Pharmacists in Geriatric Health ServicesAGITATENCT03412903
The Pharmacist in the Acute Geriatric Inpatient Treatment Team
An observational study of Pharmacists in Geriatric Health Services and Conditions Unspecified, run by Prof. Dr. med. Cornelius Bollheimer at 1 site in Germany.
Trial summary
This trial investigates the effects of a comprehensive pharmaceutical assessment in an acute care geriatric hospital on the number of hospital readmissions and patient's days spent at home. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pharmacists in Geriatric Health Services, Conditions Unspecified
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2018to 3 Apr 2020
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to the clinic for internal medicine and geriatrics of the Franziskus Hospital Aachen (chair of geriatrics and geriatric medicine of the RWTH Aachen University)
Who may be able to join
- Geriatric complex treatment (Operation and procedure code (German: "Operationen- und Prozedurenschlüssel", OPS) 8-550)
- In-patient stay for at least 7 days
- Written informed consent of the patient or the legal representative
- Existing concomitant drug therapy at the time of the inpatient admission
Who cannot join
- Patients, that were already included in the study beforehand
- Patients classified as terminally ill by the medical staff
- Patients, that are incapable to give their informed consent and who do not have a legal representative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacist in the Acute Geriatric Inpatient Treatment Team - Impact on Re-hospitalization and Trans-sectoral Communication
This trial investigates the effects of a comprehensive pharmaceutical assessment in an acute care geriatric hospital on the number of hospital readmissions and patient's days spent at home.
Read the detailed description
Drug-related problems are common in elderly patients. These problems can not only be regarded from a medical or economical point of view (i.e. hospitalization, drug related deaths, longer hospital stays and increased healthcare costs) but also from a patient centered perspective: Drug therapy may not be sufficiently explained by health care practitioners, patients might suffer from side effects, the number of different medications could be too large and their intake schedule too difficult, all of this leading to a reduced adherence. In addition, medication histories are rarely accurate in older patients and doctor's letters do not always meet the requirements of a complex drug therapy. At the transition from inpatient to outpatient treatment this can lead to a significant loss of information and subsequently cause patient harm.
In Germany, clinical, ward-based pharmacists are not yet established in contrast to other countries (i.e. Great Britain, Canada and Australia). However, the implementation of a clinical pharmacist may particularly address the problems described above. The present study therefore describes the implementation of a comprehensive pharmaceutical assessment in an acute care geriatric hospital.
The above mentioned pharmaceutical assessment consists of the following steps:
First, the pharmacist will obtain the patient's medication history following the protocol of "best possible medication history" (WHO). Furthermore, he will ascertain the patient's adherence to his/her drug regime. With the information obtained, he will then carry out a thorough medication review (regarding interactions, contraindications, suitability for the elderly, dosage regimes, etc.) in order to develop a suggestion for the best possible drug regime, which is discussed with the treating physician. In addition, he will also observe possible side effects and provide information on the background and significance of every single drug to the patient and/or his/her care-giver. Furthermore, the handling of difficult devices (i.e. insulin pens, inhalators and transdermal therapeutic systems) will be individually explained. Finally, the pharmacist will prepare a distinctive paragraph in the medical discharge report in which he explains the changes in the medication regime during the inpatient period to the general practitioner and will also elaborate possible interactions and problems concerning the patient's medication (pharmaceutical council).
The main outcome to be evaluated will be the number of hospital readmissions and drug related hospital readmissions within six months after discharge (recorded at one, three and six months). The secondary outcome will be the days spent at home (also recorded at one, three and six months), time to readmission, changes in medication within six months and the acceptance of the supposed medication regime by the general practitioner (GP).
The study will be conducted as a before and after comparison in which the steps described above will be implemented successively: In the first phase (140 patients planned for an observation period of eight months), patients will receive standard care and the pharmacist will only obtain the medication history shortly after admission. Results and discrepancies will be discussed with the attending physician of the hospital. After discharge, described outcomes will be documented. In the second phase (140 patients planned for an observation period of eight months), the pharmacist will conduct all of the activities described above. The outcomes will be documented as in phase one.
We expect that the comprehensive pharmaceutical assessment in the second phase will lead to a better coordination regarding the medication regime, enhance the patient's knowledge of their medication, thus improving their adherence to the therapy and that the pharmaceutical council will ensure a better trans-sectoral communication to the GP with a higher acceptance of the supposed drug regime in the doctor's letter. All these improvements combined might reduce hospital readmissions and increase the patient's days spent at home.
