COPDEpocapNCT04691752
Management of Patients With Chronic Obstructive Pulmonary Disease in Granada: a Clinical Audit
An observational study of COPD, run by Andalusian School of Public Health.
Trial summary
It is actually unknown how are the COPD clinical guidelines followed in primary care in Andalusia, specially for diagnosis and follow up of patients with this diseases. Detection of areas for improvement in COPD healthcare can be useful in order to implement improvement programs. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Audit
- How many people
- 2,280 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jul 2022
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnostic code for COPD in Andalusian health records- Diraya-(ICD 9 Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2)attended for any reason in a scheduled primary care office in Granada. Selection process of participant centres will be performed aiming to reflect proportionally the population distribution of Granada province and certain circumstances such as population density of some of the counties
Who may be able to join
- Adults (men or women) aged more than 40 years old
- Diagnostic code in Andalusian clinical records (Diraya) in accordance with ICD-9 (Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2)
- Current of former smokers of at least 10 pack- years
- Patient with a minimum follow up of 1 year, who have been assisted in a scheduled primary care appointment at inclusion date.
Who cannot join
- Patients with a diagnostic code for COPD attended at primary care office, but without information related with COPD in the previous year.
- Patients currently involved in any clinical trial or research study related with COPD.
- Those patients excluded will be collected in an exclusion causes chart for each centre. These patients will not affect overall number of patients targeted for each centre.
About this study
It is actually unknown how are the COPD clinical guidelines followed in primary care in Andalusia, specially for diagnosis and follow up of patients with this diseases. Detection of areas for improvement in COPD healthcare can be useful in order to implement improvement programs. This project is a clinical audit among primary care centres in Granada attending patients with COPD in the public health system
Read the detailed description
The aim of this study is to audit the attention to people with COPD among primary care centres in Granada, as well as how clinical guidelines are followed and other recommendations. The study will comprise medical records from more than 3000 patients.
- Conditions
- COPD
- Being tested
- Audit
- Keywords
- COPD, Emphysema, Chronic Bronchitis, Clinical audit, Primary Healthcare
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuditOther
Audit from clinical records
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | * Adults (men or women) aged more than 40 years old
* Diagnostic code in Andalusian clinical records (Diraya) in accordance with ICD-9 (Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2)
* Current of former smokers of at least 10 pack- years
* Patient with a minimum follow up of 1 year, who have been assisted in a scheduled primary care appointment at inclusion date. Receives: Other: Audit |
What is being measured
The primary outcome is the main question the study is designed to answer.
To audit public healthcare for patients with COPD in primary care offices in Granada.
Number of patients with a diagnosis code for COPD among participants with auitable clinical records
Measured: 1 year
Secondary outcomes (4)
To describe clinical profile of patients with COPD attended at primary care offices in Granada
Number of patients auditable with a diagnosis code for COPD attended at primary care center
Measured: 1 year
To describe the quality of care for COPD patients, focusing on determinants of variability(such as seasonality)
Pproportion of patients receiving correct diagnosis for COPD based on spirometric measurements
Measured: 1 year
To evaluate the adherence to clinical guidelines for COPD
Proportion of patients with COPD with correct diagnosis according to GesEPOC guidelines.
Measured: 1 year
To describe current available resources for COPD healthcare in the primary care level in Granada.
Number of centers with spirometry available
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andalusian School of Public Health
- Sponsor type
- Other government
- Collaborators
- Hospital de Alta Resolucion de Loja. Agencia Sanitaria Hospital de Poniente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691752
- Sponsor's protocol ID
- EASP-EPOC-18
- Acronym
- Epocap
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Chronic Obstructive Pulmonary Disease in Granada: a Clinical Audit
- ClinicalTrials.gov ID
- NCT04691752
- Acronym / sponsor ID
- Epocap / EASP-EPOC-18
- Conditions
- COPD
- Keywords
- COPD, Emphysema, Chronic Bronchitis, Clinical audit, Primary Healthcare
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,280 participants (estimated)
- Lead sponsor
- Andalusian School of Public HealthOther government
- Collaborators
- Hospital de Alta Resolucion de Loja. Agencia Sanitaria Hospital de Poniente
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- 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.
It is actually unknown how are the COPD clinical guidelines followed in primary care in Andalusia, specially for diagnosis and follow up of patients with this diseases. Detection of areas for improvement in COPD healthcare can be useful in order to implement improvement programs. This project is a clinical audit among primary care centres in Granada attending patients with COPD in the public health system
Detailed description
The aim of this study is to audit the attention to people with COPD among primary care centres in Granada, as well as how clinical guidelines are followed and other recommendations. The study will comprise medical records from more than 3000 patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: Audit* Adults (men or women) aged more than 40 years old * Diagnostic code in Andalusian clinical records (Diraya) in accordance with ICD-9 (Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2) * Current of former smokers of at least 10 pack- years * Patient with a minimum follow up of 1 year, who have been assisted in a scheduled primary care appointment at inclusion date. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnostic code for COPD in Andalusian health records- Diraya-(ICD 9 Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2)attended for any reason in a scheduled primary care office in Granada. Selection process of participant centres will be performed aiming to reflect proportionally the population distribution of Granada province and certain circumstances such as population density of some of the counties
Key inclusion criteria (4 listed)
- Adults (men or women) aged more than 40 years old
- Diagnostic code in Andalusian clinical records (Diraya) in accordance with ICD-9 (Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2)
- Current of former smokers of at least 10 pack- years
- Patient with a minimum follow up of 1 year, who have been assisted in a scheduled primary care appointment at inclusion date.
Key exclusion criteria (3 listed)
- Patients with a diagnostic code for COPD attended at primary care office, but without information related with COPD in the previous year.
- Patients currently involved in any clinical trial or research study related with COPD.
- Those patients excluded will be collected in an exclusion causes chart for each centre. These patients will not affect overall number of patients targeted for each centre.
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 |
|---|---|---|
| AuditAudit from clinical records | Other | COPD patients |
Primary outcome
To audit public healthcare for patients with COPD in primary care offices in Granada.
Time frame: 1 year
Number of patients with a diagnosis code for COPD among participants with auitable clinical records
4 secondary outcomes
To describe clinical profile of patients with COPD attended at primary care offices in Granada
Time frame: 1 year
To describe the quality of care for COPD patients, focusing on determinants of variability(such as seasonality)
Time frame: 1 year
To evaluate the adherence to clinical guidelines for COPD
Time frame: 1 year
To describe current available resources for COPD healthcare in the primary care level in Granada.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Yes. Upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Andalusian School of Public Health.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To audit public healthcare for patients with COPD in primary care offices in Granada. (time frame: 1 year). 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 5 Jan 2021.