Family Integrated Care in the NICU Shoo Lee, MBBS, FRCPC, PhD Scientific Director, Institute of Human Development, Child & Youth Health, Canadian Institutes of Health Research Professor of Paediatrics, Obstetrics & Gynecology, and Public Health, University of Toronto; Paediatrician-in-Chief, Mount Sinai Hospital;
No Conflicts to Declare MiCARE Research Centre Toronto
Kangaroo Care
Family Centered Care current practice Arrange activities for family convenience Professionals provide care, not family Family members are encouraged to visit, and to participate in baby s care in an incremental but unstructured way NICU is an open concept, with limited privacy for family members Family Baby Nurse Doctor Therapist
Estonia
Levin Study (Birth 1994) Humane Care Compared 84 care by parent with 72 care by nurses babies in the NICU Weight gain (g) Maternal Care Nurse Care 20 days 332 + 20 235 + 30 30 days 769 490 Anecdotal = 30% reduction in NI 20% reduction in LOS 50% reduction in nurse utilization improved parent/staff satisfaction
Family Integrated Care How can we adapt this philosophy of humane care for Canada? Nurse Family Integrated Care Doctor Therapist Parent Volunteer
Objectives To determine whether Family Integrated Care can be adopted in Canada Formative study of how to develop a Family Integrated Care Model for Canada Pilot study of feasibility and safety Conduct multi-center cluster RCT
The Family Integrated Care Steering Committee - Veteran Parents (x3) - Nurses (x3) - Study Coordinator - Physicians (x2) - Allied Health (x2)
Consultation & Development Veteran parents were co-chairs and key team members to translate this idea to practice Consent Literature review Protocol development Visioning a day in the life of Anticipated problems Legal and liability Ethics
What is Family Integrated Care? 1. Change in paradigm of care-giving in the NICU 2. Parents are an integral part of the care team and are partners with nurses and medical team 3. Nurses are teachers and consultants to parents 4. Parents assume most of the care for baby, except for IV, medication and tests 5. Parents gain confidence, knowledge and control Reference: A pilot cohort analytic study of Family Integrated Care in a Canadian neonatal intensive care unit. BMC Pregnancy Childbirth 2013 ; 13 Suppl 1:S12
Parental Involvement
Pilot Study Pilot start date: March, 2011 Prospective matched case control Informed consent Expected length of study: 12 months Number of patients needed: 40 patients, 80 matched controls (GA, wt, sex) Location 4 bed spaces reserved in Level II TLC area Time Commitment for Parents Minimum 8 hours each day - during day Inclusion Criteria: < 35 weeks gestation On low level respiratory support (CPAP or less) Exclusion criteria: Palliative care Severe congenital anomaly. Critical illness (unlikely to survive) Parental request for early transfer Parental inability to participate.
Supports for Parents Bedroom, bathroom, lounge, kitchen, computer facilities Sleeper lounge chairs in NICU Breast milk pumping room Free parking Meals No decrease in nursing ratio Parent buddy volunteers Access to psychologist, therapist if needed
Outcomes Infant Outcomes Zwt21-Zwt 1 Discharge weight gain 21 day wt gain (g/kg/day) FICare group Mean (sd) 0.61(0.44) 25% 21.6 (6.4) 9% Controls Mean (sd) P-value 0.49(0.41) 0.26 <0.05 20.3 (6.6) 0.48 Breastfeeding 85% 42% <0.05 Nosocomial infection 0 6(9.7%) 0.59 ROP 0 8(14.3%) <0.05 Incident reports Per 1000 patient days 0.84 25% 1.15 0.73
Parental Stress (PSS-NICU) PSS on admission PSS at 35 weeks P-value of difference Patients 3.10(0.72) 2.34(0.73) <0.001 Controls 2.83 (0.85) 3.00 (0.77)
The Celebration
FiCARE Multi-center Cluster RCT Hypothesis: FICare improves weight gain and reduces parental stress compared with standard NICU care Methods: Cluster RCT in infants born <33 weeks gestation admitted to 26 tertiary NICUs in Canada, Australia & NZ Randomization: Unit level Inclusion/Exclusion Criteria: As in pilot study Outcomes: As in pilot study
Sample Size Sample size of 695 in each arm was estimated for the primary outcome of weight gain at 21 days post enrolment as measured by the change in z-score (z score day 21- z score day 0) 80% power to detect > 25% difference in z score change Significance level of 0.05 and ICC 0.01
