Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Juan Carlos Cardet
- Enrollment
- 40
- Primary Endpoint
- Proportion of Participants Completing an Asthma Specialist Follow-Up Visit Within 3 Months After Emergency Department Discharge
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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:
- •never smokers/vapers/cannabis users; or
- •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
- •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.)
Arms & Interventions
Intervention Arm
Participants will receive two components:
- Emergency Room (ER) staff will directly contact the asthma specialist's scheduling team to arrange a follow-up appointment within 1-3 weeks.
- 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.
Intervention: ER-Initiated Telehealth Referral (Behavioral)
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Proportion of Participants Experiencing an Additional Asthma Exacerbation Within 3 Months After Emergency Department Discharge(Within 3 months after emergency department discharge)
- Change in Asthma Control Test (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)(Within 3 months after emergency department discharge)
- Adherence to Controllers (MARS5)(Within 3 months after emergency department discharge)
- Repeat ER visits(Within 3 months after emergency department discharge)
- Asthma hospitalizations(Within 3 months after emergency department discharge)
Investigators
Juan Carlos Cardet
Associate Professor - Research, College of Medicine Internal Medicine
University of South Florida