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CompletedNCT02413957Updated Jan 11, 2017

Medication Reconciliation in Comparison to an Extensive Medication Safety Check

An interventional study of Medication Reconciliation and Pharmaceutical Care in Elderly and Adverse Drug Event, sponsored by RWTH Aachen University. Completed at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-01-11.

Sponsored by RWTH Aachen University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Elderly
  • Adverse Drug Event

Keywords

  • Elderly Patients
  • Medication Safety
  • Pharmaceutical Care
  • Medication Reconciliation
03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's enrollment of 220 is above the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients included in the study previously
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • No intervention
    Controll-Group

    Patient randomized to the Control-Group will receive the traditional care by physician and nurse on the ward.

  • Experimental
    MedRec-Group

    Patient randomized to the MedRec-Group will receive the traditional care by physician and nurse on the ward and additional pharmacist led medication reconciliation.

    Other: Medication Reconciliation

  • Experimental
    AMTS-Group

    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.

    Other: Pharmaceutical Care

Interventions

  • OtherMedication 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.

  • OtherPharmaceutical 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.

06

What researchers measure

Primary outcomes

  1. incidence of adverse drug events

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. number of medication related problems

    Time frame: 1 year

  4. number of discrepancies

    Time frame: 1 year

  5. duration of taking the best possible medication history

    The duration is measured in minutes.

    Time frame: 1 year

07

Study locations

1 site
  • University Hospital Aachen
    Aachen, 52074, Germany
08

References and documents

Publications

  • 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. PubMed 24867348 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02413957
Lead sponsor
RWTH Aachen University
Collaborators
Ärztliche Zentrum für Qualität in der Medizin, Universitätsklinikum Bonn - Institut für Patientensicherheit
Responsible party
Sponsor
First posted
Apr 10, 2015
Start date
Jan 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Jan 11, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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