Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tampa General Hospital | OTHER |
| University of South Florida | OTHER |
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants will receive two components:
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. |
|
| Usual Care Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ER-Initiated Telehealth Referral | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 3 months after emergency department discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Responses will be transcribed and thematically coded. The unit of measure will be the number of participants expressing each predefined theme. |
Inclusion Criteria:
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda McNamara, BA, LPN | Contact | 813-396-2729 | Alett1@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Juan C Cardet, MD | University of South Florida | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26. PMID: 35213105; PMCID: PMC10367430. | ||
| 37490981 | Background | Ugalde IC, Ratigan A, Merriman C, Cui J, Ericson B, Busse P, Carroll JK, Casale T, Celedon JC, Coyne-Beasley T, Fagan M, Fuhlbrigge AL, Villarreal GG, Hernandez PA, Jariwala S, Kruse J, Maher NE, Manning B, Mosnaim G, Nazario S, Pace WD, Phipatanakul W, Pinto-Plata V, Riley I, Rodriguez-Louis J, Salciccioli J, Shenoy K, Shields JB, Tarabichi Y, Sosa BT, Wechsler ME, Wisnivesky J, Yawn B, Israel E, Cardet JC. Preference for and impact of telehealth vs in-person asthma visits among Black and Latinx adults. Ann Allergy Asthma Immunol. 2023 Nov;131(5):614-627.e2. doi: 10.1016/j.anai.2023.07.012. Epub 2023 Jul 23. |
Not provided
Not provided
All collected IPD
The IPD and supporting information will be available for 15 years after the conclusion of this study.
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:
Approvals Required:
• PI Approval: The PI must review and approve the release request.
Who Can Obtain Data:
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | Within 3 months after emergency department discharge |
| Repeat ER visits | Repeat ER visits for asthma | Within 3 months after emergency department discharge |
| Asthma hospitalizations | Participants who are hospitalized for asthma. | Within 3 months after emergency department discharge |
| Within 3 months of emergency department discharge |
| 37951413 | Background | Maldonado-Puebla M, Akenroye A, Busby J, Cardet JC, Louisias M. Pharmacoequity in Allergy-Immunology: Disparities in Access to Medications for Allergic Diseases and Proposed Solutions in the United States and Globally. J Allergy Clin Immunol Pract. 2024 Feb;12(2):272-280. doi: 10.1016/j.jaip.2023.11.005. Epub 2023 Nov 10. |
| 38619468 | Background | Patadia R, Casale TB, Fowler J, Patel S, Cardet JC. Advancements in biologic therapy in eosinophilic asthma. Expert Opin Biol Ther. 2024 Apr;24(4):251-261. doi: 10.1080/14712598.2024.2342527. Epub 2024 Apr 23. |
| 31472294 | Background | Inselman JW, Jeffery MM, Maddux JT, Shah ND, Rank MA. Trends and Disparities in Asthma Biologic Use in the United States. J Allergy Clin Immunol Pract. 2020 Feb;8(2):549-554.e1. doi: 10.1016/j.jaip.2019.08.024. Epub 2019 Aug 28. |
| 17983880 | Background | National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. |
| 38508336 | Background | Carr T, Tkacz J, Chung Y, Ambrose CS, Spahn J, Rane P, Wang Y, Lindsley AW, Lewing B, Burnette A. Gaps in Care Among Uncontrolled Severe Asthma Patients in the United States. J Allergy Clin Immunol Pract. 2024 Jul;12(7):1775-1782.e2. doi: 10.1016/j.jaip.2024.03.018. Epub 2024 Mar 18. |
| 35620831 | Background | Ortega H, Bharmal N, Khatri S. Primary care referral patterns for patients with asthma: analysis of real-world data. J Asthma. 2023 Mar;60(3):609-615. doi: 10.1080/02770903.2022.2082308. Epub 2022 Jun 6. |
| 31166782 | Background | Yaghoubi M, Adibi A, Safari A, FitzGerald JM, Sadatsafavi M. The Projected Economic and Health Burden of Uncontrolled Asthma in the United States. Am J Respir Crit Care Med. 2019 Nov 1;200(9):1102-1112. doi: 10.1164/rccm.201901-0016OC. |
| 29323930 | Background | Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018 Mar;15(3):348-356. doi: 10.1513/AnnalsATS.201703-259OC. |
| 20825674 | Background | Dean BB, Calimlim BC, Sacco P, Aguilar D, Maykut R, Tinkelman D. Uncontrolled asthma: assessing quality of life and productivity of children and their caregivers using a cross-sectional Internet-based survey. Health Qual Life Outcomes. 2010 Sep 8;8:96. doi: 10.1186/1477-7525-8-96. |
| Background | Most Recent National Asthma Data: Centers for Disease Control and Prevention; 2022 [Available from: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. |
| 36065106 | Background | Taunk ST, Cardet JC, Ledford DK. Clinical implications of asthma endotypes and phenotypes. Allergy Asthma Proc. 2022 Sep 1;43(5):375-382. doi: 10.2500/aap.2022.43.220047. |
| 39194521 | Background | Ishmael L, Casale T, Cardet JC. Molecular Pathways and Potential Therapeutic Targets of Refractory Asthma. Biology (Basel). 2024 Aug 1;13(8):583. doi: 10.3390/biology13080583. |
| 34763123 | Background | Buhl R, Bel E, Bourdin A, Davila I, Douglass JA, FitzGerald JM, Jackson DJ, Lugogo NL, Matucci A, Pavord ID, Wechsler ME, Kraft M. Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion. J Allergy Clin Immunol Pract. 2022 Feb;10(2):422-432. doi: 10.1016/j.jaip.2021.10.059. Epub 2021 Nov 8. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |