NCT01578525

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 30, 2015

Status Verified

May 1, 2012

Enrollment Period

2 years

First QC Date

April 13, 2012

Last Update Submit

October 29, 2015

Conditions

ElderlyPharmaceutical CareHospital ReadmissionHealth Services for the AgedMedication Safety

Keywords

medication safetyelderlypharmaceutical carehospital readmissiondrug-related readmissionHealth Services for the Aged

Outcome Measures

Primary Outcomes (1)

  • Drug-related readmission

    one year after discharge from the cooperating ward

Secondary Outcomes (7)

  • 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

  • Number of prescribed potentially inappropriate medication (PRISCUS-criteria)

    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

    one year after discharge from the cooperating ward

  • 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

  • time for intervention

    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

  • +2 more secondary outcomes

Study Arms (2)

standard care

NO INTERVENTION

Standard care (by German definition), traditional care by physician and nurse on the ward

Intensified standard care

OTHER

Intensified standard care: traditional care by physician and nurse, additional pharmaceutical care by a pharmacist during hospitalization

Other: Pharmaceutical Care Service

Interventions

Pharmaceutical Care ServiceOTHER

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

Intensified standard care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients included in this study previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, Germany

Location

Related Publications (1)

  • Lenssen R, Schmitz K, Griesel C, Heidenreich A, Schulz JB, Trautwein C, Marx N, Fitzner C, Jaehde U, Eisert A. Comprehensive pharmaceutical care to prevent drug-related readmissions of dependent-living elderly patients: a randomized controlled trial. BMC Geriatr. 2018 Jun 4;18(1):135. doi: 10.1186/s12877-018-0814-3.

    PMID: 29898670DERIVED

MeSH Terms

Interventions

Pharmaceutical Services

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Albrecht Eisert, Dr. rer. nat.

    University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, Germany

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

  • Ulrich Jaehde, Prof. Dr. rer. nat.

    University of Bonn, Pharmaceutical Institute, Clinical Pharmacy, An der Immenburg 4, 53121 Bonn, Germany

    STUDY CHAIR

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 17, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

October 30, 2015

Record last verified: 2012-05

Locations

DE(1)