Guideline treatment recommendations
OtherPatient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.
NCT Number: NCT02896257
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
VA Bedford HealthCare System, Bedford, MA, Bedford, Massachusetts, United States
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.
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:
Exclusion criteria
Patients:
Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.
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.
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.
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.
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)
Time frame: Collected at time of recommendation/order entry
Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids
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
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
Time frame: Collected at time or recommendation order entry
Among patients assigned to intervention providers, number of patients for whom recommendations are made.
VA Office of Research and Development
Fed
De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-471)
Acronym: DISCUSS COPD
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.
Published trials that share one or more normalized conditions with this study.
NCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT04722887
Alpha1-Antitrypsin Deficiency, Chronic Disease
Los Angeles, California, United States
View Trial DetailsNCT06253806
Anosmia, COVID-19
St Louis, Missouri, United States
View Trial DetailsNCT06149494
COPD, COPD Exacerbation Acute
London, United Kingdom
View Trial Details