An observational study in Patient Safety, sponsored by Nantes University Hospital. Withdrawn at 1 site in France. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by Nantes University Hospital · Observational
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.
Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Primary care professionals will be invited via an email issued to report potential patient safety incidents unrelated to COVID-19 that they have observed since March 14, 2020 (date of entry into Stage 3 of the COVID-19 epidemic)
Exclusion Criteria:
Primary care professionals reports of potential patient safety incidents, non-COVID-19 related
Describe patient safety incidents (types, severity, contributing and correcting factors) - 1000 PSI required
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
Time frame: 6 months
Describe patient safety incidents (types, severity, contributing and correcting factors) - 100 PSI required
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
Time frame: 2 months
Plan to share: No
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This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital