Clinical trial NCT06392672: Evaluation of the Effect of Drug-Related Problems in Pulmonary Embolism
Official title: Evaluation of the Effect of Management of Drug-Related Problems on Clinical Outcomes of Pulmonary Embolism Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Thromboembolisms
Keywords: Pulmonary embolism
bleeding
clinical pharmacist
drug-related problems
anticoagulation
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Istanbul Sultanbeyli State Hospital
name: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
First posted: 2024-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptance rate of suggested intervention (number)
timeFrame: From the date of randomization until there are 50 patient participants in each group. Average 1 year.
measure: Bleeding
timeFrame: From the date of randomization until there are 50 patient participants in each group. Average 1 year.
Secondary outcomes:
measure: Increase in pulmonary embolism related quality of life
timeFrame: From the date of randomization until there are 50 patient participants in each group. Average 1 year.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References: