SCORE of Medication Error in Internal Medecin Unit (SCOREME)

• ClinicalTrials.gov Identifier: NCT03422484
• Recruitment Status: Completed
• First Posted: February 5, 2018
• Last Update Posted: April 24, 2018
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Patient Hospitalized in Internal Medicine Unit	Other: Detection and correction of medication error at hospital admission

Study Design

• Study Type: Observational
• Actual Enrollment: 1957 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Developpemment of a Score to Assess Risk of Medication Errors in Internal Medecin Unit
• Actual Study Start Date: May 1, 2012
• Actual Primary Completion Date: November 1, 2017
• Actual Study Completion Date: January 1, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
People with at least one medication error; People with at least one medication error at hospital admission	Other: Detection and correction of medication error at hospital admission; Detection and correction of medication error at hospital admission
People without medication error at hospital admission; People without medication error at hospital admission

Outcome Measures

Primary Outcome Measures :

1. number of medication error [ Time Frame: 1 day ]
   number of medication error at hospital admission detected by clinical pharmacist during medication reconciliation process

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Study population was composed of patient hospitalized in internal medecine unit of Montpellier University hospital.

Criteria

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

Contacts and Locations

Locations

France

Uhmontpellier

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

• Principal Investigator: Cyril BREUKER; University Hospital, Montpellier

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Audurier Y, Roubille C, Manna F, Zerkowski L, Faucanie M, Macioce V, Castet-Nicolas A, Jalabert A, Villiet M, Fesler P, Lohan-Descamps L, Breuker C. Development and validation of a score to assess risk of medication errors detected during medication reconciliation process at admission in internal medicine unit: SCOREM study. Int J Clin Pract. 2021 Feb;75(2):e13663. doi: 10.1111/ijcp.13663. Epub 2020 Dec 14.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03422484
• Other Study ID Numbers: RECHMPL18_0030
• First Posted: February 5, 2018
• Last Update Posted: April 24, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: NC

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:

Internal medecine unit; Medication Error; Clinical Pharmacist; Medication reconciliation