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Treatment ErrorREPHVIMNCT02006797

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

A study testing reconciliation in people with Treatment Error, run by University Hospital, Tours at 21 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Treatment Error
What is being tested?
reconciliation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,176 participants
Where
21 sitesFrance
Study dates
Jan 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 1 country.

Xavier POURRAT, Pr contact

+33(2)34389539

X.POURRAT@chu-tours.fr

21 sites in 1 country

France21 sites, 21 recruiting

  • Centre Hospitalier Alès-Cévennes

    Alès, 30100

    Vincent BOUIX, +33(0)466783147, vbouix@ch-ales.fr

    Vincent BOUIX

    Not yet recruiting

  • Centre Hospitalier Universitaire

    Angers, 49000

    Frédéric MOAL, +33(0)241354956, frmoal@chu-angers.fr

    Frédéric MOAL

    Not yet recruiting

  • Centre Hospitalier

    Béthune, 62408

    Catherine FLORET, +33(0)321644133, cfloret@ch-bethune.fr

    Catherine FLORET

    Not yet recruiting

  • Centre Hospitalier

    Blois, 41000

    Mathilde EMONET, +33(0)254556633, emonetm@ch-blois.fr

    Mathilde EMONET

    Not yet recruiting

  • Hopital de la Cavale Blanche

    Brest, 29200

    Maud PERENNES, +33(0)298347600, maud.perennes@chu-brest.fr

    Maud PERENNES

    Not yet recruiting

  • Hopital ESTAING

    Clermont-Ferrand, 63000

    Anne BOYER, +33(0)473357911, aboyer@chu-clermontferrand.fr

    Anne BOYER

    Not yet recruiting

  • Hopitaux civils de Colmar

    Colmar, 68000

    Christelle LEMARIGNIER, +33(0)389124240, christelle.lemarignier@ch-colmar.fr

    Christelle LEMARIGNIER

    Not yet recruiting

  • Centre Hospitalier Compiègne-Noyon

    Compiègne, 60200

    Anne-Marie LIEBBE, +33(0)344236465, am.liebbe@ch-compiegnenoyon.fr

    Anne-Marie LIEBBE

    Not yet recruiting

  • Centre Hospitalier Universitaire

    Grenoble, 38000

    Pierrick BEDOUCH, +33(0)476765496, pbedouch@chu-grenoble.fr

    Pierrick BEDOUCH

    Not yet recruiting

  • Hopital Jacques Monod

    Le Havre, 76290

    Dorothée LAURE-OLIVIER, +33(0)2 32 73 33 90, dorothee.olivier@ch-havre.fr

    Dorothée LAURE-OLIVIER

    Not yet recruiting

  • Centre Hospitalier

    Le Mans, 72000

    Anne-marie CAMINONDO, +33(0)243432846, amcaminondo@ch-lemans.fr

    Anne-Marie CAMINONDO

    Not yet recruiting

  • CHU Conception

    Marseille, 13000

    Philippe MONGES, +33(0)491383935, Philippe.MONGES@ap-hm.fr

    Philippe MONGES

    Not yet recruiting

  • Hopital de Mercy Metz-Thionville

    Metz, 57085

    Grégory RONDELOT, +33(0)387553484, g.rondelot@chr-metz-thionville.fr

    Grégory RONDELOT

    Not yet recruiting

  • Centre Hospitalier Pierre Bérégovoy

    Nevers, 58000

    Marie-Odette TISSERON-GUYOT, +33(0)386937086, marieodette.tisseron@ch-nevers.fr

    Marie-Odette TISSERON-GUYOT

    Not yet recruiting

  • Hopital Archet

    Nice, 06000

    Rémy COLLOMP, +33(0)492039281, COLLOMP.R@chu-nice.fr

    Rémy COLLOMP

    Not yet recruiting

  • Centre Hospitalier

    Nîmes, 30000

    Clarisse ROUX, +33(0)466683739, clarisse.roux@chu-nimes.fr

    Clarisse ROUX

    Not yet recruiting

  • Centre Hospitalier Universitaire

    Poitiers, 86000

    Sophie SURY-LESTAGE, +33(0)549443801, sophie.SURY-LESTAGE@chu-poitiers.fr

    Sophie SURY-LESTAGE

    Not yet recruiting

  • Hopital Inter Armées

    Saint-Mandé, 94160

    Virginie LAMAND, +33(0)143985038, lamand.virginie@gmail.com

    Virginie LAMAND

    Not yet recruiting

  • Hopital de Hautepierre

    Strasbourg, 67000

    Bénédicte GOURIEUX, +33(0)388127803, benedicte.gourieux@chru-strasbourg.fr

    Bénédicte GOURIEUX

    Not yet recruiting

  • Centre Hospitalier Universitaire

    Toulouse, 31000

    Cécile LEBAUDY, +33(0)561776418, lebaudy.c@chu-toulouse.fr

    Cécile LEBAUDY

    Not yet recruiting

  • Centre Hospitalier Universitaire

    Tours, 37000

    Xavier POURRAT, +33(0)234389539, x.pourrat@chu-tours.fr

    Xavier POURRAT

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Treatment Error
Being tested
reconciliation
Keywords
reconciliation, discharge, pharmacist, drug related problems

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reconciliationOther

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

Study groups in NCT02006797
Study groupRoleWhat they receive
interventionExperimentalpatients with reconciliation procedure at discharge and included in the exchange process
Receives: Other: reconciliation
controlNo interventionusual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days after patient discharge

Secondary outcomes (7)

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

    Measured: day 7 after discharge

  2. clinical impact of problems

    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.

    Measured: days 7 after discharge

  3. number of non-planned hospitalization

    number of non-planned hospitalizations in each group

    Measured: days 35 after discharge

  4. patient satisfaction

    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.

    Measured: day 7 after patient discharge

  5. community pharmacist satisfaction about exchanges with hospital pharmacists

    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.

    Measured: 7 days after patient discharge

  6. time spend by hospital pharmacist on reconciliation and communication to community pharmacist

    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

    Measured: at day 2/3 after discharge

  7. percentage of drugs prescription modified by the hospital pharmacist at discharge

    Measured: at discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
1,176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02006797
Sponsor's protocol ID
PREPS12-XP/REPHVIM
Acronym
REPHVIM
Status last verified
Jan 2014
First submitted
5 Dec 2013
Last updated
24 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24981605

Questions about this trial

What is this clinical trial studying?

A study testing reconciliation in people with Treatment Error, run by University Hospital, Tours at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xavier POURRAT, Pr (+33(2)34389539, X.POURRAT@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

drug related problems (DRP) (time frame: 7 days after patient discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02006797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.

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