Asthma, Asthma Attack, Asthma Control, Asthma Exacerbations
Conditions
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
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.
Interventions
BEHAVIORALER-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.
Sponsors
Juan Carlos Cardet
Tampa General Hospital
University of South Florida
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Completing an Asthma Specialist Follow-Up Visit Within 3 Months After Emergency Department Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Experiencing an Additional Asthma Exacerbation Within 3 Months After Emergency Department Discharge | 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. |
| Change in Asthma Control Test (ACT) Score From Baseline to 3 Months | 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. |
| Improvement in quality of life via Asthma Symptom Utility Index (ASUI) | 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. |
| Adherence to Controllers (MARS5) | 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. |
| Repeat ER visits | Within 3 months after emergency department discharge | Repeat ER visits for asthma |
| Asthma hospitalizations | Within 3 months after emergency department discharge | Participants who are hospitalized for asthma. |
Countries
United States
Contacts
CONTACTAmanda McNamara, BA, LPN
PRINCIPAL_INVESTIGATORJuan C Cardet, MD
University of South Florida
Outcome results
None listed