Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: A Stepped-Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9,500
- 试验地点
- 24
- 主要终点
- Length of Stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 32 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Length of Stay
时间窗: 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).
The duration of hospitalization until final discharge.
次要结局
- Surfactant administration(First 168 hours of age.)
- Cost to healthcare system per participant(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(Within 1 hour of birth)
- Duration of respiratory support(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).)
- Head circumference in centimeters(At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).)
- Breastmilk use(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).)
- Hospital mortality(Until first discharge home, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).)
- Transfer from Level II 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).)
- Time to regain 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).)
- Number of participants with Hypoglycemia(First 24 hours of age)
- Length in centimeters(At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).)
- Number of emergency room visits per participant(Within 30 days after discharge home)
- Infant mortality before 1 year of corrected age(Before 1 year of corrected age)
- Age at achieving full enteral feeding(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(At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).)
- Number of unplanned rehospitalizations per participant(Within 30 days after discharge home)
- Staff perception of collaborative QI (EPIQ) implementation.(Year 2, 3, and 4 of study)