Compliance With Clinical Guidelines and Effect on Patient Outcome of Treatment of Hospitalised Exacerbations of COPD (ADEG-EPOC)

Compliance With Clinical Guidelines and Effect on Patient Outcome of Real-life Treatment of Hospitalised Exacerbations of COPD: a Nationwide Study in Spain

Rationale. Currently there are well-established guidelines for the management of stable COPD. However, recommendations on the treatment of COPD exacerbations (E-COPD) are based on observational studies and low-quality clinical trials. In addition, there are some controversial aspects, such as treatment with systemic steroids. On the other hand, the available information on the adherence to the recommendations of the clinical practice guidelines (CPG) and its impact on the outcome of patients is scarce.

Main objectives. (1) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the current management of hospitalized exacerbations of COPD; (2) To determine in real-life clinical practice the impact of adherence to CPG recommendations for management of COPD exacerbations as an outcome of the disease (stay, in-hospital mortality, and 90-days post-discharge readmissions and mortality); (3) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the treatment of stable COPD at admission and after discharge in patients hospitalized with exacerbated COPD; (4) To determinate in real-life clinical practice the impact of the suitability to CPG recommendations for treatment of stable COPD on 90-day post-discharge mortality and readmission of COPD.

Method. National, multicenter, observational and longitudinal study of the first consecutive 20 patients hospitalized for exacerbations of COPD between December 10 and 23, 2019 in the Internal Medicine Services of the participating Centers. Patients will be followed 90 days after discharge. A total of 400 patients will be recruited in 20 Spanish hospitals (20 per center). Independent variables: age, sex, admission service, body mass index, dyspnea (mMRC), obstruction (FEV¬₁), exacerbations in the previous year, comorbidities, bronchodilator treatment prior to admission, criteria of adequacy to the CPG in the clinical evaluation and treatment, hyperglycemia during the first 24 hours of admission, treatment of hyperglycemia and bronchodilator treatment at discharge. Outcomes: in-hospital mortality, mortality at 90 days, re-admission at 90 days. Statistical analysis: Parametric and non-parametric tests, Kaplan-Meier and ROC curves and multiple logistic regression.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Spain
  • Spain/Seville
    • Seville, Spain/Seville, Spain, 41013
      • Virgen del Rocio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients older than 40 years who have required a hospital stay for an exacerbation of COPD prospectively followed 90 days after discharge.

Description

Inclusion Criteria:

• Age over 40 years.
• COPD patient hospitalized with the main diagnosis of exacerbation of COPD and whose main diagnosis is confirmed by the discharge report and the local investigator.

Exclusion Criteria:

• Terminal disease
• Absence of spirometry confirmation of the COPD diagnosis.
• Presence of other diseases that can cause symptoms like those of a COPD exacerbation (e.g. heart failure, pneumonia, etc.), where exacerbation of COPD is not the main cause of admission.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IN-HOSPITAL MORTALITY	death from any cause	during the admission of the index episode
30-day MORTALITY	death from any cause	<30 days
90-day MORTALITY	death from any cause	31-90 days
30-day READMISSIONS	Readmission for an exacerbation of COPD	< 30 days
30-day READMISSIONS	Readmission for an exacerbation of COPD	31-90 days

Collaborators and Investigators

• Sponsor: Sociedad Española De Medicina Interna
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Francisco J Medrano, Sociedad Española De Medicina Interna

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 27, 2020
• Primary Completion (ANTICIPATED): July 30, 2020
• Study Completion (ANTICIPATED): August 30, 2020

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: January 19, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; Compliance; Inpatients; Acute exacerbation; Clinical practice guidelines; Bronchodilators
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SEMI-2019-1-COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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