跳至主要内容
临床试验/NCT06230341
NCT06230341招募中不适用

Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
16
试验地点
1
主要终点
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 4-by severity

研究概览

简要总结

In France, improving the practice of health professionals working in coordinated primary care teams (health centres called Maisons de Santé Pluriprofessionnelles - MSPs) could be facilitated by a learning system consisting of (i) a risk management support programme and (ii) the provision of a comprehensive online system combining training, reporting and support for the analysis and management of patient safety incidents (PSIs).

EVIDENS-Prim is a multi-method, multi-centre, prospective study. It aims to describe the PSIs that occur in MSPs, using an international classification system, and to describe the ways in which professionals have adopted a global approach to PSIs management, from PSI reporting to feedback.

详细描述

This method combines:

- (i) A sequential study of PSIs analysis. The sequential study will take place in three stages (coder training, collection of PSIs data via the web platform, PSIs coding).

Each PSIs reported by professionals during the implementation of the risk management support programme will be coded using the PISA multi-axial classification system (based on the WHO's International Classification for Patient Safety in Primary Care). These codes will be used to describe PSIs in coordinated practice.

- (ii) An implementation study of the learning system. The learning system is described in the intervention section. During the implementation study, two types of data collection (quantitative and qualitative) will be mobilised at the end of the support to the QualiREL Santé Regional Support Structure.

The main objective of the study is:

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

性别
All
接受健康志愿者

入选标准

  • Characteristics of the MSPs included in the study:
  • Located in the Pays de la Loire region;
  • Having a contract with a health insurance (specifications and financing defined nationally) for at least 1 year;
  • Agreeing to take part in the project;
  • Having a quality representative or committing to appoint one when they join the project.
  • Characteristics of professionals working in MSPs included:
  • All independent health professionals involved in the MSP: general practitioners and, depending on the MSP, nurses, pharmacists, podiatrists, physiotherapists, midwives, speech therapists, dentists, occupational therapists, psychomotor therapists, etc,)
  • All professionals involved in MSP outside the health sector: (coordinators, medical assistants, independent psychologists, etc.),
  • agree to take part in the project.

排除标准

  • Other group exercise modalities or other forms of coordinated exercise (other than MSP) do not have a quality representative on their team and will not be considered for inclusion.
  • Characteristics of MSPs not included in the research:
  • - Where the members of the research team work.
  • Characteristics of professionals working in MSPs included:
  • - Not included.

研究组 & 干预措施

Learning system benefits MSPs

Experimental

MSPs benefit from a learning system (described in the intervention section). MSPs are encouraged to report PSIs through the web platform provided after the initial training in each MSP and during the period of methodological support.

干预措施: Health Services Research (Other)

结局指标

主要结局

Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 4-by severity

时间窗: 18 months

Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by severity: number of PSIs of each severity (e.g. no harm, mild, moderate or severe harm, death) out of the total number of PSIs reported.

Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 1-by type

时间窗: PSIs reported by MSP professionals in the 18 months following the initial training provided

Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by type: the number of PSIs for each type out of the total number of PSIs reported.

Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 3-by results

时间窗: 18 months

Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by results: number of PSIs for each result (no harm, clinical harm, team harm) out of the total number of PSIs reported.

Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 2- by contributing factors

时间窗: 18 months

Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by contributing factors : number of PSIs for each contributing factor (e.g. factors related to the patient, staff, equipment, organisation, etc.) out of the total number of PSIs reported.

次要结局

  • Description of MSP professionals' acceptance of learning system(3 months)
  • Description of the MSP's behaviour in implementing the risk management support programme during the 18 months following the provision of the initial training.(18 months)
  • Description of the behaviour of users of the online system in the 18 months following the provision of initial training(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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