Generalizing TESTPILOT-NICU: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing in Neonatal Intensive Care Units
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Cumulative Latent Safety Threats (LST) discovered
研究概览
简要总结
Complex service interventions are neither smooth nor easy in any transitioning healthcare facility. Simulations performed in the new environment reinforce patient safety by uncovering safety threats, enabling their correction, and orienting hospital staff. This study expands upon patient safety successes at several institutions to measurably enhance patient safety at upcoming new inpatient facilities.
详细描述
Prior to opening the nation's largest single family room NICU in 2009, Women & Infants Hospital developed TESTPILOT: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing. The investigators simulated a functional NICU. 164 latent safety threats (LST) were identified without exposing a single neonate to risk. Practical changes were made to a) verbal and written communication protocols, b) admissions workflows, c) rapid team responses, d) family centered care e) scripting, f) facilities, g) supplies and equipment, and h) staffing and training issues.
"Generalizing TESTPILOT" studies how learnable and applicable this simulation-based methodology is at other institutions. Six institutions have successfully implemented TESTPILOT-NICU as of 2015. The investigators hypothesize implementations will succeed across a spectrum of care delivery structures, simulation experience and magnitudes of culture change, resulting in a broad blueprint for integrating simulation into transitioning healthcare services. Our goals include:
- Share lessons learned and support local simulation teams in their preparations;
- Quantitatively demonstrate improvement in system readiness and staff preparedness at each institution
- Assess saturation of latent safety threats over successive TESTPILOT implementations, resulting in a blueprint for similar transitions.
During Phase I the investigators standardized, refined and validated survey instruments with NICU staff and process experts. Phase II includes implementation of TESTPILOT at 15 institutions over three years. The Principal Investigator recruits each institution and guides them through the methodology, typically lasting six to eight months. Each institution's Co-Investigator and core simulation team recruits local staff for simulation, LST discovery and resolution, and survey completion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NICUs transitioning during the study period will be recruited.
- •Active NICU staff at each institution will be encouraged to participate without regard to age, gender, race, pregnancy or health status.
- •The participants will be a representative sample of the overall staff, which includes primarily women in most NICUs.
排除标准
- •Institutions unable to commit resources for simulation preparation, latent safety threat correction, or study reporting requirements
结局指标
主要结局
Cumulative Latent Safety Threats (LST) discovered
时间窗: Two months leading up to transition
LSTs are discovered during simulations, documented during debriefings, fed back to workflow committees for corrective action, and solutions may be retested in subsequent simulations
次要结局
- Average change in system readiness(Baseline (12-8 weeks prior to move), post-TESTPILOT (6-4 weeks prior), post-workshop (10 days prior) and post-transition (4-8 weeks post))
- Average change in staff preparedness(Baseline (12-8 weeks prior to move), post-TESTPILOT (6-4 weeks prior), post-workshop (10 days prior) and post-transition (4-8 weeks post))
- Qualitative review of successes and challenges(90 minute focus group discussion three months after transition)
研究者
Jesse Bender
Neonatologist
Women and Infants Hospital of Rhode Island