Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm
Recruiting · NCT07223749 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →What this trial is about
Under-diagnosis of Chronic Obstructive Pulmonary Disease (COPD) is prevalent, with an estimated 75% of adults suffering from COPD in the US, without clinical recognition. Often, the first diagnosis of COPD comes with a flare or exacerbation. In one study, 34% of patients were first diagnosed during hospitalization for an exacerbation, an event associated with a 1-year mortality rate of 26%. When COPD is finally diagnosed, it is often in the late stages, with an average lung function of 50% of normal. Conversely, COPD can be over-diagnosed, defined as symptoms in an individual without airflow obstruction. Over-diagnosed people have significantly higher rates of hospitalization, ER visits, and ambulatory care visits because individuals are treated for a disorder they don't have and are not being treated for the disorder they do have. Lack of diagnostic clarity places patients at risk of medication complications without potential benefit. Conversely, failure to diagnose preempts the benefits of therapy. To date, no reliable solution has been found to address this problem.
Who can take part
Inclusion criteria
- greater thank or equal to 40 years of age
- 2 or more encounters in the health system
- Previous Pulmonary Function Test (PFT) recorded in our Electronic Health Records (EHR) in the previous 5 years
Exclusion criteria
- cystic fibrosis
- Alpha-1 Antitrypsin Deficiency (AAD)currently pregnant
- History of a lung transplant or partial removal of the lung
- significant chest wall deformity
- neuromuscular disease that currently impacts the respiratory muscles
- surgery requiring general anesthesia or an overnight stay in the hospital within the past 30 days
Where it is running
1 location listed across 1 US state.
- Wake Forest University Health Sciences - Winston-Salem, North Carolina, United States