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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Training Intervention for PE Diagnosis
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring Pulmonary embolism, Adherence to practice guidelines, Age-adjusted D-dimer, Clinical prediction rules, Elderly patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-intervention PE Diagnosis

Post-intervention PE Diagnosis

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)
October, November, December 2016
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

Secondary Outcome Measures

Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)
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)
D-dimmer corrected by age in all cases
Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)

Full Information

First Posted
January 2, 2017
Last Updated
June 28, 2018
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT03023605
Brief Title
Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)
Acronym
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary embolism, Adherence to practice guidelines, Age-adjusted D-dimer, Clinical prediction rules, Elderly patients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention PE Diagnosis
Arm Type
No Intervention
Arm Description
Patients visited in Emergency Department, with suspected Pulmonary Embolism, before the training intervention.
Arm Title
Post-intervention PE Diagnosis
Arm Type
Experimental
Arm 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(s)
Training Intervention for PE Diagnosis
Intervention 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
Primary Outcome Measure Information:
Title
Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)
Description
October, November, December 2016
Time Frame
3 months
Title
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
Description
January, February and Mach 2017
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)
Time Frame
12 months
Title
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
Title
D-dimmer corrected by age in all cases
Time Frame
12 months
Title
Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results.
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireia Puig, PhD
Organizational Affiliation
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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