Handoffs and Transitions in Critical Care - Understanding Scalability
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 4,000
- 试验地点
- 10
- 主要终点
- Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.
研究概览
简要总结
The investigators will leverage implementation science and engineering to adapt, implement, and rigorously evaluate tailored postoperative handoff protocols and implementation strategies. In doing so, the investigators will develop a vital understanding of the factors needed for successful and sustained use of evidence-based interventions in acute care. This knowledge will inform approaches to bridge the evidence-to-practice gap that prevents effective interventions from realizing the promise of improved patient outcomes in acute care settings.
详细描述
Surgical patients who require post-surgical critical care are usually transferred from the operating room (OR) to the intensive care unit (ICU) for ongoing care. The process of transferring the patient from the OR to the ICU is called a "handoff." Handoffs involve the transfer of patient information and transfer of patient care responsibilities from the OR team to the ICU team. Multiple studies suggest that these handoffs can expose patients to preventable harm, which can be avoided with standardization of the handoff. The Handoffs and Transitions in Critical Care (HATRICC; IRB #819726) study, started in 2014, developed and implemented a standardized OR to ICU handoff process in two Penn surgical ICUs (SICUs) that did not have a standardized handoff process.
Four clinicians (surgeon, anesthetist, ICU provider, and ICU nurse) from two teams (surgical and intensive care) usually take part in handoff communication. During the HATRICC study, the investigators evaluated handoff communication between the OR and ICU teams before and after implementation of the new standardized handoff process (the "HATRICC process") in multiple ways, using observations, interviews, focus groups, and surveys. The investigators demonstrated a 20% improvement in information exchange after implementation of the HATRICC standardized handoff process, a process tailored to meet the needs of the different clinicians participating in OR to ICU handoffs.
Prior studies have indicated short-term success in standardizing OR to ICU handoffs, but sustainability of these improvement interventions has been less well studied. Two studies have demonstrated sustained or improved information exchange following the institution of structured OR to ICU handoff processes, but the factors influencing sustainability remain to be elucidated.
The aims of this study are to:
- Ascertain determinants of OR-to-ICU handoff protocol adoption and use in 12 adult and pediatric ICUs in five health systems.
- Adapt handoff protocols using engineering approaches and select tailored implementation strategies with implementation mapping.
- Test the effectiveness of tailored, multifaceted, multilevel implementation strategies.
- Design and create a digital toolkit for other ICUs to identify implementation determinants, customize OR-to-ICU handoff protocol, and select appropriate implementation strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Clinicians:
- •Age ≥ 18 years
- •Cares for patients at any point in the surgical continuum of care, including pre-operative, intra-operative, or post-operative care, OR has administrative responsibilities relevant to patient care at the study hospitals
- •Fluency in English
- •Inclusion Criteria for Patients:
- •Patient admitted for inpatient care at the study hospitals and experiences a post-operative handoff from the operating room to the intensive care unit.
排除标准
- •for Clinicians:
- •Being a member of research staff
- •Exclusion Criteria for Patients:
结局指标
主要结局
Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.
时间窗: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
Fidelity is defined as adherence to the standardized handoff intervention. Fidelity is a count of handoff steps followed, with scores ranging from 0 to 10. Fidelity will be measured by trained site-based observers. Field notes by trained observers will inform the interpretation of fidelity. Units of analysis: patient level (handoff level), ICU level.
New-onset organ failure
时间窗: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5
Per-protocol handoffs enable clinicians to follow expected care practices and to anticipate and avoid postoperative deterioration.
次要结局
- Perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory (Acceptability)(Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment)
- Perceived fit, relevance, or compatibility of the innovation in a practice setting or to address a particular issue (Appropriateness), measured by the Intervention Appropriateness Measure(Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment)
- Fidelity over time (Sustainment)(This outcome will be measured at monthly intervals starting 2 years after implementation, up to 5 years.)
- Monetary and non-monetary costs measured using the line item classification system(This outcome will be measured within 2 months of implementation; within2 months of beginning sustainment)
- Feasibility of treatment or innovation to be carried out in a practice setting, measured using the Feasibility of Intervention Measure.(Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment)
- Teamwork (effectiveness) measured using the Team Emergency Assessment Measure.(This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5)
- Clinician satisfaction measured at the individual level.(This outcome will be measured annually from Years 1 to 5.)
- Workload measured using the NASA Task Load Index.(This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.)
- Completeness of information exchange (Information Omissions) measured using a structured observation form.(This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5)
- Weighted average of the reliability-adjusted observed-to-expected ratios for component indicators of adverse events(This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.)
- AHRQ PSI 9: Perioperative hemorrhage or hematoma rate(effectiveness)(This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5)
- AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate (effectiveness)(This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.)
- AHRQ PSI 11: Postoperative respiratory failure rate (effectiveness)(This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5)
- Professionalism of handoff team during handoff.(At quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.)
- AHRQ PSI 12: Perioperative pulmonary embolism or DVT rate (effectiveness)(This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5)
- AHRQ PSI 13: Post operative sepsis rate (effectiveness)(This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5)