ClinicalTrials.gg
CompletedNCT03412903AGITATEUpdated Jul 22, 2020

The Pharmacist in the Acute Geriatric Inpatient Treatment Team

An observational study in Pharmacists in Geriatric Health Services and Conditions Unspecified, sponsored by Prof. Dr. med. Cornelius Bollheimer. Completed at 1 site in Germany. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Prof. Dr. med. Cornelius Bollheimer · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
154
Ages
70 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pharmacists in Geriatric Health Services
  • Conditions Unspecified

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
03

In context

Drug-Related Side Effects and Adverse Reactions

449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.

This study's enrollment of 154 is below the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

This is the only study on the registry with Prof. Dr. med. Cornelius Bollheimer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Geriatric complex treatment (Operation and procedure code (German: "Operationen- und Prozedurenschlüssel", OPS) 8-550)
  • In-patient stay for at least 7 days
  • Written of the patient or the legal representative
  • Existing concomitant drug therapy at the time of the inpatient admission

Exclusion criteria

Exclusion Criteria:

  • 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 and who do not have a legal representative
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
154 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  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

    Time frame: 6 months

Secondary outcomes

  1. Overall re-hospitalization

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 months

  5. Time required for the pharmacists support

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

    Time frame: 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

    Time frame: 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.

    Time frame: 6 months

07

Study locations

1 site
  • Franziskushospital
    Aachen, Northrheinwestfalia 52074, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Sep 2019, 19 months.

Of 65 non-industry observational studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24. This study's 19 months is below that.

Counting every sponsor, half of 69 studies reached it within 45 months; a quarter within 24 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Jan 29, 2018
StartActual
Jan 22, 2018
Primary completionActual
Sep 20, 2019
CompletionActual
Apr 3, 2020
Last update
Jul 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03412903
Lead sponsor
Prof. Dr. med. Cornelius Bollheimer
Responsible party
Prof. Dr. med. Cornelius Bollheimer (Univ.-Prof. Dr. med., Klinikdirektor, RWTH Aachen University) — Sponsor-investigator
First posted
Jan 29, 2018
Start date
Jan 22, 2018
Primary completion
Sep 20, 2019
Completion
Apr 3, 2020
Last update
Jul 22, 2020

Study contacts

Cornelius Bollheimer, Prof. Dr.
study director · University Hospital RWTH Aachen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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