Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

Elderly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578525
• Other study ID #: 11-192
• 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

Related Conditions & MeSH terms

• Elderly
• Health Services for the Aged
• Hospital Readmission
• Medication Safety
• Pharmaceutical Care

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