Medication Reconciliation Using Electronic Pharmaceutical Record: A Multicenter Study in the Hospitalized Elderly

NCT02906657 | Completed

• 1 other identifier: K14101
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Context Adverse drug events (ADEs) may occur in hospitalized patients and may result from discrepancies between patient's current medications and the drugs prescribed at admission (omission,, dosing errors….). Consequences of these discrepancies may be mild (e.g. isolated biological abnormalities), but may also lead to severe clinical outcomes. Medication reconciliation is a process of creating the most accurate list of patient's current medication in order to decrease discrepancies and eventually ADEs. Information technology and electronic health records are of great interest in this process. In France, medications dispensed in community pharmacies during the past 4 months are registered in a patient's electronic pharmaceutical record. The impact of this record, together with pharmacist medication reconciliation, will be tested in the CONCIPAGE study. Design The CONCIPAGE study is a national, multicenter, cluster-randomized, two-period cross-over study. It will estimate the impact of medication reconciliation, made by a pharmacist, using the patient pharmaceutical record, on the occurrence of ADEs during the hospitalization of patients aged 65 years and over.

Conditions

Adverse Drug Event

Keywords

Medication Reconciliation; Adverse Drug Event; Elderly; patient pharmaceutical record

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with at least one ADE within the first 30 days of hospital stay.

  30 days after admission

Secondary Outcomes (5)

• Distribution of the severity of adverse drug events

  30 days after admission

• Proportion of preventable adverse drug events

  30 days after admission

• 30-day mortality rate

  30 days after admission

• Proportion of patients with discrepancy(ies) between pre- and post-reconciliation prescriptions

  30 days after admission

• Incremental hospital costs per ADE avoided

  30 days after admission

Study Arms (2)

Medication reconciliation

EXPERIMENTAL

Medication reconciliation involving a pharmacist using electronic pharmaceutical records

Other: Medication reconciliation

Control

NO INTERVENTION

Usual Care

Interventions

Medication reconciliation OTHER

The medication reconciliation list will be compared to the drugs prescribed by the hospital physician at admission and discrepancies will be analyzed by discussion between the physician and the pharmacist

Medication reconciliation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients hospitalized in one of the investigation centers
• Patients (male or female) aged 65 years and over
• Patients with electronic pharmaceutical record
• Patients hospitalized more than 24 h if admitted from Sunday to Thursday, more than 72 h if admitted on Friday, and more than 48 h if admitted on Saturday.
• Patients who gave their non-opposition to take part in the study

You may not qualify if:

• Patients discharged before medication reconciliation
• Patients participating in another interventional study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hopital Saint-Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Medication Reconciliation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Medication Errors; Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Christine FERNANDEZ, PharmD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: September 20, 2016
• Study Start: November 3, 2016
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

FR (1)