The primary objective is to validate a previously established prognostic instrument in the form of an algorithm (flowchart) in patients that present with AECOPD to the department of emergency medicine for classifying for out- or inpatient treatment…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is admission rate.
Secondary outcome
The secondary study endpoints are readmission rate, average length of stay when
admitted, healthcare costs, 30-day mortality rate and health status.
Background summary
In patients with an acute exacerbation of chronic obstructive pulmonary disease
(AECOPD), no objective criteria are validated to decide which patient should be
hospitalized or which can be treated at home. In the light of increasing
healthcare costs together with the high prevalence of this condition, treatment
of AECOPD should be restructured and optimized.
Study objective
The primary objective is to validate a previously established prognostic
instrument in the form of an algorithm (flowchart) in patients that present
with AECOPD to the department of emergency medicine for classifying for out- or
inpatient treatment leading to less hospital admissions. The secondary
objectives are demonstrating that this stratification also leads to less
readmissions, shorter length of stay when admitted to the medical ward and
efficient, cost-effective care without thereby adversely affecting health
status and 30-day mortality rate.
Study design
Firstly the algorithm is validated in a prospective cohort. Secondly, a
retrospective control group is compared to this prospective group stratified
for treatment category by applying this flowchart. The primary endpoint is the
admission rate, adjusted for health status and 30-days mortality. The
secondary study endpoints are readmission rate, the average length of stay when
admitted and healthcare costs.
Intervention
The algorithm is applied in all patients presenting to the emergency department
with an acute exacerbation of COPD. It is divided into four categories based on
clinical criteria and arterial blood gas values: discharge and treatment at
home, admission to the medical ward, admission to the medical ward and start
non-invasive ventilation or admission to the intensive care unit with or
without (non-)invasive ventilation. All patients are evaluated between 5 to 10
days after inclusion in the outpatient clinic or, if still hospitalized, in the
medical ward. CCQ and MRC questionnaires are carried out.
Study burden and risks
Participation in this study leads to therapeutic decision making based on
objective parameters instead of a subjective funded decision. It is important
to note that there is no actual difference between the nature of care provided
in the medical ward and the care that could be provided at home. Therefore
there is no increased risk in participation in this study. The expected benefit
is avoidance of unnecessary admissions and in case of admission a shorter
length of stay in the hospital.
Leyweg 275
Den Haag 2545CH
NL
Leyweg 275
Den Haag 2545CH
NL
Listed location countries
Age
Inclusion criteria
- Patient is previously diagnosed with COPD supported by spirometric evidence of airflow obstruction FEV1/VC < LLN), age > 35 years, smoking history (>1 Pack Year). Or diagnosed within three months after inclusion in stable pulmonary situation.
- Patient is presenting with a probable or certain exacerbation of COPD, defined as: An acute event characterized by a worsening of the patient*s respiratory symptoms that is beyond day-to-day variations and leads to a change in medication.
Exclusion criteria
- Active malignancy with life expectancy < 12 months
- Dyspnoea otherwise explained: e.g. pulmonary embolism, acute cardiac event, pneumothorax, etc.
- New consolidation on chest radiograph suggestive for pneumonia
- Comorbidity requiring hospitalization independent of severity of AECOPD: e.g. acute renal insufficiency, electrolyte disorder, decompensated heart failure, etc.
- The subject is incapacitated
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL54541.098.15 |