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

Primary Purpose

Treatment of Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guideline treatment recommendations
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Treatment of Chronic Obstructive Pulmonary Disease focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA Bedford HealthCare System, Bedford, MA
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Proactive patient-tailored electronic consult (E-consult)

Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of COPD Exacerbation
Rate of COPD exacerbation within 6 months starting the day after index date.
Rate of Pneumonia
Rate of pneumonia within 6 months starting the day after index date.
Mortality
Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)
Number of Patients Recommended to Stop Inhaled Corticosteroids
Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids
Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers
Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers
Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date
Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date
Number of Patients for Whom Recommendations Are Made
Among patients assigned to intervention providers, number of patients for whom recommendations are made.

Full Information

First Posted
August 12, 2016
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02896257
Brief Title
De-implementing Inhaled Steroids to Improve Care and Safety in COPD
Acronym
DISCUSS COPD
Official Title
De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-471)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2016 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proactive patient-tailored electronic consult (E-consult)
Arm Type
Other
Arm Description
Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Standard practice (usual care). Primary care providers treat their patients as usual.
Intervention Type
Other
Intervention Name(s)
Guideline treatment recommendations
Intervention Description
Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.
Primary Outcome Measure Information:
Title
Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months.
Description
Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.
Time Frame
Assessed at 6 months post primary care visit defined as (index date + 180 days)
Secondary Outcome Measure Information:
Title
Rate of COPD Exacerbation
Description
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)
Title
Rate of Pneumonia
Description
Rate of pneumonia 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)
Title
Mortality
Description
Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)
Time Frame
Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)
Title
Number of Patients Recommended to Stop Inhaled Corticosteroids
Description
Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids
Time Frame
Collected at time of recommendation/order entry
Title
Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers
Description
Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers
Time Frame
Assessed during 6 months following index date
Title
Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date
Description
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
Title
Number of Patients for Whom Recommendations Are Made
Description
Among patients assigned to intervention providers, number of patients for whom recommendations are made.
Time Frame
Collected at time or recommendation order entry

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H. Au, MD MS
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian D. Helfrich, PhD MPH BA
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Bedford HealthCare System, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730-1114
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1532
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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