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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01578525
Other study ID # 11-192
Secondary ID
Status Completed
Phase N/A
First received April 13, 2012
Last updated October 29, 2015
Start date April 2012
Est. completion date April 2014

Study information

Verified date May 2012
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Other:
Pharmaceutical Care Service
Checking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria),

Locations

Country Name City State
Germany University Hospital Aachen Aachen

Sponsors (3)

Lead Sponsor Collaborator
RWTH Aachen University Apothekerstiftung Nordrhein, Duesseldorf, Foerderinitiative Pharmazeutische Betreuung e.V., Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug-related readmission one year after discharge from the cooperating ward No
Secondary Adverse drug events 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 Yes
Secondary Number of prescribed potentially inappropriate medication (PRISCUS-criteria) 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 Yes
Secondary time to readmission one year after discharge from the cooperating ward No
Secondary Number of accepted recommendations 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 Yes
Secondary time for intervention 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 No
Secondary drug-related problem 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 Yes
Secondary number of changes in medication after discharge one year No
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