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临床试验/NCT07396987
NCT07396987招募中不适用

Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation

Juan Carlos Cardet1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Proportion of Participants Completing an Asthma Specialist Follow-Up Visit Within 3 Months After Emergency Department Discharge

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Asthma diagnosis ≥1 year
  • Seen in ER for asthma exacerbation
  • Persistent asthma on controller therapy
  • ≥1 asthma exacerbation in prior year

排除标准

  • 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)

研究组 & 干预措施

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.

Intervention Arm

Experimental

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.

干预措施: ER-Initiated Telehealth Referral (Behavioral)

结局指标

主要结局

Proportion of Participants Completing an Asthma Specialist Follow-Up Visit Within 3 Months After Emergency Department Discharge

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Juan Carlos Cardet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Juan Carlos Cardet

Associate Professor - Research, College of Medicine Internal Medicine

University of South Florida

研究点 (1)

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