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NCT Number: NCT07396987

Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation

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.

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Key information

Conditions

Asthma Attack Asthma Asthma Control Asthma Exacerbations Bronchial Diseases Disease Attributes Emergencies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

We will allow for current smokers, vapers and cannabis users as long as they have not been diagnosed with COPD and have a smoking history <10 pack-years.

We will allow for COPD as long as they are:

  • never smokers/vapers/cannabis users; or
  • former or current smokers/vapers/cannabis users with normal pulmonary function tests (PFT; FEV1/FVC ratio of >70%) within 12 months of enrollment and a smoking history <10 pack-years; or
  • current or former smoker/vapers/cannabis users with obstruction on PFTs (FEV1/FVC ratio of <70%) but who demonstrate BOTH >10% acute bronchodilator reversibility AND a normal diffusing capacity both within 12 months of enrollment (stricter criteria than those used in the PREPARE trial (15) and a smoking history <10 pack-years.

Exclusion criteria

  • Patients who have seen an asthma specialist (allergist or pulmonologist) for asthma in the past 2 years
  • Diagnosis of other pulmonary diseases (e.g., COPD, interstitial lung disease, etc.)

Treatment and study plan

ER-Initiated Telehealth Referral

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Proportion of Participants Experiencing an Additional Asthma Exacerbation Within 3 Months After Emergency Department Discharge

    Time frame: Within 3 months after emergency department discharge

    A secondary asthma exacerbation will be identified using electronic health record documentation of an asthma related emergency department visit, hospitalization, or need for systemic corticosteroids within 3 months after discharge. The outcome will be reported as the proportion of participants experiencing at least one exacerbation.

  2. Change in Asthma Control Test (ACT) Score From Baseline to 3 Months

    Time frame: Within 3 months after emergency department discharge

    Asthma control will be assessed using the Asthma Control Test (ACT), a validated 5 item questionnaire with scores ranging from 5 to 25, where higher scores indicate better asthma control. The outcome will be reported as the change in ACT score from baseline to 3 months.

  3. Improvement in quality of life via Asthma Symptom Utility Index (ASUI)

    Time frame: Within 3 months after emergency department discharge

    Measure will be taken through the Asthma Symptom Utility Index (ASUI), an 11-item questionnaire, adminstered during the ER visit and at three month follow up. The summary score is continuous, ranging from 0 to 1.

  4. Adherence to Controllers (MARS5)

    Time frame: Within 3 months after emergency department discharge

    The MARS5 questionnaire is a 5-item self-report questionnaire assessing adherence to treatments like controllers, scoring from 5 (low) to 25 (high). It measures behaviors such as forgetting, altering, stopping, or skipping doses, with a score of or often indicating high adherence.

  5. Repeat ER visits

    Time frame: Within 3 months after emergency department discharge

    Repeat ER visits for asthma

  6. Asthma hospitalizations

    Time frame: Within 3 months after emergency department discharge

    Participants who are hospitalized for asthma.

Other outcomes

  1. Patient subjective experience with asthma care after ER visit, assessed using a structured qualitative interview

    Time frame: Within 3 months of emergency department discharge

    This outcome will be assessed using a semi structured qualitative interview developed for this study, conducted at the 3 month follow up call. The tool includes open ended questions designed to qualitatively evaluate participant's subjective asthma care experience after the ER visit. Themes assessed include:

    • Confusion about the asthma controller therapy regimen
    • Biologic therapy initiation or recommendations
    • Controller medication use
    • Diagnostic workup understanding
    • Whether participants report being offered information about clinical research opportunities in asthma

    Responses will be transcribed and thematically coded. The unit of measure will be the number of participants expressing each predefined theme.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda McNamara, BA, LPN

CONTACT

[email protected]

813-396-2729

Sponsors and collaborators

Lead sponsor

Juan Carlos Cardet

Other

Collaborators

  • Sanofi
  • Tampa General Hospital
  • University of South Florida

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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