Pulmonary EmbolismAPEEDNCT03023605
Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)
A study testing Training Intervention for PE Diagnosis in people with Pulmonary Embolism, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Training Intervention for PE Diagnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Are excluded:
- all patients who underwent D-dimmer test with a different diagnosis of EP and those who had a chronic EP
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- 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).
- Conditions
- Pulmonary Embolism
- Being tested
- Training Intervention for PE Diagnosis
- Keywords
- Pulmonary embolism, Adherence to practice guidelines, Age-adjusted D-dimer, Clinical prediction rules, Elderly patients
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Intervention for PE DiagnosisBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Training Intervention for PE Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)
October, November, December 2016
Measured: 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
Measured: 3 months
Secondary outcomes (4)
Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)
Measured: 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)
Measured: 12 months
D-dimmer corrected by age in all cases
Measured: 12 months
Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireia Puig, PhD, Principal investigator, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023605
- Sponsor's protocol ID
- IIBSP-EPU-2016-61
- Acronym
- APEED
- Status last verified
- Jun 2018
- First submitted
- 2 Jan 2017
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03023605
- Acronym / sponsor ID
- APEED / IIBSP-EPU-2016-61
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, Adherence to practice guidelines, Age-adjusted D-dimer, Clinical prediction rules, Elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention PE Diagnosis | No intervention | –Patients visited in Emergency Department, with suspected Pulmonary Embolism, before the training intervention. |
| Post-intervention PE Diagnosis | Experimental | Behavioral: Training Intervention for PE DiagnosisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Are excluded:
- all patients who underwent D-dimmer test with a different diagnosis of EP and those who had a chronic EP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training Intervention for PE DiagnosisFocused 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 | Behavioural | Post-intervention PE Diagnosis |
Primary outcome
Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence)
Time frame: 3 months
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
Time frame: 3 months
January, February and Mach 2017
4 secondary outcomes
Prevalence of different clinical characteristics of Pulmonary Embolism (presentation, clinical features, treatment, clinical evolution)
Time frame: 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)
Time frame: 12 months
D-dimmer corrected by age in all cases
Time frame: 12 months
Sensibility and Specificity of new algorithm (Clinical Score+ Dimmer corrected age) in the elderly population group (<65 years)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireia Puig, PhD principal investigator
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Intervention for PE Diagnosis in people with Pulmonary Embolism, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases where clinical guidelines have been followed for suspected Pulmonary Embolism in the Emergency Department (adherence) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.