Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

This study has been completed.
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: October 29, 2015
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 [ Time Frame: one year after discharge from the cooperating ward ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ 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 [ Time Frame: one year after discharge from the cooperating ward ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    time recording for pharmaceutical care service

  • 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 ] [ Designated as safety issue: Yes ]
  • number of changes in medication after discharge [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: April 2012
Study Completion Date: April 2014
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
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   (Adult, Senior)
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

Locations
Germany
University Hospital Aachen
Aachen, Germany
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
Principal Investigator: Nicolaus Marx, Prof. Dr. med. University Hospital Aachen,Internal Medicine I (Cardiology, Pneumology, Angiology and Internal Intensive Medicine)
  More Information

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: October 29, 2015
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 July 27, 2016