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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Behavioral: Training Intervention for PE Diagnosis

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).

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital De La Santa Creu I Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention PE Diagnosis; Patients visited in Emergency Department, with suspected Pulmonary Embolism, before the training intervention.
Experimental: Post-intervention PE Diagnosis; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)	October, November, December 2016	3 months
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 Outcome Measures

Outcome Measure	Time Frame
Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)	12 months
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
D-dimmer corrected by age in all cases	12 months
Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Mireia Puig, PhD, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 14, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 28, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Elderly patients; Pulmonary embolism; Adherence to practice guidelines; Age-adjusted D-dimer; Clinical prediction rules
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Embolism; Pulmonary Embolism
• Other Study ID Numbers: IIBSP-EPU-2016-61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided