Franziskushospital
Aachen, Northrheinwestfalia, 52074, Germany
NCT Number: NCT03412903
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.
Looking for future studies?
Notify Me70 year and older
All sexes
Observational
Aachen, Northrheinwestfalia, 52074, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 months
Overall number of re-hospitalizations within the observational period per patient
Time frame: 6 months
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
Time between the discharge and a potential re-hospitalization per patient
Time frame: 6 months
Adoption of the medication plan, recommended in the doctor's letter, by the further treating primary care physicians
Time frame: 6 months
Expenditure of time, required for the pharmacists support, per patient within the implementation group
Time frame: 6 months
Comparison between the pharmaceutical anamnesis conducted by the doctor and the pharmacist, respectively
Time frame: 6 months
The evaluation will be conducted by an interdisciplinary group using the focus group method.
Prof. Dr. med. Cornelius Bollheimer
Other
The Pharmacist in the Acute Geriatric Inpatient Treatment Team - Impact on Re-hospitalization and Trans-sectoral Communication
Acronym: AGITATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00400946
Chemically-Induced Disorders, Drug-Related Side Effects and Adverse Reactions
Boston, Massachusetts, United States
View Trial DetailsNCT05157191
Adverse Drug Event, Chemically-Induced Disorders
Oakland, California, United States
View Trial DetailsNCT00326482
Chemically-Induced Disorders, Digestive System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT00093353
Chemically-Induced Disorders, Diarrhea
Los Angeles, California, United States
View Trial Details