<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03023605</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-EPU-2016-61</org_study_id>
    <nct_id>NCT03023605</nct_id>
  </id_info>
  <brief_title>Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)</brief_title>
  <acronym>APEED</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the clinical impact of an educational intervention on&#xD;
      adherence to Clinical Practice Guidelines in an Emergency Department (ED), by using a&#xD;
      standardized training, for improving diagnostic sensibility and reducing unnecessary scans,&#xD;
      adverse effects and stays in the ED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Hospital de la Santa Creu i Sant Pau Emergency Department (ED) implemented a training&#xD;
      program between May and June 2015 to improve compliance and adherence to recommended clinical&#xD;
      practice and optimize the diagnosis and management of patients with suspected Pulmonary&#xD;
      Embolism (PE). The training program was standardized, systematic and continuous, with&#xD;
      subsequent reinforcement to ensure implementation. This paper aims to evaluate the clinical&#xD;
      impact of the training intervention. The establishment of training measures to improve&#xD;
      adherence to guidelines implies clinical practice improvement and benefits patients and&#xD;
      health system. Moreover, it is a simple and inexpensive intervention, and can be easily&#xD;
      reproduced in other ED.&#xD;
&#xD;
      All adult patients (&lt;18 y) with suspected pulmonary embolism attended at Emergency Department&#xD;
      will be included. Retrospective information from two different periods (before and after the&#xD;
      training intervention) will be collected. First period: 1/1/2012 - 31/12/2012 and second&#xD;
      Period: 01.06.2015 - 30/11/2015, pre and post intervention.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
      A. Primary:&#xD;
&#xD;
        1. Analyze adherence to guidelines for the evaluation of suspected PE in the ED.&#xD;
&#xD;
        2. Determine the clinical impact of training intervention (change in adherence to&#xD;
           guidelines after training measures among staff in Emergency Department)&#xD;
&#xD;
        3. Implementation and consolidation of a systematic, standardized, continuous training&#xD;
           intervention for improving processes and results.&#xD;
&#xD;
      B.- Secondary&#xD;
&#xD;
        1. Analyze PE cases (presentation, clinical features, treatment, clinical evolution)&#xD;
&#xD;
        2. analyze the clinical differences in three subgroups of patients with PE: young patients&#xD;
           (&lt;50 years), elderly patients (&lt;65 years) and cancer&#xD;
&#xD;
        3. Analyze the value of D-dimmer corrected by age in diagnostic algorithms&#xD;
&#xD;
        4. Analyze the results of a new algorithm (EPC + Dimmer corrected age) in the elderly&#xD;
           population group (&lt;65 years).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)</measure>
    <time_frame>3 months</time_frame>
    <description>October, November, December 2016</description>
  </primary_outcome>
  <primary_outcome>
    <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</measure>
    <time_frame>3 months</time_frame>
    <description>January, February and Mach 2017</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of different clinical characteristics of Pulmonary Embolism related to age (three subgroups of patients with PE: young patients (&lt;50 years), elderly patients (&lt;65 years) and cancer)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimmer corrected by age in all cases</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (&lt;65 years)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results.</measure>
    <time_frame>12 months</time_frame>
    <description>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)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">440</enrollment>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Pre-intervention PE Diagnosis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients visited in Emergency Department, with suspected Pulmonary Embolism, before the training intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-intervention PE Diagnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients visited in Emergency Department, with suspected Pulmonary Embolism, after the training intervention.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training Intervention for PE Diagnosis</intervention_name>
    <description>Focused on the Emergency Department staff and the rotating residents during the months 4 and 5 of 2015, and consisted of:&#xD;
Clinical Update Sessions for staff ED (20 physicians)&#xD;
training sessions for residents that rotate in ED (60 physicians )&#xD;
Development of a triptych, including clinical prediction scales, combination algorithm of scales and D-Dimmer value&#xD;
Development of posters, with brief information&#xD;
Dissemination by e-mail of scientific information&#xD;
Direct reminder during the working day</description>
    <arm_group_label>Post-intervention PE Diagnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are included&#xD;
&#xD;
          -  those patients who underwent a D-dimmer for suspected PE&#xD;
&#xD;
          -  all those who underwent the diagnosis of PE at discharge&#xD;
&#xD;
          -  those who died from EP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are excluded:&#xD;
&#xD;
          -  all patients who underwent D-dimmer test with a different diagnosis of EP and those&#xD;
             who had a chronic EP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireia Puig, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>June 28, 2018</last_update_submitted>
  <last_update_submitted_qc>June 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary embolism</keyword>
  <keyword>Adherence to practice guidelines</keyword>
  <keyword>Age-adjusted D-dimer</keyword>
  <keyword>Clinical prediction rules</keyword>
  <keyword>Elderly patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03023605
org study id: IIBSP-EPU-2016-61
nct id: NCT03023605
lead sponsor: 
has dmc: No
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.
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).
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)
time frame: 3 months
description: October, November, December 2016
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
time frame: 3 months
description: January, February and Mach 2017
measure: Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)
time frame: 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)
time frame: 12 months
measure: D-dimmer corrected by age in all cases
time frame: 12 months
measure: Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)
time frame: 12 months
measure: Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results.
time frame: 12 months
description: 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)
arm group label: Pre-intervention PE Diagnosis
arm group type: No Intervention
description: Patients visited in Emergency Department, with suspected Pulmonary Embolism, before the training intervention.
arm group label: Post-intervention PE Diagnosis
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Training Intervention for PE Diagnosis
description: 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
arm group label: Post-intervention PE Diagnosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mireia Puig, PhD
role: Principal Investigator
affiliation: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Embolism
mesh term: Emergencies
sharing ipd: Undecided