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NCT Number: NCT06392672

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

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.

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Key information

Conditions

Pulmonary Thromboembolisms Cardiovascular Diseases Embolism Embolism and Thrombosis Hemorrhage Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A confirmed diagnosis of pulmonary embolism (ICD-10 code: I26.0)
  • Patients visited the chest diseases outpatient clinic for post-discharge follow-up
  • Being 18 years or older.
  • Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.

Exclusion criteria

  • Being under 18 years old.
  • Lost follow up in 90th day after pulmonary embolism.

Treatment and study plan

Intervention Group: Group to which the clinical pharmacist makes recommendations

Behavioral

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.

Primary outcomes

  1. Acceptance rate of suggested intervention (number)

    Time frame: From the date of randomization until there are 50 patient participants in each group. Average 1 year.

    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.

  2. Bleeding

    Time frame: From the date of randomization until there are 50 patient participants in each group. Average 1 year.

    Occasions of bleeding within the 180th day.

Secondary outcomes

  1. Increase in pulmonary embolism related quality of life

    Time frame: From the date of randomization until there are 50 patient participants in each group. Average 1 year.

    Pulmonary embolism related Quality of life will be assesed after Clinical pharmacist intervention.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

  • Istanbul Sultanbeyli State Hospital
  • Istanbul University - Cerrahpasa
  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

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.

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