Perioperative Nursing Workload, Missed Safety-Critical Care and Near-Miss Events: A Prospective Study Guided by the Donabedian Structure-Process-Outcome Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Missed Safety-Critical Perioperative Nursing Care Index
研究概览
简要总结
This prospective, single-center observational study examines the relationship between perioperative nursing workload and safety-critical perioperative nursing care in the operating rooms of Agri Training and Research Hospital. Guided by the Donabedian structure-process-outcome framework, the study will directly observe eligible surgical procedures to record objective, procedure-level workload indicators (interruptions, task-switching, concurrent duties, procedure duration, shift timing, and equipment/supply shortages) together with the observed perioperative nurse's self-reported workload using the Turkish NASA Task Load Index (NASA-TLX), and a structured observation of nine safety-critical perioperative nursing care tasks (identification/procedure/site verification, allergy and critical preoperative information verification, positioning and pressure-injury prevention, normothermia, surgical counts, specimen/label verification, equipment and implant readiness, handoff, and documentation). Any delayed or omitted safety-critical care items, and any near-miss or process-deviation events identified and corrected before patient harm, will also be recorded using standardized forms. The study does not involve patients as direct research participants; only the perioperative work environment and voluntarily participating nurses are observed, and routine clinical care, staffing assignments, and surgical decisions will not be modified. The primary aim is to determine whether higher perioperative nursing workload is associated with a higher rate of missed/delayed safety-critical nursing care at the procedure level; secondary aims examine the association between missed safety-critical care and near-miss/process-deviation events, and, if sufficient events occur, whether missed safety-critical care mediates part of the relationship between workload and near-miss/process-deviation events.
详细描述
Background and Rationale: Perioperative care is a safety-critical setting characterized by high cognitive demand, time pressure, concurrent tasks, and frequent workflow interruptions. Operating room nurses perform multiple safety-critical care duties within the same clinical workflow, including patient and procedure verification, safe positioning, surgical counts, specimen/label verification, equipment preparation, normothermia maintenance, handoff, and documentation. Missed nursing care has been defined in the nursing literature as any required aspect of patient care that is omitted, either in part or in total, or substantially delayed (Kalisch, Landstrom, & Hinshaw, 2009). Recent literature calls for mechanism-focused research that moves beyond prevalence estimates of missed care toward understanding why care is missed and what outcomes result (Palese, 2026). Studies examining the perioperative setting through direct, procedure-level observation remain limited. While workflow interruptions and perceived workload have been linked to missed nursing care (Liu et al., 2026), it remains unclear which specific safety-critical perioperative nursing duties are most likely to be delayed or omitted under high workload, and whether this translates into near-miss or process-deviation events. This study addresses workload using both a subjective self-report tool (NASA-TLX) and directly observed objective indicators (interruptions, task-switching, concurrent duties, procedure duration, shift timing, and equipment/supply shortages).
Conceptual Model: The study's conceptual model integrates the Donabedian structure-process-outcome framework with the missed nursing care literature: perioperative workload and workflow interruptions represent exposures related to the care environment (structure); missed/delayed safety-critical perioperative nursing care represents the proximal care process; and near-miss/process-deviation events represent the safety outcome. The pre-specified pathway is: workload and interruptions to missed/delayed safety-critical care to near-miss/process-deviation events. A distinguishing feature of this design is that missed nursing care is measured through direct, procedure-level observation of applicable safety-critical tasks rather than retrospective, general self-report, allowing nurse-level perceived workload, procedure-level objective workload, and directly observed care process to be linked within the same multilevel data structure.
Aims and Research Questions: The primary aim is to examine the relationship between perioperative nursing workload and procedure-level missed/delayed safety-critical nursing care. Secondary aims are to evaluate the relationship between missed/delayed safety-critical care and near-miss/process-deviation events, to determine the independent contribution of objective workload indicators, and, if a sufficient number of near-miss events is reached, to exploratorily examine whether missed safety-critical care mediates part of the relationship between workload and near-miss/process-deviation events. Research questions: (1) What are perioperative nurses' procedure-level perceived and objective workload levels? (2) How frequently are safety-critical perioperative nursing duties delayed or omitted, and which duties are most affected? (3) Is higher perceived and objective perioperative workload independently associated with a higher Missed Safety-Critical Care Index? (4) Is missed/delayed safety-critical care associated with the occurrence of near-miss/process-deviation events? (5) If a sufficient number of near-miss events is reached, does missed/delayed safety-critical care explain part of the relationship between workload and near-miss/process-deviation events?
