Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

This study is currently recruiting participants.
Verified May 2012 by RWTH Aachen University
Sponsor:
Collaborators:
Apothekerstiftung Nordrhein, Duesseldorf
Foerderinitiative Pharmazeutische Betreuung e.V., Berlin
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01578525
First received: April 13, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Elderly
Pharmaceutical Care
Hospital Readmission
Health Services for the Aged
Medication Safety
Other: Pharmaceutical Care Service

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Medication Safety of Elderly Patients in Hospital and Ambulatory Setting Considering the Transitions of Care for Home-cared Patients and Nursing Home Residents

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Drug-related readmission [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse drug events [ Designated as safety issue: Yes ]
  • Number of prescribed potentially inappropriate medication (PRISCUS-criteria) [ Designated as safety issue: Yes ]
    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]

  • time to readmission [ Designated as safety issue: No ]
  • Number of accepted recommendations in the intervention group [ Designated as safety issue: Yes ]
  • time for intervention [ Designated as safety issue: No ]
    time recording for pharmaceutical care service

  • drug-related problem [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard care
Standard care (by German definition), traditional care by physician and nurse on the ward
Other: Pharmaceutical Care Service
Checking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria),
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),

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578525

Contacts
Contact: Albrecht Eisert, PharmD +49 241 8080063 aeisert@ukaachen.de

Locations
Germany
University Hospital Aachen Recruiting
Aachen, Germany
Contact: Albrecht Eisert    +492418080063    aeisert@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
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
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01578525     History of Changes
Other Study ID Numbers: 11-192
Study First Received: April 13, 2012
Last Updated: May 14, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
medication safety
elderly
pharmaceutical care
hospital readmission
drug-related readmission
Health Services for the Aged

ClinicalTrials.gov processed this record on April 23, 2014