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Length of StayABC-QINCT05231200

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

A study testing QI Team Building, QI education and Standardized care bundle- respiratory care in people with Length of Stay, run by University of Calgary at 12 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 32 to 36 weeks
Conditions the study is for
Length of Stay
What is being tested?
QI Team Building, QI education and Standardized care bundle- respiratory care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,500 participants
Where
12 sitesCanada
Study dates
1 May 2023to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 to 36 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ayman Abou Mehrem, MD contact

1-403-944-3699

a.aboumehrem@ucalgary.ca

12 sites in 1 country

Canada12 sites, 12 recruiting
  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

    Mahesha Bandara, MSc

    Recruiting
  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

    Mahesha Bandara, MSc, 1-403-944-3753, mahesha.yatigalpotht@ucalgary.ca

    Recruiting
  • Rockyview General Hospital

    Calgary, Alberta, T2V 1P9

    Mahesha Bandara, MSc

    Recruiting
  • South Health Campus

    Calgary, Alberta, T3M 1M4

    Mahesha Bandara, MSc

    Recruiting
  • Grande Prairie Regional Hospital

    Calgary, Alberta, T8V 4B1

    Mahesha Bandara, MSc

    Recruiting
  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

    Mahesha Bandara, MSc

    Recruiting
  • Misericordia Community Hospital

    Edmonton, Alberta, T5R 4H5

    Mahesha Bandara, MSc

    Recruiting
  • Grey Nuns Community Hospital

    Edmonton, Alberta, T6L 5X8

    Mahesha Bandara, MSc

    Recruiting
  • Sturgeon Community Hospital

    Edmonton, Alberta, T8N 6C4

    Mahesha Bandara, MSc

    Recruiting
  • Chinook Regional Hospital

    Lethbridge, Alberta, T1J 1W5

    Mahesha Bandara, Msc

    Recruiting
  • Medicine Hat Regional Hospital

    Medicine Hat, Alberta, T1A 4H6

    Mahesha Bandara, MSc

    Recruiting
  • Red Deer Regional Hospital

    Red Deer, Alberta, T4N 4E7

    Mahesha Bandara, MSc

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Length of Stay
Being tested
QI Team Building, QI education, Standardized care bundle- respiratory care, Standardized care bundle- nutritional care, QI mentoring
Keywords
Preterm infants, Evidence-based Practice for Improving Quality, Neonatal intensive care units

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QI Team BuildingBehavioural

    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 educationBehavioural

    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 careOther

    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 careOther

    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 mentoringBehavioural

    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 networkingBehavioural

    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 careOther

    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.

Study groups in NCT05231200
Study groupRoleWhat they receive
Control Arm- Current managementActive 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.
Receives: Other: Current practice- standard of care
Intervention Arm- Collaborative Quality implementation StrategiesExperimentalThe 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of Stay

    The duration of hospitalization until final discharge.

    Measured: 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)
  1. 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.

    Measured: 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).

  2. Number of participants with Hypothermia

    Axillary temperature <36.5°C.

    Measured: Within 1 hour of birth

  3. Number of participants with Hypoglycemia

    Blood glucose <2.6 mmol/L.

    Measured: First 24 hours of age

  4. Surfactant administration

    Date and method of administration

    Measured: First 168 hours of age.

  5. Duration of respiratory support

    Total number of days administered

    Measured: 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).

  6. Age at achieving full enteral feeding

    Date when the enteral intake reaches 120 ml/kg/day.

    Measured: 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).

  7. 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.

    Measured: 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).

  8. Weight in grams

    actual values in grams

    Measured: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).

  9. Length in centimeters

    actual values in centimeters

    Measured: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).

  10. Head circumference in centimeters

    actual values in centimeters

    Measured: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).

  11. Breastmilk use

    Defined as number of feeds where infant received breastfeeding or maternal expressed breastmilk

    Measured: 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. Number of unplanned rehospitalizations per participant

    Unplanned readmission to any hospital in Alberta following discharge

    Measured: Within 30 days after discharge home

  13. Number of emergency room visits per participant

    Emergency room visits to any hospital in Alberta following discharge

    Measured: Within 30 days after discharge home

  14. Hospital mortality

    Proportion of infants who dies before first discharge home

    Measured: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).

  15. Infant mortality before 1 year of corrected age

    Corrected age = chronological age - days required for an infant to complete postmenstrual age of 40 weeks.

    Measured: Before 1 year of corrected age

  16. Transfer from Level II to Level III NICU

    Proportion of infants who require escalation of care and transfer to Level III NICU.

    Measured: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).

  17. Staff perception of collaborative QI (EPIQ) implementation.

    Semi-structured interviews with selected sample of staff from each NICU

    Measured: Year 2, 3, and 4 of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start1 May 2023
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
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)
Enrolment
9,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05231200
Sponsor's protocol ID
21-1336
Other IDs
462647
Acronym
ABC-QI
Status last verified
Jul 2025
First submitted
6 Jan 2022
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37130608

Questions about this trial

What is this clinical trial studying?

A study testing QI Team Building, QI education and Standardized care bundle- respiratory care in people with Length of Stay, run by University of Calgary at 12 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mahesha Bandara, MSc (1-403-944-3753, mahesha.yatigalpotht@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Stay (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05231200, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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