N/A
Completed N=181
De-implementing Inhaled Steroids to Improve Care and Safety in COPD
Treatment of Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT02896257 ↗
Enrolled (actual)
181
Serious AEs
12.9%
Results posted
Jan 2022
Primary outcomePrimary: Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. — 94; 174 Participants — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. |
94; 174 | <0.001 sig |
| SECONDARY Rate of COPD Exacerbation |
0.11; 0.09 | 0.47 |
| SECONDARY Rate of Pneumonia |
0.03; 0.02 | 0.42 |
| SECONDARY Mortality |
9; 10 | — |
| SECONDARY Number of Patients Recommended to Stop Inhaled Corticosteroids |
181 | — |
| SECONDARY Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers |
92.3 | — |
| SECONDARY Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date |
24 | — |
| SECONDARY Number of Patients for Whom Recommendations Are Made |
262 | — |
Eligibility Criteria
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)] = = 30%.
Exclusion Criteria
Patients:
- Very severe airflow obstruction ( 12% increase in FEV1 post bronchodilator; >375 mL post-bronchodilator improvement)
Data sourced from ClinicalTrials.gov (NCT02896257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.