Communication Between Hospital and Community Pharmacists: Impact on Drug Management at Discharge (REPHVIM)

January 23, 2014 updated by: University Hospital, Tours

Impact of Drug Reconciliation at Discharge and Pharmaceutical Communication Between Hospital and Community Pharmacists on Drug Related Problems: Study Protocol for a Cluster Randomized Cross-over Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Transition points during hospitalization are at risk of drug related problems (DRP) especially admission and discharge. Reconciliation procedure at admission lead by a clinical pharmacist had been proved to decrease DRP. The community pharmacist (CP) is often the first health professional that patients meet at discharge. He/she is in charge of dispensing their medication to patients and give treatment information. However because of lack of information community pharmacist is not always able to identify problems and this may lead to dispense wrong drugs and/or wrong dosage and/or give wrong information. The objective of this study is to assess the impact of drug reconciliation performed at discharge completed by a communication between the Hospital Pharmacist (HP) and community pharmacist on drug related problem during the 7 days following discharge at home.

The study is a cluster randomized cross-over trial. It involves 21 French universitarian and non-universitarian hospitals with 42 care units: 22 medical units and 20 surgical units. Each unit (a unit corresponds to a cluster) is involved during two consecutive 14-day periods which are randomly assigned as "experimental" or "control" where control corresponds to usual care. During the experimental period, for each eligible patient discharged during the period, a reconciliation procedure will be performed by the HP, with communication to the patient. The HP will further inform the patient's community pharmacist about patient's drug therapy [modification in home medication, acute drugs prescribed, shelved treatments and/or labs results to survey patient]. Eligible patients will be over 18, attending to the same community pharmacist for at least 3 months. We will exclude patients with a length stay over 21 days (too many therapeutic modifications), those who do not return to home, and also palliative patient. The primary outcome is a composite outcome associating any kind of drug misuse during the 7 days following discharge. It will be assessed by phone at day 7 (+/-2) by a pharmacist in charge of the study (PCS) will phone both patients and community pharmacists . The secondary outcome will be the unplanned hospitalizations observed in each group assessed by phone at day 35 (+/-5). We plan to recruit 1,176 patients, i.e. 14 per period per unit.

This study will assess the impact of a reconciliation procedure at discharge followed by a communication between HP and community pharmacists . Also it will identify the type of patients for which the intervention is the most relevant in France and may be generalized to other countries that have the same care organisation.

Study Type

Interventional

Enrollment (Anticipated)

