COPD Assessment and Management Bundle Versus Usual Care
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring pulmonary disease, chronic obstructive airflow, spirometry, primary healthcare, guideline-based therapy
Eligibility Criteria
Inclusion Criteria:
Patients, male and female, who are at least 40 years of age, receive primary treatment at the University of Illinois , and with any one of the following:
New Diagnosis
Inpatient or emergency department setting
New physician-diagnosis of COPD and/or new physician-diagnosis of asthma with a ≥10 pack year smoking without a spirometry 4 weeks or more after discharge from diagnosis setting.
Outpatient setting
- A new physician diagnosis of COPD within the past 6 months prior to their visit, without a spirometry or with a normal spirometry within the past 5 years prior to the diagnosis to the time of their visit.
- A new physician diagnosis of asthma within past 6 months and a ≥10 pack year smoking history prior to their visit, without a diagnosis of COPD, without a spirometry or with a pre-bronchodilator spirometry with evidence of obstruction within the past 5 years prior to the diagnosis to the time of their visit.
Any patient with an existing physician-diagnosis of asthma within the past 2 years but > 6 months prior to the time of their visit and a ≥10 pack year smoking history, without a diagnosis of COPD, using a respiratory medication in the past year, and no spirometry on record or had a pre-bronchodilator spirometry with evidence of obstruction on record for at least the past 5 years.
Existing Diagnosis
- Any patient with an existing physician-diagnosis of COPD within the past 2 years but > 6 months prior to the time of their visit, and using a respiratory medication in the past year but no spirometry on record or had a spirometry without evidence of chronic obstruction in the past 5 years.
Exclusion Criteria:
- Unable to perform adequate spirometry (e.g. muscle weakness, tracheostomy, cognitive dysfunction, mental retardation or other psychiatric disorders)
- Non-English speaking
- Pregnancy
- Any patient planning to move away from the city within the next year.
- Seen by a pulmonary specialist in the past 3 years.
- Any terminal illness with a life expectancy of <6 months (e.g. hospice care, malignancies)
- Any patient with a physician diagnosis of COPD and had a pre or post-bronchodilator spirometry with evidence of chronic obstruction on record.
Sites / Locations
- University of Illinois
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
COPD assessment and management recommendations
Usual Care
Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews.
Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference.