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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Другое 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 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
• Другое 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 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 nutriti
• Поведенческое 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.
• Поведенческое 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 a
• Другое 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.

Первичные конечные точки

• Length of Stay [Срок оценки: 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).]

Вторичные конечные точки (12)

• Cost to healthcare system per participant [Срок оценки: 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).]
• Number of participants with Hypothermia [Срок оценки: Within 1 hour of birth]
• Number of participants with Hypoglycemia [Срок оценки: First 24 hours of age]
• Surfactant administration [Срок оценки: First 168 hours of age.]
• Duration of respiratory support [Срок оценки: 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).]
• Age at achieving full enteral feeding [Срок оценки: 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).]
• Time to regain birth weight [Срок оценки: 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).]
• Weight in grams [Срок оценки: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).]
• Length in centimeters [Срок оценки: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).]
• Head circumference in centimeters [Срок оценки: At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).]
• Breastmilk use [Срок оценки: 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).]
• Number of unplanned rehospitalizations per participant [Срок оценки: Within 30 days after discharge home]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Канада · 12 центров

• Peter Lougheed Centre — Calgary
• Foothills Medical Centre — Calgary
• Rockyview General Hospital — Calgary
• South Health Campus — Calgary
• Grande Prairie Regional Hospital — Calgary
• Royal Alexandra Hospital — Edmonton
• Misericordia Community Hospital — Edmonton
• Grey Nuns Community Hospital — Edmonton
• … и ещё 4 центра

Публикации

• 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 random PMID 37130608

Идентификаторы

NCT: NCT05231200 · 21-1336 · 462647

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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