NCT02006797

Brief Summary

This study will evaluate the impact of a communication between hospital pharmacist and community pharmacists in addition to drugs reconciliation procedure at discharge. It will be conducted in 21 french public hospitals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

21 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

December 5, 2013

Last Update Submit

January 23, 2014

Conditions

Keywords

reconciliationdischargepharmacistdrug related problems

Outcome Measures

Primary Outcomes (1)

  • drug related problems (DRP)

    The primary outcome is a composite endpoint associated all the problems/dysfunctions that can be observed from the hospital to home during 7 days after discharge. We will be taking in account the occurence of a dysfunction every time that one of the following problems will happen: - first drug problem; the drug taken by the patient has a problem: it is not the right medicine (Name, form, route, dose). The fault may be 1) an error between the processing of transcription at the admission and the discharge, 2) a therapeutic modification related to therapeutic formulary restriction, the home medication is replaced by an another one that may be less adaptated to patient, 3) an error linked to the writing. Second : patient due to patient; the patient doesn't take what was prescribed and / or treatments that he takes are stopped. Third- :presence of a gap in the continuity and duration of therapy: the patient could not have his medication when he's coming at the pharmacy

    7 days after patient discharge

Secondary Outcomes (7)

  • all compounds of the composite primary outcome measure (patient errors, medical error and DRP)

    day 7 after discharge

  • clinical impact of problems

    days 7 after discharge

  • number of non-planned hospitalization

    days 35 after discharge

  • patient satisfaction

    day 7 after patient discharge

  • community pharmacist satisfaction about exchanges with hospital pharmacists

    7 days after patient discharge

  • +2 more secondary outcomes

Study Arms (2)

intervention

EXPERIMENTAL

patients with reconciliation procedure at discharge and included in the exchange process

Other: reconciliation

control

NO INTERVENTION

usual care

Interventions

medication reconciliation at discharge and communication of this intervention to patient's community pharmacist

intervention

Eligibility Criteria

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

You may qualify if:

  • patients over 18
  • patients attending to the same CP for at least 3 months
  • patients speaking french

You may not qualify if:

  • patients with a length stay over 21 days (too many therapeutic modifications),
  • patients who do not return to home,
  • palliative patients and/or expected end of life
  • patients that will not give their informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Centre Hospitalier Alès-Cévennes

Alès, 30100, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Angers, 49000, France

NOT YET RECRUITING

Centre Hospitalier

Béthune, 62408, France

NOT YET RECRUITING

Centre Hospitalier

Blois, 41000, France

NOT YET RECRUITING

Hopital de la Cavale Blanche

Brest, 29200, France

NOT YET RECRUITING

Hopital ESTAING

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Hopitaux civils de Colmar

Colmar, 68000, France

NOT YET RECRUITING

Centre Hospitalier Compiègne-Noyon

Compiègne, 60200, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Grenoble, 38000, France

NOT YET RECRUITING

Hopital Jacques Monod

Le Havre, 76290, France

NOT YET RECRUITING

Centre Hospitalier

Le Mans, 72000, France

NOT YET RECRUITING

CHU Conception

Marseille, 13000, France

NOT YET RECRUITING

Hopital de Mercy Metz-Thionville

Metz, 57085, France

NOT YET RECRUITING

Centre Hospitalier Pierre Bérégovoy

Nevers, 58000, France

NOT YET RECRUITING

Hopital Archet

Nice, 06000, France

NOT YET RECRUITING

Centre Hospitalier

Nîmes, 30000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Poitiers, 86000, France

NOT YET RECRUITING

Hopital Inter Armées

Saint-Mandé, 94160, France

NOT YET RECRUITING

Hopital de Hautepierre

Strasbourg, 67000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Toulouse, 31000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Tours, 37000, France

RECRUITING

Related Publications (1)

  • Pourrat X, Roux C, Bouzige B, Garnier V, Develay A, Allenet B, Fraysse M, Halimi JM, Grassin J, Giraudeau B. Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial. Trials. 2014 Jun 30;15:260. doi: 10.1186/1745-6215-15-260.

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

  • Xavier POURRAT, Pr

    Centre Hospitalier Régional Universitaire de Tours

    STUDY DIRECTOR

Central Study Contacts

Xavier POURRAT, Pr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

December 1, 2015

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations