Compliance With Clinical Guidelines and Effect on Patient Outcome of Treatment of Hospitalised Exacerbations of COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

— ADEG-EPOC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04237896
• Other study ID #: SEMI-2019-1-COPD
• Status: Not yet recruiting
• Start date: January 27, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: January 2020
• Source: Sociedad Española De Medicina Interna
• Contact: Francisco J Medrano, MD
• Phone: +34 654824512
• Email: medrano[@]cica.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	Virgen del Rocío University Hospital	Seville	Spain/Seville

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española De Medicina Interna	GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

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