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

Not Applicable

Completed

• Conditions: Treatment of Chronic Obstructive Pulmonary Disease
• Interventions: Other: Guideline treatment recommendations

• Registration Number: NCT02896257
• Lead Sponsor: VA Office of Research and Development

Brief 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.

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.

Study Timeline

• Study First Submitted: 2016-08-12
• Study Start: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2019-07-29
• Study Completion: 2021-06-30
• Results First Submitted: 2021-10-18
• Results First Submitted QC: 2021-12-16
• Results First Posted: 2022-01-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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%.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive patient-tailored electronic consult (E-consult)	Guideline treatment recommendations	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months.	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.

Secondary Outcome Measures

Name	Time	Method
Rate of COPD Exacerbation	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.
Mortality	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)
Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers	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
Rate of Pneumonia	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.
Number of Patients for Whom Recommendations Are Made	Collected at time or recommendation order entry	Among patients assigned to intervention providers, number of patients for whom recommendations are made.
Number of Patients Recommended to Stop Inhaled Corticosteroids	Collected at time of recommendation/order entry	Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids
Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date	Assessed at 6 months post index date	Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date

Trial Locations

Locations (2)

VA Bedford HealthCare System, Bedford, MA; 🇺🇸 Bedford, Massachusetts, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States