Clinical trial NCT03412903: The Pharmacist in the Acute Geriatric Inpatient Treatment Team
Official title: The Pharmacist in the Acute Geriatric Inpatient Treatment Team - Impact on Re-hospitalization and Trans-sectoral Communication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 154
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief 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.

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.

Eligibility criteria: 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 informed consent of the patient or the legal representative
* Existing concomitant drug therapy at the time of the inpatient admission

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 informed consent and who do not have a legal representative

Primary outcomes:
measure: Drug related re-hospitalization
timeFrame: 6 months
Secondary outcomes:
measure: Overall re-hospitalization
timeFrame: 6 months
measure: Days spent at home
timeFrame: 6 months
measure: Period of time until the potential re-hospitalization into the inpatient sector
timeFrame: 6 months
measure: Acceptance of the recommended medication plan by the further treating primary care physicians
timeFrame: 6 months
measure: Time required for the pharmacists support
timeFrame: 6 months
measure: Completeness of the pharmaceutical anamnesis in the course of the inpatient admission
timeFrame: 6 months
measure: Evaluation of the clinical relevance of the medicinal products, which were not assessed by the doctors
timeFrame: 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Franziskushospital
state: Northrheinwestfalia
Study officials:
affiliation: University Hospital RWTH Aachen
name: Cornelius Bollheimer, Prof. Dr.
role: STUDY_DIRECTOR
References: