Clinical trial NCT01578525: Medication Safety of Elderly Patients in Hospital and Ambulatory Setting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Pharmaceutical Care
Hospital Readmission
Health Services for the Aged
Medication Safety
Keywords: medication safety
elderly
pharmaceutical care
hospital readmission
drug-related readmission
Health Services for the Aged
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Apothekerstiftung Nordrhein, Duesseldorf
name: Foerderinitiative Pharmazeutische Betreuung e.V., Berlin
First posted: 2012-04-17
Enrollment: 61
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Drug-related readmission
timeFrame: one year after discharge from the cooperating ward
Secondary outcomes:
measure: Adverse drug events
timeFrame: 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
measure: Number of prescribed potentially inappropriate medication (PRISCUS-criteria)
timeFrame: 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
measure: time to readmission
timeFrame: one year after discharge from the cooperating ward
measure: Number of accepted recommendations in the intervention group
timeFrame: 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
measure: time for intervention
timeFrame: 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
measure: drug-related problem
timeFrame: 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
measure: number of changes in medication after discharge
timeFrame: one year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
affiliation: University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, Germany
name: Albrecht Eisert, Dr. rer. nat.
role: STUDY_DIRECTOR
affiliation: University Hospital Aachen, Department of Urology, Pauwelsstr. 30, 50274 Aachen, Germany
name: Axel Heidenreich, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Aachen, Department of Neurology, Pauwelsstr. 30, 52074 Aachen, Germany
name: Joerg B Schulz, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Aachen, Internal Medicine III (Gastroenterology and Metabolic Disorders), Pauwelsstr. 30, 52074 Aachen, Germany
name: Christian Trautwein, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bonn, Pharmaceutical Institute, Clinical Pharmacy, An der Immenburg 4, 53121 Bonn, Germany
name: Ulrich Jaehde, Prof. Dr. rer. nat.
role: STUDY_CHAIR
affiliation: University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, Germany
name: Rebekka Heumueller
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Aachen,Internal Medicine I (Cardiology, Pneumology, Angiology and Internal Intensive Medicine)
name: Nicolaus Marx, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.