Hypotheses: H1 (primary): As perioperative nursing workload increases, the rate of missed/delayed safety-critical care at the procedure level will increase. H1a: A higher Missed Safety-Critical Care Index will be associated with an increased likelihood of near-miss/process-deviation events. H1b (exploratory): If a sufficient number of events is reached, missed/delayed safety-critical care will explain part of the relationship between perioperative workload and near-miss/process-deviation events.
Setting and Design: This is a single-center, prospective, analytic observational study conducted in the operating rooms of Agri Training and Research Hospital. Routine clinical practice will not be altered, and the researchers will not intervene in clinical decisions, team task allocation, surgical technique, or patient care. Data collection is planned to take place over approximately 8-12 weeks between October 2026 and December 2026, following institutional and ethics committee approval. The unit of analysis is the surgical procedure; because the same nurse may be observed across multiple procedures, the data have a clustered structure with procedures nested within nurses, which will be accounted for using appropriate multilevel models.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •(Perioperative Nurses):
- •Actively on duty as a perioperative (operating room) nurse at Agri Training and Research Hospital
- •At least 3 months of operating room experience
- •Voluntary agreement to participate and to complete the post-procedure NASA-TLX form
排除标准
- •(Perioperative Nurses):
- •Extended leave or medical report resulting in inactive duty during the data collection period
- •Withdrawal from the study
- •Failure to complete the post-procedure workload assessment form
- •Inclusion Criteria (Surgical Procedures):
- •Performed in the operating rooms of Agri Training and Research Hospital
- •Involves a participating perioperative nurse who is actively on duty
- •Elective or planned surgical procedure
- •At least a portion of the safety-critical care items are directly observable
- •Exclusion Criteria (Surgical Procedures):
- •Emergency/resuscitative circumstances that would affect the clinical flow being observed
- •Procedures in which observation could not be completed
- •Observation records missing core variables
研究组 & 干预措施
Perioperative Nurses and Observed Surgical Procedures
Perioperative nurses working in the operating rooms of Agri Training and Research Hospital who voluntarily consent to participate, together with the eligible elective/planned surgical procedures in which a participating nurse is actively on duty during the study period. Each eligible procedure is directly observed by a researcher using a standardized objective workload observation form and a structured safety-critical perioperative nursing care observation form; near-miss/process-deviation events are logged using a standardized form; and the observed nurse completes the Turkish NASA Task Load Index (NASA-TLX) shortly after the procedure. No experimental intervention, diagnostic test, or change to routine clinical care is assigned; participants are observed under usual perioperative practice.
干预措施: Structured Direct Observation and Workload Assessment (Other)
结局指标
主要结局
Missed Safety-Critical Perioperative Nursing Care Index
时间窗: Assessed once per surgical procedure during the intraoperative period (from procedure start to end), for procedures observed over approximately 8-12 weeks between October 2026 and December 2026
Proportion of applicable safety-critical perioperative nursing care items (patient/procedure/surgical-site verification, allergy and critical preoperative information verification, positioning and pressure-injury prevention, normothermia, surgical count, specimen/label verification, equipment/implant readiness, safe handoff, and required documentation) scored as delayed/partial or not done, divided by the total number of applicable safety-critical items for that procedure, as directly observed using the Safety-Critical Perioperative Nursing Care Observation Form.
次要结局
- Occurrence of Near-Miss/Process-Deviation Events(Assessed once per surgical procedure during the intraoperative period, for procedures observed over approximately 8-12 weeks between October 2026 and December 2026)
- Association Between Objective Workload Indicators and Missed Safety-Critical Care(Assessed once per surgical procedure during the intraoperative period, for procedures observed over approximately 8-12 weeks between October 2026 and December 2026)
- Perceived and Objective Perioperative Nursing Workload(Assessed once per surgical procedure, shortly after procedure completion, for procedures observed over approximately 8-12 weeks between October 2026 and December 2026)
研究者
Volkan Gokmen
Dr.
Agri Ibrahim Cecen University
