跳至主要内容
临床试验/NCT02983136
NCT02983136已完成不适用

Safe Hands at the Sharp End- Implementing Aseptic Technique in the Operating Room, A Prospective Controlled Study With an Embedded Process Evaluation

Göteborg University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Surgical site infections

研究概览

简要总结

The aim of this integrated Knowledge Translation (iKT) study is to develop and test a multifaceted implementation intervention for feasibility, acceptability and effectiveness. The intervention will be tailored to fit the context of the operating room (OR), to promote OR team members' use of aseptic techniques during the care of frail persons undergoing acute fracture surgery of the hip.

Through the use of an iKT approach, the investigators hypothesise that building on leadership support, partnership between researchers, managers/clinical leaders and healthcare professionals, a solid foundation for the sustained implementation of patient safety innovations can be created.

详细描述

PROJECT DESCRIPTION

Aim The aim of this iKT study is to develop and test a multifaceted implementation intervention for feasibility, acceptability and effectiveness.The intervention will be tailored to fit the inner context of the operating department, to promote anaesthetic providers use of aseptic techniques.

Theory In designing the present study, the investigators followed the four iterative phases as identified by the UK Medical Research Council (MRC) framework for developing and evaluating complex interventions(1): *Review of the theoretical basis for the innovation and the context *Conducting pre studies and designing the intervention,*The exploratory trial i.e. the intervention implementation and evaluation.

The aim of the leadership intervention is to support the leaders in developing a participatory and effective leadership behaviours that promote the OR team's use of aseptic techniques and facilitate inter professional learning. The middle and front-line leaders of the study OR will participate in an intervention based on an iKT model inspired by person-centeredness (2) social construction and complexity thinking (3). The care professionals participating in this in this study are considered active partners and co-creators of the implementation process and activities. This type of collaborative approach means that the researchers, leaders and the OR team work closely together throughout the research process in order to produce findings that are relevant for users and context (4). Using this innovative approach represents a major departure from the concept of 'compliance' and a shift towards change as a result of a participatory and mindful processes (5). In the inter-professional dialogues, the following principles will underpin the process:

  • All partners are experts with various professional experiences,
  • Power differentials among partners are acknowledged and sensitively addressed,
  • All partners discuss potential benefits and harm of the innovation, research and implementation strategy,
  • The process is capacity-building for everyone and encompasses opportunities for mutual learning (4).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
否

入选标准

  • •All staff currently working at the intervention site and control site are eligibly for inclusion
  • •All patient that are undergoing hip fracture surgery at the control and study site and have given informed consent

排除标准

  • •ongoing infection before surgery

研究组 & 干预措施

Study site

Experimental

The study arm will consist of managers and staff at at the operating department of a University hospital in western Sweden' The intervention is based on partnership, dialogue and inter-professional learning

干预措施: Dialogue and inter-professional learning (Behavioral)

Control site

No Intervention

The Control arm will consist of managers and staff at at the operating department of a University hospital in south Sweden

结局指标

主要结局

Surgical site infections

时间窗: 1 year

At discharge, after 6 weeks and 1 year data will be collect on post-operative infections.

次要结局

  • Hand hygiene and Aseptic techniques(At baseline, 6, 12 and 18 month after the start of the intervention)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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