Condition category
Injury, Occupational Diseases, Poisoning
Date applied
22/12/2010
Date assigned
07/02/2011
Last edited
01/07/2013
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 Loraine Lie-A-Huen

ORCID ID

Contact details

Department of Hospital Pharmacy
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
+31 (0)20 566 9111
L.LieaHuen@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of an active on-ward participation of hospital pharmacists in internal medicine teams on preventable adverse drug events in elderly in-patients

Acronym

WINGS Study

Study hypothesis

To investigate whether an active participation of hospital pharmacists in a care team on the ward can be an effective approach in reducing prescribing errors and related patient harm in elderly in-patients admitted to Internal Medicine ward.

Ethics approval

Before the start of this study, the research protocol was submitted for consideration to the Medical Ethics Committee of the Academic Medical Center/University of Amsterdam. This Medical Ethics Committee judged the protocol as not needing an official approval.

This decision was sent in a letter by Medical Ethics Committee, dated 14th February 2007 (ref: 0717.0176). In this letter the Medical Ethics Committe states that for the above mentioned scientific project, the Dutch Medical Research involving Human Subjects Act (WMO) does not apply. This means that an official approval of the study by our committee is not required.

Study design

Multicentre interrupted time series study

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Adverse drug events

Intervention

"Ward Oriented Pharmacy", a concept based on Clinical Pharmacy practice, will be developed and introduced to Internal Medicine wards. "Ward Oriented Pharmacy" entails an active participation of hospital pharmacists in care teams by implementing a multidisciplinary medication-safety program for elderly in-patients.

In the WINGS study an interrupted time series design is used. Before and after the introduction of the intervention on the Internal Medicine wards, a pre- and post- measurement was performed.

Per measurement three data points were strategically chosen (a total of six data points). Every data point had at least 50 patients included. The data for the pre-measurement were collected between April 2007 and November 2007. The data for the post-measurement were collected between November 2009 and June 2010.

If an included patient was readmitted or died within 3 months after index hospitalisation (hospitalisation included in the study), this outcome was recorder in a WINGS database.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The incidence, severity, type, preventability and follow-up of ADEs in elderly in-patients
2. The number of all and preventable ADEs per 100 admissions of elderly in-patients admitted to an Internal Medicine ward

Secondary outcome measures

1. The number of selected medication errors per total number of medication orders
2. The number of readmissions within three months after index admission

Overall trial start date

01/03/2007

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participating hospitals are: Academic Medical Centre in Amsterdam, Westfries Gasthuis Hospital in Hoorn, Spaarne Hospital in Hoofddorp, the Netherlands
2. All consecutive patients aged 65 years or older
3. Length of stay of 24 hours or longer
4. Using 5 or more scheduled medications
5. Admitted to a internal medicine ward of the participating hospitals during observation points

No patient will be sampled more than once.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Admitted for scheduled chemotherapy, radiation therapy or transplantation
2. Transferred from another hospital or from another non-internal medicine ward within the hospital

Recruitment start date

01/03/2007

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Hospital Pharmacy
Amsterdam
1105AZ
Netherlands

Sponsor information

Organisation

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Postbox 93 245
The Hague
2509 AE
Netherlands
+31 (0)70 349 51 11
info@zonmw.nl

Sponsor type

Research organisation

Website

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

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21612624
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22673927

Publication citations

  1. Protocol

    Klopotowska JE, Wierenga PC, de Rooij SE, Stuijt CC, Arisz L, Kuks PF, Dijkgraaf MG, Lie-A-Huen L, Smorenburg SM, , The effect of an active on-ward participation of hospital pharmacists in Internal Medicine teams on preventable Adverse Drug Events in elderly inpatients: protocol of the WINGS study (Ward-oriented pharmacy in newly admitted geriatric seniors)., BMC Health Serv Res, 2011, 11, 124, doi: 10.1186/1472-6963-11-124.

  2. Results

    Klopotowska JE, Wierenga PC, Smorenburg SM, Stuijt CC, Arisz L, Kuks PF, Dijkgraaf MG, Lie-A-Huen L, de Rooij SE, , Recognition of adverse drug events in older hospitalized medical patients., Eur. J. Clin. Pharmacol., 2013, 69, 1, 75-85, doi: 10.1007/s00228-012-1316-4.

Additional files

Editorial Notes