An interventional study of ER-Initiated Telehealth Referral in Asthma Attack, Asthma Control and Asthma Exacerbations, sponsored by Juan Carlos Cardet. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Juan Carlos Cardet · Not applicable, Interventional, and Health services research
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →This is the only study on the registry with Juan Carlos Cardet as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
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.
Time frame: Within 3 months after emergency department discharge
Proportion of Participants Experiencing an Additional Asthma Exacerbation 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.
Time frame: Within 3 months after emergency department discharge
Change in Asthma Control Test (ACT) Score From Baseline to 3 Months
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.
Time frame: Within 3 months after emergency department discharge
Improvement in quality of life via Asthma Symptom Utility Index (ASUI)
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.
Time frame: Within 3 months after emergency department discharge
Adherence to Controllers (MARS5)
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.
Time frame: Within 3 months after emergency department discharge
Repeat ER visits
Repeat ER visits for asthma
Time frame: Within 3 months after emergency department discharge
Asthma hospitalizations
Participants who are hospitalized for asthma.
Time frame: Within 3 months after emergency department discharge
Patient subjective experience with asthma care after ER visit, assessed using a structured qualitative interview
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.
Time frame: Within 3 months of emergency department discharge
Plan to share: Yes — All collected IPD
Supporting information: Study protocol, Statistical analysis plan
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
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