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

University of Calgary

Status: Enrolling

Conditions: Length of Stay

Treatments: Other: Standardized care bundle- nutritional care; Behavioral: QI mentoring; Behavioral: Collaborative networking; Other: Standardized care bundle- respiratory care; Behavioral: QI education; Behavioral: QI Team Building; Other: Current practice- standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05231200

462647 (Other Grant/Funding Number)

21-1336

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,500 estimated patients

Sex: All

Ages: 32 to 36 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9,500 participants in 2 patient groups

Control Arm- Current management

Active Comparator group

Description:

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.

Treatment:

Other: Current practice- standard of care

Intervention Arm- Collaborative Quality implementation Strategies

Experimental group

Description:

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.

Treatment:

Behavioral: QI Team Building

Behavioral: QI education

Behavioral: Collaborative networking

Other: Standardized care bundle- respiratory care

Behavioral: QI mentoring

Other: Standardized care bundle- nutritional care