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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03955965
Other study ID # OPTICONCIL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date November 15, 2018

Study information

Verified date May 2019
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients.

This study aimed to identify risk factors of unintended medication discrepancies (UMD) in an emergency department. Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.


Description:

Emergency patients are at high risk of medication errors, for different reasons: emergency admission, patients who don't know their at-home treatment (polymedicated, cognitive disorders, etc) and who don't have their medical prescriptions available.

Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients. However, prioritization is essential to ensure a better efficiency of pharmaceutical resources.

In our center, a pharmacy resident has been assigned to medication reconciliation in the emergency department since November 2017, in collaboration with a clinical pharmacist. Every morning, 3 to 4 patients benefit from medication reconciliation (patients who will be transfered to another unit within our hospital).

The main objective was to identify risk factors of unintended medication discrepancies (UMD) in order to prioritize patients who will benefit from this newly implemented activity.

Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.

All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018 were included. Were not included patients with a medication reconciliation performed but transfered to another hospital right after the emergency department visit.

This was a retrospective, monocentric, observational study. Number of patients required was 200. Variables collected were:

- demographics (age, sex, lifestyle, comorbidities),

- emergency care variables (date and time of medical care beginning, ambulance arrival, adressing type, medical prescriptions availability, main diagnosis, date and hour of medical prescriptions in the emergency department, prescriber (pharmacy/doctor), destination unit of patients)

- organizational variables (number of daily emergency visits, number of patients hospitalized within the emergency department),

- medical notes information on at-home treatment (number of missing information, of incorrect information, number of prescriptions in at-home treatment)

- medication reconciliation variables (date of medication reconciliation, number of sources of information needed, number of actual prescriptions in at-home treatment, number of intended medication discrepancies, number and type of UMD, time needed for medication reconciliation).


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date November 15, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018

Exclusion Criteria:

- Patients transfered to another hospital right after the emergency department visit

Study Design


Intervention

Other:
Medication reconciliation
No intervention was performed other than collecting data on patients' medical files

Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variables influencing the number of UMD in the emergency department Variation of the number of UMD for each variable was measured to identify the impact of each factor on medication errors (linear regression). Variables measured were the variables described in the protocol section. Nov2017-Apr2018
Secondary Number and type of UMD Nov2017-Apr2018
Secondary Correction rate of UMD Nov2017-Apr2018
Secondary Impact of organizational variables on the number of UMD Nov2017-Apr2018
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