Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 5:51 PM
Study NCT ID:
NCT03023605
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2017-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-14', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to clinical guidelines after the implementation of a systematic, standardized, continuous training intervention for improving processes and results.', 'timeFrame': '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)'}], 'primaryOutcomes': [{'measure': 'Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)', 'timeFrame': '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', 'timeFrame': '3 months', 'description': 'January, February and Mach 2017'}], 'secondaryOutcomes': [{'measure': 'Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)', 'timeFrame': '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)', 'timeFrame': '12 months'}, {'measure': 'D-dimmer corrected by age in all cases', 'timeFrame': '12 months'}, {'measure': 'Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary embolism', 'Adherence to practice guidelines', 'Age-adjusted D-dimer', 'Clinical prediction rules', 'Elderly patients'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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.\n\nOBJECTIVES\n\nA. Primary:\n\n1. Analyze adherence to guidelines for the evaluation of suspected PE in the ED.\n2. Determine the clinical impact of training intervention (change in adherence to guidelines after training measures among staff in Emergency Department)\n3. Implementation and consolidation of a systematic, standardized, continuous training intervention for improving processes and results.\n\nB.- Secondary\n\n1. Analyze PE cases (presentation, clinical features, treatment, clinical evolution)\n2. analyze the clinical differences in three subgroups of patients with PE: young patients (\\<50 years), elderly patients (\\<65 years) and cancer\n3. Analyze the value of D-dimmer corrected by age in diagnostic algorithms\n4. Analyze the results of a new algorithm (EPC + Dimmer corrected age) in the elderly population group (\\<65 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are included\n* those patients who underwent a D-dimmer for suspected PE\n* all those who underwent the diagnosis of PE at discharge\n* those who died from EP.\n\nExclusion Criteria:\n\n* Are excluded:\n* all patients who underwent D-dimmer test with a different diagnosis of EP and those who had a chronic EP'}, 'identificationModule': {'nctId': 'NCT03023605', 'acronym': 'APEED', 'briefTitle': 'Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Adherence to Clinical Guidelines in the Diagnosis of Pulmonary Embolism in an Emergency Department. Analysis of the Clinical Impact of a Training Intervention (APEED)', 'orgStudyIdInfo': {'id': 'IIBSP-EPU-2016-61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pre-intervention PE Diagnosis', 'description': 'Patients visited in Emergency Department, with suspected Pulmonary Embolism, before the training intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Post-intervention PE Diagnosis', 'description': 'Patients visited in Emergency Department, with suspected Pulmonary Embolism, after the training intervention.\n\nTraining 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.', 'interventionNames': ['Behavioral: Training Intervention for PE Diagnosis']}], 'interventions': [{'name': 'Training Intervention for PE Diagnosis', 'type': 'BEHAVIORAL', 'description': 'Focused on the Emergency Department staff and the rotating residents during the months 4 and 5 of 2015, and consisted of:\n\n1. Clinical Update Sessions for staff ED (20 physicians)\n2. training sessions for residents that rotate in ED (60 physicians )\n3. Development of a triptych, including clinical prediction scales, combination algorithm of scales and D-Dimmer value\n4. Development of posters, with brief information\n5. Dissemination by e-mail of scientific information\n6. Direct reminder during the working day', 'armGroupLabels': ['Post-intervention PE Diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Mireia Puig, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}