NCT03029052

Brief Summary

Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP). The investigators aim to assess in this study the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of medication reconciliation at discharge we expect a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

January 20, 2017

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge.

    The number of in-hospital prescription changes will be evaluated only on discharge prescription transmitted to the patient (after prescription analysis by a clinical pharmacist in the "reconciliation" group) Compared to the list of all current medications at admission, in-hospital prescription changes include the following: * Adding a new drug * Discontinuing a drug * Drug switch * Modifying a dose Among these hospital prescription changes, some will not be maintained by the PCP one month after discharge. In-hospital prescription changes not maintained by the PCP will be evaluated on the first prescription of the PCP following discharge.

    1 month

Study Arms (2)

Control group

NO INTERVENTION

Medical and pharmaceutical management (at admission, during hospitalization and at discharge) will follow standard healthcare procedures of the department.

Reconciliation group

EXPERIMENTAL

Standard healthcare procedures and pharmacist's involvement

Behavioral: Reconciliation

Interventions

ReconciliationBEHAVIORAL

In addition to standard healthcare procedures, the pharmacist will analyze discharge prescriptions and proceed to medication reconciliation. A patient's counseling session will also be provided by the pharmacist. A reconciliation mail will be addressed to the PCP.

Reconciliation group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years old
  • hospitalized in infectious disease department
  • with a chronic disease and a current medical prescription including at least three drugs
  • discharged home or nursing home
  • not opposed to the study

You may not qualify if:

  • foreigners, patients under legal guardianship
  • advanced dementia (MMS\<20) or phone tracking impossible
  • primary care physician opposed to answer questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Raymond poincaré

Garches, 92150, France

Location

MeSH Terms

Interventions

Medication Reconciliation

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Frederique BOUCHAND, PharmD

    APHP

    PRINCIPAL INVESTIGATOR
  • Benjamin DAVIDO, MD

    APHP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Monocenter, randomized, controlled, pilot study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

Study Start

February 8, 2017

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations