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

NCT ID: NCT04237896

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2020-08-30

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Sociedad Española De Medicina Interna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco J Medrano

Role: PRINCIPAL_INVESTIGATOR

Sociedad Española De Medicina Interna

Locations

Virgen del Rocío University Hospital

Seville, Spain/Seville, Spain

Countries

Spain

Central Contacts

Francisco J Medrano, MD

Role: CONTACT

medrano@cica.es

+34 654824512

Other Identifiers

SEMI-2019-1-COPD

Identifier Type: -

Identifier Source: org_study_id