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Clinical Trials/NCT04348552
NCT04348552
Withdrawn
Not Applicable

Non-COVID Patient-safety Incidents Reported by Primary Care Professionals in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study

Nantes University Hospital1 site in 1 countryApril 28, 2020
ConditionsPatient Safety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Safety
Sponsor
Nantes University Hospital
Locations
1
Primary Endpoint
Describe patient safety incidents (types, severity, contributing and correcting factors) - 100 PSI required
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

The COVID-19 epidemic is causing a global health crisis. In France, it has imposed a major reorganization of the healthcare system. This emergency reorganization is unprecedented. It involved first, second and third line care. Following this reorganization and from the first days of confinement, a decrease in care activity not related to COVID-19 was observed in médical offices, in emergency services, and in secondary and tertiary care services. This decrease in activity could indicate a decrease in pathologies related to work, transportation or non-COVID-19 infections, due to a favourable effect of lockdown. Nevertheless, some health professionals report the opposite in the media and on social networks, an unusual increase in events (appendicular peritonitis treated late, increase in domestic violence, etc.), while others are surprised by a decrease in activity that is difficult to explain (leukaemia diagnoses by biologists, for example). One hypothesis is that such changes could be related to the reorganisation of the health care system or to the consequences of lockdown.

The World Health Organization (WHO) recommends a systematic collection and analysis of patient safety incidents (also called "adverse events" in France). The objective is to assess the roles of the system and human factors in patient safety, in order to propose changes to the global system and local organisation. In France, there is a system for reporting serious adverse events related to care. Only 4% of the 820 serious adverse events reported in 2018 were reported by primary healthcare professionals (1). However, patient safety incidents in primary care are known to have specific mechanisms, types and mechanisms (2).

We hypothesize that the COVID-19 health crisis may have induced unusual patient safety incidents through new mechanisms in a context associating reorganization of the healthcare system and population lockdown. Such a scenario requires the implementation of a massive collection of potential incidents and their systematic and well-structured analysis.

Thus, the objective of our study is to describe patient safety incidents related to the reorganization of care and/or lockdown in the context of the COVID-19 health crisis (types, severity, mechanisms) reported by primary care professionals in France.

    • Carson-Stevens A, Hibbert P, Avery A, Butlin A, Carter B, Cooper A, et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open. 2015 Dec 1;5(12):e009079.
Registry
clinicaltrials.gov
Start Date
April 28, 2020
End Date
June 28, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Primary care professionals practising in primary care in France
  • Any patient undergoing primary care

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Describe patient safety incidents (types, severity, contributing and correcting factors) - 100 PSI required

Time Frame: 2 months

Describe patient safety incidents (types, severity, contributing and correcting factors) caused by the reorganization of care and/or lockdown reported by French primary care professionals in the context of the COVID-19 health crisis - 100 PSI required

Describe patient safety incidents (types, severity, contributing and correcting factors) - 1000 PSI required

Time Frame: 6 months

Describe patient safety incidents (types, severity, contributing and correcting factors) caused by the reorganization of care and/or lockdown reported by French primary care professionals in the context of the COVID-19 health crisis - 1000 PSI required

Study Sites (1)

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