Medication Reconciliation in Comparison to an Extensive Medication Safety Check

Elderly Clinical Trial

Official title:

Pilot Project to Investigate the Influence of Medication Reconciliation and an Extensive Medication Safety Check on the Number of Adverse Drug Events in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413957
• Other study ID #: 14178
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: January 10, 2017
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient 65 years and older

• written informed consent patient or the legal representative

• existing medication therapy at hospitalization

• admission to one of the project wards via emergency department (non elective)

Exclusion Criteria:

• patients included in the study previously

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions
• Elderly

Intervention

Other:
• Medication Reconciliation
Pharmacist take the best possible medication history (BPMH), comparison of the BPMH with the admission order (AMO), clarify and solve al discrepancies between the BPMH and the AMO.
• Pharmaceutical Care
Checking medication under safety considerations (medication at admission, during hospital stay, at discharge); recommendations for inappropriate medication (e.g. contraindications or interactions) or medication related problems. Pharmaceutical care includes Medication Reconciliation.

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen

Sponsors (3)

Lead Sponsor	Collaborator
RWTH Aachen University	Ärztliche Zentrum für Qualität in der Medizin, Universitätsklinikum Bonn - Institut für Patientensicherheit

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Franzen K, Lenssen R, Jaehde U, Eisert A. [Medication Reconciliation-theory and practice]. Ther Umsch. 2014 Jun;71(6):335-42. doi: 10.1024/0040-5930/a000521. Review. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse drug events		1 year	Yes
Secondary	Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy	Severity scale for medication related problems: minor, significative, major, critical, catastrophic	1 year	Yes
Secondary	Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy	Severity scale for discrepancies: minor, significative, major, critical, catastrophic	1 year	Yes
Secondary	number of medication related problems		1 year	No
Secondary	number of discrepancies		1 year	No
Secondary	duration of taking the best possible medication history	The duration is measured in minutes.	1 year	No