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

Overview

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.

Full Title of Study: “De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-471)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 29, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: Proactive patient-tailored electronic consult (E-consult)
    • Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
  • No Intervention: usual care
    • Standard practice (usual care). Primary care providers treat their patients as usual.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Rate of COPD exacerbation
    • Time Frame: Over the intervention and follow-up period, up to 35 months
    • Rate of COPD exacerbation
  • Rate of pneumonia
    • Time Frame: Over the intervention and follow-up period, up to 35 months
    • Rate of pneumonia
  • Mortality
    • Time Frame: Assessed during 6 months following primary care visit
    • Mortality
  • Number of patients recommended to stop inhaled corticosteroids
    • Time Frame: Over the intervention period, up to 28 months
    • Among intervention patients who meet entry and exclusion criteria, number of patients recommended to stop inhaled corticosteroids
  • Proportion of recommendations accepted by primary care providers
    • Time Frame: Assessed during 6 months following primary care visit
    • Among intervention patients who meet entry and exclusion criteria, proportion of recommendations accepted by primary care providers.
  • Percentage of patients where ICS recommendations are accepted but restarted by 6 months following primary care visit
    • Time Frame: Assessed at 6 months post primary care visit
    • Percentage of patients where ICS recommendations are accepted but restarted by 6 months following primary care visit
  • Number of patients for whom recommendations are made
    • Time Frame: Over the intervention period, up to 28 months
    • Among intervention patients who meet entry and exclusion criteria, number of patients for whom recommendations are made.

Participating in This Clinical Trial

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 >= 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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David H. Au, MD MS, Principal Investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
    • Christian D. Helfrich, PhD MPH BA, Principal Investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA

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