- Keywords
- Acute geriatric treatment, Inpatient treatment team, Elderly, Pharmacist, Comprehensive pharmaceutical assessment, Medication history, Medication reconciliation, Adherence, Medication therapy management, Pharmaceutical consultation, Drug-Related Side Effects and Adverse Reactions, Drug interactions, Pharmaceutical Council, Drug regime acceptance, Patient Care Team, Hospital Pharmacy Service, Polypharmacy, Hospitalization, Pharmaceutical Services
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | First observational period: Standard care without an advising pharmacist, 140 patients | |
| Implementation group | Second observational period: Standard care with an advising pharmacist, 140 patients | |
| Learning success group | Second observational period: Standard care without an advising pharmacist, 30 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug related re-hospitalization
Number of re-hospitalizations with causal relation to one or more medicinal products, to examine the potential effect of an advising pharmacist
Measured: 6 months
Secondary outcomes (7)
Overall re-hospitalization
Overall number of re-hospitalizations within the observational period per patient
Measured: 6 months
Days spent at home
Number of days within the observational period not spent in a hospital, short-term care facility, rehabilitation centre, day-care hospital, emergency department or other medical facilities
Measured: 6 months
Period of time until the potential re-hospitalization into the inpatient sector
Time between the discharge and a potential re-hospitalization per patient
Measured: 6 months
Acceptance of the recommended medication plan by the further treating primary care physicians
Adoption of the medication plan, recommended in the doctor's letter, by the further treating primary care physicians
Measured: 6 months
Time required for the pharmacists support
Expenditure of time, required for the pharmacists support, per patient within the implementation group
Measured: 6 months
Completeness of the pharmaceutical anamnesis in the course of the inpatient admission
Comparison between the pharmaceutical anamnesis conducted by the doctor and the pharmacist, respectively
Measured: 6 months
Evaluation of the clinical relevance of the medicinal products, which were not assessed by the doctors
The evaluation will be conducted by an interdisciplinary group using the focus group method.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start22 Jan 2018
- Primary completion20 Sep 2019
- Study completion3 Apr 2020
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 Pharmacists in Geriatric Health ServicesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Cornelius Bollheimer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Cornelius Bollheimer, RWTH Aachen University
- Investigators
- Cornelius Bollheimer, Prof. Dr., Study director, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412903
- Sponsor's protocol ID
- 17-137
- Other IDs
- EK 230/17
- Acronym
- AGITATE
- Status last verified
- Jul 2020
- First submitted
- 19 Jan 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freitag M, Franzen J, Just KS, Eisert A, Bollheimer LC, Laurentius T. Pharmacist-Led Medication Management in Acute Geriatric Medicine and Its Associations with Rehospitalizations: A Cohort Study. Gerontology. 2024;70(9):914-929. doi: 10.1159/000539710. Epub 2024 Jun 19.
PubMed 38897188
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacist in the Acute Geriatric Inpatient Treatment Team - Impact on Re-hospitalization and Trans-sectoral Communication
- ClinicalTrials.gov ID
- NCT03412903
- Acronym / sponsor ID
- AGITATE / 17-137
- Keywords
- Acute geriatric treatment, Inpatient treatment team, Elderly, Pharmacist, Comprehensive pharmaceutical assessment, Medication history, Medication reconciliation, Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Prof. Dr. med. Cornelius BollheimerUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 29 Jan 2018 (actual)
- 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.
This trial investigates the effects of a comprehensive pharmaceutical assessment in an acute care geriatric hospital on the number of hospital readmissions and patient's days spent at home.
Detailed description
Drug-related problems are common in elderly patients. These problems can not only be regarded from a medical or economical point of view (i.e. hospitalization, drug related deaths, longer hospital stays and increased healthcare costs) but also from a patient centered perspective: Drug therapy may not be sufficiently explained by health care practitioners, patients might suffer from side effects, the number of different medications could be too large and their intake schedule too difficult, all of this leading to a reduced adherence. In addition, medication histories are rarely accurate in older patients and doctor's letters do not always meet the requirements of a complex drug therapy. At the transition from inpatient to outpatient treatment this can lead to a significant loss of information and subsequently cause patient harm.
In Germany, clinical, ward-based pharmacists are not yet established in contrast to other countries (i.e. Great Britain, Canada and Australia). However, the implementation of a clinical pharmacist may particularly address the problems described above. The present study therefore describes the implementation of a comprehensive pharmaceutical assessment in an acute care geriatric hospital.
