Clinical trial NCT03023605: Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism
Adherence to practice guidelines
Age-adjusted D-dimer
Clinical prediction rules
Elderly patients
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)
timeFrame: 3 months
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: D-dimmer corrected by age in all cases
timeFrame: 12 months
measure: Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)
timeFrame: 12 months
Other outcomes:
measure: Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results.
timeFrame: 12 months
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
name: Mireia Puig, PhD
role: PRINCIPAL_INVESTIGATOR
References: