COPD Clinical Trial
Official title:
Assessment of the Appropriateness Admission From Emergency Departments in the Exacerbation of COPD. Validity of Explicit Criteria and Study of the Variability Between Different Centers of NHS. Multicenter Study IRYSS-Appropriateness-COPD.
Objectives: To estimate the rate of appropriate hospital admissions , and of discharge to
home episodes that would have been appropriate admissions to the hospital, on patients with
exacerbations of their COPD by using appropriateness explicit criteria developed with the
RAND appropriateness methodology. To evaluate the validity of those criteria by looking at
their correlation with morbid-mortality, use of medications and health resources. To
identify the variability in the appropriateness admission/discharge among the different
centres participating on the study.
Methodology: Prospective observational cohort study. 1. The investigators will apply the
previously developed explicit criteria to a sample of COPD exacerbations presented in each
of the Emergency Department of each participating hospital (16 centres). 2. The
investigators will evaluate if there is variability among centres by comparing their
appropriateness rates. 3. To study the validity of the criteria, on those admitted the
investigators will collect information on their evolution (length of stay, need of
medication, quality of life), complications, vital status during their admission until
discharge, and up to 2 months after the visit to the Emergency Department the vital status,
complications, readmissions and quality of life. On those discharged to home from the
Emergency Department, the investigators will check the presence of complications, vital
status, readmissions and quality of life. People trained will collect all the needed
information, in the Emergency Department, during their admission, or by personal interview
to all discharged to home and to all at 2 months after the visit to the Emergency
Department.
A prospective cohort study was performed to validate the explicit criteria developed by the
RAM. Other goals for the cohort study were: to predict mortality, ICU or IRCU admission,
hospital length of stay, changes in symptoms and to evaluate variability among hospitals in
the appropriateness of hospital admission of patients experiencing COPD exacerbations and to
study variability in access to care and outcomes. Sixteen hospitals belonging to the Spanish
National Health Service agreed to participate: Hospital Costa del Sol, Hospital Valme,
Hospital de Motril, Corporació Sanitaria Parc Taulí, Hospital del Mar, Hospital
Universitario de La Princesa, Hospital Universitario Gregorio Marañón, Hospital
Universitario La Paz, Hospital de Móstoles, Hospital Marqués de Valdecilla, Hospital Santa
Marina, Hospital San Eloy, Hospital Galdakao-Usansolo, Hospital Txagorritxu, Complejo
Hospitalario Donostia, and Hospital Cruces.
Patients attending the EDs of any of the 16 hospitals with an exacerbation of COPD were
informed of the goals of the study and invited to voluntarily participate in it. All
information was kept confidential. The Institutional Review Boards of the participating
hospitals approved this project. Recruitment started in June 2008 and ended in September
2010.
Patients were candidates for the study if they presented to the ED of any of the
participating hospitals with symptoms consistent of an exacerbation of COPD. Exacerbation
was defined as an event in the natural course of the disease characterized by a change in
the patient's baseline dyspnea, cough, and/or sputum that was beyond normal day-to-day
variations, was acute in onset, and may have warranted a change in regular medication in a
patient with underlying COPD. Two possible presentations were considered:
Existing COPD. Patients were considered to have been previously diagnosed with COPD if they
had a FEV1/forced vital capacity (FVC) quotient <70%, and a negative bronchodilation test
with FEV1 change <200 mL and under 15% of the baseline value.
New COPD. Patients not previously diagnosed with COPD but in whom the disease was suspected
were also eligible for inclusion in the study. This included smokers or former smokers of
more than 15 packs per year with dyspnea, cough, or expectoration for more than three months
per year, and experiencing symptoms resembling a clinical manifestation compatible with COPD
exacerbation. The diagnosis had to be confirmed by spirometry within 60 days after the index
episode at a time when the patient was stable, i.e., the absence of any increase in symptoms
or changes in background therapy. If a diagnosis of COPD was not confirmed, the patient was
excluded from the study.
