Optimizing the Pharmacotherapy of Vascular Surgery Patients at Hospital Admission, at Discharge and at Post-discharge Check-up: Quasi-experimental Clinical Uncontrolled Trial (PHAROS)
Study Details
Study Description
Brief Summary
This project aims to assess the impact of pharmaceutical care in collaboration with physicians on prevalence of DRPs at hospital admission, discharge and at post-discharge check-up (4 - 8 weeks after patient's discharge from hospital) in patients with carotid 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 degree of acceptance of the proposed changes in pharmacotherapy by physicians, ATC groups of drugs with the highest incidence of DRPs and identify patients at highest risk for DRPs taking in consideration their personal and health information.
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 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 hospitalized at the Department of Vascular Surgery.
Primary outcomes:
Change in the prevalence rate of DRPs at a) hospital admission vs. hospital discharge, b) hospital discharge vs. post-discharge check-up.
Secondary outcomes:
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acceptance rate of pharmaceutical intervention by physician
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identification of factors that increase patients' odds for DRPs at hospital admission
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score that expresses patients´ knowledge of his pharmacotherapy
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Medication reconciliation, medication review and patient education performed by a trained pharmacist in three 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:
- 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:
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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.
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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:
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prescription drugs
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over-the-counter drugs
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nutritional supplements
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herbal medicines, medicinal teas
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recreational drugs
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regular consumption of certain foods (e.g. grapefruit)
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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.
- 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.
- 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.
- At the first ambulatory check-up (approximately after 4 - 8 weeks after discharge)
The pharmacist performs a MR by obtaining BPMH, similar to the previous admission of the patient to the hospital. MR form for patient's post-discharge check-up is used (attachment No. 8). When evaluating a current patient's pharmacotherapy, the list of patient's pharmacotherapy at discharge will be used as a source of information. The pharmacist will compare the lists of medicines, focusing on the identification of DRPs in current treatment compared to the pharmacotherapy at the time of discharge.
Patients whose health condition is not controlled at the National Institute of cardiovascular diseases will be contacted and investigated by phone.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in prevalence rate of drug related problems [through study completion, an average of 1 year]
Change in the prevalence rate of drug related problems at a) hospital admission vs. hospital discharge, b) hospital discharge vs. post-discharge check-up.
Secondary Outcome Measures
- patients characteristics [through study completion, an average of 1 year]
weight in kilograms
- patients characteristics [through study completion, an average of 1 year]
height in meters
- patients characteristics [through study completion, an average of 1 year]
diagnosis
- patients characteristics [through study completion, an average of 1 year]
biochemical and hematological parameters (levels of Na+, K+, Cr, CKD-EPI, platelet levels)
- patients characteristics [through study completion, an average of 1 year]
age
- patients characteristics [through study completion, an average of 1 year]
sex
- patients characteristics [through study completion, an average of 1 year]
social and employement status
- patients characteristics [through study completion, an average of 1 year]
level of understanding of used pharmacotherapy
- Medication characteristics [through study completion, an average of 1 year]
name of drug/medicine
- Medication characteristics [through study completion, an average of 1 year]
ATC of drug
- Medication characteristics [through study completion, an average of 1 year]
dose
- Medication characteristics [through study completion, an average of 1 year]
dosage form of medicine
- Medication characteristics [through study completion, an average of 1 year]
frequency of using
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years at the date of admission for hospitalization
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patients taking at least 3 medications
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patients with carotid artery disease, peripheral arterial disease
Exclusion Criteria:
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Acute patients.Due to the urgent health condition, medication reconciliation is not the priority in these patients, furthermore, rendering the BPMH collection impossible.
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Patients transferred from other hospitals/wards
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Not willing to sign the informed consent form for the study
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Not understanding Slovak language
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Presence of any mental disorder affecting memory and recall ability (such as Alzheimer's disease)
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Any other reason at the discretion of the investigator why he/she deems the participant not eligible for study participation (all such reasons will be recorded)
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Participation in another clinical study
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Furthermore, patients transferred to other hospitals/wards will be excluded from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | National Institute of Cardiovascular Diseases, Slovakia | Bratislava | Slovakia | 833 48 |
Sponsors and Collaborators
- National Institute of Cardiovascular Diseases, Slovakia
Investigators
- Principal Investigator: Slavka Porubcova, PharmDr., National Institute of Cardiovascular Diseases
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PHAR008NUSCH