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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Length of Stay
• Intervention / Treatment: Other: Current practice- standard of care; 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 9500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman Abou Mehrem, MD; Phone Number: 1-403-944-3699; Email: a.aboumehrem@ucalgary.ca
• Study Contact Backup: Name: Mahesha Bandara, MSc; Phone Number: 1-403-944-3753; Email: mahesha.yatigalpotht@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3M 1M4
      • Recruiting
      • South Health Campus
      • Contact: Mahesha Bandara, MSc
    • Calgary, Alberta, Canada, T2N 2T9
      • Recruiting
      • Foothills Medical Centre
      • Contact: Mahesha Bandara, MSc; Phone Number: 1-403-944-3753; Email: mahesha.yatigalpotht@ucalgary.ca
    • Calgary, Alberta, Canada, T1Y 6J4
      • Recruiting
      • Peter Lougheed Centre
      • Contact: Mahesha Bandara, MSc
    • Calgary, Alberta, Canada, T2V 1P9
      • Recruiting
      • Rockyview General Hospital
      • Contact: Mahesha Bandara, MSc
    • Calgary, Alberta, Canada, T8V 4B1
      • Recruiting
      • Grande Prairie Regional Hospital
      • Contact: Mahesha Bandara, MSc
    • Edmonton, Alberta, Canada, T5H 3V9
      • Recruiting
      • Royal Alexandra Hospital
      • Contact: Mahesha Bandara, MSc
    • Edmonton, Alberta, Canada, T6L 5X8
      • Recruiting
      • Grey Nuns Community Hospital
      • Contact: Mahesha Bandara, MSc
    • Edmonton, Alberta, Canada, T5R 4H5
      • Recruiting
      • Misericordia Community Hospital
      • Contact: Mahesha Bandara, MSc
    • Edmonton, Alberta, Canada, T8N 6C4
      • Recruiting
      • Sturgeon Community Hospital
      • Contact: Mahesha Bandara, MSc
    • Lethbridge, Alberta, Canada, T1J 1W5
      • Recruiting
      • Chinook Regional Hospital
      • Contact: Mahesha Bandara, MSc
    • Medicine Hat, Alberta, Canada, T1A 4H6
      • Recruiting
      • Medicine Hat Regional Hospital
      • Contact: Mahesha Bandara, MSc
    • Red Deer, Alberta, Canada, T4N 4E7
      • Recruiting
      • Red Deer Regional Hospital
      • Contact: Mahesha Bandara, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm- Current management; 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; 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.
Experimental: Intervention Arm- Collaborative Quality implementation 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.	Behavioral: QI 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.; Behavioral: QI 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.; Other: Standardized 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; 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.; Other: Standardized 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; 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.; Behavioral: QI 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.; Behavioral: Collaborative 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.

What is the study measuring?

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
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
Surfactant administration	Date and method of administration	First 168 hours of age.

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services; University of Alberta; Covenant Health, Canada
• Investigators: Principal Investigator: Ayman Abou Mehrem, MD, University of Calgary; Principal Investigator: Jennifer Toye, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Preterm infants; Evidence-based Practice for Improving Quality; Neonatal intensive care units
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 21-1336; 462647 (Other Grant/Funding Number: CIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed, the de-identified, archived data will be transmitted to and stored at the Federated Research Data Repository (FRDR), for use by other researchers including those outside of the study.
• IPD Sharing Time Frame: Data will be available after completion of the study and publication of the main manuscript.
• IPD Sharing Access Criteria: Approval from the principle investigator and the ABC-QI Trial Data Management Committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No