Treatment of Chronic Obstructive Pulmonary Disease Clinical Trial
— DISCUSS COPDOfficial title:
De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-471)
Verified date | July 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Quality Enhancement Research Initiative (QuERI) project is designed to determine efficacy and acceptance of an intervention method to provide primary care providers with patient-tailored electronic consults and corresponding unsigned orders for de-implementation of inhaled corticosteroids (ICS) for patients with COPD when ICS are not indicated by guidelines.
Status | Completed |
Enrollment | 181 |
Est. completion date | June 30, 2021 |
Est. primary completion date | July 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Provider: Primary care provider (medical doctor/osteopathic physician, nurse practitioner, physician assistant [MD/DO, NP, PA]) assigned to a PACT from VA Puget Sound Health Care System or Edith Nourse Rogers Memorial Veterans Hospital (Bedford VA). Patient: - Patient is a Veteran who is assigned a VA PCP and has received Rx for an inhaled corticosteroid within the past 180 days. - Patient has an inpatient or outpatient diagnosis of COPD in the prior two years. - Patient has undergone spirometry in the past 5 years that indicates either no airflow obstruction or mild to moderate airflow obstruction indicated by a forced expiratory volume 1 (FEV1)/[greater of forced vital capacity (FVC) or vital capacity (VC)] =< 0.7 & FEV1% predicted >= 30%. Exclusion Criteria: Patients: - Very severe airflow obstruction (<30% FEV1 % predicted) - Severe disease as indicated by 1 inpatient COPD exacerbation in the year prior - Severe disease as indicated by 2 outpatient COPD exacerbations in the year prior - International Classification of Diseases (ICD) 9 and/or 10 diagnosed or clinically indicated asthmatics - Significant bronchodilator response on spirometry (>12% increase in FEV1 post bronchodilator; >375 mL post-bronchodilator improvement) |
Country | Name | City | State |
---|---|---|---|
United States | VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts |
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. | Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date. | Assessed at 6 months post primary care visit defined as (index date + 180 days) | |
Secondary | Rate of COPD Exacerbation | Rate of COPD exacerbation within 6 months starting the day after index date. | Within 6 months defined as (index date +1 day) to (index date + 180 days) | |
Secondary | Rate of Pneumonia | Rate of pneumonia within 6 months starting the day after index date. | Within 6 months defined as (index date +1 day) to (index date + 180 days) | |
Secondary | Mortality | Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days) | Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days) | |
Secondary | Number of Patients Recommended to Stop Inhaled Corticosteroids | Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids | Collected at time of recommendation/order entry | |
Secondary | Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers | Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers | Assessed during 6 months following index date | |
Secondary | Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date | Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date | Assessed at 6 months post index date | |
Secondary | Number of Patients for Whom Recommendations Are Made | Among patients assigned to intervention providers, number of patients for whom recommendations are made. | Collected at time or recommendation order entry |