Clinical trial NCT02006797: Communication Between Hospital and Community Pharmacists: Impact on Drug Management at Discharge
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Error
Keywords: reconciliation
discharge
pharmacist
drug related problems
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 1176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: drug related problems (DRP)
timeFrame: 7 days after patient discharge
Secondary outcomes:
measure: all compounds of the composite primary outcome measure (patient errors, medical error and DRP)
timeFrame: day 7 after discharge
measure: clinical impact of problems
timeFrame: days 7 after discharge
measure: number of non-planned hospitalization
timeFrame: days 35 after discharge
measure: patient satisfaction
timeFrame: day 7 after patient discharge
measure: community pharmacist satisfaction about exchanges with hospital pharmacists
timeFrame: 7 days after patient discharge
measure: time spend by hospital pharmacist on reconciliation and communication to community pharmacist
timeFrame: at day 2/3 after discharge
measure: percentage of drugs prescription modified by the hospital pharmacist at discharge
timeFrame: at discharge
Other outcomes:
Locations:
city: Ales
country: France
facility: Centre Hospitalier Alès-Cévennes
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Bethune
country: France
facility: Centre Hospitalier
city: Blois
country: France
facility: Centre Hospitalier
city: Brest
country: France
facility: Hopital de la Cavale Blanche
city: Clermont-ferrand
country: France
facility: Hopital ESTAING
city: Colmar
country: France
facility: Hopitaux civils de Colmar
city: Compiegne
country: France
facility: Centre Hospitalier Compiègne-Noyon
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire
city: Le Havre
country: France
facility: Hopital Jacques Monod
city: Le Mans
country: France
facility: Centre Hospitalier
city: Marseille
country: France
facility: CHU Conception
city: Metz
country: France
facility: Hopital de Mercy Metz-Thionville
city: Nevers
country: France
facility: Centre Hospitalier Pierre Bérégovoy
city: Nice
country: France
facility: Hopital Archet
city: Nimes
country: France
facility: Centre Hospitalier
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire
city: Saint Mande
country: France
facility: Hopital Inter Armées
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire
city: Tours
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: Centre Hospitalier Régional Universitaire de Tours
name: Xavier POURRAT, Pr
role: STUDY_DIRECTOR
References:
citation: 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.