NCT02413957

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

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

Study Start

First participant enrolled

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 12, 2015

Last Update Submit

January 10, 2017

Conditions

ElderlyAdverse Drug Event

Keywords

Elderly PatientsMedication SafetyPharmaceutical CareMedication Reconciliation

Outcome Measures

Primary Outcomes (1)

  • incidence of adverse drug events

    1 year

Secondary Outcomes (5)

  • Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy

    1 year

  • Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy

    1 year

  • number of medication related problems

    1 year

  • number of discrepancies

    1 year

  • duration of taking the best possible medication history

    1 year

Study Arms (3)

Controll-Group

NO INTERVENTION

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

MedRec-Group

EXPERIMENTAL

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

AMTS-Group

EXPERIMENTAL

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

Medication ReconciliationOTHER

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.

MedRec-Group
Pharmaceutical CareOTHER

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.

AMTS-Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • \- patients included in the study previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

Related 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. German.

    PMID: 24867348BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Medication ReconciliationPharmaceutical Services

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Medication ErrorsDrug TherapyTherapeuticsMedical ErrorsHealth ServicesHealth Care Facilities Workforce and ServicesMedication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

April 10, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

DE(1)