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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Background: Over 26 million Americans have chronic obstructive pulmonary disease (COPD), which is the third leading cause of death in the United States. Unfortunately, few patients receive proven therapies and many receive therapies known to have safer alternatives. One major reason is the competing demands of primary care providers (PCPs) who manage 90% of patients with COPD. The research team has developed a population management approach where pulmonary specialists provide evidence-based recommendations as an E-consult with unsigned orders to PCPs. PCPs can then quickly review the E-consult and sign, modify, or discontinue these orders. The investigators found this intervention led to marked improvements in the quality-of-care delivered and patients' COPD-related quality-of-life. While promising, this approach is limited by a paucity of pulmonary providers nationwide. Clinical pharmacists are 20 times more prevalent as pulmonary specialists and some regions of VA (VISN 17, COPD Cares) have assigned clinical pharmacists a role in the management of patients with COPD. However, the relative effectiveness of pharmacist-led management is yet to be established.
Study Description: This study tests population management for COPD provided by pharmacists relative to pulmonary specialists. The investigators are conducting a cluster randomized clinical trial at five medical centers and their associated clinics within the Department of Veterans Affair. Study staff will randomize PCPs to population management conducted by either pulmonary specialists or pharmacists. Within PCPs' panels, study staff will use VA electronic health record to identify patients with evidence of COPD. Pulmonologists and pharmacists will review these patients and provide guideline-based recommendations to PCPs. Pulmonary specialists and pharmacists will then deliver evidence-based recommendations through E-consults coupled with unsigned orders for primary care providers to sign, modify or decline.
Outcomes: Investigators will assess if proactive, population management recommendations by clinical pharmacists and pulmonary specialists lead to non-inferior outcomes for patients with COPD. The primary outcome will be a composite endpoint of COPD exacerbation, pneumonia, hospitalization, or death six month after intervention. Secondary outcomes will include 1) the proportion of guideline recommended therapies received by patients, 2) COPD-related quality-of-life as measured by the Clinical COPD Questionnaire, and 3) PCP acceptance of recommendations, 4) each individual outcome within the primary composite endpoint above, and 5) patient- and caregiver-incurred costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist led | Active Comparator | Pharmacists will conduct population health management for patients with COPD |
|
| Pulmonologist led | Active Comparator | Pulmonologists will conduct population health management for patients with COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Population-health management | Other | Population-health management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with COPD exacerbation, pneumonia, hospitalization, or Death (composite outcome) | 180 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| COPD-related quality- of-life | Clinical COPD Questionnaire (CCQ). The CCQ includes 10 items encompassing three domains (symptoms, functional state, and mental state). Response options range from "never" to "almost all the time" and are scored from 0-to-6. The total score is calculated by the addition of each item divided by the total number of items, producing a range of scores between 0-6. | 90 days after intervention |
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Inclusion Criteria:
Participants may be PCP physicians and advance practice providers (APP) practicing at participating sites, and their patients who are diagnosed with or treated for COPD based on the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucas M Donovan, MD | VA Puget Sound Health Care System | Principal Investigator |
| David H Au, MD | VA Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | United States | ||
| Portland VA Medical Center |
We will share a de-identified data set with the Patient-Centered Outcomes Research Institute-designated repository
2028
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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 | Feb 24, 2026 | Mar 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000076602 | Population Health Management |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Proportion of patients with COPD exacerbation | 180 days after intervention |
| Proportion of patients with pneumonia | 180 days after intervention |
| Proportion of patients with hospitalization | 180 days after intervention |
| Proportion of patients with Death | 180 days after intervention |
| Quality of COPD care | Proportion of evidence-based practices received | 90 days after intervention |
| Acceptance of Recommendations | Proportion of recommendations that are accepted by PCPs | 90 days after intervention |
| Heterogeneity of treatment effect on primary and secondary outcomes by subgroup | Compare heterogeneity of treatment effect on primary and secondary outcomes by intervention priority/risk, age, race, sex, rurality, and multimorbidity. | 180 days after intervention |
| Patient-incurred costs | Compare differences in incurred costs using electronic health record data and surveys to estimate costs for care related to COPD, pneumonia, and hospitalizations. These costs will include estimated costs for transportation, copays for visits and medications, and opportunity costs for time spent on care. | 180 days after intervention |
| Caregiver-incurred costs | Compare differences in caregiver-incurred costs using electronic health record data and surveys to estimate costs incurred by caregivers for time spent accompanying patients to care related to COPD, pneumonia, and hospitalizations. These costs will include estimated costs for transportation and opportunity costs for time spent on care. | 180 days after intervention |
| Portland |
| Oregon |
| 97239 |
| United States |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States |
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
| Mann-Grandstaff VA Medical Center | Spokane | Washington | 99205 | United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |