Back to resultsMedication Reconciliation in Comparison to an Extensive Medication Safety Check
Primary Purpose
Elderly, Adverse Drug Event
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Medication Reconciliation
Pharmaceutical Care
Sponsored by
About this trial
This is an interventional health services research trial for Elderly focused on measuring Elderly Patients, Medication Safety, Pharmaceutical Care, Medication Reconciliation
Eligibility Criteria
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
Sites / Locations
- University Hospital Aachen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Controll-Group
MedRec-Group
AMTS-Group
Arm Description
Patient randomized to the Control-Group will receive the traditional care by physician and nurse on the ward.
Patient randomized to the MedRec-Group will receive the traditional care by physician and nurse on the ward and additional pharmacist led medication reconciliation.
Patient randomized to the AMTS-Group will receive the traditional care by physician and nurse on the ward and additional pharmaceutical care by a pharmacist.
Outcomes
Primary Outcome Measures
incidence of adverse drug events
Secondary Outcome Measures
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
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
number of medication related problems
number of discrepancies
duration of taking the best possible medication history
The duration is measured in minutes.
Full Information
NCT ID
NCT02413957
First Posted
January 12, 2015
Last Updated
January 10, 2017
Sponsor
RWTH Aachen University
Collaborators
Ärztliche Zentrum für Qualität in der Medizin, Universitätsklinikum Bonn - Institut für Patientensicherheit
1. Study Identification
Unique Protocol Identification Number
NCT02413957
Brief Title
Medication Reconciliation in Comparison to an Extensive Medication Safety Check
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
Collaborators
Ärztliche Zentrum für Qualität in der Medizin, Universitätsklinikum Bonn - Institut für Patientensicherheit
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Adverse Drug Event
Keywords
Elderly Patients, Medication Safety, Pharmaceutical Care, Medication Reconciliation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controll-Group
Arm Type
No Intervention
Arm Description
Patient randomized to the Control-Group will receive the traditional care by physician and nurse on the ward.
Arm Title
MedRec-Group
Arm Type
Experimental
Arm Description
Patient randomized to the MedRec-Group will receive the traditional care by physician and nurse on the ward and additional pharmacist led medication reconciliation.
Arm Title
AMTS-Group
Arm Type
Experimental
Arm Description
Patient randomized to the AMTS-Group will receive the traditional care by physician and nurse on the ward and additional pharmaceutical care by a pharmacist.
Intervention Type
Other
Intervention Name(s)
Medication Reconciliation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmaceutical Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of adverse drug events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy
Description
Severity scale for medication related problems: minor, significative, major, critical, catastrophic
Time Frame
1 year
Title
Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy
Description
Severity scale for discrepancies: minor, significative, major, critical, catastrophic
Time Frame
1 year
Title
number of medication related problems
Time Frame
1 year
Title
number of discrepancies
Time Frame
1 year
Title
duration of taking the best possible medication history
Description
The duration is measured in minutes.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24867348
Citation
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. German.
Results Reference
background
Learn more about this trial
Medication Reconciliation in Comparison to an Extensive Medication Safety Check
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