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

NCT04237896 | Unknown

• 1 other identifier: SEMI-2019-1-COPD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic obstructive pulmonary disease; Acute exacerbation; Inpatients; Clinical practice guidelines; Bronchodilators; Compliance

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española De Medicina Interna: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Virgen del Rocío University Hospital

Seville, Spain/Seville, 41013, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum and serum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Patient Compliance

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Francisco J Medrano

  Sociedad Española De Medicina Interna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco J Medrano, MD

CONTACT

+34 654824512; medrano@cica.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: January 27, 2020
• Primary Completion: July 30, 2020
• Study Completion: August 30, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)