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

NCT06392672 | Completed

• 1 other identifier: Pahrm. Role in Pulm. Embolism
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Thromboembolisms

Keywords

Pulmonary embolism; bleeding; clinical pharmacist; drug-related problems; anticoagulation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Increase in pulmonary embolism related quality of life

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

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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

Interventions

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• Istanbul University - Cerrahpasa: collaborator
• Istanbul Sultanbeyli State Hospital: collaborator
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Embolism; Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: January 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

TU (1)