Emergency PatientsCharmedNCT02356926
Cross Checking to Reduce Adverse Events in the Emergency Department
An observational study of Emergency Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Multicenter cluster randomized study to evaluate the reduction of the rate of severe medical errors with implementation of systematic cross checkings between emergency physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Patients
- How many people
- 1,680 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency patients
Who may be able to join
- All patients that visit the ED during one of the two periods of recruitment, monday to friday between 8:30am and 4:30pm, will be screened for inclusion. We chose this time interval as they correspond to period that can be exposed to a cross checking, which will occur at 11:30 am, 2:00 pm and 4:30 pm.
Who cannot join
- Patients whose care is not provided by an EP (for example psychiatrist or maxillo-facial surgeon)
- Scheduled return attendance to the ED
- Low severity, defined by
- Triage level 5 on a 1 to 5 scale 13,14
- Patients referred to a "minor" or "fast track" unit
- Patients discharged home less than 1 hours after first contact with an EP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Checking to Reduce Adverse Events Resulting From Medical Errors in the Emergency Department
Multicenter cluster randomized study to evaluate the reduction of the rate of severe medical errors with implementation of systematic cross checkings between emergency physician.
Read the detailed description
The CHARMED study is a prospective, multicenter, cluster-randomized cross-over study in six EDs in France. Centers will be randomly assigned to use routine management or systematic cross checking in the first period, and will use the alternative strategy in the second period (Fig 1). Patients will be recruited in six centers in France
In both periods, from 9am to 5pm, a CRT will be present in the ED to collect variables on providers and patients.
In the control period, usual care and routine management will be provided. In the intervention group, systematic cross-checking will be implemented three times a day from 8:30am to 6:00pm between emergency physicians. The CRT will seek emergency physicians (EP) by pairs for crosschecking. Senior physicians will use peer crosschecking (i.e. crosschecker will also be an emergency senior physician). The CRT will assist the pairing. Each EP will prepare to present all his or her current patients. Patient presentation will be will be protocolised (see below), although usual presentation will be sought as this is the presentation method already in place for handover. The crosschecking will occur in the presence of the CRT and in the ED, in any medical office staff room, or cubicle available.
Each EP will then have to present the patients he is actually taking care of, with brief description of the case. After a case has been presented by the EP, the comments and advice of the crosschecker will be sought.
In accordance to national and international recommendations 1,2,15, the following definitions will be used:
Medical Error: Failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim. The severity of an error will be classified using the National Coordinating Council on Medical Error and Reporting (NCCMERP) from A to I 16, as shown in table 2.
Adverse event (AE): An injury that might have resulted from medical care (or lack thereof).
Near Miss: A medical error that has the potential to cause an adverse event, but did not either by chance or after an intervention. A near miss is an error of severity B, C or D.
Preventable AE: An AE associated with an error. A preventable AE is a medical error of severity E, F, G, H or I.
Severe Medical Error (SME): preventable AE or a near miss. The primary objective is to assess whether the implementation of Systematic Cross Serious unexplained guideline violation (local or national), even in the absence of any documented injury, will be considered an AE. Checking in the ED will reduce the rate of severe medical errors. The primary endpoint is the rate of SME in the seven days following ED visits. As previously described, the subsequent adverse events might not clearly appear in the ED settings, hence is considered as a SME 8. Hospital or ED re-attendance within the next 7 days will be also considered as an adverse event.
Secondary endpoints include the followings:
- Rate of AE and preventable AE
- Rate of Near Miss
- Severity of SME
- Factors associated to SME:
- Related to patient (age, chief complaint, comorbidities, triage level)
- Related to physician (grade, experience, number of physician involved, handoff)
- Related to the ED visit (Time of visit, daily occupancy, crowding, waiting time, length of stay, total number of emergency physicians)
- Conditions
- Emergency Patients
- Keywords
- Adverse events, Medical errors, Emergency department, Cross checking
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Usual care and routine management | |
| Cross checking | Systematic cross checking between emergency physicians at 11:30, 14:00 and 16:30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events and preventable adverse events in the 7 days after admission to the emergency
Occurrence of SAEs or "near miss" in the 7 days after admission to the emergency, defined as:
- Serious Adverse Event (SAE): A damage or injury that may be the result of a medical intervention, or lack thereof.
- Or "near miss" medical error with the potential to cause damage that has been intercepted or who luckily did not reach the patient
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergency PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonathan Freund, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356926
- Sponsor's protocol ID
- NI14017
- Other IDs
- CRC13074
- Acronym
- Charmed
- Status last verified
- Jun 2016
- First submitted
- 2 Feb 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Freund Y, Goulet H, Leblanc J, Bokobza J, Ray P, Maignan M, Guinemer S, Truchot J, Feral-Pierssens AL, Yordanov Y, Philippon AL, Rouff E, Bloom B, Cachanado M, Rousseau A, Simon T, Riou B. Effect of Systematic Physician Cross-checking on Reducing Adverse Events in the Emergency Department: The CHARMED Cluster Randomized Trial. JAMA Intern Med. 2018 Jun 1;178(6):812-819. doi: 10.1001/jamainternmed.2018.0607.
PubMed 29710111Freund Y, Rousseau A, Berard L, Goulet H, Ray P, Bloom B, Simon T, Riou B. Cross-checking to reduce adverse events resulting from medical errors in the emergency department: study protocol of the CHARMED cluster randomized study. BMC Emerg Med. 2015 Sep 4;15:21. doi: 10.1186/s12873-015-0046-1.
