NCT03023605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

January 2, 2017

Last Update Submit

June 28, 2018

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolismAdherence to practice guidelinesAge-adjusted D-dimerClinical prediction rulesElderly patients

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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 Outcomes (1)

  • Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results.

    12 months

Study Arms (2)

Pre-intervention PE Diagnosis

NO INTERVENTION

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

Post-intervention PE Diagnosis

EXPERIMENTAL

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

Interventions

Training Intervention for PE DiagnosisBEHAVIORAL

Focused on the Emergency Department staff and the rotating residents during the months 4 and 5 of 2015, and consisted of: 1. Clinical Update Sessions for staff ED (20 physicians) 2. training sessions for residents that rotate in ED (60 physicians ) 3. Development of a triptych, including clinical prediction scales, combination algorithm of scales and D-Dimmer value 4. Development of posters, with brief information 5. Dissemination by e-mail of scientific information 6. Direct reminder during the working day

Post-intervention PE Diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Are excluded:
  • all patients who underwent D-dimmer test with a different diagnosis of EP and those who had a chronic EP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Mireia Puig, PhD

    Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 18, 2017

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

March 1, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

ES(1)