- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03422484
SCORE of Medication Error in Internal Medecin Unit (SCOREME)
April 23, 2018 updated by: University Hospital, Montpellier
Developpemment of a Score to Assess Risk of Medication Errors in Internal Medecin Unit
Transfers between interfaces of care are recognized as a source of medication discrepancies, medication errors (MEs) and potentially adverse drug events.
ME are very common at hospital and may have important clinical and economic consequences.
The lack and loss of medication information and communication between health professionals at points of care transition may often lead to ME.
According to the literature, up to two thirds of medication histories contain at least one error.
Some studies have compared pharmaceutical team with physician or nurse on the detection of UMD or ME and have reported that pharmacists were one of the best health care providers to establish medication history.
To improve medication safety and decrease MEs rate, several institutions have recommended to develop medication reconciliation at all transition points such as admission, transfer and discharge.
Medication reconciliation is the process that compares a patient's medication order to all medications that the patient has been taking and should take at admission, transfer and discharge of hospitalization.
Medication reconciliation programs led by pharmacists are effective to reduce medications discrepancies.
However, studies evaluating the efficacy of medication reconciliation program are very heterogeneous in terms of populations, definitions and methodology.
Thus, proportion of ME differs enormously between studies, ranging from under 10% to over 60% at admission of hospitalization.
Elderly patients with their numerous comorbidities associated with polypharmacy, such as patients of internal medecin unit, are at high risk of ME and at risk of safety issues.
However, medication reconciliation process is very time consuming with an average of 30 minutes by patient.
Thereby, review of all inpatients within 24 hours of admissions is very difficult or impossible.
Targeting "high-risk situation" and "high-risk patient" are crucial to detect ME before causing harm.
Therefore, evaluating the risk of MEs and their potential consequences in specific population of internal medicine unit using a validated medication reconciliation process seems of utmost importance for internal medicine specialist clinical practice and the decrease of ME rate.
Consequently, the aim of our study was to (i) evaluate the prevalence of ME in an internal medicine unit at admission of hospitalization, (ii) determine the type of medication involved and the potential clinical impact of ME and (iii) identify factors associated with a risk of ME and serious ME.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1957
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study population was composed of patient hospitalized in internal medecine unit of Montpellier University hospital.
Description
Inclusion criteria:
- Patients aged above 18 years old, admitted to the department during the study period and hospitalized for at least 24 hours
Exclusion criteria:
- NA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
People with at least one medication error
People with at least one medication error at hospital admission
|
Detection and correction of medication error at hospital admission
|
|
People without medication error at hospital admission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of medication error
Time Frame: 1 day
|
number of medication error at hospital admission detected by clinical pharmacist during medication reconciliation process
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of variable associated to the risk of ME
Time Frame: 1 day
|
number of variable associated to the risk of ME detected by logistic regression analysis
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cyril BREUKER, University Hospital, Montpellier
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2012
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
January 26, 2018
First Submitted That Met QC Criteria
February 2, 2018
First Posted (Actual)
February 5, 2018
Study Record Updates
Last Update Posted (Actual)
April 24, 2018
Last Update Submitted That Met QC Criteria
April 23, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL18_0030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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