Clinical trial NCT05718102: Pragmatic Trial to Enhance Quality Safety, and Patient Experience in COPD
Official title: Pragmatic Trial to Enhance Quality Safety, and Patient Experience in COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-02-08
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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:

  1. Recent discharge from hospital for COPD exacerbation
  2. Recent outpatient exacerbation (emergency room (ER), primary care)
  3. Received prescription for an inhaled corticosteroid (ICS) but does not meet criteria for ICS use
  4. Diagnosis of COPD and/or treatment and active smoker not receiving smoking cessation aide
  5. Treatment for COPD without evidence of spirometry within 10 years, or no airflow obstruction on existing spirometry

Primary outcomes:
measure: Proportion of patients with COPD exacerbation, pneumonia, hospitalization, or Death (composite outcome)
timeFrame: 180 days after intervention
Secondary outcomes:
measure: COPD-related quality- of-life
timeFrame: 90 days after intervention
measure: Proportion of patients with COPD exacerbation
timeFrame: 180 days after intervention
measure: Proportion of patients with pneumonia
timeFrame: 180 days after intervention
measure: Proportion of patients with hospitalization
timeFrame: 180 days after intervention
measure: Proportion of patients with Death
timeFrame: 180 days after intervention
measure: Quality of COPD care
timeFrame: 90 days after intervention
measure: Acceptance of Recommendations
timeFrame: 90 days after intervention
measure: Heterogeneity of treatment effect on primary and secondary outcomes by subgroup
timeFrame: 180 days after intervention
measure: Patient-incurred costs
timeFrame: 180 days after intervention
measure: Caregiver-incurred costs
timeFrame: 180 days after intervention
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Spokane
country: United States
facility: Mann-Grandstaff VA Medical Center
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Lucas M Donovan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System
name: David H Au, MD
role: PRINCIPAL_INVESTIGATOR
References: