NCT04691752

Brief 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. This project is a clinical audit among primary care centres in Granada attending patients with COPD in the public health system

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

December 17, 2020

Last Update Submit

January 2, 2021

Conditions

Keywords

COPDEmphysemaChronic BronchitisClinical auditPrimary Healthcare

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (4)

  • To describe clinical profile of patients with COPD attended at primary care offices in Granada

    1 year

  • To describe the quality of care for COPD patients, focusing on determinants of variability(such as seasonality)

    1 year

  • To evaluate the adherence to clinical guidelines for COPD

    1 year

  • To describe current available resources for COPD healthcare in the primary care level in Granada.

    1 year

Study Arms (1)

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.

Other: Audit

Interventions

AuditOTHER

Audit from clinical records

COPD patients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 31, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Upon reasonable request

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
When recruitment is finished