NCT01814280

Brief Summary

Background: Medication reviews performed on admission to hospitals reduce medication errors; however, evidence of effect on morbidity and mortality is currently inconsistent. It is known that patients' risks of experiencing medication errors are dependent on both patient- and drug factors, e.g. age, co-morbidity, number of drugs, risk of side effects. Aim and hypothesis: The aim of this pilot study is to study acute medical patients' risk of getting a medication error based on an algorithm that takes into account both patient and drug related factors. Secondary, the investigators will explore whether our methods are applicable in a randomised controlled trial. The investigators will also decide the number of patients in a randomised controlled trial based on this pilot study. The hypothesis is that an algorithm that has already been developed can stratify patients according to their risk of experiencing a medication error. Methods: 100 acute admitted patients will be risk stratified at admission (\>8 hours after). The patients who have highest risks of medication errors will receive a medication review performed by either a clinical pharmacist or a clinical pharmacologist.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

August 16, 2012

Last Update Submit

November 27, 2013

Conditions

Keywords

Medication errorsMedication reviewRisk stratificationPatient safety

Outcome Measures

Primary Outcomes (1)

  • Medication errors

    The patients' electronic medical record will be assessed for medication errors during the patients' hospitalization. It will be assesed by a clinical pharmacologist to assess the validity of the algorithm. Medication errors are defined as errors in prescriptions that either harm or have the potential to harm the patients.

    During the patients' hospital stay

Study Arms (1)

Medication review

OTHER

Medication review performed by either a clinical pharmacist or a clinical pharmacologist

Other: Medication review

Interventions

Medication review performed by either a clinical pharmacist or a clinical pharmacologist

Medication review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acutely admitted patients
  • Age\>17 years

You may not qualify if:

  • Dying patients
  • Suicial patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital,

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2012

First Posted

March 19, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations