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
2 other identifiers
interventional
9,500
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2022
CompletedFirst Posted
Study publicly available on registry
February 9, 2022
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
July 18, 2025
July 1, 2025
4.3 years
January 6, 2022
July 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
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).
Number of participants with Hypothermia
Within 1 hour of birth
Number of participants with Hypoglycemia
First 24 hours of age
Surfactant administration
First 168 hours of age.
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).
- +12 more secondary outcomes
Study Arms (2)
Control Arm- Current management
ACTIVE COMPARATORNICUs 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.
Intervention Arm- Collaborative Quality implementation Strategies
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- University of Albertacollaborator
- Alberta Health servicescollaborator
- Covenant Health, Canadacollaborator
Study Sites (12)
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Rockyview General Hospital
Calgary, Alberta, T2V 1P9, Canada
South Health Campus
Calgary, Alberta, T3M 1M4, Canada
Grande Prairie Regional Hospital
Calgary, Alberta, T8V 4B1, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Misericordia Community Hospital
Edmonton, Alberta, T5R 4H5, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
Sturgeon Community Hospital
Edmonton, Alberta, T8N 6C4, Canada
Chinook Regional Hospital
Lethbridge, Alberta, T1J 1W5, Canada
Medicine Hat Regional Hospital
Medicine Hat, Alberta, T1A 4H6, Canada
Red Deer Regional Hospital
Red Deer, Alberta, T4N 4E7, Canada
Related Publications (1)
Abou Mehrem A, Toye J, Aziz K, Benzies K, Alshaikh B, Johnson D, Faris P, Soraisham A, McNeil D, Al Hamarneh YN, Foss K, Foulston C, Johns C, Zimmermann GL, Zein H, Hendson L, Kumaran K, Price D, Singhal N, Shah PS. Alberta Collaborative Quality Improvement Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI) Trial: a protocol for a multicentre, stepped-wedge cluster randomized trial. CMAJ Open. 2023 May 2;11(3):E397-E403. doi: 10.9778/cmajo.20220177. Print 2023 May-Jun.
PMID: 37130608DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ayman Abou Mehrem, MD
University of Calgary
- PRINCIPAL INVESTIGATOR
Jennifer Toye, MD
University of Alberta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2022
First Posted
February 9, 2022
Study Start
May 1, 2023
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be available after completion of the study and publication of the main manuscript.
- Access Criteria
- Approval from the principle investigator and the ABC-QI Trial Data Management Committee.
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.