Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)
NCT ID: NCT05231200
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
9500 participants
INTERVENTIONAL
2023-05-01
2027-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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.
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.
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
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.
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
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.
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.
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.
Interventions
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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.
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.
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
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.
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
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
32 Weeks
36 Weeks
ALL
No
Sponsors
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University of Alberta
OTHER
Alberta Health services
OTHER
Covenant Health, Canada
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Ayman Abou Mehrem, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Jennifer Toye, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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Peter Lougheed Centre
Calgary, Alberta, Canada
Foothills Medical Centre
Calgary, Alberta, Canada
Rockyview General Hospital
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Grande Prairie Regional Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Misericordia Community Hospital
Edmonton, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Sturgeon Community Hospital
Edmonton, Alberta, Canada
Chinook Regional Hospital
Lethbridge, Alberta, Canada
Medicine Hat Regional Hospital
Medicine Hat, Alberta, Canada
Red Deer Regional Hospital
Red Deer, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, Msc
Role: primary
Mahesha Bandara, MSc
Role: primary
Mahesha Bandara, MSc
Role: primary
References
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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.
Other Identifiers
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462647
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
21-1336
Identifier Type: -
Identifier Source: org_study_id
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