Clinical trial NCT02879799: Family Integrated Care (FICare) in Level II NICUs
Official title: Family Integrated Care (FICare) in Level II NICUs: An Innovative Program for Alberta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Family-centered care
Family-integrated care
Neonatal intensive care unit
Premature
Infant
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 765
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Birth admission length of stay
timeFrame: Hospital length of stay in days, expected to range between 14 and 24 days; some infants may require a longer admission
Secondary outcomes:
measure: Nosocomial infection
timeFrame: From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants)
measure: Adverse events
timeFrame: From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants)
measure: Number of times infant NPO
timeFrame: From date of birth (admission) to date of discharge from hospital - up to 24 days (may be longer for some infants)
measure: Taking breast milk
timeFrame: On date of admission, date of discharge, and date at 2-months corrected age
measure: Number of re-admissions to hospital
timeFrame: From date of discharge from hospital to date at 2-months corrected age
measure: Number of emergency room visits
timeFrame: From date of discharge from hospital to date at 2-months corrected age
measure: Number of unplanned visits to physician or other provider
timeFrame: From date of discharge from hospital to date at 2-months corrected age
Other outcomes:
measure: Parental confidence in caring for their infant questionnaire
timeFrame: On date of admission, on date of discharge, and at 2-months corrected age
measure: Breastfeeding self-efficacy questionnaire
timeFrame: On date of admission, on date of discharge, and at 2-months corrected age
measure: Parental psychosocial distress (stress, anxiety, depression) questionnaires
timeFrame: On date of admission, date of discharge, and date at 2-months corrected age
measure: Staff satisfaction questionnaire
timeFrame: 12 months post-implementation
measure: Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times).
timeFrame: From birth admission date to hospital discharge date; from hospital discharge date to 2-months corrected age
measure: Indirect societal costs (out-of-pocket costs to the family including parking, transportation, lodging, food, and time off work) collected in parent journal
timeFrame: From birth admission date to hospital discharge date - up to 24 days (may be longer for some infants)
measure: Demographics (including mother and father age; education; family income; marital status)
timeFrame: Baseline
measure: Maternal health data (including chronic diseases; ART; antenatal steroids; pregnancy complications; mode of delivery; parity/gravida)
timeFrame: Baseline
measure: Infant health data (including DOB; Apgar; multiple birth; admission illness severity; medications; interventions; weight gain)
timeFrame: Date of discharge from hospital - up to 24 days post birth (may be longer for some infants)
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Misericordia Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Grande Prairie
country: Canada
facility: Queen Elizabeth II Hospital
state: Alberta
city: Lethbridge
country: Canada
facility: Chinook Regional Hospital
state: Alberta
city: Medicine Hat
country: Canada
facility: Medicine Hat Regional Hospital
state: Alberta
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Karen Benzies, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Abhay Lodha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Khalid Aziz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Vibhuti Shah, MD
role: PRINCIPAL_INVESTIGATOR
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