AzTrials
AzTrials

Treatment of Chronic Obstructive Pulmonary DiseaseDISCUSS COPDNCT02896257

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

A study testing Guideline treatment recommendations in people with Treatment of Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Guideline treatment recommendations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
2 sitesUnited States
Study dates
6 Sep 2016to 30 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • VA Bedford HealthCare System, Bedford, MA

    Bedford, Massachusetts, 01730-1114

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

Other trials in United States

About this study

Official title: De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-471)

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.

Read the detailed description

Chronic obstructive pulmonary disease (COPD) is among the most common medical diagnoses among Veterans. Approximately half of those who carry a diagnosis of COPD are prescribed inhaled corticosteroids (ICS), despite ICS having no role among those patients without fixed airflow obstruction (AFO) and a limited role among those who do. Guidelines explicitly state that ICS for COPD patients should be limited to those with severe AFO and those with frequent exacerbations. Even this benefit comes at a cost, as ICS use has been shown in multiple randomized controlled trials to increase rates of pneumonia. After prolonged exposure, ICS is also associated with higher bone fracture risk, incidence of cataracts and poor diabetes control. Among patients without disease or with mild-moderate AFO and low risk of exacerbation, ICS have no demonstrated efficacy, but retain the risk of harm. For this reason, evidence-based guidelines specifically recommend against their use in mild-moderate AFO.

The goal of this project is to improve the delivery and safety of care by de-implementing the ineffective use of ICS among Veterans with a diagnosis of COPD who otherwise lack a clinical indication for the medication. The primary aim is to reduce ICS use among Veterans with limited clinical indication for the medication. Investigators will test an intervention to de-implement unnecessary use of inhaled corticosteroids in Veterans with chronic obstructive pulmonary disease (COPD) by having pulmonologists assume more responsibility for supporting COPD patients. The investigators will compare a substitution approach using proactive patient-tailored electronic consult (E-consult) compared to usual care with a single-session education outreach, which represents a non-intensive unlearning approach. The investigators are targeting the intervention to Patient Aligned Care Team (PACT) providers who are randomized to either receive the intervention or not receive the intervention. For patients within intervention PACTs, the project clinicians will leverage the VA's integrated healthcare informatics system using specialist support through proactive patient-tailored electronic consults (E-consult) and inputting unsigned orders on behalf of Primary Care Providers (PCPs) to recommend and facilitate de-implementation of ICS. Primary care providers will have final say in accepting (signing), modifying, or declining the recommendations.

Being tested
Guideline treatment recommendations
Keywords
Quality Improvement, Quality Enhancement Research Initiatives, QuERI, Interventional, Multicenter, Inhaled corticosteroids, Pneumonia, Safety, De-implementation, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive, Pulmonary Diseases, Chronic Obstructive COPD
Medical subject headings
Pneumonia, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guideline treatment recommendationsOther

    Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.

Study groups in NCT02896257
Study groupRoleWhat they receive
Proactive patient-tailored electronic consult (E-consult)OtherPrimary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Receives: Other: Guideline treatment recommendations
Usual careNo interventionStandard practice (usual care). Primary care providers treat their patients as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed at 6 months post primary care visit defined as (index date + 180 days)

Secondary outcomes (7)

  1. Rate of COPD Exacerbation

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

    Measured: Within 6 months defined as (index date +1 day) to (index date + 180 days)

  2. Rate of Pneumonia

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

    Measured: Within 6 months defined as (index date +1 day) to (index date + 180 days)

  3. Mortality

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

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

  4. Number of Patients Recommended to Stop Inhaled Corticosteroids

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

    Measured: Collected at time of recommendation/order entry

  5. 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

    Measured: Assessed during 6 months following index date

  6. 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

    Measured: Assessed at 6 months post index date

  7. Number of Patients for Whom Recommendations Are Made

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

    Measured: Collected at time or recommendation order entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2016 (estimated)
  2. Study start6 Sep 2016
  3. Primary completion29 Jul 2019
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02896257
Sponsor's protocol ID
QUX 16-009
Other IDs
QUE 15-271
Acronym
DISCUSS COPD
Status last verified
Jul 2023
First submitted
12 Aug 2016
Last updated
27 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Guideline treatment recommendations in people with Treatment of Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. (time frame: Assessed at 6 months post primary care visit defined as (index date + 180 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02896257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in