Patient SafetyPSI-RECORd-GPNCT04346121
Non-COVID Patient-safety Incidents Reported by General Practitioners in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study.cRisis
An observational study of Patient Safety, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety
- What is being tested?
- GPs reports of potential patient safety incidents, non-COVID-19 related
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2020to 29 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: General practitioners 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)
Who may be able to join
- General practitioners practising in primary care, in France, who have given their consent to receive e-mails from the Collège National des Généralistes Enseignants (CNGE)
- Any patient undergoing primary care
Who cannot join
- Other primary health care professionals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-COVID Patient-safety Incidents Reported by General Practitioners in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study.
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).
Read more
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 general practitioners in France.
- 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-indesirables-graves-associes-a-des-soins-eigs
- 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.
- Conditions
- Patient Safety
- Being tested
- GPs reports of potential patient safety incidents, non-COVID-19 related
- Keywords
- Safety care, COVID, primary care, organization of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPs reports of potential patient safety incidents, non-COVID-19 relatedOther
GPs reports of potential patient safety incidents, non-COVID-19 related
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe patient safety incidents (types, severity, contributing and correcting factors) - 1000 PSI required
Describe patient safety incidents (types, severity, contributing and correcting factors) by the reorganization of care and/or lockdown reported by French GPs in the context of the COVID-19 health crisis - 1000 PSI required
Measured: 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) by the reorganization of care and/or lockdown reported by French GPs in the context of the COVID-19 health crisis - 100 PSI required
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start28 Apr 2020
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal FOURNIER, Doctor, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346121
- Sponsor's protocol ID
- RC20_0182
- Acronym
- PSI-RECORd-GP
- Status last verified
- Sep 2022
- First submitted
- 10 Apr 2020
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fournier JP, Amelineau JB, Hild S, Nguyen-Soenen J, Daviot A, Simonneau B, Bowie P, Donaldson L, Carson-Stevens A. Patient-safety incidents during COVID-19 health crisis in France: An exploratory sequential multi-method study in primary care. Eur J Gen Pract. 2021 Dec;27(1):142-151. doi: 10.1080/13814788.2021.1945029.
PubMed 34212814
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-COVID Patient-safety Incidents Reported by General Practitioners in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study.
- ClinicalTrials.gov ID
- NCT04346121
- Acronym / sponsor ID
- PSI-RECORd-GP / RC20_0182
- Conditions
- Patient Safety
- Keywords
- Safety care, COVID, primary care, organization of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 general practitioners in France.
- 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-indesirables-graves-associes-a-des-soins-eigs
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General practitioners 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)
Key inclusion criteria (2 listed)
- General practitioners practising in primary care, in France, who have given their consent to receive e-mails from the Collège National des Généralistes Enseignants (CNGE)
- Any patient undergoing primary care
Key exclusion criteria (1 listed)
- Other primary health care professionals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPs reports of potential patient safety incidents, non-COVID-19 relatedGPs reports of potential patient safety incidents, non-COVID-19 related | Other | – |
Primary outcome
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) by the reorganization of care and/or lockdown reported by French GPs in the context of the COVID-19 health crisis - 1000 PSI required
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) by the reorganization of care and/or lockdown reported by French GPs in the context of the COVID-19 health crisis - 100 PSI required
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Derived from this study: PubMed 34212814Fournier JP, Amelineau JB, Hild S, Nguyen-Soenen J, Daviot A, Simonneau B, Bowie P, Donaldson L, Carson-Stevens A. Patient-safety incidents during COVID-19 health crisis in France: An exploratory sequential multi-method study in primary care. Eur J Gen Pract. 2021 Dec;27(1):142-151. doi: 10.1080/13814788.2021.1945029.
Related trials for Patient Safety
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pascal FOURNIER, Doctor study chair
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe patient safety incidents (types, severity, contributing and correcting factors) - 1000 PSI required (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04346121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.