COPD Assessment and Management Bundle Versus Usual Care

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Comparative Effectiveness of COPD Assessment and Management Bundle Versus Usual Care in Patients Suspected of Having COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833026
• Other study ID #: 2012-0997
• Secondary ID: K23HL094461
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: May 2016

Study information

• Verified date: December 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Spirometry test
For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test will be performed that will evaluate how well and how fast the subject can breath and blow out air.

Drug:
• Levalbuterol
The spirometry test will be performed with a breathing medication called Levalbuterol (Xopenex®). Levalbuterol is used in standard practice for COPD and is commonly used during spirometry.

Locations

Country	Name	City	State
United States	University of Illinois	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Accurate Classification of Irreversible Airflow Obstruction	accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was <0.7.	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