The above mentioned pharmaceutical assessment consists of the following steps:
First, the pharmacist will obtain the patient's medication history following the protocol of "best possible medication history" (WHO). Furthermore, he will ascertain the patient's adherence to his/her drug regime. With the information obtained, he will then carry out a thorough medication review (regarding interactions, contraindications, suitability for the elderly, dosage regimes, etc.) in order to develop a suggestion for the best possible drug regime, which is discussed with the treating physician. In addition, he will also observe possible side effects and provide information on the background and significance of every single drug to the patient and/or his/her care-giver. Furthermore, the handling of difficult devices (i.e. insulin pens, inhalators and transdermal therapeutic systems) will be individually explained. Finally, the pharmacist will prepare a distinctive paragraph in the medical discharge report in which he explains the changes in the medication regime during the inpatient period to the general practitioner and will also elaborate possible interactions and problems concerning the patient's medication (pharmaceutical council).
The main outcome to be evaluated will be the number of hospital readmissions and drug related hospital readmissions within six months after discharge (recorded at one, three and six months). The secondary outcome will be the days spent at home (also recorded at one, three and six months), time to readmission, changes in medication within six months and the acceptance of the supposed medication regime by the general practitioner (GP).
The study will be conducted as a before and after comparison in which the steps described above will be implemented successively: In the first phase (140 patients planned for an observation period of eight months), patients will receive standard care and the pharmacist will only obtain the medication history shortly after admission. Results and discrepancies will be discussed with the attending physician of the hospital. After discharge, described outcomes will be documented. In the second phase (140 patients planned for an observation period of eight months), the pharmacist will conduct all of the activities described above. The outcomes will be documented as in phase one.
We expect that the comprehensive pharmaceutical assessment in the second phase will lead to a better coordination regarding the medication regime, enhance the patient's knowledge of their medication, thus improving their adherence to the therapy and that the pharmaceutical council will ensure a better trans-sectoral communication to the GP with a higher acceptance of the supposed drug regime in the doctor's letter. All these improvements combined might reduce hospital readmissions and increase the patient's days spent at home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –First observational period: Standard care without an advising pharmacist, 140 patients |
| Implementation group | – | –Second observational period: Standard care with an advising pharmacist, 140 patients |
| Learning success group | – | –Second observational period: Standard care without an advising pharmacist, 30 patients |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the clinic for internal medicine and geriatrics of the Franziskus Hospital Aachen (chair of geriatrics and geriatric medicine of the RWTH Aachen University)
Key inclusion criteria (4 listed)
- Geriatric complex treatment (Operation and procedure code (German: "Operationen- und Prozedurenschlüssel", OPS) 8-550)
- In-patient stay for at least 7 days
- Written informed consent of the patient or the legal representative
- Existing concomitant drug therapy at the time of the inpatient admission
Key exclusion criteria (3 listed)
- Patients, that were already included in the study beforehand
- Patients classified as terminally ill by the medical staff
- Patients, that are incapable to give their informed consent and who do not have a legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug related re-hospitalization
Time frame: 6 months
Number of re-hospitalizations with causal relation to one or more medicinal products, to examine the potential effect of an advising pharmacist
7 secondary outcomes
Overall re-hospitalization
Time frame: 6 months
Days spent at home
Time frame: 6 months
Period of time until the potential re-hospitalization into the inpatient sector
Time frame: 6 months
Acceptance of the recommended medication plan by the further treating primary care physicians
Time frame: 6 months
Time required for the pharmacists support
Time frame: 6 months
Completeness of the pharmaceutical anamnesis in the course of the inpatient admission
Time frame: 6 months
Evaluation of the clinical relevance of the medicinal products, which were not assessed by the doctors
Time frame: 6 months
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 22 Jul 2020.
- Derived from this study: PubMed 38897188Freitag M, Franzen J, Just KS, Eisert A, Bollheimer LC, Laurentius T. Pharmacist-Led Medication Management in Acute Geriatric Medicine and Its Associations with Rehospitalizations: A Cohort Study. Gerontology. 2024;70(9):914-929. doi: 10.1159/000539710. Epub 2024 Jun 19.
- Individual participant dataSharing planned: No
Related trials for Pharmacists in Geriatric Health Services
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Polypharmacy, Pharmacogenetics
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.
Cornelius Bollheimer, Prof. Dr. study director
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacists in Geriatric Health Services and Conditions Unspecified, run by Prof. Dr. med. Cornelius Bollheimer 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 3 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 22 Jul 2020. 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 re-hospitalization (time frame: 6 months). 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 NCT03412903, 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 22 Jul 2020.