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Completed

NCT Number: NCT02896257

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Bedford HealthCare System, Bedford, MA, Bedford, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Guideline treatment recommendations

Other

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

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Rate of COPD Exacerbation

    Time frame: 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.

  2. Rate of Pneumonia

    Time frame: 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.

  3. Mortality

    Time frame: 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)

  4. Number of Patients Recommended to Stop Inhaled Corticosteroids

    Time frame: Collected at time of recommendation/order entry

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

  5. Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers

    Time frame: 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

  6. Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date

    Time frame: Assessed at 6 months post index date

    Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date

  7. Number of Patients for Whom Recommendations Are Made

    Time frame: Collected at time or recommendation order entry

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: DISCUSS COPD

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Sep 12, 2016
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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