Grand Rounds October 11, 2024: Early Diagnosis and Treatment of Asthma and COPD (Shawn Aaron, MD)

Speaker

Shawn Aaron, MD
Professor
University of Ottawa

Keywords

Respiratory Symptoms; Guideline-Directed Care; Standard Care; Phone Recruitment; Randomized Controlled Trial

Key Points

  • Up to 70% of individuals with asthma or Chronic Obstructive Pulmonary Disease (COPD) remain undiagnosed. The 2007 – 2012 U.S. National Health and Nutritional Examination survey of randomly selected American adults found obstructive lung disease in 13% of the sample, 71% of whom had never been diagnosed.
  • Inspired by an encounter with a patient who had undiagnosed asthma, Dr. Aaron and his team developed three research questions for the Undiagnosed COPD and Asthma in the Population, or UCAP, study: 1) Can we find adults with undiagnosed asthma or COPD in the community? 2) Are they sick? 3) Can we treat them early to improve health outcomes?
  • They used a case-finding approach to identify symptomatic individuals with undiagnosed cases of either disease. Case-finding evaluates subgroups of people at increased risk of a disease; in this case, they looked at adults with undiagnosed respiratory symptoms.
  • To identify that sample, the team called over 1.1 million Canadian residents. After initial screening of the 50,000 contacts who indicated that there was someone in the household with respiratory symptoms, 2,857 of 4,272 eligible participants underwent testing with spirometry. A fifth of the sample had undiagnosed asthma or COPD.
  • Compared to a healthy age- and sex-matched control group, the adults with undiagnosed COPD or asthma had lower quality of life, worse symptoms and health status, and significant work impairment.
  • To determine whether early diagnosis of previously undiagnosed symptomatic asthma or COPD, and subsequent treatment, improves health outcomes, the team randomly assigned the participants diagnosed with asthma or COPD to the intervention or to usual care.
  • All participants and participants’ primary care providers (PCPs) were given a copy of their interpreted spirometry report with their diagnosis. The intervention group received treatment from a pulmonologist and an asthma/COPD educator; the control group received usual care from their PCP.
  • Guideline-directed treatment of undiagnosed COPD or asthma by a pulmonologist and an educator was found to improve healthcare utilization, symptoms, quality of life and lung function more than usual care.
  • In practice, not all patients can or will be treated by a lung specialist. The trial results indicated that the health of people with asthma or COPD will still improve if they are diagnosed and receive the usual care.

Discussion Themes

Cold-calling, though ultimately effective, was an expensive and inefficient screening and recruitment method. In the future, the team will attempt to drive people with respiratory symptoms to the study website by advertising in the community and on social media.

The research team considered a few iterations of the control arm, including a design in which the control group was informed of their diagnosis later on in the trial. They decided to compare guideline-directed treatment to usual care after reviewing the ethical considerations and the potential for inappropriate randomization.

Case-finding in a sample of people living in asthma or COPD “hotspots,” or in other high-risk populations, could increase the efficiency of the method but narrow the applicability of the findings.

Volunteer bias likely impacted the diversity of the sample; a disproportionate number of the volunteers were white (97%) and older, with an average age of 63.

Grand Rounds October 11, 2024: Early Diagnosis and Treatment of Asthma and COPD (Shawn Aaron, MD)

Speaker:

Shawn Aaron, MD
Professor
University of Ottawa

Title: Early Diagnosis and Treatment of Asthma and COPD

Date: Friday, October 11, 2024, 1:00-2:00 p.m. ET

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June 17, 2022: PREPARE: A Successful, Primarily Remote Pragmatic Trial in Black and Latinx Population with Asthma: Challenges and Successes (Elliot Israel, MD)

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