Clinical trial NCT04237896: Compliance With Clinical Guidelines and Effect on Patient Outcome of Treatment of Hospitalised Exacerbations of COPD
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease
Acute exacerbation
Inpatients
Clinical practice guidelines
Bronchodilators
Compliance
Lead sponsor: Sociedad Española De Medicina Interna
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2020-01-23
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: IN-HOSPITAL MORTALITY
timeFrame: during the admission of the index episode
measure: 30-day MORTALITY
timeFrame: <30 days
measure: 90-day MORTALITY
timeFrame: 31-90 days
measure: 30-day READMISSIONS
timeFrame: < 30 days
measure: 30-day READMISSIONS
timeFrame: 31-90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Virgen del Rocío University Hospital
state: Spain/Seville
Study officials:
affiliation: Sociedad Española De Medicina Interna
name: Francisco J Medrano
role: PRINCIPAL_INVESTIGATOR
References: