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

Treatment Error Clinical Trial

— REPHVIM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02006797
• Other study ID #: PREPS12-XP/REPHVIM
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2013
• Last updated: January 23, 2014
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: University Hospital, Tours
• Contact: Xavier POURRAT, Pr
• Phone: +33(2)34389539
• Email: X.POURRAT[@]chu-tours.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1176
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Treatment Error

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Alès-Cévennes	Ales
France	Centre Hospitalier Universitaire	Angers
France	Centre Hospitalier	Bethune
France	Centre Hospitalier	Blois
France	Hopital de la Cavale Blanche	Brest
France	Hopital ESTAING	Clermont-ferrand
France	Hopitaux civils de Colmar	Colmar
France	Centre Hospitalier Compiègne-Noyon	Compiegne
France	Centre Hospitalier Universitaire	Grenoble
France	Hopital Jacques Monod	Le Havre
France	Centre Hospitalier	Le Mans
France	CHU Conception	Marseille
France	Hopital de Mercy Metz-Thionville	Metz
France	Centre Hospitalier Pierre Bérégovoy	Nevers
France	Hopital Archet	Nice
France	Centre Hospitalier	Nimes
France	Centre Hospitalier Universitaire	Poitiers
France	Hopital Inter Armées	Saint Mande
France	Hopital de Hautepierre	Strasbourg
France	Centre Hospitalier Universitaire	Toulouse
France	Centre Hospitalier Universitaire	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	all compounds of the composite primary outcome measure (patient errors, medical error and DRP)		day 7 after discharge	Yes
Secondary	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.	days 7 after discharge	Yes
Secondary	number of non-planned hospitalization	number of non-planned hospitalizations in each group	days 35 after discharge	Yes
Secondary	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.	day 7 after patient discharge	No
Secondary	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.	7 days after patient discharge	No
Secondary	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	at day 2/3 after discharge	No
Secondary	percentage of drugs prescription modified by the hospital pharmacist at discharge		at discharge	Yes