PubMed 26340941
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Checking to Reduce Adverse Events Resulting From Medical Errors in the Emergency Department
- ClinicalTrials.gov ID
- NCT02356926
- Acronym / sponsor ID
- Charmed / NI14017
- Conditions
- Emergency Patients
- Keywords
- Adverse events, Medical errors, Emergency department, Cross checking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,680 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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.
Multicenter cluster randomized study to evaluate the reduction of the rate of severe medical errors with implementation of systematic cross checkings between emergency physician.
Detailed description
The CHARMED study is a prospective, multicenter, cluster-randomized cross-over study in six EDs in France. Centers will be randomly assigned to use routine management or systematic cross checking in the first period, and will use the alternative strategy in the second period (Fig 1). Patients will be recruited in six centers in France
In both periods, from 9am to 5pm, a CRT will be present in the ED to collect variables on providers and patients.
In the control period, usual care and routine management will be provided. In the intervention group, systematic cross-checking will be implemented three times a day from 8:30am to 6:00pm between emergency physicians. The CRT will seek emergency physicians (EP) by pairs for crosschecking. Senior physicians will use peer crosschecking (i.e. crosschecker will also be an emergency senior physician). The CRT will assist the pairing. Each EP will prepare to present all his or her current patients. Patient presentation will be will be protocolised (see below), although usual presentation will be sought as this is the presentation method already in place for handover. The crosschecking will occur in the presence of the CRT and in the ED, in any medical office staff room, or cubicle available.
Each EP will then have to present the patients he is actually taking care of, with brief description of the case. After a case has been presented by the EP, the comments and advice of the crosschecker will be sought.
In accordance to national and international recommendations 1,2,15, the following definitions will be used:
Medical Error: Failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim. The severity of an error will be classified using the National Coordinating Council on Medical Error and Reporting (NCCMERP) from A to I 16, as shown in table 2.
Adverse event (AE): An injury that might have resulted from medical care (or lack thereof).
Near Miss: A medical error that has the potential to cause an adverse event, but did not either by chance or after an intervention. A near miss is an error of severity B, C or D.
Preventable AE: An AE associated with an error. A preventable AE is a medical error of severity E, F, G, H or I.
Severe Medical Error (SME): preventable AE or a near miss. The primary objective is to assess whether the implementation of Systematic Cross Serious unexplained guideline violation (local or national), even in the absence of any documented injury, will be considered an AE. Checking in the ED will reduce the rate of severe medical errors. The primary endpoint is the rate of SME in the seven days following ED visits. As previously described, the subsequent adverse events might not clearly appear in the ED settings, hence is considered as a SME 8. Hospital or ED re-attendance within the next 7 days will be also considered as an adverse event.
Secondary endpoints include the followings:
- Rate of AE and preventable AE
- Rate of Near Miss
- Severity of SME
- Factors associated to SME:
- Related to patient (age, chief complaint, comorbidities, triage level)
- Related to physician (grade, experience, number of physician involved, handoff)
- Related to the ED visit (Time of visit, daily occupancy, crowding, waiting time, length of stay, total number of emergency physicians)
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Usual care and routine management |
| Cross checking | – | –Systematic cross checking between emergency physicians at 11:30, 14:00 and 16:30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency patients
Key inclusion criteria (1 listed)
- All patients that visit the ED during one of the two periods of recruitment, monday to friday between 8:30am and 4:30pm, will be screened for inclusion. We chose this time interval as they correspond to period that can be exposed to a cross checking, which will occur at 11:30 am, 2:00 pm and 4:30 pm.
Key exclusion criteria (6 listed)
- Patients whose care is not provided by an EP (for example psychiatrist or maxillo-facial surgeon)
- Scheduled return attendance to the ED
- Low severity, defined by
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of adverse events and preventable adverse events in the 7 days after admission to the emergency
Time frame: 7 days
Occurrence of SAEs or "near miss" in the 7 days after admission to the emergency, defined as: * Serious Adverse Event (SAE): A damage or injury that may be the result of a medical intervention, or lack thereof. * Or "near miss" medical error with the potential to cause damage that has been intercepted or who luckily did not reach the patient
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 23 Feb 2017.
- Derived from this study: PubMed 29710111Freund Y, Goulet H, Leblanc J, Bokobza J, Ray P, Maignan M, Guinemer S, Truchot J, Feral-Pierssens AL, Yordanov Y, Philippon AL, Rouff E, Bloom B, Cachanado M, Rousseau A, Simon T, Riou B. Effect of Systematic Physician Cross-checking on Reducing Adverse Events in the Emergency Department: The CHARMED Cluster Randomized Trial. JAMA Intern Med. 2018 Jun 1;178(6):812-819. doi: 10.1001/jamainternmed.2018.0607.
- Derived from this study: PubMed 26340941Freund Y, Rousseau A, Berard L, Goulet H, Ray P, Bloom B, Simon T, Riou B. Cross-checking to reduce adverse events resulting from medical errors in the emergency department: study protocol of the CHARMED cluster randomized study. BMC Emerg Med. 2015 Sep 4;15:21. doi: 10.1186/s12873-015-0046-1.
Related trials for Emergency Patients
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Recruiting
Peer Support Workers Study
Substance Use Disorder (SUD)
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.
Yonathan Freund principal investigator
Assistance Publique - Hôpitaux de Paris
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 Emergency Patients, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 6 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 23 Feb 2017. 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?
Rate of adverse events and preventable adverse events in the 7 days after admission to the emergency (time frame: 7 days). 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 NCT02356926, which also lists 2 linked publications.
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 23 Feb 2017.