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

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.

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

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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