Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04930302 |
| Other study ID # |
PHAR008NUSCH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
National Institute of Cardiovascular Diseases, Slovakia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This project aims to assess the impact of pharmaceutical care in collaboration with
physicians on prevalence of DRPs at hospital admission and discharge in patients with carotid
artery disease or lower extermity artery disease hospitalized at the Department of Vascular
Surgery.
The key focus area of this project will be the identification of DRPs, their occurrence and
type. As a part of further research, the investigators want to analyze the a) acceptance rate
of pharmaceutical intervention by physicians. Proportion of accepted interventions by
physicians was calculated and b) patients' understanding of his/her pharmacotherapy assessed
on a three-point scale at hospital admission.
Hypothesis:
Null hypothesis: Pharmaceutical care provided at hospital admission and at hospital discharge
does not reduce prevalence rates of DRPs in patients with carotid artery disease or lower
extermity artery disease hospitalized at the Department of Vascular Surgery.
Alternative hypothesis: Pharmaceutical care provided at hospital admission and at hospital
discharge reduces prevalence rates of DRPs in patients with carotid artery disease or lower
extermity artery disease hospitalized at the Department of Vascular Surgery.
Primary outcomes:
Change in the prevalence rate of DRPs at hospital admission vs. hospital discharge.
Secondary outcomes:
1. acceptance rate of pharmaceutical intervention by physician
2. patients' understanding of his/her pharmacotherapy
Description:
Medication reconciliation, medication review and patient education performed by a trained
pharmacist in two timepoints.
All comments with a proposal from the pharmacist will be recorded in written together with a
record of the therapy, entered in the patient's medical record and communicated with the
physician.
Timepoints for intervention:
1. At hospital admission
The patient is normally admitted to the planned hospitalization by the physician in
cooperation with the nurse as described above. If the patient is over 18 years of age,
takes more than three medicines, speaks and understands Slovak language and has signed
an informed consent to participate in biomedical research, after being placed in a bed,
a pharmacist comes to the patient and performs MR. During MR, the pharmacist creates a
record of the patient's therapy (MR form for admission - attachment No. 2), the original
of which is placed in the patient's medical record, and a copy is placed to pharmacist´s
records.
Steps in MR:
1. As part of the invitation to hospitalization (by telephone, in writing), the
patient will be asked to bring all their medications and a complete medication
list, which will be used in consultation with the pharmacist regarding their proper
use.
2. Completion of BPMH
BPMH is a treatment overview obtained by a healthcare professional that contains
all the medicines (prescription medicines and over-the-counter drugs) that the
patient is taking, using various sources of information. The source of information
can be a drug record, an admission report and a course, historical records from the
HIS, information from the patient or his family member. BPMH is different and more
complex than the routine history of primary treatment (which is often a rapid
history of patient treatment). The BPMH includes the name of the medicine, the
dose, the frequency and the route of the medicines that the patient is currently
taking, although it may differ from what was actually written in the drug list.
The types of drugs that need to be recorded for BPMH include:
- prescription drugs
- over-the-counter drugs
- nutritional supplements
- herbal medicines, medicinal teas
- recreational drugs
- regular consumption of certain foods (e.g. grapefruit)
- special emphasis should be placed on specific forms of medicines such as
inhalers, eye drops, topical semi-solid medicines, or medicines taken every
few weeks (bisphosphonates)
One of the recorded parameters is patient understanding. It is evaluated in three
steps - the patient knows / does not know the name of the drug (1/0), the patient
knows / does not know the indication of the drug (1/0) and the patient knows / does
not know the dosage of the drug (1/0).
If the patient is unable to attend the interview, other sources may be used to
obtain a medical history or to clarify conflicting information. Other resources
should never be a substitute for a thorough conversation with the patient and / or
family members.
3. Verification and documentation of BPMH
Medicinal product information should be verified by more than one other source. Sources
for the initial acquisition of an overview of pharmacotherapy are the admission report,
the history of hospitalization, outpatient reports, HIS, the course at admission. The
investigators verify the information obtained by speaking with a patient or his family
member, the provided drug list or drugs.
Within the WHO SOP, the investigators chose a retroactive MR model at admission for our
biomedical research. In a retroactive model, in accordance with the method described
above, the patient is admitted by a physician in cooperation with a nurse by default,
and a drug course is created, a daily prescription of drugs for the patient. In this
case, the BPMH is determined after admission by a physician / nurse.
The result of Part b) is a comparison of prescribed and actually used medicines to
patients (BMPH) with marked discrepancies.
Medication review with pharmaceutical intervention at patient admission The basis for
performing patient therapy optimization is the acquisition of BPMH and patient factors
such as the reason for hospitalization, current health status, comorbidities, height,
weight, heart rate, blood pressure and the results of examinations of biochemical and
hematological parameters.
The detected BPMH is written to the case report form (CRF) (attachment No. 4) . It is
then analyzed in the context of the patient's overall health condition and DRPs are
identified. Each detected discrepancy is assigned an alphanumeric code according to the
PCNE V9.00 classification. The patient's personal data is anonymized.
Discrepancies in therapy should be consulted with the treating physician within 24 hours
of admission.
Evaluation of therapy based on DRPs and PCNE classification After receiving BPMH and a
detailed study of the reason for hospitalization, current medical condition, and any
comorbidities of the patient, the pharmacist draws information about the patient's
weight, height, heart rate, and blood pressure from the admission report. Subsequently,
he/she studies the results of biochemical and hematological examinations. The pharmacist
focuses on the results of examinations related to pharmacotherapy and the determination
of the function of elimination organs. These are mainly the serum potassium, serum
creatinine, serum uric acid, liver transaminases, lipidogram, C-reactive protein. Renal
function is calculated based on the Cockcroft and Gault creatinine clearance estimate
and the CKD-EPI glomerular filtration rate estimate. From the hematological results, the
pharmacist focuses on INR, aPTT-R, anti Xa activity, platelet count and others.
The pharmacist controls duplication in the drugs used; the indications of the drugs used
according to the patient's comorbidities; compliance with the maximum recommended doses
of drugs according to the SPC; the suitability of the choice of dosage form; drug
interactions using the computerized interaction database, the LexiComp℗, SPC,
pharmacological findings, published scientific papers and case reports; newly manifested
adverse drug reactions.
2. At hospital discharge
The pharmacist performs a MR when discharging a patient from the hospital, similar to the
admission. MR form for discharge is used (attachment No. 5). When evaluating a patient's
pharmacotherapy on discharge from hospital, the BPMH obtained at the patient's admission will
be used as a source of information. The BPMH is then compared with the list of medicines that
are recorded in the release report. The pharmacist will compare the two lists of medicines,
focusing on the identification of DRPs with special regard to the re-introduction of the
chronic therapy which the patient was taking before coming to the hospital. As part of this
research, the pharmacist will meet with the patient during his discharge from the hospital
and discuss with him the management of his further pharmacotherapy. Pharmacists provide an
understandable summary list of patient's medicines explaining importance and the correct use
of medicine (attachment No. 6).
Medication review with pharmaceutical intervention at patient discharge The pharmacist
analyzes pharmacotherapy in the context of the patient's state of health and the results of
laboratory tests, similar to the patient's admission as described above. Detected DRPs are
then consulted with the treating physician and recorded in the CRF.
The result of the pharmacist's intervention at discharge is the completion of the MR form for
discharge and the writing of all comments on pharmacotherapy in the form of a summary report.
Discrepancies and comments are consulted with the physician.
