Condition category
Not Applicable
Date applied
04/03/2010
Date assigned
06/04/2010
Last edited
17/11/2010
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

Ms Trine R. H. Nielsen

ORCID ID

Contact details

Ringstedgade 63
Naestved
DK-4700
Denmark
trn@regionsjaelland.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pharmaceutical optimization of the medication process during admission to hospital: A multicentre, randomised, controlled trial

Acronym

POMP

Study hypothesis

A pharmaceutical intervention consisting of: review and use of patient 'sown drugs, secondary medication history, medication review and entry of proposed prescriptions in the electronic medication system will reduce the number of adverse drug events during hospital stay.

Ethics approval

Approval by the Danish Ethics Committee is not applicable since the study is not of biomedical nature

Study design

Multicentre interventional prospective randomised clinical controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

In-hospital adverse drug events

Intervention

Please note that the anticipated end date for this trial has been extended from 01/11/10 to 31/03/10.

Intervention Group
1. Review and use of patient own drugs by clinical pharmacist.
2. Clinical pharmacist taking secondary medication history.
3. Medication review by clinical pharmacist.
4. Entry of proposed prescriptions in the electronic medication system by pharmacist, ready for approval by doctor.
The intervention takes place on the day the patient is admitted, and the duration of the intervention is approximately 1.5 hours.

Control Group
Standard care with no pharmacist involvement

There is no follow up examination, but re-admission rates will be noted for 1 year post intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Number of patients with in-hospital adverse drug events, detected by Adverse Drug Event Trigger Tool.

Secondary outcome measures

1. Length of hospital stay
2. Number of readmissions during the first year after admission
3. Direct cost for the hospital

Overall trial start date

08/03/2010

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients being admitted to an internal medicine ward
2. Age 18 years or more
3. Taking 4 types of medicine or more each day
4. Able to understand participant's information written in Danish

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

648 (across 3 centres)

Participant exclusion criteria

1. Patients transferred from other hospitals in the area
2. Dying or terminally ill patients
3. Patients being discharged within 48 hours from admission

Recruitment start date

08/03/2010

Recruitment end date

31/03/2011

Locations

Countries of recruitment

Denmark

Trial participating centre

Ringstedgade 63
Naestved
DK-4700
Denmark

Sponsor information

Organisation

Region Zealand Hospital Pharmacy (Region Sjaelland Sygehusapoteket) (Denmark)

Sponsor details

Ringstedgade 63
Naestved
DK-4700
Denmark

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

Region Zealand (Region Sjaelland) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Region Zealand Hospital Pharmacy (Region Sjaelland Sygehusapoteket) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hospital pharmacists and Amgros' Research and Development (Sygehusapotekernes- og Amgros’ Forsknings- og udviklingsfond) (Denmark)

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

Publication citations

Additional files

Editorial Notes