Length of Stay
Conditions
Keywords
Preterm infants, Evidence-based Practice for Improving Quality, Neonatal intensive care units
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALQI Team Building
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.
BEHAVIORALQI education
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.
OTHERStandardized care bundle- respiratory care
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.
OTHERStandardized care bundle- nutritional care
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.
BEHAVIORALQI mentoring
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.
BEHAVIORALCollaborative networking
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.
OTHERCurrent practice- standard of care
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.
Sponsors
University of Alberta
Alberta Health services
Covenant Health, Canada
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A stepped-wedge cluster randomized trial (SW-CRT) design. Each of the 12 participating NICUs (10 Level II and 2 Level III) are considered clusters and will be randomized to transition to the intervention arm at one of three-time points over a period of four years. The first year will be a baseline period where no clusters are exposed to the intervention. Based on the randomization, four NICUs will transition to the intervention arm at the end of each year. All clusters will have transitioned to the intervention arm by the start of year four.
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 36 Weeks
Healthy volunteers
No
Inclusion criteria
Preterm Infants: Infants born at 32 to 36 weeks' gestation and admitted to the participating NICUs or postpartum units. Quality Improvement Implementation Survey version 2 (QIIS-II) and semi-structured interview participants: Management staff, nurses, nurse practitioners, physicians, and allied health staff employed in participating NICUs.
Exclusion criteria
* Preterm Infants: * Major congenital anomalies or chromosomal abnormalities. * Primary admission to a surgical NICU: Alberta Children's Hospital or Stollery Children's Hospital. * Infants born in or transferred to a NICU outside Alberta. * Patients who have imposed confidentiality restrictions on accessing their health records.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 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). | The duration of hospitalization until final discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staff perception of collaborative QI (EPIQ) implementation. | Year 2, 3, and 4 of study | Semi-structured interviews with selected sample of staff from each NICU |
| Cost to healthcare system per participant | 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). | 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. |
| Number of participants with Hypothermia | Within 1 hour of birth | Axillary temperature \<36.5°C. |
| Number of participants with Hypoglycemia | First 24 hours of age | Blood glucose \<2.6 mmol/L. |
| Surfactant administration | First 168 hours of age. | Date and method of administration |
| Duration of respiratory support | 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). | Total number of days administered |
| Age at achieving full enteral feeding | 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). | Date when the enteral intake reaches 120 ml/kg/day. |
| Time to regain birth weight | 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). | Difference in days between birth date and date when the infants regains or exceeds birth weight after initial weight loss. |
| Transfer from Level II to Level III NICU | Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date). | Proportion of infants who require escalation of care and transfer to Level III NICU. |
| Length in centimeters | At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date). | actual values in centimeters |
| Head circumference in centimeters | At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date). | actual values in centimeters |
| Breastmilk use | 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). | Defined as number of feeds where infant received breastfeeding or maternal expressed breastmilk |
| Number of unplanned rehospitalizations per participant | Within 30 days after discharge home | Unplanned readmission to any hospital in Alberta following discharge |
| Number of emergency room visits per participant | Within 30 days after discharge home | Emergency room visits to any hospital in Alberta following discharge |
| Hospital mortality | Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date). | Proportion of infants who dies before first discharge home |
| Infant mortality before 1 year of corrected age | Before 1 year of corrected age | Corrected age = chronological age - days required for an infant to complete postmenstrual age of 40 weeks. |
| Weight in grams | At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date). | actual values in grams |
Countries
Canada
Contacts
Primary ContactMahesha Bandara, MSc
Backup ContactAyman Abou Mehrem, MD
Outcome results
None listed