Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: A Stepped-Wedge Cluster Randomized Trial

Conditions
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Length of Stay

Intervention / Treatment
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* Behavioral: QI Team Building
* Behavioral: QI education
* Other: Standardized care bundle- respiratory care
* Other: Standardized care bundle- nutritional care
* Behavioral: QI mentoring
* Behavioral: Collaborative networking
* Other: Current practice- standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm- Current management<br>NICUs in the control arm can continue conducting QI activities relevant to current practice and current standard of care, but without receiving the interventions until they transition to the intervention arm. | Other: Current practice- standard of care<br>* 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.<br>|
| Experimental: Intervention Arm- Collaborative Quality implementation Strategies<br>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. | Behavioral: QI Team Building<br>* 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.<br>Behavioral: QI education<br>* 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.<br>Other: Standardized care bundle- respiratory care<br>* 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 establishing effective ventilation in the delivery room prevention of hypothermia early diagnosis and management of respiratory distress with continuous positive airway pressure (CPAP) standardized approach for surfactant indications and administration standardized approach for early extubation.<br>Other: Standardized care bundle- nutritional care<br>* 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 early initiation of enteral or parenteral nutrition; standardized tables for feeding initiation and progression optimizing breastfeeding and use of mother's own milk standardized approach for a transition from enteral nutrition via tube feeds to oral feeds.<br>Behavioral: QI mentoring<br>* 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.<br>Behavioral: Collaborative networking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | The duration of hospitalization until final discharge. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Within 1 hour of birth | 
| Number of participants with Hypoglycemia | Blood glucose <2.6 mmol/L. | First 24 hours of age | 
| Surfactant administration | Date, type, and method of administration | First 168 hours of age. | 
| Duration of respiratory support | Total number of days administered | 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. | 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). | 
| 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. | 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 | 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 | 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 | 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 | 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 | Within 30 days after discharge home | 
| Number of emergency room visits per participant | Emergency room visits to any hospital in Alberta following discharge | Within 30 days after discharge home | 
| Hospital mortality | Proportion of infants who dies before first discharge home | 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. | 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. | 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 | Year 2, 3, and 4 of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm infants, Evidence-based Practice for Improving Quality, Neonatal intensive care units