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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Hospital Pitié-Salpêtrière

    Paris

Other trials in France

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)
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 groups in NCT02356926
Study groupRoleWhat they receive
ControlUsual care and routine management
Cross checkingSystematic 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.

  1. 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.

  1. First posted6 Feb 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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)
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 29710111
  • Freund 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

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.

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