跳至主要内容
临床试验/NCT07833111
NCT07833111已完成不适用

Development and Psychometric Evaluation of the Perioperative Care Process Adherence Scale (PCPAS): A Multicenter Methodological Study

Volkan Gokmen1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2026年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
450
试验地点
1
主要终点
Construct Validity of the PBSUO: Factor Structure via Exploratory and Confirmatory Factor Analysis

研究概览

简要总结

This study aims to develop a new measurement instrument, the Perioperative Care Process Adherence Scale (PBSUO), and to evaluate its psychometric properties. The scale is designed to measure the degree to which nurses working in operating rooms and surgical wards adhere to evidence-based perioperative care processes, including operating room safety, early postoperative monitoring and complication prevention, Enhanced Recovery After Surgery (ERAS) components, patient education and communication, and documentation continuity.

The study is a multicenter methodological (scale development and psychometric validation) study conducted with nurses from operating rooms and surgical wards at three hospitals. Scale development proceeds in four phases: (1) generation of an initial item pool based on a literature review grounded in the Donabedian structure-process-outcome quality model, (2) content validity evaluation by a panel of 8-12 content experts, (3) cognitive pilot testing with 20-30 perioperative nurses to refine item wording and clarity, and (4) administration of the refined scale to a large multicenter sample (approximately 320-450 nurses) for exploratory and confirmatory factor analysis, evaluation of a second-order factor structure, reliability analysis, convergent and discriminant validity, measurement invariance between operating room and surgical ward nurses, and test-retest reliability over a two-week interval.

The study does not involve any clinical intervention, physical procedure, or performance evaluation of participants; participation consists solely of completing self-report questionnaires, and results will not be shared with participants' employers or affect their employment status.

详细描述

Background and Rationale

One of the key determinants of clinical outcomes in perioperative care is consistent adherence to evidence-based care processes. The Donabedian structure-process-outcome model emphasizes that process quality is closely linked to clinical outcomes, making it critical to render process performance measurable for quality management purposes (Donabedian, 1988). In the perioperative context, this process spans a multi-component chain of care encompassing operating room safety (e.g., surgical safety checklist use), early postoperative monitoring, complication prophylaxis, pain management, Enhanced Recovery After Surgery (ERAS) components such as early mobilization and early feeding, effective communication, patient education, and documentation continuity (Ljungqvist et al., 2017).

The perioperative period constitutes a high-risk, time-critical "acute vulnerability window" in which the surgical stress response, hemodynamic fluctuations, analgesia requirements, early complication development, and safety threats escalate simultaneously within a short time frame. Adherence, therefore, is not merely the existence of a protocol but the timely, correctly sequenced, and well-coordinated implementation of its components. Much of the existing literature on process performance has approached measurement through the lens of "missed nursing care" or care omission, which captures what care was not delivered but does not fully capture holistic adherence to evidence-based care (encompassing presence, timing, continuity, and coordination of care). Existing perioperative nursing scales largely measure patient experience/perception (PREMs) or general care-quality perception, or focus on competency rather than directly modeling process adherence at a performance-near level. This gap motivates the development of a new instrument capable of jointly capturing operating-room and ward-based nursing process adherence, evaluated with rigorous psychometric methods including measurement invariance testing across work settings.

Aims

The purpose of this study is to develop the Perioperative Care Process Adherence Scale (PBSUO) and to evaluate its content validity, construct validity (exploratory and confirmatory factor analysis), convergent and discriminant validity, internal consistency, and temporal reliability in a multicenter sample. Additional aims include testing measurement invariance between operating room and surgical ward nurses and confirming a second-order (hierarchical) factor structure in which sub-dimensions (e.g., operating room safety and team coordination; early monitoring and complication prevention; ERAS adherence; documentation continuity; patient education and communication) load onto a general "overall process adherence" higher-order factor.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • •Actively working in an operating room or surgical ward for at least 3 months
  • •Directly involved in the clinical perioperative care process
  • •Age 18 years or older
  • •Voluntary participation with written informed consent

排除标准

  • •Administrative role without direct clinical care delivery
  • •Newly oriented staff still in the orientation period
  • •A communication barrier that would prevent completion of the questionnaire

结局指标

主要结局

Construct Validity of the PBSUO: Factor Structure via Exploratory and Confirmatory Factor Analysis

时间窗: Single administration during the large-sample data collection phase (Phase 4), within the study period, March-August 2026

Evaluation of the factor structure of the Perioperative Care Process Adherence Scale (PBSUO) through exploratory factor analysis (principal axis factoring, promax rotation) and confirmatory factor analysis, including testing of a second-order (hierarchical) factor model, assessed via model fit indices (KMO, Bartlett test of sphericity, CFI, TLI, RMSEA, SRMR).

次要结局

  • Internal Consistency Reliability of the PBSUO(Single administration during the large-sample data collection phase (Phase 4), within the study period, March-August 2026)
  • Convergent and Discriminant Validity and Measurement Invariance of the PBSUO(Single administration during the large-sample data collection phase (Phase 4), within the study period, March-August 2026)
  • Temporal (Test-Retest) Reliability of the PBSUO(Two administrations approximately 2 weeks apart, within the study period, March-August 2026)

研究者

发起方
Volkan Gokmen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Volkan Gokmen

Assistant Professor

Agri Ibrahim Cecen University

研究点 (1)

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