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Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by RWTH Aachen University.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014