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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-36
SponsorUniversity of Calgary

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • QI Team Building

    Behavioral

    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

    Behavioral

    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

    Other intervention

    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

    Other intervention

    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

    Behavioral

    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

    Behavioral

    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

    Other intervention

    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.

Treatment groups

9,500 Participants
are divided into 2 treatment groups
Group A: Control Arm- Current managementActive comparator 1 intervention
Group B: Intervention Arm- Collaborative Quality implementation StrategiesExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Length of Stay

The duration of hospitalization until final discharge.

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).

Secondary outcomes

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.

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).
2

Number of participants with Hypothermia

Axillary temperature \<36.5°C.

Time frame
Within 1 hour of birth
3

Number of participants with Hypoglycemia

Blood glucose \<2.6 mmol/L.

Time frame
First 24 hours of age
4

Surfactant administration

Date and method of administration

Time frame
First 168 hours of age.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

University of Alberta

Collaborator

Alberta Health services

Collaborator

Covenant Health, Canada

Collaborator