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Not yet recruiting NCT07396987

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

No phase Interventional Asthma Attack Asthma Control Asthma Exacerbations Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ER-Initiated Telehealth Referral.
Who it may be relevant to
Registry conditions: Asthma Attack, Asthma Control, Asthma Exacerbations, Asthma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 corticost

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]
Secondary outcome measures (6)
  • Proportion of Participants Experiencing an Additional Asthma Exacerbation Within 3 Months After Emergency Department Discharge [Time frame: Within 3 months after emergency department discharge]
  • Change in Asthma Control Test (ACT) Score From Baseline to 3 Months [Time frame: Within 3 months after emergency department discharge]
  • Improvement in quality of life via Asthma Symptom Utility Index (ASUI) [Time frame: Within 3 months after emergency department discharge]
  • Adherence to Controllers (MARS5) [Time frame: Within 3 months after emergency department discharge]
  • Repeat ER visits [Time frame: Within 3 months after emergency department discharge]
  • Asthma hospitalizations [Time frame: Within 3 months after emergency department discharge]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter
  • Ugalde IC, Ratigan A, Merriman C, Cui J, Ericson B, Busse P, Carroll JK, Casale T, Celedon JC, Coyne-Beasley T, Fagan M, Fuhlbrigge AL, Villarreal GG, Hernandez PA, Jariwala S, Kruse J, Maher NE, Manning B, Mosnaim G, Nazario S, Pace WD, Phipatanakul W, Pinto-Plata V, Riley I, Rodriguez-Louis J, Salciccioli J, Shenoy K, Shields JB, Tarabichi Y, Sosa BT, Wechsler ME, Wisnivesky J, Yawn B, Israel E, PMID 37490981
  • Maldonado-Puebla M, Akenroye A, Busby J, Cardet JC, Louisias M. Pharmacoequity in Allergy-Immunology: Disparities in Access to Medications for Allergic Diseases and Proposed Solutions in the United States and Globally. J Allergy Clin Immunol Pract. 2024 Feb;12(2):272-280. doi: 10.1016/j.jaip.2023.11.005. Epub 2023 Nov 10. PMID 37951413
  • Patadia R, Casale TB, Fowler J, Patel S, Cardet JC. Advancements in biologic therapy in eosinophilic asthma. Expert Opin Biol Ther. 2024 Apr;24(4):251-261. doi: 10.1080/14712598.2024.2342527. Epub 2024 Apr 23. PMID 38619468
  • Inselman JW, Jeffery MM, Maddux JT, Shah ND, Rank MA. Trends and Disparities in Asthma Biologic Use in the United States. J Allergy Clin Immunol Pract. 2020 Feb;8(2):549-554.e1. doi: 10.1016/j.jaip.2019.08.024. Epub 2019 Aug 28. PMID 31472294
  • National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. PMID 17983880
  • Carr T, Tkacz J, Chung Y, Ambrose CS, Spahn J, Rane P, Wang Y, Lindsley AW, Lewing B, Burnette A. Gaps in Care Among Uncontrolled Severe Asthma Patients in the United States. J Allergy Clin Immunol Pract. 2024 Jul;12(7):1775-1782.e2. doi: 10.1016/j.jaip.2024.03.018. Epub 2024 Mar 18. PMID 38508336
  • Ortega H, Bharmal N, Khatri S. Primary care referral patterns for patients with asthma: analysis of real-world data. J Asthma. 2023 Mar;60(3):609-615. doi: 10.1080/02770903.2022.2082308. Epub 2022 Jun 6. PMID 35620831

Identifiers

NCT: NCT07396987 · ORIGINS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