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ID
Source
Brief title
Health condition
High risk patients on (orthopaedic) surgical wards
Sponsors and support
Department Clinical Pharmacy
Radboud University Nijmegen Medical Center
Mevr. J.M. Bos, hospital pharmacist
Dr. C. Kramers, internist-clinical pharmacologist
KNMP (www,knmp.nl)
UVIT (www.uvit.nl)
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
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.
Intervention
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.
Department Clinical Pharmacy
PO box 9015
J.M. Bos
Nijmegen 6500 GS
The Netherlands
+31 (0)24 3657600
jm.bos@cwz.nl
Department Clinical Pharmacy
PO box 9015
J.M. Bos
Nijmegen 6500 GS
The Netherlands
+31 (0)24 3657600
jm.bos@cwz.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL2676 |
NTR-old | NTR2804 |
Other | ZonMw : 171101004 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |