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

May 22, 2026 updated by: Juan Carlos Cardet

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Amanda McNamara, BA, LPN
  • Phone Number: 813-396-2729
  • Email: Alett1@usf.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  1. never smokers/vapers/cannabis users; or
  2. 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
  3. 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm

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
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.
No Intervention: Usual Care Arm

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 months after emergency department discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Within 3 months after emergency department discharge
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.
Within 3 months after emergency department discharge
Repeat ER visits
Time Frame: Within 3 months after emergency department discharge
Repeat ER visits for asthma
Within 3 months after emergency department discharge
Asthma hospitalizations
Time Frame: Within 3 months after emergency department discharge
Participants who are hospitalized for asthma.
Within 3 months after emergency department discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 months of emergency department discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Carlos Cardet

Collaborators

Sanofi
University of South Florida
Tampa General Hospital

Investigators

  • Principal Investigator: Juan C Cardet, MD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORIGINS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

The IPD and supporting information will be available for 15 years after the conclusion of this study.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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