Asthma Acute, Asthma Attack
Conditions
Keywords
Asthma flare-up, Asthma management, remote clinic, pulmonologist
Brief summary
Asthma exacerbations leading to emergency department visits or hospitalization are associated with a high risk of recurrent exacerbations, poor disease control, and increased healthcare utilization in the months following discharge. Early specialist follow-up during this vulnerable transition period remains limited, and many patients do not receive optimized long-term asthma management. The purpose of this study is to evaluate whether a structured remote asthma clinic intervention initiated shortly after hospital discharge can reduce recurrent exacerbations and improve asthma-related outcomes compared to standard community care. This prospective randomized study will enroll 220 adult patients (18-75 years) presenting to the emergency department at Tel Aviv Sourasky Medical Center with an asthma exacerbation. Participants will be randomly assigned to one of two groups: 1. Intervention group - will undergo two structured remote pulmonology follow-up visits via secure video consultation within 7-21 days and 5 months after discharge, including treatment optimization, inhaler technique assessment, and self-management education. 2. Control group - will continue standard community care without additional intervention. All participants will complete scheduled follow-up assessments over 12 months, including evaluation of exacerbations, asthma control, healthcare utilization, and medication use.
Detailed description
Data collection: Participants will be followed for 12 months after enrollment. In the intervention group, remote clinic visits will be conducted 7-21 days after discharge and again 5 months after enrollment. In addition, follow-up phone calls will be conducted at 3 months, 9 months, and 12 months after enrollment. The control group will undergo follow-up phone calls at the same assessment time points, without remote clinic intervention. Data collected will include recurrent exacerbations, systemic corticosteroid use, emergency department visits, hospitalizations, medication changes, rescue inhaler use, and asthma symptom burden assessed using the Asthma Control Test (ACT). Participants will be randomized to their respective intervention groups using a secure system of sequentially numbered, opaque, sealed envelopes (SNOSE) containing the treatment assignments. To maintain strict allocation concealment and minimize selection bias, the entire randomization process will be managed exclusively by an independent study coordinator. The principal investigators and clinical research team members directly involved in participant enrollment, care, and data collection will have no involvement in the generation, maintenance, or opening of the assignment envelopes. The independent coordinator will open the designated envelope only after a participant has successfully completed the baseline assessment and met all eligibility criteria. Sample Size Calculation: Based on preliminary data, the average exacerbation rate during the first 3 months is expected to be 0.25 exacerbations per patient in the control group and 0.10 in the intervention group. To detect this difference with 80% power and a significance level of 0.05, 100 participants are required in each group. Assuming a 10% loss to follow up, the planned sample size is 220 participants (110 participants per group).
Interventions
OTHERFollow-up in a remote flare-up clinic
Participants assigned to the intervention group will undergo two structured remote pulmonology visits via secure video consultation, conducted 7-21 days and 5 months after discharge following an asthma exacerbation. The intervention will include assessment of asthma control and exacerbation history, inhaler technique evaluation, treatment optimization, and asthma self-management education according to current guidelines. Additional follow-up phone assessments will be conducted at 3, 9, and 12 months for study outcome evaluation only.
Sponsors
Tel-Aviv Sourasky Medical Center
The Dalia and Eli Hurvitz Foundation Grant
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data collection during the phone-calls in both groups will be conducted by personnel blinded to group allocation. All outcomes will be filled in a similar form without identifying information and stored in a combined folder for both the intervention and control groups. Data will be entered to the study database by personnel blinded to group allocation. The statistical analysis will be performed by a statistician blinded to group allocation.
Intervention model description
For inclusion, all patients presenting to the emergency department at Tel Aviv Sourasky Medical Center with an asthma exacerbation will be identified weekly using the institutional electronic medical records system (Chameleon). The diagnosis of asthma exacerbation and eligibility for enrollment will be verified by a study pulmonologist. Eligible patients will be contacted by the research coordinator within one week of discharge, provided with information regarding the study, and asked for preliminary agreement to participate. Following informed consent, participants will undergo 1:1 randomization to either the intervention or control group using sealed identical envelopes prepared in advance. The intervention group will participate in structured remote pulmonology visits conducted 7-21 days and 5 months after discharge, while the control group will continue standard community care with follow-up assessments only.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Presentation to the emergency department with an asthma exacerbation. * Ability to complete telephone follow-up and access to a personal e-mail account. * Agreement to participate in the study. * Written or verbal informed consent according to study group assignment.
Exclusion criteria
* Uncontrolled cardiac disease. * Any other uncontrolled medical condition. * Inability to complete telephone follow-up. * Pregnancy. * Patients lacking decision-making capacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Exacerbations Rate | From enrollment to 3 months | The primary outcome will be the rate of severe asthma exacerbations, assessed as the total number of severe asthma exacerbations following enrollment divided by the number of participants in each study group. The primary analysis will be performed according to the intention-to-treat principle. severe asthma exacerbations defined as worsening asthma requiring treatment with systemic glucocorticoids for at least 3 days or worsening symptoms leading to an emergency department visit or hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Arrival due to asthma exacerbations | From enrollment to 3 months | The rate of asthma exacerbations leading to hospital arrival between the intervention and control. |
| Change in Asthma Control Test (ACT) score | From enrollment to 3 months | Change in asthma control score from baseline to 3 months between the intervention and control. Values range 5-25, with higher scores indicating better control. |
| Adherent to Treatment Guidelines | From enrollment to 3 months | Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control. This will be defined as the percentage of patients taking the GINA-recommended inhaled corticosteroid dose, as self-reported in the 3-months follow-up. |
| Percentage of ≥1 asthma exacerbations | From enrollment to 3 months | The percentage of patients in each study groups that had ≥1 asthma exacerbations. |
| Asthma Exacerbations Rate - extended follow-up | From enrollment to 12 months | The primary outcome will be the rate of severe asthma exacerbations, assessed as the total number of severe asthma exacerbations following enrollment divided by the number of participants in each study group. The primary analysis will be performed according to the intention-to-treat principle. severe asthma exacerbations defined as worsening asthma requiring treatment with systemic glucocorticoids for at least 3 days or worsening symptoms leading to an emergency department visit or hospitalization. |
| Hospital Arrival due to asthma exacerbations - extended follow-up | From enrollment to 12 months | The rate of asthma exacerbations leading to hospital arrival between the intervention and control. |
| Change in Asthma Control Test (ACT) score - extended follow-up | From enrollment to 12 months | Change in asthma control score from baseline to 12 months between the intervention and control. Values range 5-25, with higher scores indicating better control. |
| Adherent to Treatment Guidelines - extended follow-up | From enrollment to 12 months | Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control. This will be defined as the percentage of patients taking the GINA-recommended inhaled corticosteroid dose, as self-reported in the 12-months follow-up. |
| Exacerbation Frequency | From 12 months prior to enrollment through 12 months following enrollment. | Change in exacerbation frequency during the first year following enrollment compared to the year prior to study enrollment, defined as the percentage change in the rate of severe asthma exacerbations before and after the intervention. |
| Percentage of ≥1 asthma exacerbations - extended follow-up | From enrollment to 12 months | The percentage of patients in each study groups that had ≥1 asthma exacerbations. |
Countries
Israel
Contacts
CONTACTAmir Bar-Shai
Outcome results
None listed