Reducing Medication Errors on Basis of an Individual Risk... | NCT01814280

Studies
Reducing Medication Errors on Basis of an Individual Risk Assessment

NCT01814280

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 28, 2013Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Drug Safety

Interventions

Medication review

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Aug 16, 2012

First Submission Date that Met QC Criteria

Mar 15, 2013

First Posted Date

Mar 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2013

Last Update Posted Date

Nov 28, 2013Estimated

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medication review	Other	Medication review performed by either a clinical pharmacist or a clinical pharmacologist	Other: Medication review

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medication review	Other	Medication review performed by either a clinical pharmacist or a clinical pharmacologist	Medication review

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acutely admitted patients
Age>17 years

Exclusion Criteria:

Dying patients
Suicial patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital,		Aarhus		8000	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000090143	Medication Review

Ancestor Terms

ID	Term
D008509	Medication Systems
D009934	Organization and Administration
D006298	Health Services Administration
D010346	Patient Care Management

Browse Leaves

Not provided

Browse Branches

Not provided