ElderlyNCT01578525
Medication Safety of Elderly Patients in Hospital and Ambulatory Setting
A study testing Pharmaceutical Care Service in people with Elderly and Pharmaceutical Care, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly, Pharmaceutical Care, Hospital Readmission
- What is being tested?
- Pharmaceutical Care Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- patients included in this study previously
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Elderly, Pharmaceutical Care, Hospital Readmission, Health Services for the Aged, Medication Safety
- Being tested
- Pharmaceutical Care Service
- Keywords
- medication safety, elderly, pharmaceutical care, hospital readmission, drug-related readmission, Health Services for the Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical Care ServiceOther
Checking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria),
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pharmaceutical Care Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-related readmission
Measured: one year after discharge from the cooperating ward
Secondary outcomes (7)
Adverse drug events
Measured: 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)
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]
Measured: 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
Measured: one year after discharge from the cooperating ward
Number of accepted recommendations in the intervention group
Measured: 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 recording for pharmaceutical care service
Measured: 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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Apothekerstiftung Nordrhein, Duesseldorf, Foerderinitiative Pharmazeutische Betreuung e.V., Berlin
- Responsible party
- Sponsor
- Investigators
- Albrecht Eisert, Dr. rer. nat., Study director, University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, GermanyAxel Heidenreich, Prof. Dr. med., Principal investigator, University Hospital Aachen, Department of Urology, Pauwelsstr. 30, 50274 Aachen, GermanyJoerg B Schulz, Prof. Dr. med., Principal investigator, University Hospital Aachen, Department of Neurology, Pauwelsstr. 30, 52074 Aachen, GermanyChristian Trautwein, Prof. Dr. med., Principal investigator, University Hospital Aachen, Internal Medicine III (Gastroenterology and Metabolic Disorders), Pauwelsstr. 30, 52074 Aachen, GermanyUlrich Jaehde, Prof. Dr. rer. nat., Study chair, University of Bonn, Pharmaceutical Institute, Clinical Pharmacy, An der Immenburg 4, 53121 Bonn, GermanyRebekka Heumueller, Principal investigator, University Hospital Aachen, Hospital Pharmacy, Steinbergweg 20, 52074 Aachen, GermanyNicolaus Marx, Prof. Dr. med., Principal investigator, University Hospital Aachen,Internal Medicine I (Cardiology, Pneumology, Angiology and Internal Intensive Medicine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578525
- Sponsor's protocol ID
- 11-192
- Status last verified
- May 2012
- First submitted
- 13 Apr 2012
- Last updated
- 30 Oct 2015
- Results posted
- No
Publications
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.
PubMed 29898670
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01578525
- Acronym / sponsor ID
- 11-192
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Apothekerstiftung Nordrhein, Duesseldorf, Foerderinitiative Pharmazeutische Betreuung e.V., Berlin
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –Standard care (by German definition), traditional care by physician and nurse on the ward |
| Intensified standard care | Other | Other: Pharmaceutical Care ServiceIntensified standard care: traditional care by physician and nurse, additional pharmaceutical care by a pharmacist during hospitalization |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- patients included in this study previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical Care ServiceChecking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria), | Other | Intensified standard care |
Primary outcome
Drug-related readmission
Time frame: one year after discharge from the cooperating ward
7 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Derived from this study: PubMed 29898670Lenssen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical Care Service in people with Elderly and Pharmaceutical Care, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug-related readmission (time frame: one year after discharge from the cooperating ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01578525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.