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
- 12
- 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.
研究组 & 干预措施
Control Arm- Current management
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.
干预措施: Current practice- standard of care (Other)
Intervention Arm- Collaborative Quality implementation 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.
干预措施: Collaborative networking (Behavioral)
Intervention Arm- Collaborative Quality implementation 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.
干预措施: QI Team Building (Behavioral)
Intervention Arm- Collaborative Quality implementation 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.
干预措施: QI education (Behavioral)
Intervention Arm- Collaborative Quality implementation 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.
干预措施: Standardized care bundle- respiratory care (Other)
Intervention Arm- Collaborative Quality implementation 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.
干预措施: Standardized care bundle- nutritional care (Other)
Intervention Arm- Collaborative Quality implementation 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.
干预措施: QI mentoring (Behavioral)
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
- Weight in grams(At discharge home in survivors, assessed up to a corrected age of 6 months (6 months after their birth due date).)
- 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).)
- 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)