ElderlyNCT02413957
Medication Reconciliation in Comparison to an Extensive Medication Safety Check
A study testing Medication Reconciliation and Pharmaceutical Care in people with Elderly and Adverse Drug Event, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The purpose of this study is to determine wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly, Adverse Drug Event
- What is being tested?
- Medication Reconciliation and Pharmaceutical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Jan 2016
- 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 and older
- written informed consent patient or the legal representative
- existing medication therapy at hospitalization
- admission to one of the project wards via emergency department (non elective)
Who cannot join
- patients included in the study previously
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Project to Investigate the Influence of Medication Reconciliation and an Extensive Medication Safety Check on the Number of Adverse Drug Events in the Elderly
The purpose of this study is to determine wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention.
- Conditions
- Elderly, Adverse Drug Event
- Being tested
- Medication Reconciliation, Pharmaceutical Care
- Keywords
- Elderly Patients, Medication Safety, Pharmaceutical Care, Medication Reconciliation
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication ReconciliationOther
Pharmacist take the best possible medication history (BPMH), comparison of the BPMH with the admission order (AMO), clarify and solve al discrepancies between the BPMH and the AMO.
Pharmaceutical CareOther
Checking medication under safety considerations (medication at admission, during hospital stay, at discharge); recommendations for inappropriate medication (e.g. contraindications or interactions) or medication related problems. Pharmaceutical care includes Medication Reconciliation.
| Study group | Role | What they receive |
|---|---|---|
| Controll-Group | No intervention | Patient randomized to the Control-Group will receive the traditional care by physician and nurse on the ward. |
| MedRec-Group | Experimental | Patient randomized to the MedRec-Group will receive the traditional care by physician and nurse on the ward and additional pharmacist led medication reconciliation. Receives: Other: Medication Reconciliation |
| AMTS-Group | Experimental | Patient randomized to the AMTS-Group will receive the traditional care by physician and nurse on the ward and additional pharmaceutical care by a pharmacist. Receives: Other: Pharmaceutical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse drug events
Measured: 1 year
Secondary outcomes (5)
Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy
Severity scale for medication related problems: minor, significative, major, critical, catastrophic
Measured: 1 year
Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy
Severity scale for discrepancies: minor, significative, major, critical, catastrophic
Measured: 1 year
number of medication related problems
Measured: 1 year
number of discrepancies
Measured: 1 year
duration of taking the best possible medication history
The duration is measured in minutes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ärztliche Zentrum für Qualität in der Medizin, Universitätsklinikum Bonn - Institut für Patientensicherheit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413957
- Sponsor's protocol ID
- 14178
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2015
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Franzen K, Lenssen R, Jaehde U, Eisert A. [Medication Reconciliation-theory and practice]. Ther Umsch. 2014 Jun;71(6):335-42. doi: 10.1024/0040-5930/a000521. German.
PubMed 24867348
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project to Investigate the Influence of Medication Reconciliation and an Extensive Medication Safety Check on the Number of Adverse Drug Events in the Elderly
- ClinicalTrials.gov ID
- NCT02413957
- Acronym / sponsor ID
- 14178
- Conditions
- Elderly, Adverse Drug Event
- Keywords
- Elderly Patients, Medication Safety, Pharmaceutical Care, Medication Reconciliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Ärztliche Zentrum für Qualität in der Medizin, Universitätsklinikum Bonn - Institut für Patientensicherheit
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Apr 2015 (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 wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controll-Group | No intervention | –Patient randomized to the Control-Group will receive the traditional care by physician and nurse on the ward. |
| MedRec-Group | Experimental | Other: Medication ReconciliationPatient randomized to the MedRec-Group will receive the traditional care by physician and nurse on the ward and additional pharmacist led medication reconciliation. |
| AMTS-Group | Experimental | Other: Pharmaceutical CarePatient randomized to the AMTS-Group will receive the traditional care by physician and nurse on the ward and additional pharmaceutical care by a pharmacist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient 65 years and older
- written informed consent patient or the legal representative
- existing medication therapy at hospitalization
- admission to one of the project wards via emergency department (non elective)
Key exclusion criteria (1 listed)
- patients included in the 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 |
|---|---|---|
| Medication ReconciliationPharmacist take the best possible medication history (BPMH), comparison of the BPMH with the admission order (AMO), clarify and solve al discrepancies between the BPMH and the AMO. | Other | MedRec-Group |
| Pharmaceutical CareChecking medication under safety considerations (medication at admission, during hospital stay, at discharge); recommendations for inappropriate medication (e.g. contraindications or interactions) or medication related problems. Pharmaceutical care includes Medication Reconciliation. | Other | AMTS-Group |
Primary outcome
incidence of adverse drug events
Time frame: 1 year
5 secondary outcomes
Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy
Time frame: 1 year
Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy
Time frame: 1 year
number of medication related problems
Time frame: 1 year
number of discrepancies
Time frame: 1 year
duration of taking the best possible medication history
Time frame: 1 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 11 Jan 2017.
- Background: PubMed 24867348Franzen K, Lenssen R, Jaehde U, Eisert A. [Medication Reconciliation-theory and practice]. Ther Umsch. 2014 Jun;71(6):335-42. doi: 10.1024/0040-5930/a000521. German.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Reconciliation and Pharmaceutical Care in people with Elderly and Adverse Drug Event, 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 4 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 11 Jan 2017. 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?
incidence of adverse drug events (time frame: 1 year). 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 NCT02413957, 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 11 Jan 2017.