Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuan Carlos Cardet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Asthma diagnosis ≥1 year
Seen in ER for asthma exacerbation
Persistent asthma on controller therapy
Disqualifiers
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.)
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
Trial design
Design model
Parallel
Treatments tested in this trial
ER-Initiated Telehealth Referral
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Usual Care ArmNo intervention 0 interventions
Trial outcomes
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.
Time frame
Within 3 months after emergency department dischargeSecondary outcomes
1
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 discharge2
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 discharge3
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 discharge4
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 dischargeOther outcomes
1
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 dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Juan Carlos Cardet
Lead sponsor
University of South Florida
Sponsor institution
Tampa General Hospital
Collaborator
University of South Florida
Collaborator
Sanofi
Collaborator
Source ClinicalTrials.gov