Parent education program Intervention Sites Nurse education program (workshop/binders/education day/on line education) provided to > 90 % of nursing staff Unit policies and procedures support family integration and prolonged parental presence Opportunities created for peer to peer support Veteran parent volunteer training and support Parents enrolled and orientated to their role in their infants care and the unit, role in rounds supported by the site study coordinator
Patient Eligibility/ Enrollment
Infant Characteristics Baseline Characteristics Control Group Intervention Group #infants ( #site) 873(12) 827(13) Gender, % (n/n) 53.56 ( 467/872 ) 54.42 ( 449/825) Birth weight (g), mean (sd) 1263 (419) 1210 (411) GA group, %(n/n) 22-28 weeks 29-33 weeks 42.5 ( 371/873 ) 50.06 ( 414/827 ) 57.5 ( 502/873 ) 49.94 ( 413/827 ) Age at enrollment(days), median (IQ range) 12 (6-23) 15 (8-28) CGA at enrollment(weeks), median (IQ range) 32 (30-33) 31 (30-33) CPAP at enrollment, %(n/n) 50.2 (421/839) 50.6 (370/729) TPN at enrollment,%(n/n) 44.0 (369/839) 39.8 (290/729) Small gestational age, %(n/n) 11.62 ( 101/869 ) 9.82 ( 81/825 ) Apgar score<7 at 5 min, %(n/n) 26.8 ( 231/862 ) 27.75 ( 227/818 ) Singleton, %(n/n) 59.93 ( 522/871 ) 67.71 ( 560/827 ) Surfactant use, %(n/n) 45.91 ( 399/869 ) 52.48 ( 434/827 ) Caffeine use, %(n/n) 88.03 ( 765/869 ) 88.15 ( 729/827 ) Maternal age (years), mean (sd) 31.4 (5.4) 31.3 (5.5) Cesarean, %(n/n) 63.34 ( 546/862 ) 58.11 ( 480/826 )
Multivariable Analysis Adjusted difference in the outcome (95%CI; Intervention vs Control) P-value Zwt21-Zwt1 0.11 (0.07,0.16) <0.0001 (Wt21-Wt1) 2.17 (1.3,3.0) <0.0001 ((Wt21-Wt1)/Wt1)*100/21 1.69 (1.04,2.33) <0.0001 Adjusted OR of outcomes (95% CI) NI 0.80 (0.39, 1.62) 0.53 NEC 1.35 (0.64, 2.86) 0.42 BPD 0.73 (0.36, 1.48) 0.39 Note: Multivariable linear model and logistic regression model with GEE approach were used for continuous outcomes and binary outcomes respectively, adjusted for gestational age, age at enrollment, small gestational age, singleton, surfactant use and cesarean ROP3 0.94 (0.65, 1.34) 0.72 Mortality 1.63 (0.32, 8.2) 0.55
Difference in Weight Change Over Time Figure 1. The figure shows the difference in weight change (Wt-Wt1) between intervention and control groups (weight change for intervention weight change for control ) over time, where Wt1=weight at enrollment (Day 0). The difference in weight change was estimated using Mixed-effect model for repeated measures with random intercept accounting for the clustering, adjusted for gestational age, age at enrollment, small gestational age, singleton, surfactant use and cesarean.
Parent Stress Score (PSS-NICU) Figure 2. The figure shows the comparison in total parental stress score over time between intervention and control groups, using mixed-effect models for repeated measures, accounting for the clustering due to site effect.
Parent Anxiety Score (STAI) Figure 3. The figure shows the comparison in total parental anxiety score over time between intervention and control groups, using mixed-effect models for repeated measures, accounting for the clustering due to site effect.
Feeding on Discharge Control Interventi on P-value # infants available > 6 feeds/day breast milk 780 505 14% 39% 0.001 > 8 feeds/day formula 31% 14% <0.0001
Conclusion FiCARE improves both the infant and parent outcomes Long term neurodevelopmental follow up study is underway Further studies are required to examine the feasibility and safety of applying this model to different environments and patient populations
Other FiCARE Trials Follow-Up study Level 2 study Ventilated patients trial FiCARE China FiCARE USA FiCARE UK NAS Trial Surgical and complex patients trial Other areas of pediatrics & health care?
Neurodevelopmental Outcomes at 18 months CGA in China RCT (BSID) Variable FiCARE Control p-value MDI 95 9 86 9 <0.01 PDI 87 9 80 8 <0.01
New Sinai NICU
Principles to Ponder Bring families back into care process Empower families Treat the family as a single care unit
Acknowledgements: Canadian & ANZ Partners
2 nd FiCARE Conference September 8-9, 2018 Sydney, Australia With acknowledgements: Canadian Neonatal Network Canadian Institutes of Health Research Ontario Ministry of Health & Long Term Care Participating Institutions