1176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ales, France, 30100
        • Not yet recruiting
        • Centre Hospitalier Alès-Cévennes
        • Contact:
      • Angers, France, 49000
        • Not yet recruiting
        • Centre Hospitalier Universitaire
        • Contact:
        • Principal Investigator:
          • Frédéric MOAL
      • Bethune, France, 62408
        • Not yet recruiting
        • Centre hospitalier
        • Contact:
        • Principal Investigator:
          • Catherine FLORET
      • Blois, France, 41000
        • Not yet recruiting
        • Centre hospitalier
        • Contact:
        • Principal Investigator:
          • Mathilde EMONET
      • Brest, France, 29200
        • Not yet recruiting
        • Hôpital de la Cavale Blanche
        • Contact:
        • Principal Investigator:
          • Maud PERENNES
      • Clermont-ferrand, France, 63000
        • Not yet recruiting
        • Hopital Estaing
        • Contact:
        • Principal Investigator:
          • Anne BOYER
      • Colmar, France, 68000
        • Not yet recruiting
        • Hopitaux Civils de Colmar
        • Contact:
        • Principal Investigator:
          • Christelle LEMARIGNIER
      • Compiegne, France, 60200
        • Not yet recruiting
        • Centre Hospitalier Compiègne-Noyon
        • Contact:
        • Principal Investigator:
          • Anne-Marie LIEBBE
      • Grenoble, France, 38000
        • Not yet recruiting
        • Centre Hospitalier Universitaire
        • Contact:
        • Principal Investigator:
          • Pierrick BEDOUCH
      • Le Havre, France, 76290
        • Not yet recruiting
        • Hopital Jacques Monod
        • Contact:
        • Principal Investigator:
          • Dorothée LAURE-OLIVIER
      • Le Mans, France, 72000
        • Not yet recruiting
        • Centre hospitalier
        • Contact:
        • Principal Investigator:
          • Anne-Marie CAMINONDO
      • Marseille, France, 13000
        • Not yet recruiting
        • CHU Conception
        • Contact:
        • Principal Investigator:
          • Philippe MONGES
      • Metz, France, 57085
        • Not yet recruiting
        • Hopital de Mercy Metz-Thionville
        • Contact:
        • Principal Investigator:
          • Grégory RONDELOT
      • Nevers, France, 58000
        • Not yet recruiting
        • Centre Hospitalier Pierre Bérégovoy
        • Contact:
        • Principal Investigator:
          • Marie-Odette TISSERON-GUYOT
      • Nice, France, 06000
        • Not yet recruiting
        • Hôpital Archet
        • Contact:
        • Principal Investigator:
          • Rémy COLLOMP
      • Nimes, France, 30000
        • Not yet recruiting
        • Centre hospitalier
        • Contact:
        • Principal Investigator:
          • Clarisse ROUX
      • Poitiers, France, 86000
        • Not yet recruiting
        • Centre Hospitalier Universitaire
        • Contact:
        • Principal Investigator:
          • Sophie SURY-LESTAGE
      • Saint Mande, France, 94160
        • Not yet recruiting
        • Hopital Inter Armées
        • Contact:
        • Principal Investigator:
          • Virginie LAMAND
      • Strasbourg, France, 67000
        • Not yet recruiting
        • Hôpital de Hautepierre
        • Contact:
        • Principal Investigator:
          • Bénédicte GOURIEUX
      • Toulouse, France, 31000
        • Not yet recruiting
        • Centre Hospitalier Universitaire
        • Contact:
        • Principal Investigator:
          • Cécile LEBAUDY
      • Tours, France, 37000
        • Recruiting
        • Centre Hospitalier Universitaire
        • Contact:
        • Principal Investigator:
          • Xavier POURRAT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intervention
patients with reconciliation procedure at discharge and included in the exchange process
Other: reconciliation
medication reconciliation at discharge and communication of this intervention to patient's community pharmacist
NO_INTERVENTION: control
usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drug related problems (DRP)
Time Frame: 7 days after patient discharge
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
all compounds of the composite primary outcome measure (patient errors, medical error and DRP)
Time Frame: day 7 after discharge
day 7 after discharge
clinical impact of problems
Time Frame: days 7 after discharge
all problems will be scored of the potential iatrogenic impact (from 0: none to 3: fatal) by a team associated a nephrologist, a cardiologist, a gastroenterologist and a clinical pharmacist.
days 7 after discharge
number of non-planned hospitalization
Time Frame: days 35 after discharge
number of non-planned hospitalizations in each group
days 35 after discharge
patient satisfaction
Time Frame: day 7 after patient discharge
the patient will have to tell his satisfaction about his drugs management by health professionals at discharge. It will be evaluated by a Likert scale with 4 items.
day 7 after patient discharge
community pharmacist satisfaction about exchanges with hospital pharmacists
Time Frame: 7 days after patient discharge
the community pharmacist will have to tell his satisfaction about his drugs management by health professionals at discharge. It will be evaluated by a Likert scale with 4 items.
7 days after patient discharge
time spend by hospital pharmacist on reconciliation and communication to community pharmacist
Time Frame: at day 2/3 after discharge
the hospital pharmacist will notice the time spent to patient reconciliation and communicate informations to community pharmacist. Time will be those declared by the hospital pharmacist
at day 2/3 after discharge
percentage of drugs prescription modified by the hospital pharmacist at discharge
Time Frame: at discharge
at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Xavier POURRAT, Pr, Centre Hospitalier Regional Universitaire de Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PREPS12-XP/REPHVIM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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