|- candidate number||15372|
|- NTR Number||NTR4159|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-sep-2013|
|- Secondary IDs||12-097 MedRec at ICU Transfers|
|- Public Title||MEDICATION RECONCILIATION BY PHARMACISTS IN DUTCH CRITICAL CARE PATIENTS|
|- Scientific Title||MEDICATION RECONCILIATION BY PHARMACISTS IN DUTCH CRITICAL CARE PATIENTS|
|- hypothesis||medication reconciliation by pharmacists decreases the amount of medication transfer errors in patients admitted to the intensive care|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||-Admitted to the intensive care units of the Erasmus MC Rotterdam and Haga Teaching Hospital The Hague during the study period.|
-Admitted to the intensive care units for 24 hours or more.
|- Exclusion criteria||-No medication before intensive care admission. AND no medication after intensive care.|
-(the Erasmus MC Rotterdam): Admitted to the intensive care unit for home treatment mechanical ventilation (so called CTB).
-Admission and discharge within 72 hours inbetween Friday night and Sunday midnight
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||6-jan-2013|
|- planned closingdate||1-sep-2014|
|- Target number of participants||280|
|- Interventions||medication reconciliation at the moment of intensive care admission and discharge by a pharmacist.|
|- Primary outcome||TRANSFER ERRORS:|
-The proportion of patients with one or more transfer error on admission to the intensive care unit
-The proportion of patients with one or more transfer error after discharge from the intensive care unit.
|- Secondary outcome||ADVERSE DRUG EVENTS:|
-Number of potential adverse drug events (caused by medication transfer errors) for patients admitted to the intensive care unit from another hospital ward.
-Number of potential adverse drug events (caused by medication transfer errors) for patients discharged from the intensive care unit to another hospital ward.
-Costs involved with the medicationreconciliation process (labour costs pharmacy technician)
-Cost reduction due to preventing errors (medication costs; costs of prevented (potential) adverse drug events, toxicity and/or symptoms per intensive care admission)
-Medical consumption associated with the consequences of medication transfer errors, such as number of intensive care unit days and medical specialist- and nursing staff time, will be recorded and estimated from the hospital’s perspective.
-The prevention of adverse events, toxicity and/or symptoms could result in decreased medical consumption which may compensate the increased costs incurred for employing an intensive care pharmacy technician.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Liesbeth Bosma|
|- CONTACT for SCIENTIFIC QUERIES|| Liesbeth Bosma|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam, Apotheek Haagse Ziekenhuizen (AHZ)|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Cooperating Health Insurance Companies Fund “zorgvernieuwing”|
|- Brief summary||SUMMARY|
Rationale: Previous studies from our project team have shown that medication reconciliation at the moment of hospital admission or discharge by pharmacy technicians results in increased patient safety. Whether this is also the case at the moment of admission to or discharge from the intensive care unit (internal hospital transfer) is unknown.
Objective: The aim of the study is to show the effect of medication reconciliation by a pharmacist, in patients admitted to and discharged from the intensive care unit on medication errors.
Study design: A one year observational before/after stA one year before/after intervention study design will be used, with medication transfer errors as the primary outcome.
Study population: All patients admitted to the intensive care units of the Erasmus MC Rotterdam and Haga Teaching Hospital The Hague.
Intervention:The intervention consists of medication reconciliation at the moment of intensive care admission and discharge by a pharmacist.
Main study parameters/endpoints:
The proportion of patients with one or more transfer error on admission to the intensive care unit and the proportion of patients with one or more transfer error after discharge from the intensive care unit.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The only possible burden will be an interview done by the pharmacy technician to obtain necessary information about the medication history of the patient at the moment of intensive care admission and discharge.
|- Main changes (audit trail)|
|- RECORD||5-sep-2013 - 19-nov-2013|