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| ID | Type | Description | Link |
|---|---|---|---|
| QUE 15-271 | Other Grant/Funding Number | Department of Veterans Affairs |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | No Intervention | Standard practice (usual care). Primary care providers treat their patients as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guideline treatment recommendations | Other | Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of COPD Exacerbation | Rate of COPD exacerbation within 6 months starting the day after index date. | Within 6 months defined as (index date +1 day) to (index date + 180 days) |
| Rate of Pneumonia |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730-1114 | United States | ||
| VA Puget Sound Health Care System Seattle Division, Seattle, WA |
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Prior to study start, we identified 139 primary care teams eligible for randomization; 2 primary care teams lost their associated provider prior to study start, leaving 137 primary care teams for initial randomization. Periodically, the Corporate Data Warehouse was queried to determine active primary care providers(PCPs) and their care teams. New PCPs and new care teams were added, resulting in a total of 220 distinct PCP-primary care team combinations.
Prior to study start, we stratified all primary care teams based on site, provider type, and median number of eligible patients. Primary care teams were the unit of randomization, and providers were randomized along with their primary care team in a 1:1 ratio. For new providers, the unit of randomization was at the level of the PCP (stratified by site, provider type and median number of eligible patients).Only PCPs were considered enrolled. Patients were not considered enrolled in this study.
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Primary care providers treat their patients as usual. |
| FG001 | Intervention | Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Providers |
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| Patients |
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Baseline characteristics for age, sex, ethnicity, race not collected from primary care providers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Patients | Standard practice (usual care). Primary care providers treat their patients as usual. |
| BG001 | Intervention Patients | Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids. Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data not collected from providers. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patient participants that are assigned to usual care or intervention primary care providers. | Posted | Count of Participants | Participants | Assessed at 6 months post primary care visit defined as (index date + 180 days) |
|
6 months
Adverse events were not collected from providers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Standard practice (usual care). Primary care providers treat their patients as usual. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalized for COPD exacerbation within the 180 days after the index date. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Au | VA Puget Sound Health Care System | 206-764-2504 | David.Au@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2021 | Dec 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Rate of pneumonia within 6 months starting the day after index date.
| Within 6 months defined as (index date +1 day) to (index date + 180 days) |
| Mortality | Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days) | 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 | Among patients of intervention PCPs, 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 | Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers | Assessed during 6 months following index date |
| 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 | Assessed at 6 months post index date |
| Number of Patients for Whom Recommendations Are Made | Among patients assigned to intervention providers, number of patients for whom recommendations are made. | Collected at time or recommendation order entry |
| Seattle |
| Washington |
| 98108-1532 |
| United States |
| NOT COMPLETED |
|
|
| BG002 | Usual Care Providers | Standard practice (usual care). Primary care providers treat their patients as usual. |
| BG003 | Intervention Providers | Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids. Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Data not collected from providers. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Data not collected from providers. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Data not collected from providers. | Count of Participants | Participants |
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| Race (NIH/OMB) | Data not collected from providers. | Count of Participants | Participants |
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| Region of Enrollment | Data not collected from providers. | Count of Participants | Participants |
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| Smoking | Data not collected from providers. | Count of Participants | Participants |
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| Provider type | Data not applicable to patient participants. | Count of Participants | Participants |
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| Site | Count of Participants | Participants |
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| Mean number of eligible patients | Mean number of potentially eligible patients assigned to the PCP at time of randomization. | Data not applicable to patient participants. | Mean | Standard Deviation | number of patients |
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| Secondary | Rate of COPD Exacerbation | Rate of COPD exacerbation within 6 months starting the day after index date. | Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis. | Posted | Number | Events per 6 months of person-time | Within 6 months defined as (index date +1 day) to (index date + 180 days) |
|
|
|
|
| Secondary | Rate of Pneumonia | Rate of pneumonia within 6 months starting the day after index date. | Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis. | Posted | Number | Events per 6 months of person-time | Within 6 months defined as (index date +1 day) to (index date + 180 days) |
|
|
|
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| Secondary | Mortality | Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days) | Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis. | Posted | Count of Participants | Participants | Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days) |
|
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| Secondary | Number of Patients Recommended to Stop Inhaled Corticosteroids | Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids | Patient participants assigned to intervention PCPs. | Posted | Count of Participants | Participants | Collected at time of recommendation/order entry |
|
|
|
| Secondary | 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 | Recommendations to discontinue inhaled corticosteroids. A recommendation to discontinue inhaled corticosteroids was made only once per patient. | Posted | Number | Percentage of recommendations | Assessed during 6 months following index date |
|
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| Secondary | 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 | Patients where ICS discontinuation recommendation was accepted. | Posted | Count of Participants | Participants | Assessed at 6 months post index date |
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| Secondary | Number of Patients for Whom Recommendations Are Made | Among patients assigned to intervention providers, number of patients for whom recommendations are made. | We identified 269 patients meeting entry and exclusion criteria cared for by a primary care provider assigned to the intervention group. Of these, 262 received an electronic consult with recommendations for guideline concordant COPD care. | Posted | Count of Participants | Participants | Collected at time or recommendation order entry |
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| 9 |
| 281 |
| 41 |
| 281 |
| 0 |
| 281 |
| EG001 | Intervention | Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids. Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care. | 10 | 269 | 30 | 269 | 0 | 269 |
|
| Outpatient COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Experienced an outpatient COPD exacerbation within the 180 days after the index date. |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Experienced either an inpatient or outpatient pneumonia event within 180 days after the index date. |
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| >=65 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Missing |
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| Site 2 |
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