The ABC-QI Trial aims to implement collaborative quality improvement (QI) strategies to standardize care for 32-36 week infants in Level 2 and 3 Neonatal intensive care units (NICUs) across the province of Alberta. The investigators want to know if using validated quality improvement methods and evidence-based care bundles will decrease the duration of hospital stay and get babies home as quickly as possible.
A stepped-wedge cluster randomized trial will be conducted in 12 NICUs across Alberta (10 Level II and 2 Level III). Each NICU is considered a cluster and will be randomized to transition to the intervention arm at one of three time points. The planned trial interventions include: Intervention arm (Collaborative QI Strategies): The study intervention is a constellation of collaborative QI strategies: 1) QI Team Building; 2) QI Education; 3) Implementation of 2 standardized practice care bundles (Respiratory Care, and Nutritional Care); 4) QI mentoring; and 5) Collaborative networking. Based on the randomization, 4 NICUs will transition to the intervention arm at the end of each year. Control arm (current management): All participating NICUs will be in the control arm during the first year prior to randomization to create a baseline of the current practices and between-units variation. NICUs in the control arm can continue conducting QI activities relevant to current practice, but without receiving the interventions outlined above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
9,500
Each NICU will create a core QI team composed of 6-8 multidisciplinary members including a parent advisor, when feasible. This team will lead the QI activities and education, and champion the culture and practice change in the unit.
Each NICU QI team will receive standardized QI education using the 6-hour EPIQ Workshop which involves hands-on approach to enable teams to successfully implement QI projects together. EPIQ 10 Steps and QI Tools will be used to build the team's understanding of QI using realistic improvement opportunities based on the standardized care bundles identified in the trial.
A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for stabilization and respiratory care in moderate and late preterm infants (MLPIs) including 1. establishing effective ventilation in the delivery room 2. prevention of hypothermia 3. early diagnosis and management of respiratory distress with continuous positive airway pressure (CPAP) 4. standardized approach for surfactant indications and administration 5. standardized approach for early extubation.
Peter Lougheed Centre
Calgary, Alberta, Canada
RECRUITINGFoothills Medical Centre
Calgary, Alberta, Canada
RECRUITINGLength of Stay
The duration of hospitalization until final discharge.
Time frame: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Cost to healthcare system per participant
The investigators will use the Canadian Institute for Health Information Patient Cost Estimator to calculate the daily cost based on the Case Mix Groups for gestational age and birth weight.
Time frame: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Number of participants with Hypothermia
Axillary temperature \<36.5°C.
Time frame: Within 1 hour of birth
Number of participants with Hypoglycemia
Blood glucose \<2.6 mmol/L.
Time frame: First 24 hours of age
Surfactant administration
Date and method of administration
Time frame: First 168 hours of age.
Duration of respiratory support
Total number of days administered
Time frame: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Age at achieving full enteral feeding
Date when the enteral intake reaches 120 ml/kg/day.
Time frame: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for nutritional support in MLPIs including 1. early initiation of enteral or parenteral nutrition; 2. standardized tables for feeding initiation and progression 3. optimizing breastfeeding and use of mother's own milk 4. standardized approach for a transition from enteral nutrition via tube feeds to oral feeds.
Each NICU in the intervention arm will have one or more assigned members of the study team who are experienced in collaborative QI and EPIQ methods. The mentors will help local QI teams to engage frontline staff in QI and navigate the unit-specific challenges.
The study team will conduct virtual meetings every 2 months for the NICUs in intervention arm allowing local QI teams to discuss progress, and share data. The investigators will arrange annual in-person or virtual meetings for the NICUs in the intervention arm to present projects, successes, and lessons learned. These NICUs will have continuing access to the data and will receive quarterly reports using statistical process control charts outlining the unit's performance compared to other units and to the group average.
All participating NICUs will be in the control arm during the first year prior to randomization to create a baseline of the current practices and between-units variation. NICUs in the control arm can continue conducting QI activities relevant to current practice, but without receiving the interventions outlined above until they transition to the intervention arm. The investigators will capture these activities and account for them in the analysis.
Rockyview General Hospital
Calgary, Alberta, Canada
RECRUITINGSouth Health Campus
Calgary, Alberta, Canada
RECRUITINGGrande Prairie Regional Hospital
Calgary, Alberta, Canada
RECRUITINGRoyal Alexandra Hospital
Edmonton, Alberta, Canada
RECRUITINGMisericordia Community Hospital
Edmonton, Alberta, Canada
RECRUITINGGrey Nuns Community Hospital
Edmonton, Alberta, Canada
RECRUITINGSturgeon Community Hospital
Edmonton, Alberta, Canada
RECRUITINGChinook Regional Hospital
Lethbridge, Alberta, Canada
RECRUITING...and 2 more locations
Time to regain birth weight
Difference in days between birth date and date when the infants regains or exceeds birth weight after initial weight loss.
Time frame: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Weight in grams
actual values in grams
Time frame: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
Length in centimeters
actual values in centimeters
Time frame: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
Head circumference in centimeters
actual values in centimeters
Time frame: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
Breastmilk use
Defined as number of feeds where infant received breastfeeding or maternal expressed breastmilk
Time frame: Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Number of unplanned rehospitalizations per participant
Unplanned readmission to any hospital in Alberta following discharge
Time frame: Within 30 days after discharge home
Number of emergency room visits per participant
Emergency room visits to any hospital in Alberta following discharge
Time frame: Within 30 days after discharge home
Hospital mortality
Proportion of infants who dies before first discharge home
Time frame: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Infant mortality before 1 year of corrected age
Corrected age = chronological age - days required for an infant to complete postmenstrual age of 40 weeks.
Time frame: Before 1 year of corrected age
Transfer from Level II to Level III NICU
Proportion of infants who require escalation of care and transfer to Level III NICU.
Time frame: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
Staff perception of collaborative QI (EPIQ) implementation.
Semi-structured interviews with selected sample of staff from each NICU
Time frame: Year 2, 3, and 4 of study