Clinical trial NCT05231200: Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)
Official title: Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: a Stepped-Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Length of Stay
Keywords: Preterm infants
Evidence-based Practice for Improving Quality
Neonatal intensive care units
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Alberta Health services
name: Covenant Health, Canada
First posted: 2022-02-09
Enrollment: 9500
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.
  * Patients who have imposed confidentiality restrictions on accessing their health records.

Primary outcomes:
measure: Length of Stay
timeFrame: 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:
measure: Cost to healthcare system per participant
timeFrame: 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).
measure: Number of participants with Hypothermia
timeFrame: Within 1 hour of birth
measure: Number of participants with Hypoglycemia
timeFrame: First 24 hours of age
measure: Surfactant administration
timeFrame: First 168 hours of age.
measure: Duration of respiratory support
timeFrame: 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).
measure: Age at achieving full enteral feeding
timeFrame: 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).
measure: Time to regain birth weight
timeFrame: 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).
measure: Weight in grams
timeFrame: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
measure: Length in centimeters
timeFrame: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
measure: Head circumference in centimeters
timeFrame: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).
measure: Breastmilk use
timeFrame: 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).
measure: Number of unplanned rehospitalizations per participant
timeFrame: Within 30 days after discharge home
measure: Number of emergency room visits per participant
timeFrame: Within 30 days after discharge home
measure: Hospital mortality
timeFrame: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
measure: Infant mortality before 1 year of corrected age
timeFrame: Before 1 year of corrected age
measure: Transfer from Level II to Level III NICU
timeFrame: Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).
measure: Staff perception of collaborative QI (EPIQ) implementation.
timeFrame: Year 2, 3, and 4 of study
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Calgary
country: Canada
facility: Grande Prairie Regional Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Misericordia Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Sturgeon Community Hospital
state: Alberta
city: Lethbridge
country: Canada
facility: Chinook Regional Hospital
state: Alberta
city: Medicine Hat
country: Canada
facility: Medicine Hat Regional Hospital
state: Alberta
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ayman Abou Mehrem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Jennifer Toye, MD
role: PRINCIPAL_INVESTIGATOR
References: