and/or sepsis workups; (5) reduce readmission and unplanned emergency room and physician visits up to 2 months corrected age (CA); (6) increase parental knowledge, skills, and confidence in caring for their infant at discharge and 2 months CA; (7) increase rates of feeding breast milk and breastfeeding self-efficacy at discharge and 2 months CA; (8) decrease parental psychosocial distress (stress, anxiety, depression) at discharge and 2 months CA, (9) improve healthcare provider satisfaction; and (10) decrease direct and indirect costs because of reduced LOS and readmission.
The FICare Alberta research study was co-developed in collaboration with Alberta Health Services operational leaders and clinicians. Nursing and medical directors at the ten Level II NICUs across Alberta embraced the idea of FICare. Buy-in is particularly notable given that sites were aware that they could be randomized to either FICare or control condition. The investigators addressed the potential for unanticipated compensatory reactions (i.e., demoralization) by offering delayed implementation of FICare at control sites. The investigators discussed development, testing, and execution of the FICare implementation plan, as well as how we can integrate changes for the new model into routine care. The investigators learned that several sites were already using some elements of FICare, albeit in an unstructured and unintegrated way. If results of FICare show improved outcomes and/or reduced costs, we will assist with implementation and provide training to staff at the control sites.
Conditions
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Premature Birth
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Implement Family Integrated Care
Dynamic education and support intervention for families of preterm infants.
Group Type
EXPERIMENTAL
Implement Family Integrated Care
Intervention Type
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.
Monitor Standard Practices
Standard nursing care of preterm infants and their families.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
* Mothers who are not able to communicate in English.
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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University of Calgary
OTHER
Sponsor Role
lead
Responsible Party
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Karen Benzies
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Karen Benzies, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Abhay Lodha, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Khalid Aziz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Vibhuti Shah, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Peter Lougheed Centre
Calgary, Alberta, Canada
Site Status
Rockyview General Hospital
Calgary, Alberta, Canada
Site Status
South Health Campus
Calgary, Alberta, Canada
Site Status
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Site Status
Misericordia Community Hospital
Edmonton, Alberta, Canada
Site Status
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Site Status
Queen Elizabeth II Hospital
Grande Prairie, Alberta, Canada
Site Status
Chinook Regional Hospital
Lethbridge, Alberta, Canada
Site Status
Medicine Hat Regional Hospital
Medicine Hat, Alberta, Canada
Site Status
Red Deer Regional Hospital
Red Deer, Alberta, Canada
Site Status
Countries
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Canada
References
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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.
Reference Type
BACKGROUND
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
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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.
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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.
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BACKGROUND
Alberta Perinatal Health Program: Provincial Perinatal Report. Alberta Health Services; 2013.
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BACKGROUND
Harijan P, Boyle EM. Health outcomes in infancy and childhood of moderate and late preterm infants. Semin Fetal Neonatal Med. 2012 Jun;17(3):159-62. doi: 10.1016/j.siny.2012.02.002. Epub 2012 Mar 13.
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BACKGROUND
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BACKGROUND
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BACKGROUND
Johnson S, Evans TA, Draper ES, Field DJ, Manktelow BN, Marlow N, Matthews R, Petrou S, Seaton SE, Smith LK, Boyle EM. Neurodevelopmental outcomes following late and moderate prematurity: a population-based cohort study. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F301-8. doi: 10.1136/archdischild-2014-307684. Epub 2015 Apr 1.
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BACKGROUND
Guy A, Seaton SE, Boyle EM, Draper ES, Field DJ, Manktelow BN, Marlow N, Smith LK, Johnson S. Infants born late/moderately preterm are at increased risk for a positive autism screen at 2 years of age. J Pediatr. 2015 Feb;166(2):269-75.e3. doi: 10.1016/j.jpeds.2014.10.053. Epub 2014 Dec 2.
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BACKGROUND
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BACKGROUND
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BACKGROUND
Chan E, Quigley MA. School performance at age 7 years in late preterm and early term birth: a cohort study. Arch Dis Child Fetal Neonatal Ed. 2014 Nov;99(6):F451-7. doi: 10.1136/archdischild-2014-306124. Epub 2014 Jun 25.
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BACKGROUND
de Jong M, Verhoeven M, van Baar AL. School outcome, cognitive functioning, and behaviour problems in moderate and late preterm children and adults: a review. Semin Fetal Neonatal Med. 2012 Jun;17(3):163-9. doi: 10.1016/j.siny.2012.02.003. Epub 2012 Feb 23.
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BACKGROUND
van Baar AL, Vermaas J, Knots E, de Kleine MJ, Soons P. Functioning at school age of moderately preterm children born at 32 to 36 weeks' gestational age. Pediatrics. 2009 Jul;124(1):251-7. doi: 10.1542/peds.2008-2315.
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Kerstjens JM, de Winter AF, Bocca-Tjeertes IF, Bos AF, Reijneveld SA. Risk of developmental delay increases exponentially as gestational age of preterm infants decreases: a cohort study at age 4 years. Dev Med Child Neurol. 2012 Dec;54(12):1096-101. doi: 10.1111/j.1469-8749.2012.04423.x. Epub 2012 Sep 30.
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Schonhaut L, Armijo I, Perez M. Gestational age and developmental risk in moderately and late preterm and early term infants. Pediatrics. 2015 Apr;135(4):e835-41. doi: 10.1542/peds.2014-1957. Epub 2015 Mar 2.
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Dean S. Reporting and analytics. Child Health Strategic Clinical Network meeting. Calgary, AB: Alberta Health Services; 2012, October 12.
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Petrou S, Khan K. Economic costs associated with moderate and late preterm birth: primary and secondary evidence. Semin Fetal Neonatal Med. 2012 Jun;17(3):170-8. doi: 10.1016/j.siny.2012.02.001. Epub 2012 Feb 23.
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Petrou S, Eddama O, Mangham L. A structured review of the recent literature on the economic consequences of preterm birth. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F225-32. doi: 10.1136/adc.2009.161117. Epub 2010 May 20.
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BACKGROUND
Benzies KM, Magill-Evans JE, Hayden KA, Ballantyne M. Key components of early intervention programs for preterm infants and their parents: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2013;13 Suppl 1(Suppl 1):S10. doi: 10.1186/1471-2393-13-S1-S10. Epub 2013 Jan 31.
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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.
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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.
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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.
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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.
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Related Links
Access external resources that provide additional context or updates about the study.
http://www.ucalgary.ca/ficare/
Study Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AIHS-PRIHS 201400399
Identifier Type: -
Identifier Source: org_study_id
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