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Completed

NCT Number: NCT03023605

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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:

  • Analyze adherence to guidelines for the evaluation of suspected PE in the ED.
  • Determine the clinical impact of training intervention (change in adherence to guidelines after training measures among staff in Emergency Department)
  • Implementation and consolidation of a systematic, standardized, continuous training intervention for improving processes and results.

B.- Secondary

  • Analyze PE cases (presentation, clinical features, treatment, clinical evolution)
  • analyze the clinical differences in three subgroups of patients with PE: young patients (<50 years), elderly patients (<65 years) and cancer
  • Analyze the value of D-dimmer corrected by age in diagnostic algorithms
  • Analyze the results of a new algorithm (EPC + Dimmer corrected age) in the elderly population group (<65 years).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Training Intervention for PE Diagnosis

Behavioral

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

  • Clinical Update Sessions for staff ED (20 physicians)
  • training sessions for residents that rotate in ED (60 physicians )
  • Development of a triptych, including clinical prediction scales, combination algorithm of scales and D-Dimmer value
  • Development of posters, with brief information
  • Dissemination by e-mail of scientific information
  • Direct reminder during the working day

Primary outcomes

  1. Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)

    Time frame: 3 months

    October, November, December 2016

  2. Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence) after training measures among staff in Emergency Department

    Time frame: 3 months

    January, February and Mach 2017

Secondary outcomes

  1. Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)

    Time frame: 12 months

  2. Prevalence of different clinical characteristics of Pulmonary Embolism related to age (three subgroups of patients with PE: young patients (<50 years), elderly patients (<65 years) and cancer)

    Time frame: 12 months

  3. D-dimmer corrected by age in all cases

    Time frame: 12 months

  4. Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)

    Time frame: 12 months

Other outcomes

  1. Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results.

    Time frame: 12 months

    Number of patients with suspected pulmonary embolism in whom the decision to perform D-Dimer and TC was based on clinical probability scores (Wells and Geneva test)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Adherence to Clinical Guidelines in the Diagnosis of Pulmonary Embolism in an Emergency Department. Analysis of the Clinical Impact of a Training Intervention (APEED)

Acronym: APEED

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 18, 2017
Registry last updated
Jul 2, 2018

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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