SAN DIEGO -- Identifying symptomatic individuals in the community with undiagnosed asthma and chronic obstructive pulmonary disease (COPD) and then linking them with specialty care reduced healthcare utilization and symptom burden, a randomized trial in Canada showed.
The study first identified more than 500 adults with undiagnosed asthma or COPD via targeted case-finding methods and told them about their condition. After randomization to pulmonologist-directed care or usual care with their primary care provider, the annualized rate of participant-initiated healthcare utilization for respiratory illness was cut in half in the intervention group (0.53 vs 1.12 events per person-year; incidence rate ratio [IRR] 0.48, 95% CI 0.36-0.63, P<0.001).
And at 1 year, patients assigned to the intervention -- which involved guideline-based care from a pulmonologist and an asthma-COPD educator -- also had significantly greater improvements in disease-specific quality of life, symptom burden, and forced expiratory volume in 1 second (FEV1), reported Shawn Aaron, MD, of the University of Ottawa in Ontario, at the American Thoracic Society annual meeting.
Notably, however, individuals assigned to primary care also experienced improvements in these secondary outcomes.
"Obviously when you give people diagnoses you change behavior," said Aaron. "Before they were suffering at home and not going to see doctors. Once we told them they had asthma or COPD, many of them in the control group ran to see a doctor."
Findings from the so-called UCAP trial were simultaneously published in the .
Many people in the community with respiratory symptoms actually have undiagnosed or , putting them at risk for worse quality of life, the researchers explained. But early diagnosis through case finding, such as the strategy used in the trial, could potentially reduce disease progression and future acute care use while also alleviating patients' symptoms with treatment.
"If you're a patient or person in the community and you're suffering from lung disease -- that shortness of breath, or cough, or wheeze, or chest tightness, and you've never been diagnosed with lung disease, you need to go to your physician and you need to recount your symptoms," Aaron told 鶹ý. "Don't suffer, because if we can diagnose you we can treat you and make you much better."
initially conducted automated telephone calls to over a million households near the 17 trial sites in Canada to inquire about household members with respiratory symptoms (shortness of breath, prolonged cough, wheezing, or increased mucus or sputum production in the past 6 months). After that, 38,353 people who engaged with the calls and had respiratory symptoms were interviewed for trial eligibility.
Ultimately, 508 individuals with COPD (n=258) or asthma (n=250) were randomized to the pulmonologist-directed intervention or to usual care with a primary care physician after receiving a confirmed diagnosis (airflow obstruction on spirometry and scores of 6 or above on the Asthma Screening Questionnaire or 20 or above on the COPD Diagnostic Questionnaire). Participants were excluded if they had a previous diagnosis of lung disease, used respiratory inhalers beyond as-needed short-acting beta-agonists (SABAs), had contraindications to spirometry, or were in their third trimester of pregnancy.
Participants had a median age of 63 years, an average body mass index of 30, and 61% were men. About half of the participants were former smokers, about a quarter were current smokers, and the rest were never-smokers. The vast majority (~85%) did not use any respiratory medications at baseline, while 14% used a SABA as needed. Severity of baseline airflow obstruction was mild or moderate for most.
Patients in both groups had their spirometry report and diagnosis sent to their primary care provider. In the intervention group, participants met with a trial pulmonologist and asthma-COPD educator at randomization and had a scheduled 4-month follow-up visit. This group received prescriptions for guideline-recommended medications along with disease education, behavioral counseling, and other care such as instructions on allergen or smoke avoidance, recommendations for routine pneumococcal and flu vaccination, and pharmacologic therapy for smoking cessation if they were current smokers.
The annualized rate of participant-initiated healthcare utilization for respiratory illness was the study's primary endpoint, and the effect of the intervention was consistent across the asthma (IRR 0.49, 95% CI 0.33-0.73) and COPD (IRR 0.46, 95% CI 0.31-0.67) subgroups.
Overall, the different levels of healthcare utilization for respiratory illness (hospitalization, emergency department visit, specialist visit, primary care visit) were numerically lower for the intervention group, but the differences were only significant when it came to primary care visits (0.36 vs 0.91 per person-year; IRR 0.39, 95% CI 0.29-0.53).
Secondary endpoints included changes from baseline to 1 year on the St. George Respiratory Questionnaire (SGRQ) to measure disease-specific quality-of-life, the COPD Assessment Test (CAT) to measure symptom burden, FEV1, and SF-36 total score for overall quality of life.
Mean between-group differences significantly favored the intervention group for the SGRQ, CAT, and FEV1 at 12 months:
- SGRQ total score: -3.5 points (95% CI -6.0 to -0.9)
- CAT total score: -1.3 points (95% CI -2.4 to -0.1)
- Pre-bronchodilator FEV1: 94 ml (95% CI 50-138)
- SF-36 total score: 1.9 points (-0.4 to 4.2)
Over the course of the trial, 92% of the intervention group and 60% of the usual-care group started a new medication for their asthma or COPD, with a long-acting beta-agonist (LABA) plus inhaled glucocorticoid being the most common option in each group (40% and 21%, respectively).
Active smokers were more likely to quit at 12 months if they were assigned to the intervention group (14% vs 7% in the usual care group).
Adverse events (AEs) were reported in 21 participants in the intervention group versus 14 participants in the usual-care group, often dizziness or syncope related to the spirometry and cramping possibly from medications. Serious AEs resulting in hospitalization were reported in five intervention-group participants and seven usual-care participants. Four deaths occurred at the 12-month follow-up: two in the intervention group (lung cancer and cardiac arrest) and two in the usual-care group (cardiac arrest and liver failure).
The researchers cited several limitations to their findings, including that the study was not powered for subgroup analyses of secondary outcomes, that participation required a registered telephone number, and that older adults appeared more willing to participate. Furthermore, the intervention may not be feasible in other health systems where access to specialty care is more limited. They also noted that the case-finding approach was somewhat inefficient, given how many interviews were required to ultimately find fewer than 600 adults eligible for inclusion.
Disclosures
This trial was supported by funding from the Canadian Institutes of Health Research.
Aaron reported relationships with AstraZeneca, GSK, and Sanofi. Coauthors reported relationships with Amgen, AstraZeneca, Boehringer Ingelheim, the Canadian Thoracic Society, the Canadian Institutes of Health Research, Covis, Fonds de Recherche du Québec - Santé, EAPOC, Genzyme, GSK, Institut National de Santé Publique du Québec, Janssen, Merck, Novartis, the Ottawa Hospital Research Institute, Regeneron, the Rossy Cancer Network, Sanofi, Takeda, Teva, and Valeo.
Primary Source
New England Journal of Medicine
Aaron SD, et al "Early diagnosis and treatment of COPD and asthma -- a randomized, controlled trial" N Engl J Med 2024; DOI: 10.1056/NEJMoa2401389.