Telehealth for Childhood Asthma

(TEACH-ER Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Daily controller

Disqualifiers: Cystic fibrosis, Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

430 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators propose a randomized controlled trial of Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) vs. enhanced care (EC). TEACH-ER includes: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (Zoom) when possible, featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. The investigators will enroll 430 children (ages 3-12 yrs) from the two dedicated pediatric EDs in our region, and follow all participants for a 12-month period. The investigators will call caregivers to complete blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge. The investigators will assess the effectiveness of TEACH-ER in reducing the need for additional asthma-related ED visits or hospitalizations in the 1-months after enrollment. Additional outcomes of interest include asthma symptoms, medication adherence, absenteeism from work and school, quality of life, and the delivery of care consistent with national asthma care guidelines.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems likely that participants will continue their current asthma medications, as the study focuses on enhancing asthma care.

What data supports the effectiveness of the treatment Enhanced Care (EC), Psychoeducational and Supportive Intervention, Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) for childhood asthma?

Research shows that telemedicine programs can reduce emergency room visits and improve daily living activities for asthma patients. Additionally, tailored asthma education in emergency settings can increase confidence in managing asthma and reduce urgent care visits. ^{1 2 3 4 5}

Is telehealth for childhood asthma safe for children?

The research articles reviewed do not provide specific safety data for telehealth interventions for childhood asthma, but they do suggest that educational programs and self-management strategies are generally safe and can reduce emergency room visits and hospitalizations. ^{5 6 7 8 9}

How is the TEACH-ER treatment for childhood asthma unique?

The TEACH-ER treatment is unique because it uses telehealth to enhance asthma care at home after an emergency room visit, focusing on facilitating follow-up care and promoting guideline-based management, which is different from traditional in-person follow-ups. ^{2 7 10 11 12}

Eligibility Criteria

This trial is for children aged 3-12 with persistent asthma or poor control, living in Monroe County, NY. They must have had an emergency visit for acute asthma and be on a daily controller medication as per NHLBI guidelines. Excluded are those who can't understand English or Spanish, lack phone access, are in foster care without guardian consent, or have other significant medical conditions.

Inclusion Criteria

Child and caregiver live in Monroe County, NY

My child is between 3 and 12 years old.

I have asthma that requires daily medication.

Exclusion Criteria

I do not have major health issues like cystic fibrosis or serious heart disease that could affect asthma assessments.

No access to a working phone for follow-up surveys

Children in foster care or other situations in which consent cannot be obtained from a legal guardian

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Education and Discharge

Brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications

1 day

1 visit (in-person)

Telehealth Follow-up

Virtual primary care follow-up within 1 week of discharge using in-home telemedicine, featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans

1 week

1 visit (virtual)

Continued Virtual Visits

Two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices

2 weeks

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment through blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge

12 months

4 visits (telephone)

Treatment Details

Interventions

• Enhanced Care (EC)
• Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)

Trial Overview The study compares TEACH-ER—a telehealth program including education in the ER, virtual follow-ups with home medication delivery—and Enhanced Care (EC). It aims to see if TEACH-ER reduces further emergency visits/hospitalizations over a year and improves symptoms, adherence to medication, quality of life and guideline-based care.

Participant Groups

Group I: Telehealth-Enhanced Asthma Care for Home After the Emergency Room Experimental Treatment 1 Intervention

New model of patient-centered asthma management.

Group II: Enhanced Care (EC) Comparison Group Active Control 1 Intervention

Standard emergency department care for asthma exacerbations, enhanced through a report of recent symptoms sent to PCPs, and systematic feedback on asthma management/care at intervals that parallel the TEACH-ER group's telemedicine assessments.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A tailored self-management intervention delivered in the pediatric emergency department significantly increased caregivers' confidence in managing their child's asthma 14 days after the intervention.

The intervention group had more well-asthma visits and fewer urgent care or emergency department visits at 9 months, particularly among children with intermittent asthma, indicating potential long-term benefits of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering tailored asthma family education in a pediatric emergency department setting: a pilot study. Sockrider, MM., Abramson, S., Brooks, E., et al.[2019]

The telemedicine-based program (TEAM-ED) significantly improved follow-up visits and preventive care actions for children with asthma after an emergency department visit, with 91% of participants attending at least one telemedicine visit.

While TEAM-ED showed better follow-up and preventive medication use, it did not lead to overall improvements in asthma morbidity or medication adherence, highlighting the need for ongoing management support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Telemedicine Enhanced Asthma Management through the Emergency Department (TEAM-ED) Program on Asthma Morbidity: A Randomized Controlled Trial. Halterman, JS., Fagnano, M., Tremblay, P., et al.[2023]

A telemedicine system for monitoring asthma at home significantly reduced emergency room visits and improved daily living activities for patients at high risk of hospitalization over a six-month period.

Patients using the telemedicine system successfully measured and transmitted their peak expiratory flow (PEF) values, leading to noticeable improvements in their PEF, indicating effective asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tele-medicine system for high-risk asthmatic patients]. Kokubu, F., Suzuki, H., Sano, Y., et al.[2006]

A follow-up clinic for asthma patients in the emergency department significantly reduced the number of unscheduled visits for asthma care, with an average of 1.39 visits in the intervention group compared to 2.34 in the control group, indicating improved management of asthma.

