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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Germany1 site
  • Franziskushospital

    Aachen, Northrheinwestfalia, 52074

Other trials in Germany

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 groups in NCT03412903
Study groupRoleWhat they receive
Control groupFirst observational period: Standard care without an advising pharmacist, 140 patients
Implementation groupSecond observational period: Standard care with an advising pharmacist, 140 patients
Learning success groupSecond 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.

  1. 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)
  1. Overall re-hospitalization

    Overall number of re-hospitalizations within the observational period per patient

    Measured: 6 months

  2. 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

  3. 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

  4. 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

  5. Time required for the pharmacists support

    Expenditure of time, required for the pharmacists support, per patient within the implementation group

    Measured: 6 months

  6. 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

  7. 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.

  1. First posted29 Jan 2018
  2. Study start22 Jan 2018
  3. Primary completion20 Sep 2019
  4. Study completion3 Apr 2020

Resources

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)
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

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.

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