Patients were excluded from the study if they had COPD complicated by a comorbidity such as
pneumonia, pneumothorax, or pulmonary embolism; lung cancer; or left cardiac insufficiency.
Other exclusion criteria included a diagnosis of asthma, extensive bronchiectasis, sequelae
of tuberculosis, pleural thickening, or restrictive diseases. Patients who did not wish to
participate were also excluded.
Data collected for the cohort study A substantial amount of clinical and other data were
needed to meet the objectives of the IRYSS-CAS. Data from several time points were needed:
during the patient's evaluation in the ED; at the time the decision was made to hospitalize
the patient or discharge him or her to home; in the medical ward (if needed); and during
post-hospitalization or post-discharge follow-up. It must be noted that ED physicians were
not asked to gather any information other than what they would usually collect for a patient
experiencing an exacerbation of COPD. Instead, trained data managers gathered data from
hospital and primary care medical records using a manual of instructions that aimed to
standardize data collection.
Some of the information required a review of the patient's medical records. Patients
admitted to the hospital were interviewed at 1 and 7 days after admission. Patients
discharged from the ED to home were interviewed by telephone at, around, 1 and 7 days after
discharge. All patients were interviewed by telephone 60 days after the index event.
In the ED. As is true for almost any encounter in the ED, substantial information is
gathered for a patient experiencing an exacerbation of COPD. The main data collected were
those related to the patient's respiratory function (gasometry, respiratory rate, dyspnea),
consciousness level measured by the Glasgow Coma scale, background, and presence of other
pathologies as those recorded in the Charlson Comorbidity Index.
At the time of decision making. Data collected at the ED decision time was related to the
patient's respiratory status at that moment as well as variables needed to create the
appropriateness scenarios, determine the severity of the exacerbation, and evaluate other
study criteria .
In the hospital. For patients admitted to the hospital, we collected data directly from the
patient's medical record and from a direct interview with him or her from the first day
after admission until discharge. Patients were interviewed about their general health status
(response to question 1 of the Short Form 36 (SF-36) questionnaire[16]), degree of dyspnea,
based on the Medical Research Council Dyspnea Index[17], physical activity level (based on a
scale employed previously in various studies and also completed the EuroQol-5D. Patients
were also asked about social support and level of functional dependency. This information
was recorded in the first 24 hours after arrival to the ED and at discharge.
Following discharge to home from the ED. Among patients discharged to home from the ED,
telephone interviews were conducted around 1 day, 7 days, and 60 days after discharge to
assess the level of dyspnea, physical activity, and general health (see previous
description), the use of and response to medications, need for supplemental oxygen, the need
for visits to the patient's primary care physician, subsequent ED visits or hospital
readmissions, vital status, presence of other symptoms, social support, and level of
functional dependency.
During follow-up. Data collected during follow-up included general health status (SF-36
question), degree of dyspnea, physical activity level, and quality of life, all as
previously described. Readmission within 30 days of the index exacerbation for the same
reason, or readmission for any reason between 31 and 60 days after the index exacerbation
was recorded, as were complications, including all signs, symptoms, syndromes or diseases,
which appeared or worsened during the 60-day observation period attributable to COPD or its
treatment. For all patients with known COPD, additional variables collected from medical
records include baseline severity of COPD as measured by FEV1; hospital admissions during
the previous 12 months; baseline therapy (inhaled long-acting beta agonist, long-acting
anticholinergics, inhaled corticosteroid and/or supplemental oxygen), the presence of
associated diseases such as diabetes, hypertension, ischemic heart disease and/or valve
disease, cor pulmonale, peptic ulcer disease, psychiatric disorders, rheumatic disease,
history of stroke or deep vein thrombosis, and others needed to determine the Charlson
Comorbidity Index.
Mortality information at one year was also recorded for all patients.
;
Observational Model: Cohort, Time Perspective: Prospective
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