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Clinical Trials/NCT02906657
NCT02906657CompletedNot Applicable

Development of Medication Reconciliation Using Electronic Pharmaceutical Record: a National Multicenter, Cluster-randomized, Two-period Crossover Study in Elderly Hospitalized in Geriatrics, Internal Medicine and Orthopedic Surgery

Assistance Publique - Hôpitaux de Paris2 sites in 1 country2,000 target enrollmentStarted: November 3, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,000
Locations
2
Primary Endpoint
Proportion of patients with at least one ADE within the first 30 days of hospital stay.

Study Overview

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.

Detailed Description

Context Adverse drug events (ADEs) may occur in community or hospitalized patients. A review of the literature reports an incidence of ADEs varying from 0.1 to 61.4 %. This wide range may be explained by different designs and case-mix in the studies. For instance, the incidence of ADEs is higher in surgical wards or in the elderly, and increases with the number of prescribed drugs. In the elderly, the risk of ADE has been reported as 2-fold higher than that of a younger population. Some ADEs may not have been prevented, for example when the event was associated with an intended or known effect (e.g. neutropenia after cytotoxic drugs administration). However, some other ADEs might have been prevented whenever they were related to medications errors (omission, commission, dosing errors, prescription despite known allergies...). The proportion of preventable ADEs has been reported to range from 25% to 43% of total ADEs.

ADE can lead to extra monitoring because of biological abnormalities but also in more serious cases, to temporary or permanent harms, and even to death.

Prolonged hospitalizations are also attributed to ADE. Gastrointestinal tract events are the most common type of ADEs, followed by electrolyte and renal events, hemorrhages, metabolic and endocrine events. Drugs involved are cardiovascular drugs, followed by analgesics, antibiotics and anticoagulants.

Discrepancies between patient's current medication and the drugs prescribed at hospital admission hospital are frequent (27 to 54%) and have been reported in numerous studies. Potential consequences of such discrepancies have been extensively studied but data dealing with clinical outcomes are sparse.

Medication reconciliation is a process aiming at the creation of the most appropriate list of patient's medications, thus decreasing medication discrepancies and eventually ADE. Medication reconciliation can be performed by physicians, nurses, pharmacists. Usual sources of information for medication reconciliation are patient's prescriptions from the attending physician, patient's interview, hospital records... Additionally, information technology and electronic health records are of great help in this process. In France, drugs dispensed to a patient in community pharmacies during the 4 past months are registered in his/her electronic pharmaceutical record which is available to any pharmacist nationwide. This database is protected and can be consulted after recognition of the patient's healthcare card. To date, the contribution of this record to medication reconciliation has not been studied. The CONCIPAGE study will estimate the impact of a medication reconciliation using patient pharmaceutical record, on the occurrence of ADEs during the hospitalization of patients aged 65 years and over.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 30 days after admission

Secondary Outcomes

  • Proportion of preventable adverse drug events(30 days after admission)
  • Distribution of the severity of adverse drug events(30 days after admission)
  • Proportion of patients with discrepancy(ies) between pre- and post-reconciliation prescriptions(30 days after admission)
  • 30-day mortality rate(30 days after admission)
  • Incremental hospital costs per ADE avoided(30 days after admission)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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