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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Hopital 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
        • Hôpitaux 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
        • Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xavier POURRAT, Pr, Centre Hospitalier Régional 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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