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

NCT02896257 | Completed Results

• 2 other identifiers: QUX 16-009QUE 15-271
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 2

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.

Conditions

Treatment of Chronic Obstructive Pulmonary Disease

Keywords

Quality Improvement; Quality Enhancement Research Initiatives; QuERI; Interventional; Multicenter; Inhaled corticosteroids; Pneumonia; Safety; De-implementation; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Diseases, Chronic Obstructive COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of COPD Exacerbation

  Within 6 months defined as (index date +1 day) to (index date + 180 days)

• Rate of Pneumonia

  Within 6 months defined as (index date +1 day) to (index date + 180 days)

• Mortality

  Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)

• Number of Patients Recommended to Stop Inhaled Corticosteroids

  Collected at time of recommendation/order entry

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

  Assessed during 6 months following index date

Study Arms (2)

Proactive patient-tailored electronic consult (E-consult)

OTHER

Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.

Other: Guideline treatment recommendations

Usual care

NO INTERVENTION

Standard practice (usual care). Primary care providers treat their patients as usual.

Interventions

Guideline treatment recommendations OTHER

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

Proactive patient-tailored electronic consult (E-consult)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Pneumonia; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections

Results Point of Contact

• Title: Dr. David Au
• Organization: VA Puget Sound Health Care System

David.Au@va.gov

206-764-2504

Study Officials

• David H. Au, MD MS

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

• Christian D. Helfrich, PhD MPH BA

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: September 12, 2016
• Study Start: September 6, 2016
• Primary Completion: July 29, 2019
• Study Completion: June 30, 2021
• Last Updated: July 27, 2023
• Results First Posted: January 5, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)