Optimizing the Pharmacotherapy of Vascular Surgery Patients at Hospital Admission, at Discharge and at Post-discharge Check-up: Quasi-experimental Clinical Uncontrolled Trial (PHAROS)

NCT04930302 | Completed

• 1 other identifier: PHAR008NUSCH
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 1.acceptance rate of pharmaceutical intervention by physician
2. 2.patients' understanding of his/her pharmacotherapy

Conditions

Medication Errors and Other Product Use Errors and Issues

Outcome Measures

Primary Outcomes (1)

• Change in prevalence rate of drug related problems

  Change in the prevalence rate of drug related problems at a) hospital admission vs. hospital discharge, b) hospital discharge vs. post-discharge check-up.

  through study completion, an average of 1 year

Secondary Outcomes (13)

• patients characteristics

  through study completion, an average of 1 year

• patients characteristics

  through study completion, an average of 1 year

• patients characteristics

  through study completion, an average of 1 year

• patients characteristics

  through study completion, an average of 1 year

• patients characteristics

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years of age) Vascular surgery patients with carotid artery disease or lower extremity artery disease admitted for hospitalization at the study setting during the course of the study.

You may qualify if:

• Age ≥18 years at the date of admission for hospitalization
• patients taking at least 3 medications
• patients with carotid artery disease or lower extremity artery disease

You may not qualify if:

• Acute patients.Due to the urgent health condition, medication reconciliation is not the priority in these patients, furthermore, rendering the BPMH collection impossible.
• Patients transferred from other hospitals/wards
• Not willing to sign the informed consent form for the study
• Not understanding Slovak language
• Presence of any mental disorder affecting memory and recall ability (such as Alzheimer's disease)
• 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)
• Participation in another clinical study
• Furthermore, patients transferred to other hospitals/wards will be excluded from the study.

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Slovakia: lead

Study Sites (1)

National Institute of Cardiovascular Diseases, Slovakia

Bratislava, 833 48, Slovakia

Location

Related Publications (2)

• Porubcova S, Lajtmanova K, Szmicsekova K, Slezakova V, Tomka J, Tesar T. Optimizing the Pharmacotherapy of Vascular Surgery Patients at Hospital Admission and Discharge (PHAROS): Protocol for a Quasi-Experimental Clinical Uncontrolled Trial. JMIR Res Protoc. 2025 Mar 19;14:e60728. doi: 10.2196/60728.

  PMID: 40106812 DERIVED

• Porubcova S, Szmicsekova K, Lajtmanova K, Slezakova V, Jakubik M, Drobna E, Tomka J, Kobliskova Z, Masarykova L, Lehocka L, Tesar T. Pharmacist-led interventions for vascular surgery patients: a prospective study on reducing drug-related problems. BMC Health Serv Res. 2024 Dec 18;24(1):1564. doi: 10.1186/s12913-024-12015-7.

  PMID: 39695586 DERIVED

Study Officials

• Slavka Porubcova, PharmDr.

  National Institute of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 18, 2021
• Study Start: September 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 1, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)