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

Treatment of Chronic Obstructive Pulmonary Disease Clinical Trial

— DISCUSS COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896257
• Other study ID #: QUX 16-009
• Secondary ID: QUE 15-271
• Status: Completed
• Phase: N/A
• Start date: September 6, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 COPD when ICS are not indicated by guidelines.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Treatment of Chronic Obstructive Pulmonary Disease

Intervention

Other:
• Guideline treatment recommendations
Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

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