Condition category
Not Applicable
Date applied
02/08/2010
Date assigned
19/08/2010
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Margreeth Vroom

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.b.vroom@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

On-ward participation of a hospital pharmacist in a Dutch Intensive Care Unit reduces prescribing errors and related patient harm: an intervention study

Acronym

Study hypothesis

Patients admitted to an Intensive Care Unit (ICU) are at high risk for medication errors and related patient harm (preventable Adverse Drug Events [ADEs]), due to the critical nature of their illnesses, polypharmacy, use of high-risk drugs, and a high frequency of changes in pharmacotherapy.
Several studies have shown that on-ward, daily participation of a clinical pharmacist in the ICU can effectively and efficiently reduce the number of medication errors and related patient harm.
Given the increasing awareness of medication safety problems in The Netherlands, a proactive on-ward involvement of Dutch hospital pharmacists (an active approach) seems also desirable. Within the current organization model of the hospital pharmacy in The Netherlands, mostly a passive approach is utilized in the form of on-call consultation duty by a hospital pharmacist.

The aim of this trial is to investigate whether participation of a hospital pharmacist can be an effective approach in reducing prescribing errors and related patient harm (preventable Adverse Drug Events [ADEs]) in Dutch healthcare setting.

Ethics approval

The Medical Ethics Committee of the Academic Medical Centre/University of Amsterdam confirmed that this trial does not require ethics approval under the Medical Research Involving Human Subjects Act (WMO) on the 23rd of June 2010 (ref: 10.17.1044)

Study design

Prospective study comparing a baseline period with an intervention period.

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

N/A

Condition

Preventable Adverse Drug Events (ADEs); pharmacist participation; drug prescribing

Intervention

The intervention was an on-ward participation program for a hospital pharmacist consisting of the following activities: The hospital pharmacist assigned for this study evaluated each new medication order for its appropriateness of indication and duration of therapy, drug dosage and frequency, risk of drug-drug and drug-disease interactions as well as pharmacological duplications and omissions. The international and national pharmacotherapy guidelines and local evidence-based pharmacotherapy protocols were used for this evaluation. For each prescribing issue detected, the ICU hospital pharmacist recorded the date, patient characteristics, admission type, medication details and his recommendation. The detected prescribing issues and the recommendations were discussed with the attending ICU physicians during the daily multidisciplinary patient review meeting. If consensus was reached between the ICU hospital pharmacist and the attending ICU physicians on a recommendation regarding a prescribing issue, then that issue was scored as a prescribing error and the medication order was corrected by the responsible attending ICU physician. If consensus could not be reached, the prescribing issue was not scored as a prescribing error and medication order was regarded as 'appropriate'.

The total duration of the intervention was 8 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The incidence of prescribing errors per 1000 monitored patient-days.

Secondary outcome measures

The number of prescribing errors per 1000 monitored patient days that resulted in patient harm (preventable Adverse Drug Events).

Overall trial start date

03/10/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients admitted to the ICU between October 3, 2005 and June 30, 2006

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Medication orders of 1173 patients were reviewed by the hospital pharmacists involved in the study

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

03/10/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Postbox 93 245
The Hague
2509 AE
Netherlands
info@zonmw.nl

Sponsor type

Research council

Website

http://www.zonmw.nl/nl/

Funders

Funder type

Research council

Funder name

Netherlands Organization for Health Research and Development (ZonMW) (Netherlands) - partially funded by research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academic Medical Centre (AMC) (Netherlands) - Hospital Pharmacy Department and Adult ICU Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20920322

Publication citations

  1. Results

    Klopotowska JE, Kuiper R, van Kan HJ, de Pont AC, Dijkgraaf MG, Lie-A-Huen L, Vroom MB, Smorenburg SM, On-ward participation of a hospital pharmacist in a Dutch intensive care unit reduces prescribing errors and related patient harm: an intervention study., Crit Care, 2010, 14, 5, R174, doi: 10.1186/cc9278.

Additional files

Editorial Notes