NCT02896257: DISCUSS COPD

De-implementing Inhaled Steroids to Improve Care and Safety in COPD

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing Guideline treatment recommendations in Treatment of Chronic Obstructive Pulmonary Disease in 181 participants. Completed in 30 June 2021.

Timeline

6 September 2016

Primary endpoint
29 July 2019

30 June 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	181
Start date	6 September 2016
Primary completion	29 July 2019
Estimated completion	30 June 2021
Sites	2 locations across United States

Drugs / interventions tested

• Guideline treatment recommendations

Conditions studied

• Treatment of Chronic Obstructive Pulmonary Disease — all drugs for Treatment of Chronic Obstructive Pulmonary Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Treatment of Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. Primary · Assessed at 6 months post primary care visit defined as (index date + 180 days)

Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.

Group	Value	95% CI
Usual Care	94
Intervention	174

Rate of COPD Exacerbation Secondary · Within 6 months defined as (index date +1 day) to (index date + 180 days)

Rate of COPD exacerbation within 6 months starting the day after index date.

Group	Value	95% CI
Usual Care	0.11
Intervention	0.09

Rate of Pneumonia Secondary · Within 6 months defined as (index date +1 day) to (index date + 180 days)

Rate of pneumonia within 6 months starting the day after index date.

Group	Value	95% CI
Usual Care	0.03
Intervention	0.02

Mortality Secondary · Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)

Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)

Group	Value	95% CI
Usual Care	9
Intervention	10

Number of Patients Recommended to Stop Inhaled Corticosteroids Secondary · Collected at time of recommendation/order entry

Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids

Group	Value	95% CI
Intervention	181

Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers Secondary · Assessed during 6 months following index date

Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers

Group	Value	95% CI
Intervention	92.3

Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date Secondary · Assessed at 6 months post index date

Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date

Group	Value	95% CI
Intervention	24

Number of Patients for Whom Recommendations Are Made Secondary · Collected at time or recommendation order entry

Among patients assigned to intervention providers, number of patients for whom recommendations are made.

Group	Value	95% CI
Intervention	262

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care

Serious: 41/281 (15%)

Deaths: 9/281

Intervention

Serious: 30/269 (11%)

Deaths: 10/269

Serious adverse events (3 terms)

Reaction	System	Usual Care	Intervention
Outpatient COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Inpatient COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Outpatient COPD Exacerbation, Pneumonia, Inpatient COPD Exacerbation.

Data from ClinicalTrials.gov NCT02896257 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trends and Rural-Urban Differences in the Initial Prescription of Low-Value Inhaled Corticosteroids among U.S. Veterans with Chronic Obstructive Pulmonary Disease.
   Duan KI, Donovan LM, Spece LJ, Feemster LC, et al · · 2023 · cited 9× · PMID 36867427 · DOI 10.1513/annalsats.202205-458oc