|- candidate number||4331|
|- NTR Number||NTR1519|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-nov-2008|
|- Secondary IDs||25519 ABR-form|
|- Public Title||PCAD (Pharmaceutical Consultation At Discharge)|
|- Scientific Title||The effect of pharmaceutical consultation at discharge by the hospital pharmacy on the readmission rate in a multicultural population of internal medicine patients.|
|- Healt Condition(s) or Problem(s) studied||Drug related problems|
|- Inclusion criteria||1. Patients at the department of internal medicine who are prescribed at least one medication.|
|- Exclusion criteria||1. No informed consent given
2. Discharged within 24 hours
3. Terminally ill according to their treating physician
4. Unable to be counseled (physically/mentally/language restrictions only if familiy can't be counseled also)
5. Discharged out of office hours
6. Discharged to a nursing home.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-apr-2009|
|- planned closingdate||31-dec-2010|
|- Target number of participants||720|
|- Interventions||The PCAD project consists of the following three interventions:|
- medication reconciliation at admission and discharge (i.e. correcting discrepancies and checking quality of pharmacotherapy),
- individualized patient counseling at discharge, also for non-native Dutch patients
- structured communication between the hospital and primary care.
|- Primary outcome||Re-hospitalisations after six months will be the primary outcome measure.|
|- Secondary outcome||- interventions registered during the PCAD project (medication errors, quality of pharmacotherapy etc.)|
- compliance, change in attitude about medication, satisfaction with medication information
- costs, quality of life
|- Timepoints||- counseling at discharge and questionnaire on compliance, change in attitude about medication, satisfaction with medication information.
- Patient fills in the questionnaire again at one month after discharge.
- Patient fills in a cost diary during three months.
- Re-hospitalisation within 6 months after hospitalization are checked.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. F. Karapinar|
|- CONTACT for SCIENTIFIC QUERIES||Drs. F. Karapinar|
|- Sponsor/Initiator ||Sint Lucas Andreas Ziekenhuis|
(Source(s) of Monetary or Material Support)
|Sint Lucas Andreas Ziekenhuis|
|- Brief summary||Rationale: |
Hospital admissions are a risk factor for the occurrence of discontinuity in medication use, which may lead to suboptimal outcomes of instituted pharmacotherapy.
This may be caused by: unintended discrepancies in the hospital medication versus the medication used at home, insufficient patient counselling and insufficient communication to primary care about for example changes in pharmacotherapy. At present it is unknown whether interventions aimed at these aspect indeed result in less discontinuity and thus in less harm.
The objective is to determine the effect on re-admission rates of specific interventions aimed at improving hospital discharge with respect to medication transfer within a multicultural patient population.
An observational study will be performed in which the effects of the interventions will be compared between the usual care group (pre-intervention phase) and the study group (post-intervention phase).
The study will be performed at the internal medicine ward. All patients being discharged with at least one prescribed drug will be included in the study unless they meet one of the following exclusion criteria: no informed consent given, discharged within 24 hours, terminally ill according to their treating physician, physically/mentally unable to be counseled, discharged out of office hours, the patient nor his family can be informed in a language spoken by the counselors, and discharged to a nursing home.
The intervention will consist of: medication reconciliation at admission and discharge, individualized patient counseling at discharge and structured communication between the hospital and primary care.
Main study parameters/endpoints:
The primary outcome measure is the readmission rate. In addition several secondary outcome measures with respect to medication safety will be analysed, such as compliance, change in attitude about medication, satisfaction with medication information, quality of life and costs. Interrupted time series analysis will be used for data-analysis.
|- Main changes (audit trail)|
|- RECORD||3-nov-2008 - 10-nov-2008|