Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

Overview

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.

Full Title of Study: “Medication Safety of Elderly Patients in Hospital and Ambulatory Setting Considering the Transitions of Care for Home-cared Patients and Nursing Home Residents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: standard care
    • Standard care (by German definition), traditional care by physician and nurse on the ward
  • Other: Intensified standard care
    • Intensified standard care: traditional care by physician and nurse, additional pharmaceutical care by a pharmacist during hospitalization

Clinical Trial Outcome Measures

Primary Measures

  • Drug-related readmission
    • Time Frame: one year after discharge from the cooperating ward

Secondary 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
  • 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
    • 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
  • 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
  • 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
    • 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
  • number of changes in medication after discharge
    • Time Frame: one year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Collaborator
    • Apothekerstiftung Nordrhein, Duesseldorf
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Albrecht Eisert, Dr. rer. nat., Study Director, University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, Germany
    • Axel Heidenreich, Prof. Dr. med., Principal Investigator, University Hospital Aachen, Department of Urology, Pauwelsstr. 30, 50274 Aachen, Germany
    • Joerg B Schulz, Prof. Dr. med., Principal Investigator, University Hospital Aachen, Department of Neurology, Pauwelsstr. 30, 52074 Aachen, Germany
    • Christian Trautwein, Prof. Dr. med., Principal Investigator, University Hospital Aachen, Internal Medicine III (Gastroenterology and Metabolic Disorders), Pauwelsstr. 30, 52074 Aachen, Germany
    • Ulrich Jaehde, Prof. Dr. rer. nat., Study Chair, University of Bonn, Pharmaceutical Institute, Clinical Pharmacy, An der Immenburg 4, 53121 Bonn, Germany
    • Rebekka Heumueller, Principal Investigator, University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, Germany
    • Nicolaus Marx, Prof. Dr. med., Principal Investigator, University Hospital Aachen,Internal Medicine I (Cardiology, Pneumology, Angiology and Internal Intensive Medicine)

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