Testing a computer algorithm to find COPD
Validation of a Chronic Obstructive Pulmonary Disease (COPD) Predictive Algorithm
This project will test whether a computer algorithm using medical record data can identify people aged 40 and older with COPD who have recent pulmonary function tests in the Wake Forest health system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT07223749 on ClinicalTrials.gov |
What this trial studies
This observational effort will validate a COPD-detection algorithm that relies on structured electronic health record (EHR) data rather than symptom documentation. Researchers will apply the algorithm to records for adults aged 40+ with at least two encounters and a pulmonary function test recorded in the past five years and compare algorithm flags against measured airflow obstruction on PFTs. The protocol excludes people with conditions that independently alter lung function (for example cystic fibrosis, alpha-1 antitrypsin deficiency, lung transplant, major recent surgery, significant chest wall deformity, neuromuscular respiratory disease, or current pregnancy). The aim is to measure how accurately the algorithm identifies true COPD cases using the Wake Forest EHR dataset.
Who should consider this trial
Good fit: Adults aged 40 or older with at least two encounters in the Wake Forest health system and a pulmonary function test recorded in the prior five years who do not have excluded conditions are the intended candidates.
Not a fit: People younger than 40, those without a prior PFT in the Wake Forest EHR, or patients with excluded diagnoses or recent major surgery are unlikely to benefit from this validation effort.
Why it matters
Potential benefit: If successful, the algorithm could help find undiagnosed COPD earlier and guide patients to appropriate treatments such as bronchodilators, smoking cessation, vaccination, and pulmonary rehabilitation.
How similar studies have performed: Similar EHR-based risk tools and targeted case-finding approaches have shown promise in smaller studies, but widely validated COPD detection algorithms remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Brian J Wells, MD, PhD — Wake Forest University Health Sciences
- Study coordinator: Brian J Wells, MD
- Email: Brian.Wells@Advocatehealth.org
- Phone: 336-257-7128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.