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Идёт набор NCT06230341

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

Без фазы С лечением Adverse Event

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Health Services Research.
Кому может быть актуально
Состояния в реестре: Adverse Event. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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:

\- To Describe PSIs occurring in MSPs as part of the coordinated exercise and over an 18-month period, according to the 4 coding frameworks of the PISA classification: (i) types of events (main and contributing), (ii) contributing factors, (iii) outcomes of PSIs, (iv) severity of harm.

The secondary objectives, linked to the evaluation of the implementation of the learning system, are

* To examine the acceptance of the learning system by the teams, * To describe the effective use of the web platform by professionals, * To describe the MSP's ownership of the risk management support programme.

Вмешательства

  • Другое Health Services Research
    MSPs benefit from a learning system. The learning system combines an individualised support programme provided by a regional support structure for quality and safety in health care (QualiREL Santé) and the provision of a web platform. Based on the 4 dimensions of the Shortell model, the support programme includes initial training (6 months) and personalised methodological support (18 months) for each MSP. A web platform is provided to MSPs to enable them to implement the full approach of the Ris

Первичные конечные точки

  • Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 1-by type [Срок оценки: PSIs reported by MSP professionals in the 18 months following the initial training provided]
  • Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 2- by contributing factors [Срок оценки: 18 months]
  • Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 3-by results [Срок оценки: 18 months]
  • Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 4-by severity [Срок оценки: 18 months]
Вторичные конечные точки (3)
  • Description of MSP professionals' acceptance of learning system [Срок оценки: 3 months]
  • Description of the behaviour of users of the online system in the 18 months following the provision of initial training [Срок оценки: 18 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. [Срок оценки: 18 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Франция · 1 центр
  • Nantes Université — Nantes

Идентификаторы

NCT: NCT06230341 · RC23_0402 · RSP22N005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