Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)

NCT ID: NCT03023605

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-03-31

Brief Summary

The purpose of this study is to analyze the clinical impact of an educational intervention on adherence to Clinical Practice Guidelines in an Emergency Department (ED), by using a standardized training, for improving diagnostic sensibility and reducing unnecessary scans, adverse effects and stays in the ED.

Detailed Description

The Hospital de la Santa Creu i Sant Pau Emergency Department (ED) implemented a training program between May and June 2015 to improve compliance and adherence to recommended clinical practice and optimize the diagnosis and management of patients with suspected Pulmonary Embolism (PE). The training program was standardized, systematic and continuous, with subsequent reinforcement to ensure implementation. This paper aims to evaluate the clinical impact of the training intervention. The establishment of training measures to improve adherence to guidelines implies clinical practice improvement and benefits patients and health system. Moreover, it is a simple and inexpensive intervention, and can be easily reproduced in other ED.

All adult patients (<18 y) with suspected pulmonary embolism attended at Emergency Department will be included. Retrospective information from two different periods (before and after the training intervention) will be collected. First period: 1/1/2012 - 31/12/2012 and second Period: 01.06.2015 - 30/11/2015, pre and post intervention.

OBJECTIVES

A. Primary:

1. Analyze adherence to guidelines for the evaluation of suspected PE in the ED.

2. Determine the clinical impact of training intervention (change in adherence to guidelines after training measures among staff in Emergency Department)

3. Implementation and consolidation of a systematic, standardized, continuous training intervention for improving processes and results.

B.- Secondary

1. Analyze PE cases (presentation, clinical features, treatment, clinical evolution)

2. analyze the clinical differences in three subgroups of patients with PE: young patients (<50 years), elderly patients (<65 years) and cancer

3. Analyze the value of D-dimmer corrected by age in diagnostic algorithms

4. Analyze the results of a new algorithm (EPC + Dimmer corrected age) in the elderly population group (<65 years).

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pre-intervention PE Diagnosis

Patients visited in Emergency Department, with suspected Pulmonary Embolism, before the training intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-intervention PE Diagnosis

Patients visited in Emergency Department, with suspected Pulmonary Embolism, after the training intervention.

Training intervention centered on emergency department staff, regarding the application of clinical probability scores (Wells and Geneva scores) to guide the determination of D-dimer and the performance of pulmonary CT in patients with suspected pulmonary embolism.

Group Type: EXPERIMENTAL

Training Intervention for PE Diagnosis

Intervention Type: BEHAVIORAL

Focused on the Emergency Department staff and the rotating residents during the months 4 and 5 of 2015, and consisted of:

1. Clinical Update Sessions for staff ED (20 physicians)

2. training sessions for residents that rotate in ED (60 physicians )

3. Development of a triptych, including clinical prediction scales, combination algorithm of scales and D-Dimmer value

4. Development of posters, with brief information

5. Dissemination by e-mail of scientific information

6. Direct reminder during the working day

Interventions

Training Intervention for PE Diagnosis

Focused on the Emergency Department staff and the rotating residents during the months 4 and 5 of 2015, and consisted of:

1. Clinical Update Sessions for staff ED (20 physicians)

2. training sessions for residents that rotate in ED (60 physicians )

3. Development of a triptych, including clinical prediction scales, combination algorithm of scales and D-Dimmer value

4. Development of posters, with brief information

5. Dissemination by e-mail of scientific information

6. Direct reminder during the working day

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Are included
• those patients who underwent a D-dimmer for suspected PE
• all those who underwent the diagnosis of PE at discharge
• those who died from EP.

Exclusion Criteria

• Are excluded:
• all patients who underwent D-dimmer test with a different diagnosis of EP and those who had a chronic EP

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mireia Puig, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

IIBSP-EPU-2016-61

Identifier Type: -

Identifier Source: org_study_id