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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03023605
Other study ID # IIBSP-EPU-2016-61
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date March 2018

Study information

Verified date June 2018
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date March 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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: 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

Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results. 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) 12 months
Primary Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence) October, November, December 2016 3 months
Primary 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 January, February and Mach 2017 3 months
Secondary Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution) 12 months
Secondary 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) 12 months
Secondary D-dimmer corrected by age in all cases 12 months
Secondary Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years) 12 months
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