Speaker
Elliot Israel, MD
Professor of Medicine, Harvard Medical School
Keywords
PREPARE, Asthma
Key Points
- Asthma effects 70% of the American population, but there is a disproportionate burden of asthma in Black and Latinx adults, evidenced by twice the number of emergency room visits and asthma-related deaths relative to whites. Puerto Ricans have four times the asthma-related deaths related to whites, and efforts to reduce these disparities have been mostly unsuccessful. The efforts that have been kind of successful have generally been very labor intensive and so economically unfeasible.
- PREPARE is a randomized, 1:1 open-label, pragmatic clinical trial. The population was 1,201 Black and Latinx adults with modern to severe persistent asthma, who are on inhaled corticosteroids and they had to have an asthma control test <20 (considered inadequate control) or they had to have an exacerbation requiring corticosteroids in the past year. It was a self-identified population, doctor diagnosed, no limitations on smoking or co-morbidities. There was only one visit for the 15 month study, the enrollment visit at a clinic.
- Participants were randomized to PARTICS (Patient Activated Reliever Triggered ICS) or continued usual care. All patients watched a video on optimal care; PARTICS patients were given an ICS inhaler in addition to underlying therapy. They were instructed to take 1 puff of ICS every time they used their beta-agonist and 5 puffs when they used a nebulizer without changing their underlying therapy. Refills of the PARTICS inhaler available by a 1-800 number. All patients were asked to complete monthly surveys. The last patient was enrolled in March 2020 (pre-COVID) and followed through the pandemic.
- This study recruited 1,201 patients, with a 90% survey completion rate and 4% data loss. The study found that PARTICS reduces asthma exacerbations by .13/person/year. This is equal to or greater than the reduction in severe exacerbations seen in SMART studies by NAEPP. It was a clinically important reduction in exacerbations. For the intervention group, we saw improvement in asthma control and improved quality of life and reduced days lost from usual activities. The cost was only 1.1 extra ICS inhaler/year.
- A lot of the success of the study was the involvement of stakeholder groups. Patient advisors helped us with recruitment – emphasized the importance of people who look and talk like us, simple messages, use specific Spanish vernacular, immediate payment for survey completion, appreciation notes from investigators, advisors reviewed all patient-facing materials.
- One unexpected challenge discovered during the pilot was that patients do not typically use the words “rescue” and “maintenance” for their inhalers; the solution was to ask what they call their inhalers at enrollment and have that prepopulated into the inhaler survey questions. During the pilot we also received patient feedback on incentives for the survey, such as reimbursements for time to fill out the survey plus a chance to win $300 for completing within 7 days, one-click link to access the survey, and three reminders were sent. Phone call follow up was still needed.
Discussion Themes
–Patient partners identified for us the barriers from the populations, including a barrier among Latinx patients for corticosteroids and concerns that they will cause diabetes, make me short, make me sick. We found an explanation that helped them understand.
–The recall accuracy of the exacerbations was mildly noisy. We thought people would clearly remember that they got a treatment but it was in the range of 20-30% in both arms.
Read more about PREPARE and visit the study website.
Tags
#pctGR, @Collaboratory1