Treatment Error Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02014987 -
Running Related Injury Among Novice Runners
|
Phase 0 |