Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

October 29, 2015 updated by: RWTH Aachen University

Medication Safety of Elderly Patients in Hospital and Ambulatory Setting Considering the Transitions of Care for Home-cared Patients and Nursing Home Residents

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • University Hospital Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Pharmaceutical Care Service
Checking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria),

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Drug-related readmission
Time Frame: one year after discharge from the cooperating ward
one year after discharge from the cooperating ward

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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]
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
time to readmission
Time Frame: one year after discharge from the cooperating ward
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
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
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
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
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RWTH Aachen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Apothekerstiftung Nordrhein, Duesseldorf
Foerderinitiative Pharmazeutische Betreuung e.V., Berlin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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