Management of Patients With Chronic Obstructive Pulmonary Disease in Granada: a Clinical Audit (Epocap)

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

Study Overview

• Status: Not yet recruiting
• Conditions: COPD
• Intervention / Treatment: Other: Audit

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 Type: Observational
• Enrollment (Anticipated): 2280

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Audit from clinical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 year
To evaluate the adherence to clinical guidelines for COPD	Proportion of patients with COPD with correct diagnosis according to GesEPOC guidelines.	1 year
To describe current available resources for COPD healthcare in the primary care level in Granada.	Number of centers with spirometry available	1 year

Collaborators and Investigators

• Sponsor: Andalusian School of Public Health
• Collaborators: Hospital de Alta Resolucion de Loja. Agencia Sanitaria Hospital de Poniente

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: COPD; Chronic Bronchitis; Emphysema; Primary Healthcare; Clinical audit
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: EASP-EPOC-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Upon reasonable request
• IPD Sharing Time Frame: When recruitment is finished
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No