Medication Safety of Elderly Patients in Hospital and Ambulatory Setting
This study is currently recruiting participants.
Verified May 2012 by RWTH Aachen University
Sponsor:
RWTH Aachen University
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
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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 May 23, 2013