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



Status:Enrolling by invitation
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:10/26/2018
Start Date:September 6, 2016
End Date:September 30, 2019

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

This Quality Enhancement Research Initiative (QuERI) 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.

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.

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 an forced expiratory
volume 1 (FEV1)/[greater of forced vital capacity (FVC) or vital capacity (VC)] =< 0.7
& FEV1% predicted >= 50%.

Exclusion Criteria:

Patients:

- Severe or very severe airflow obstruction (<50% 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)
We found this trial at
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