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临床试验/NCT07687251
NCT07687251已完成不适用

Primary Nursing: Uno Studio Pre e Post - Studio PRIMARY

Università degli Studi del Piemonte Orientale Amedeo Avogadro5 个研究点 分布在 1 个国家目标入组 1,708 人开始时间: 2019年11月22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
1,708
试验地点
5
主要终点
healthcare-associated infection (HAI)

研究概览

简要总结

The aim of this quasi-experimental before-after study is to evaluate whether the implementation of the Primary Nursing (PN) pattern of care improves nursing-sensitive outcomes in adult inpatients and nurse-related outcomes across hospital wards in Northern Italy.

The main questions it aims to answer are:

  1. What is the impact of the PN on inpatients' nursing-sensitive outcomes, including healthcare-associated infections, falls, pressure injuries, functional status, and patient satisfaction?
  2. What is the impact of the PN on nurse-related outcomes, including burnout, missed nursing care, job satisfaction, and intention to leave?

This study follows a multicentre, uncontrolled before-after design: in the pre-intervention phase, wards operated according to their existing nursing care models (functional or team nursing); this was followed by the implementation of the PN across all participating wards.

The PN assigns each patient to a single reference nurse who is responsible for planning, delivering, and evaluating nursing care throughout the entire hospital stay. In the primary nurse's absence, an associate nurse ensures continuity by following the individualised care plan.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • (patients):
  • Hospital stay of at least 48 hours in the study ward
  • Capacity to provide written informed consent
  • Clinical conditions permitting completion of self-reported outcome measures
  • Inclusion Criteria (nurses):
  • - Nursing staff employed in the study ward for at least 6 months

排除标准

  • Nursing staff joining the ward after the implementation phase of the PN model

结局指标

主要结局

healthcare-associated infection (HAI)

时间窗: From hospital admission to discharge (approximately 10 days)

An infection acquired during hospitalisation, with onset on Day 3 or later, or earlier following an invasive device/procedure on Day 1-2. Patients were monitored for HAIs throughout their stay in the study ward, and the occurrence of HAIs was recorded by the nurse at patient discharge in both the pre- and post-PN implementation phases.

次要结局

  • New pressure injury(From hospital admission to hospital discharge (approximately 10 days))
  • Job satisfaction(baseline (pre-PN) and post-PN (approximately 21 months))
  • Patient fall(From hospital admission to hospital discharge (approximately 10 days))
  • Discharge outcome(At hospital discharge (approximately 10 days))
  • Length of hospital stay(From hospital admission to hospital discharge (approximately 10 days))
  • Functional status (Barthel Index)(At hospital admission and at discharge (approximately 10 days))
  • Patient satisfaction (Caring Behaviours Inventory, CBI)(At hospital discharge (approximately 10 days))
  • Nurse's burnout(baseline (pre-PN) and post-PN (approximately 21 months))
  • Intention to leave(baseline (pre-PN) and post-PN (approximately 21 months))
  • Missed nursing care(baseline (pre-PN) and post-PN (approximately 21 months))

研究者

发起方
Università degli Studi del Piemonte Orientale Amedeo Avogadro
申办方类型
Other
责任方
Sponsor

研究点 (5)

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