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

Length of Stay Clinical Trial

— ABC-QI  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05231200
• Other study ID #: 21-1336
• Secondary ID: 462647
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 30, 2027

Study information

• Verified date: January 2024
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9500
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Length of Stay
• Premature Birth

Intervention

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.
• 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.
• 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.
• 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.

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services, Covenant Health, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	Number of participants with Hypothermia	Axillary temperature <36.5°C.	Within 1 hour of birth
Secondary	Number of participants with Hypoglycemia	Blood glucose <2.6 mmol/L.	First 24 hours of age
Secondary	Surfactant administration	Date and method of administration	First 168 hours of age.
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Number of unplanned rehospitalizations per participant	Unplanned readmission to any hospital in Alberta following discharge	Within 30 days after discharge home
Secondary	Number of emergency room visits per participant	Emergency room visits to any hospital in Alberta following discharge	Within 30 days after discharge home
Secondary	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).
Secondary	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
Secondary	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).
Secondary	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