Background and Significance: Over 26 million Americans have chronic obstructive pulmonary disease (COPD). COPD is a serious lung disease and the third leading cause of death in the United States. Patients with COPD often live with the condition for decades with daily symptoms of shortness of breath and cough. These symptoms can escalate quickly during episodes known as exacerbations, which can be life-threatening.
After decades of research, we have developed a number of treatments that are known to improve quality-of-life and reduce exacerbations. Unfortunately, few patients receive these proven therapies. Instead, many patients experience avoidable harm after receiving therapies that are known to have safer alternatives. Efforts to increase delivery of proven treatments through education and outreach have been unsuccessful. One major reason is the competing demands of primary care providers (PCPs) who manage COPD in more than 90 percent of patients. The project’s research team developed an approach where pulmonary specialists would identify patients with COPD, review their medical records, and deliver recommendations to patients’ PCPs. Pulmonary specialists also send the PCPs unsigned orders so that PCPs can deliver this recommended care quickly and easily. The study team found this system improved delivery of proven therapies and patient’s quality of life. This method of care delivery is called population management.
However, there are few pulmonary specialists across the country, and this limits the ability to provide this kind of population management on a wide scale. To serve more patients, pharmacists could also provide population management for COPD. Pharmacists are healthcare providers who are experts in the appropriate use of medications. Pharmacists already provide population management for conditions like hypertension and diabetes. This study will test pharmacists’ ability to provide population management for COPD relative to pulmonary specialists.
Specific Aims: The study has four main goals.
- Aim 1: Examine whether quality of COPD care (e.g., delivery of proven treatments) is worse among patients with COPD who receive population management performed by clinical pharmacists, relative to pulmonary specialists.
- Aim 2: Examine whether patient outcomes are worse among patients with COPD who receive population management performed by clinical pharmacists relative to pulmonary specialists. The patient outcomes compared will include quality of life (aim 2a) and poor clinical outcomes including exacerbations, hospitalization, lung infections, and death (aim 2b).
- Aim 3. Examine whether pulmonary specialists may provide better population management among high-risk groups (e.g., those who are sicker, live in rural areas, or those in racial/ethnic minority groups).
- Aim 4. Perform interviews to understand the perspectives of patients, PCPs, and health system leaders about the different population management approaches.
Study Description: The study team will conduct this clinical trial at five medical centers and 38 associated clinics within the Department of Veterans Affairs (VA) in the states of Washington, Oregon, Minnesota, and Massachusetts. The study will recruit at least 200 PCPs and will randomly assign them to population management by either pulmonary specialists or pharmacists. The team will then look at the participating PCP’s patient panels to identify patients with COPD who might benefit from receiving better care quality. Pulmonary specialists and pharmacists will review patients based on the group to which their PCP is assigned. After review, pulmonary specialists and pharmacists will then deliver evidence-based recommendations to PCPs along with unsigned orders to streamline care. The study team expects to provide recommendations to at least 4,000 patients.
Primary and Secondary Outcomes: Primary outcomes will be (1) the percentage of guideline-recommended therapies that patients receive as measured from the medical record, (2) quality of life as measured by the Clinical COPD Questionnaire, and (3) whether patients experience a COPD exacerbation, lung infections, hospitalization, or death as measured from medical records.
Secondary outcomes will include how often PCPs accept recommendations and how often patients experience each outcome noted above.
The study team is working with patients nationwide as well as the COPD Foundation and national leaders within the Department of Veterans affairs to perform this trial
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.