|- candidate number||9158|
|- NTR Number||NTR2804|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-feb-2011|
|- Secondary IDs||171101004 ZonMw|
|- Public Title||Intensive pharmacovigilance of high-risk patients on hospital surgical wards.|
|- Scientific Title||Intensive pharmacovigilance of high-risk patients on hospital surgical wards.|
|- hypothesis||Intensive pharmacovigilance in high-risk patients, much less intensive pharmacovigilance in low-risk patients and an education program for prescribers will lead to a reduction of medication related events (death, disability, increased hospital stay or readmission) due to prescription errors on (orthopaedic) surgical wards.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||All patients admitted to wards of surgery and orthopaedic surgery of two hospitals during the study period, consisting of 6 months usual care and 6 months intervention (sample size per group is 5300).|
|- Exclusion criteria||N/A|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||31-jan-2013|
|- Target number of participants||10600|
|- Interventions||1. A team of hospital pharmacists-clinical pharmacologists and internists-clinical pharmacologist will train participating hospital pharmacists to perform intensive pharmacovigilance in high-risk patients;|
2. Selection of high risk patients by a screening method;
3. Intensive pharmacovigilance in high risk patients: Structured medication review will be performed combining clinical data and the list of current medication of the patient;
4. Less intensive pharmacovigilance of low risk patients: Automatically finishing of alerts, which are known to be without harm for low risk patients (90%), without intervention of the hospital pharmacist;
5. Education program for physicians and physician assistants: The most important pharmacologic items will be discussed and national and hospital guidelines, related to these subjects will be explained.
|- Primary outcome||Unintended drug related problems due to prescription errors, that lead to death, disability, increased length of hospital stay and readmission.|
Outcomes are judged by opinions of a panel of experts.
|- Secondary outcome||1. Serious prescription errors;|
2. Non-serious prescription errors;
3. Guideline adherence.
Outcomes are judged by opionions of a panel of experts.
A pharmaco-economic evaluation will be performed.
|- Timepoints||Time schedule of the study:|
1. 4 months of preparation of the study;
2. 6 months of usual care period;
3. 3 months of implementation of the intervention;
4. 6 months of intervention period;
5. 5 months of analyzing data and writing of the manuscript.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| J.M. Bos|
|- CONTACT for SCIENTIFIC QUERIES|| J.M. Bos|
|- Sponsor/Initiator ||Canisius Wilhelmina Hospital, Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, KNMP, UVIT|
|- Brief summary||An open intervention, assessment blinded, before/after study in two community hospitals to reduce events (death, disability, increased hospital stay or readmission) due to prescription errors on surgical wards. In this study intensive pharmacovigilance in high risk patients, much less intensive pharmacovigilance in low risk patients and an education program for prescribers. The primary end point of this study is death, disability, increased hospital stay or readmission due to presciption errors. Secundary endpoints are rate of prescription errors, guideline adherence and a pharmaco economic evaluation. Two groups of minimal 5300 patients will be analysed to detect a 50% reduction of events.|
|- Main changes (audit trail)|
|- RECORD||23-feb-2011 - 20-mrt-2011|