NCT03955965

Brief Summary

Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients. This study aimed to identify risk factors of unintended medication discrepancies (UMD) in an emergency department. Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

May 15, 2019

Last Update Submit

May 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Variables influencing the number of UMD in the emergency department

    Variation of the number of UMD for each variable was measured to identify the impact of each factor on medication errors (linear regression). Variables measured were the variables described in the protocol section.

    Nov2017-Apr2018

Secondary Outcomes (3)

  • Number and type of UMD

    Nov2017-Apr2018

  • Correction rate of UMD

    Nov2017-Apr2018

  • Impact of organizational variables on the number of UMD

    Nov2017-Apr2018

Study Arms (1)

Emergency patients with medication reconciliation

All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018

Other: Medication reconciliation

Interventions

No intervention was performed other than collecting data on patients' medical files

Emergency patients with medication reconciliation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018

You may qualify if:

  • All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018

You may not qualify if:

  • Patients transfered to another hospital right after the emergency department visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Emergencies

Interventions

Medication Reconciliation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medication ErrorsDrug TherapyTherapeuticsMedical ErrorsHealth ServicesHealth Care Facilities Workforce and ServicesMedication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Jennifer Corny, PharmD

    Pharmacy Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 20, 2019

Study Start

April 1, 2018

Primary Completion

May 1, 2018

Study Completion

November 15, 2018

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations