Examination of the Standardized Use of the Pulmonary Embolism SOP in the Clinical Routine of the Emergency Department.

NCT04049370 | Unknown

• 1 other identifier: SOP_PE_Giannitsis
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Usage of a guideline-compliant SOP in each chest pain unit (CPU) is instrumental in establishing the diagnosis of a pulmonary embolism without time delay. With the integration of this SOP as a "clinical decision tool" (CDT) into the electronic database of the CPU, the standardized application of the pulmonary embolism SOP in the clinical routine of the CPU will be tested using a retro- and prospective approach.

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism; clinical decision tool; standard operating procedure

Outcome Measures

Primary Outcomes (3)

• Guideline adherence

  • Percent guideline adherence or violation of guideline recommendations (quality)

  6 months

• Appropriateness of CT imaging

  • Ratio of diagnostic CT: total CT

  6 months

• Missed pulmonary embolism

  * Number of indicated but not performed CT examinations * Number of unnecessary CT at low pretest probability

  6 months

Secondary Outcomes (3)

• Appropriate biomarker utilization

  6 months

• Inappropriate biomarker utilization

  6 months

• efficacy of CT imaging

  6 months

Other Outcomes (2)

• Length of stay in emergency department

  6 months

• Time to diagnosis

  6 months

Study Arms (2)

Retrospective data collection of the "actual state"

Retrospective data collection of the "actual state" 6 months prior to August 2019.

Other: No intervention

Prospective data collection

Prospective data collection after implementation of the quality assurance measure for another 6 months (SOP as clinical decision tool into the electronic database of the CPU).

Interventions

No intervention OTHER

Assessment of the "actual state" prior to implementation of the SOP as clinical decision tool into the electronic database of the chest pain unit.

Retrospective data collection of the "actual state"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises all patients presenting in the CPU with signs and symptoms of a pulmonary embolism (no preselection of patients).

You may qualify if:

• Patients over the age of 18 with suspected pulmonary embolism in the CPU (with or without D-dimer determination)

You may not qualify if:

• Patients in whom the determination of the D-dimer concentration was made for other reasons, such as venous thrombosis or aortic syndrome
• Patients who have been suspected to have a pulmonary embolism already before presenting in the CPU
• Patients with confirmed diagnosis or already measured D-dimers

Sponsors & Collaborators

• Heidelberg University: lead

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Evangelos Giannitsis, Prof.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitali Koch, Dr.

CONTACT

0049 6221-56 8676; Vitali.Koch@med.uni-heidelberg.de

Maximilian Beythien, Dr.

CONTACT

0049 6221-56 8676; Maximilian.Beythien@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 8, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: August 8, 2019

Record last verified: 2019-08