Clinical trial NCT01833026: COPD Assessment and Management Bundle Versus Usual Care
Official title: Comparative Effectiveness of COPD Assessment and Management Bundle Versus Usual Care in Patients Suspected of Having COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: pulmonary disease
chronic obstructive airflow
spirometry
primary healthcare
guideline-based therapy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-04-16
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that makes it harder to breathe over time. To date, there is no cure for COPD, but it can be managed when diagnosed and proper medical care is provided.

The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient outcomes (the condition of a patient's health) compared to usual care which may or may not include the use of spirometry. Spirometry is a standardized test used in medical practice that measures how much air your lungs can hold and how forcefully you can breathe out.

For this study, the investigators will compare two groups: 1) intervention (treatment) group and 2) usual care group (control). The intervention group will have a spirometry test and the results will be provided to the primary care physician. The usual care group will not initially have a spirometry test. Both groups will be followed for outcomes.

Detailed description: The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient associated outcomes compared to usual care which may or may not include the use of spirometry. To do this, we propose a comparative effectiveness trial of introducing a COPD assessment and management bundle targeted to primary care providers for patients suspected of having COPD versus usual care.

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

1. 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
2. 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.
3. 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.
4. 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
5. 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:

1. Unable to perform adequate spirometry (e.g. muscle weakness, tracheostomy, cognitive dysfunction, mental retardation or other psychiatric disorders)
2. Non-English speaking
3. Pregnancy
4. Any patient planning to move away from the city within the next year.
5. Seen by a pulmonary specialist in the past 3 years.
6. Any terminal illness with a life expectancy of \<6 months (e.g. hospice care, malignancies)
7. Any patient with a physician diagnosis of COPD and had a pre or post-bronchodilator spirometry with evidence of chronic obstruction on record.

Primary outcomes:
measure: Number of Participants With Accurate Classification of Irreversible Airflow Obstruction
timeFrame: spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Min Joo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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