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

Patient Safety Clinical Trial

— PSI-RECORd-XP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04348552
• Other study ID #: RC20_0183
• Status: Withdrawn
• Start date: April 28, 2020
• Est. completion date: June 28, 2020

Study information

• Verified date: September 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

1. - HAS. Retour d'expérience sur les événements indésirables graves associés à des soins (EIGS) [Internet]. [cited 2020 Apr 7]. Available from: https://www.has-sante.fr/jcms/c_2882289/fr/retour-d-experience-sur-les-evenements-indesi rables-graves-associes-a-des-soins-eigs

2. - 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 28, 2020
• Est. primary completion date: June 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary care professionals practising in primary care in France

• Any patient undergoing primary care

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Patient Safety

Intervention

Other:
• Primary care professionals reports of potential patient safety incidents, non-COVID-19 related
Primary care professionals reports of potential patient safety incidents, non-COVID-19 related

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	2 months