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

April 29, 2024 updated by: Muhammed Yunus BEKTAY, Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Group: Group in which only observation is made by the clinical pharmacist For patients in this group, no intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received treatment for pulmonary embolism and met the inclusion criteria. The participant will take standard treatment. Evaluations will be recorded.
Experimental: Intervention Group
Intervention Group: Group to which the clinical pharmacist makes recommendations For patients in this group, intervention (i.e. recommendation) will be made to physician in charge by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received treatment for pulmonary embolism and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of randomization until there are 50 patient participants in each group. Average 1 year.
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.
From the date of randomization until there are 50 patient participants in each group. Average 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of randomization until there are 50 patient participants in each group. Average 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pahrm. Role in Pulm. Embolism

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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