NCT07396987 · Juan Carlos Cardet
Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation
What this study is about
This study is testing a new way to help adults with asthma get follow up care after an emergency room (ER) visit for an asthma attack. Many people who come to the ER for asthma never see an asthma specialist afterward, even though specialists can offer treatments such as advanced inhalers or biologic medicines that may prevent future attacks. The study will compare two approaches.
View original scientific description
This study is testing a new way to help adults with asthma get follow up care after an emergency room (ER) visit for an asthma attack. Many people who come to the ER for asthma never see an asthma specialist afterward, even though specialists can offer treatments such as advanced inhalers or biologic medicines that may prevent future attacks. The study will compare two approaches. One group will receive a telehealth appointment with an asthma specialist that is scheduled for them before they leave the ER. The other group will receive the usual care, which typically includes a standard referral but no scheduled appointment. All participants will be offered a prescription for standard controller medication at discharge. The main question the study aims to answer is whether arranging a telehealth visit directly from the ER increases the number of patients who complete a follow up appointment with an asthma specialist within three months. The study will also look at whether this approach improves asthma control, reduces repeat ER visits, and helps patients better understand and use their asthma medications. This research may help identify a practical way to improve access to asthma specialists and reduce the burden of asthma for patients who frequently rely on emergency care.
Interventions
BEHAVIORAL
ER-Initiated Telehealth Referral
Participants assigned to the intervention arm will receive an asthma specialist follow up appointment that is scheduled directly from the emergency department before discharge. Emergency department staff will contact the specialist clinic to arrange a telehealth visit within 1-3 weeks. The telehealth visit will address asthma symptoms, medication use, and follow-up care needs. All participants, including those in the intervention arm, will be offered a prescription for standard inhaled corticosteroid/long-acting beta-agonist controller therapy at discharge. The intervention focuses on improving access to specialist care through proactive scheduling and telehealth delivery.
Primary outcome measures
Proportion of Participants Completing an Asthma Specialist Follow-Up Visit Within 3 Months After Emergency Department Discharge
Time frame: Within 3 months after emergency department discharge
Completion of an asthma specialist follow-up visit will be assessed using documentation in the electronic health record. A visit will be counted if the record shows that the participant completed a telehealth or in-person appointment with an asthma specialist within 3 months after the emergency department discharge. The outcome will be reported as the proportion of participants in each study arm who completed a qualifying specialist visit during the 3-month follow-up period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years
- Asthma diagnosis ≥1 year
- Seen in ER for asthma exacerbation
- Persistent asthma on controller therapy
- ≥1 asthma exacerbation in prior year
Exclusion criteria
- Patients who have seen an asthma specialist (allergist or pulmonologist) for asthma in the past 1 year
- Diagnosis of other pulmonary diseases (e.g., COPD, interstitial lung disease, etc.) We will allow for current smokers, vapers and cannabis users as long as they meet one of the COPD-allowable pathways below. COPD-allowable pathways: If none of the below are satisfied, then exclude for COPD. Documentation: PFTs must be within 36 months of enrollment date; smoking history must be calculated and entered in this form based on patient input. Pack- year history will be collected for characterization/analysis but will not determineeligibility. We will allow for COPD as long as they are:
- never smokers/vapers/cannabis users;
- former or current smokers/vapers/cannabis users with normal PFTs with FEV1/FVC \>=70% documented in a medical record within 36 months of the enrollment date
- former or current smoker/vapers/cannabis users with obstruction noted on PFTs (i.e., FEV1/FVC \<70%) but who demonstrates BOTH acute bronchodilator reversibility (i.e., \>10% increase in either FEV1%predicted or FVC% predicted) AND have a normal diffusing capacity (DLCO)
Where
- Tampa, Florida
Collaborators
Tampa General Hospital, University of South Florida, Sanofi
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations