|- candidate number||2259|
|- NTR Number||NTR777|
|- ISRCTN||aanpassingen ISRCTN04371570|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||22-sep-2006|
|- Secondary IDs||N/A |
|- Public Title||Introduction and effects of structured drug counselling in the hospital.|
|- Scientific Title||Introduction and effects of structured drug counselling in the hospital.|
|- ACRONYM||Introduction and effects of structural information about medicines: the patient as a guard for his medication safety|
|- hypothesis||The intervention lead to:|
1. More knowledge about (the use of) prescribed medicines;
2. A better use of medicines during the stay in the hospital and after discharge.
|- Healt Condition(s) or Problem(s) studied||Cancer, Lung disease, Drug counselling|
|- Inclusion criteria||1. Admission at one of the participating departments;|
2. Informed consent;
3. Duration of admission at least 3 days maximally a month.
|- Exclusion criteria||1. Patients younger than 18 years;|
2. Patients who are emotionally or physically not capable to participate;
3. Senile dementia, confusion of the patient;
4. Inability to express in Dutch language.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||2-okt-2006|
|- planned closingdate||1-jun-2007|
|- Target number of participants||240|
|- Interventions||1. Personalized computer generateed medications reminder charts during admission and discharge and brochures about specific medicines; |
2. Patient safety chart with instructions for safe and correct use of medicines.
The intervention measurements at the departments of lung diseases and oncology lasts three months. The control measeruments lasts three months (same departments).
|- Primary outcome||1. Difference in knowledge about prescribed medicines between intervention and control group at measurement II, per patient corrected for the basis at measurement I
2. Differences in correct use of medicines between intervention and control group at measurement III
|- Secondary outcome||1. Differences in spotting and reporting medication deviations during the distribution of medicines in hospital between intervention and control group (measurement II);|
2. Differences in satisfaction about the received information about medicines (measurement II).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. M. van den Hout|
|- CONTACT for SCIENTIFIC QUERIES||PhD. C. Wagner|
|- Sponsor/Initiator ||VU University Medical Center, Nederlands instituut voor onderzoek van de gezondheidszorg (NIVEL)|
(Source(s) of Monetary or Material Support)
|Agis Health Insurance , Orde van Medisch Specialisten|
|- Brief summary||Additional information design:|
3 measurements at the departments of lung diseases and oncology during intervention period as well as control period.
Measurement I: 1-3 days after admission.
Meaurement II: during discharge.
Measurement III: during re-admission or control visit.
Size of the 4 groups: 60 patients per department and apart for intervention en control (power calculation).
|- Main changes (audit trail)|
|- RECORD||22-sep-2006 - 1-dec-2009|