Evaluation of the Effect of Drug-Related Problems in Pulmonary Embolism

Pulmonary Thromboembolisms Clinical Trial

Official title:

Evaluation of the Effect of Management of Drug-Related Problems on Clinical Outcomes of Pulmonary Embolism Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06392672
• Other study ID #: Pahrm. Role in Pulm. Embolism
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2024
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pulmonary embolism (PE) presents notable risks of morbidity and mortality, underscoring the need for customized anticoagulant treatment. There is a scarcity of research examining drug-related issues (DRPs) in PE. This research endeavor seeks to assess how addressing DRPs affects the clinical outcomes of PE patients receiving outpatient care, offering valuable insights to bolster patient safety measures.

This study will conduct a randomized controlled trial on PE patients in Istanbul, Turkey, from January 15, 2022, to January 15, 2023. The intervention group (IG) will receive clinical pharmacist (CP) recommendations for DRPs, while the control group (CG) will undergo observation only. Evaluations will occur at 90- and 180-days post-discharge, focusing on DRPs, CP interventions, and patient outcomes. Data will be systematically recorded and analyzed, adhering to ethical standards and employing the PCNE v9.1 classification system.

Description:

Pulmonary embolism (PE) involves the blockage of the pulmonary artery or one of its branches by materials like thrombus from elsewhere in the body. This condition is linked to increased mortality and morbidity rates, and if left untreated, it can result in recurring episodes. Additionally, using anticoagulant therapy poses a significant risk of severe bleeding.

Recent guidelines recommend customizing the duration of PE treatment based on the type of underlying risk factor, distinguishing between transient and persistent factors. Prolonged treatment without a persistent risk factor may heighten the risk of bleeding. Hence, selecting appropriate treatment options tailored to individual patient needs is crucial.

The main goal of our study is to evaluate how managing drug-related problems (DRPs) in pulmonary embolism (PE) outpatients influences their clinical outcomes. This research aims to provide valuable insights into the effectiveness of interventions targeting DRPs within the framework of PE management .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. A confirmed diagnosis of pulmonary embolism (ICD-10 code: I26.0)

2. Patients visited the chest diseases outpatient clinic for post-discharge follow-up

3. Being 18 years or older.

4. Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.

Exclusion Criteria:

1. Being under 18 years old.

2. Lost follow up in 90th day after pulmonary embolism.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Pulmonary Thromboembolisms
• Thromboembolism

Intervention

Behavioral:
• Intervention Group: Group to which the clinical pharmacist makes recommendations
The drugs administered to patients during scheduled hospital visits will be recorded. A detailed medication review will be conducted by the clinical pharmacist. As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (4)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Istanbul Sultanbeyli State Hospital, Istanbul University - Cerrahpasa (IUC), Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance rate of suggested intervention (number)	Acceptance rate of suggested intervention. Dru-related problems and recommendations are classified according to PCNE (Pharmaceutical Care Network Europe) version 9.1. It was recorded how many suggestions were made in the intervention group and how many of these suggestions were accepted.	From the date of randomization until there are 50 patient participants in each group. Average 1 year.
Primary	Bleeding	Occasions of bleeding within the 180th day.	From the date of randomization until there are 50 patient participants in each group. Average 1 year.
Secondary	Increase in pulmonary embolism related quality of life	Pulmonary embolism related Quality of life will be assesed after Clinical pharmacist intervention.	From the date of randomization until there are 50 patient participants in each group. Average 1 year.