Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

October 29, 2015 updated by: RWTH Aachen University

Medication Safety of Elderly Patients in Hospital and Ambulatory Setting Considering the Transitions of Care for Home-cared Patients and Nursing Home Residents

The purpose of this study is to determine whether additional pharmaceutical care for elderly patients (home-cared patients, nursing-home residents) has a positive impact on drug-related readmissions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • University Hospital Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient 65 years old or older
  • patient admitted to one of the project wards
  • minimum hospitalization: 3 days
  • written informed consent (patient or the legal representative)
  • current medication of the patient at hospitalization

Exclusion Criteria:

  • patients included in this study previously

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: standard care
Standard care (by German definition), traditional care by physician and nurse on the ward
OTHER: Intensified standard care
Intensified standard care: traditional care by physician and nurse, additional pharmaceutical care by a pharmacist during hospitalization
Other: Pharmaceutical Care Service
Checking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria),

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Drug-related readmission
Time Frame: one year after discharge from the cooperating ward
one year after discharge from the cooperating ward

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug events
Time Frame: during hospital stay on cooperating wards(continuous data collection during routine ward rounds;hence,duration of data collection is dependent on individual hospital stay of each patient, up to 1 year) and 1 year after discharge from the cooperating ward
during hospital stay on cooperating wards(continuous data collection during routine ward rounds;hence,duration of data collection is dependent on individual hospital stay of each patient, up to 1 year) and 1 year after discharge from the cooperating ward
Number of prescribed potentially inappropriate medication (PRISCUS-criteria)
Time Frame: during hospital stay on cooperating wards(continuous data collection during routine ward rounds;hence,duration of data collection is dependent on individual hospital stay of each patient, up to 1 year) and 1 year after discharge from the cooperating ward
The PRISCUS list was developed in 2010 for the German market. Potentially inappropriate medications were judged as inappropriate by an expert panel using the Delphi technique. [Holt et al., Dtsch Arztebl 2010]
during hospital stay on cooperating wards(continuous data collection during routine ward rounds;hence,duration of data collection is dependent on individual hospital stay of each patient, up to 1 year) and 1 year after discharge from the cooperating ward
time to readmission
Time Frame: one year after discharge from the cooperating ward
one year after discharge from the cooperating ward
Number of accepted recommendations in the intervention group
Time Frame: during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group
during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group
time for intervention
Time Frame: during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group
time recording for pharmaceutical care service
during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group
drug-related problem
Time Frame: during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group
during hospital stay on cooperating wards (continuous data collection during routine ward rounds; hence, duration of data collection is dependent on individual hospital stay of each patient, up to one year) in the intervention group
number of changes in medication after discharge
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

Apothekerstiftung Nordrhein, Duesseldorf
Foerderinitiative Pharmazeutische Betreuung e.V., Berlin

Investigators

  • Study Director: Albrecht Eisert, Dr. rer. nat., University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, Germany
  • Principal Investigator: Axel Heidenreich, Prof. Dr. med., University Hospital Aachen, Department of Urology, Pauwelsstr. 30, 50274 Aachen, Germany
  • Principal Investigator: Joerg B Schulz, Prof. Dr. med., University Hospital Aachen, Department of Neurology, Pauwelsstr. 30, 52074 Aachen, Germany
  • Principal Investigator: Christian Trautwein, Prof. Dr. med., University Hospital Aachen, Internal Medicine III (Gastroenterology and Metabolic Disorders), Pauwelsstr. 30, 52074 Aachen, Germany
  • Study Chair: Ulrich Jaehde, Prof. Dr. rer. nat., University of Bonn, Pharmaceutical Institute, Clinical Pharmacy, An der Immenburg 4, 53121 Bonn, Germany
  • Principal Investigator: Rebekka Heumueller, University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, Germany
  • Principal Investigator: Nicolaus Marx, Prof. Dr. med., University Hospital Aachen,Internal Medicine I (Cardiology, Pneumology, Angiology and Internal Intensive Medicine)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (ESTIMATE)

April 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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