Recruiting

Telehealth Approach

Sponsor:

Juan Carlos Cardet

Code:

NCT07396987

Conditions

Asthma Attack

Asthma Control

Asthma Exacerbations

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ER-Initiated Telehealth Referral

Study Details

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

Study ID

NCT07396987

Start date

Jul 19, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Exclusion Criteria:

  • Patients who have seen an asthma specialist (allergist or pulmonologist) for asthma in the past 1 year
  • Diagnosis of other pulmonary diseases (e.g., COPD, interstitial lung disease, etc.)

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:

  • never smokers/vapers/cannabis users;
  • former or current smokers/vapers/cannabis users with normal PFTs with FEV1/FVC >=70% documented in a medical record within 36 months of the enrollment date
  • former or current smoker/vapers/cannabis users with obstruction noted on PFTs (i.e., FEV1/FVC <70%) but who demonstrates BOTH acute bronchodilator reversibility (i.e., >10% increase in either FEV1%predicted or FVC% predicted) AND have a normal diffusing capacity (DLCO)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amanda McNamara, BA, LPN

813-396-2729Alett1@usf.edu

Locations

Tampa General Hospital Emergency Room

Recruiting

Tampa, Florida, United States, 33606

Contacts

Hope Brunner, RN, BSN

813-844-7289hbrunner@tgh.org

More Information

Sponsor

Juan Carlos Cardet

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Juan Carlos Cardet on 2026-09-14.