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

NCT07396987 | Not Yet Recruiting

• 1 other identifier: ORIGINS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma Attack; Asthma Control; Asthma Exacerbations; Asthma

Keywords

asthma; asthma exacerbation; asthma control; inhaled corticosteroid; Long-Acting Beta-Agonist; Long-Acting Muscarinic Antagonist; Emergency Room; Asthma Control Test; Medication Adherence Report Scale for Asthma; Asthma Symptom Utility Index; barriers to care; social determinants of health; access to care; telehealth; telemedicine

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Completing an Asthma Specialist Follow-Up Visit 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.

  Within 3 months after emergency department discharge

Secondary Outcomes (6)

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

  Within 3 months after emergency department discharge

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

  Within 3 months after emergency department discharge

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

  Within 3 months after emergency department discharge

• Adherence to Controllers (MARS5)

  Within 3 months after emergency department discharge

• Repeat ER visits

  Within 3 months after emergency department discharge

Other Outcomes (1)

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

  Within 3 months of emergency department discharge

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants will receive two components: 1. Emergency Room (ER) staff will directly contact the asthma specialist's scheduling team to arrange a follow-up appointment within 1-3 weeks. 2. The follow-up appointment will be conducted via telehealth (including phone calls) to assess follow-up care and asthma control of all participants. Both Arms: • All participants will be offered a prescription for twice-daily ICS/LABA (fluticasone/salmeterol) controller therapy at ER discharge after signing informed consent. These medications are standard of care for asthma. Asthma-related surveys and study-specific questionnaires, "medication side effects (open-ended)" and "follow-up care questions" will be administered during the ER visit and again at the 3-month follow-up phone call.

Behavioral: ER-Initiated Telehealth Referral

Usual Care Arm

NO INTERVENTION

Participants will receive an EMR-based referral to an outpatient allergy clinic, with the option of a telehealth or in-person visit at their discretion. This referral will be offered during the 3-month follow-up phone call to ensure clinical equipoise. Both Arms: • All participants will be offered a prescription for twice-daily ICS/LABA (fluticasone/salmeterol) controller therapy at ER discharge after signing informed consent. These medications are standard of care for asthma. Asthma-related surveys and study-specific questionnaires, "medication side effects (open-ended)" and "follow-up care questions" will be administered during the ER visit and again at the 3-month follow-up phone call.

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Juan Carlos Cardet: lead
• Tampa General Hospital: collaborator
• University of South Florida: collaborator
• Sanofi: collaborator

Related Publications (15)

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  BACKGROUND

• 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, Cardet JC. Preference for and impact of telehealth vs in-person asthma visits among Black and Latinx adults. Ann Allergy Asthma Immunol. 2023 Nov;131(5):614-627.e2. doi: 10.1016/j.anai.2023.07.012. Epub 2023 Jul 23.

  PMID: 37490981 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Yaghoubi M, Adibi A, Safari A, FitzGerald JM, Sadatsafavi M. The Projected Economic and Health Burden of Uncontrolled Asthma in the United States. Am J Respir Crit Care Med. 2019 Nov 1;200(9):1102-1112. doi: 10.1164/rccm.201901-0016OC.

  PMID: 31166782 BACKGROUND

• Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018 Mar;15(3):348-356. doi: 10.1513/AnnalsATS.201703-259OC.

  PMID: 29323930 BACKGROUND

• Dean BB, Calimlim BC, Sacco P, Aguilar D, Maykut R, Tinkelman D. Uncontrolled asthma: assessing quality of life and productivity of children and their caregivers using a cross-sectional Internet-based survey. Health Qual Life Outcomes. 2010 Sep 8;8:96. doi: 10.1186/1477-7525-8-96.

  PMID: 20825674 BACKGROUND

• Most Recent National Asthma Data: Centers for Disease Control and Prevention; 2022 [Available from: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm.

  BACKGROUND

• Taunk ST, Cardet JC, Ledford DK. Clinical implications of asthma endotypes and phenotypes. Allergy Asthma Proc. 2022 Sep 1;43(5):375-382. doi: 10.2500/aap.2022.43.220047.

  PMID: 36065106 BACKGROUND

• Ishmael L, Casale T, Cardet JC. Molecular Pathways and Potential Therapeutic Targets of Refractory Asthma. Biology (Basel). 2024 Aug 1;13(8):583. doi: 10.3390/biology13080583.

  PMID: 39194521 BACKGROUND

• Buhl R, Bel E, Bourdin A, Davila I, Douglass JA, FitzGerald JM, Jackson DJ, Lugogo NL, Matucci A, Pavord ID, Wechsler ME, Kraft M. Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion. J Allergy Clin Immunol Pract. 2022 Feb;10(2):422-432. doi: 10.1016/j.jaip.2021.10.059. Epub 2021 Nov 8.

  PMID: 34763123 BACKGROUND

MeSH Terms

Conditions

Asthma; Emergencies

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan C Cardet, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda McNamara, BA, LPN

CONTACT

813-396-2729; Alett1@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor - Research, College of Medicine Internal Medicine

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD and supporting information will be available for 15 years after the conclusion of this study.
• Access Criteria: Data will be labeled with unique deidentified codes. Only Tampa General Hospital and University of South Florida staff authorized on this or future related research would have access to the data. There are no specimens being collected for this study. Release requests will be submitted to the Principal Investigator (PI) at: Dr. Juan Carlos Cardet, MD For IRB Study # STUDY009146 409 Bayshore Blvd, 5th Floor Tampa, FL 33606 Requests should include the following information: * Purpose of the data use * Description of the data requested * Intended future research or analysis * Any associated agreements (e.g., Data Use Agreements or Material Transfer Agreements) Approvals Required: • PI Approval: The PI must review and approve the release request. Who Can Obtain Data: * Qualified Researchers: Only individuals with appropriate credentials and institutional affiliations may receive data. * External Collaborators: Must be covered under a formal agreement (e.g., IRB reliance agreement, data