Patients who attended the follow-up clinic showed better compliance with inhaled corticosteroid use and reported improved quality of life, with more patients experiencing no limitations in daily activities and functional quality of life after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved asthma outcomes in a high-morbidity pediatric population: results of an emergency department-based randomized clinical trial. Teach, SJ., Crain, EF., Quint, DM., et al.[2022]

In a study of 107 children with asthma visiting emergency departments, 38% of the visits were deemed potentially avoidable due to inadequate prehospital treatment, highlighting a significant gap in self-management practices.

The presence of a Written Asthma Action Plan (WAAP) did not independently reduce the likelihood of avoidable visits, suggesting that additional strategies, such as improving asthma education and developing electronic self-management tools, are needed to enhance care and reduce emergency visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoidable Emergency Visits for Acute Asthma in Children: Prevalence and Risk Factors. Beydon, N., Cochez, M., Mahut, B., et al.[2022]

In a study of 140 children aged 2-16 with asthma, interactive education during hospitalization led to significantly fewer hospitalizations (10.1% vs 22.5%) compared to didactic education at 6 months, indicating its potential effectiveness in reducing severe asthma episodes.

While there were no differences in emergency department visits between the two education methods, the interactive group showed improved inhaler technique and better patient-reported asthma symptoms and quality of life at 12 months, suggesting that interactive education may enhance long-term asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Inpatient Asthma Education: A Randomized Controlled Trial. Samady, W., Rodriguez, VA., Gupta, R., et al.[2022]

A self-management program for asthmatic children, involving 26 participants aged 2 to 14, led to significantly fewer hospitalizations and emergency room visits, demonstrating its efficacy in managing asthma.

The educational intervention resulted in tenfold less school absenteeism and improved understanding and compliance with asthma management, indicating that effective education can enhance treatment outcomes for children with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching self-management skills to asthmatic children and their parents in an ambulatory care setting. Fireman, P., Friday, GA., Gira, C., et al.[2018]

An educational program aimed at reducing emergency room visits for asthma in 253 children did not succeed in its goal, as both the experimental and control groups still had significant ER visits in the year following the intervention.

Specifically, the experimental group had 55 ER visits from 24 patients, while the control group had 39 visits from 18 patients, indicating that the educational approach did not effectively lower emergency care usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a patient education program on emergency room use for inner-city children with asthma. Shields, MC., Griffin, KW., McNabb, WL.[2022]

A bedside asthma education program was implemented for high-risk children at a children's hospital, involving 45 minutes of individualized education and a follow-up call, aimed at reducing repeat emergency department visits and hospitalizations.

Despite the intervention, there was no significant improvement in repeat emergency department utilization or hospitalizations among the 698 children who received the education compared to a matched control group over a 12-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A matched-cohort evaluation of a bedside asthma intervention for patients hospitalized at a large urban children's hospital. Davis, AM., Benson, M., Cooney, D., et al.[2021]

The study involved 10 pediatric patients with persistent asthma who used an Internet-based telehealth system to monitor their medication adherence and asthma control, showing significant improvement in inhaler technique scores during the second study period.

Caregivers reported improved quality of life for patients in the virtual education group, and the telehealth system effectively reduced emergency department visits and hospital admissions, indicating its efficacy and acceptance among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based store-and-forward video home telehealth system for improving asthma outcomes in children. Chan, DS., Callahan, CW., Sheets, SJ., et al.[2019]

Telemedicine in school settings for asthma education showed positive or neutral effects on quality of life and self-management behaviors for children, with no reported negative effects from the interventions.

Clinical outcomes related to asthma management, such as airway inflammation and medication use, had mixed results, indicating that while some improvements were noted, further validation of these telemedicine methods is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedical Asthma Education and Health Care Outcomes for School-Age Children: A Systematic Review. Culmer, N., Smith, T., Stager, C., et al.[2021]

The interactive computer-assisted asthma education program (PEMT) was well-received by children in the emergency department, with 81% finding it very easy to use and 75% expressing a willingness to use it again.

After participating in the PEMT program, children showed a significant 13% improvement in their knowledge about asthma management, indicating its effectiveness as an educational tool in acute care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study to evaluate self initiated computer patient education in children with acute asthma in pediatric emergency department. Joshi, A., Lichenstein, R., Rafei, K., et al.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

Delivering tailored asthma family education in a pediatric emergency department setting: a pilot study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of the Telemedicine Enhanced Asthma Management through the Emergency Department (TEAM-ED) Program on Asthma Morbidity: A Randomized Controlled Trial. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

[Tele-medicine system for high-risk asthmatic patients]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Improved asthma outcomes in a high-morbidity pediatric population: results of an emergency department-based randomized clinical trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Avoidable Emergency Visits for Acute Asthma in Children: Prevalence and Risk Factors. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Interactive Inpatient Asthma Education: A Randomized Controlled Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Teaching self-management skills to asthmatic children and their parents in an ambulatory care setting. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of a patient education program on emergency room use for inner-city children with asthma. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A matched-cohort evaluation of a bedside asthma intervention for patients hospitalized at a large urban children's hospital. [2021]

10. England pubmed.ncbi.nlm.nih.gov

An Internet-based store-and-forward video home telehealth system for improving asthma outcomes in children. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Telemedical Asthma Education and Health Care Outcomes for School-Age Children: A Systematic Review. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot study to evaluate self initiated computer patient education in children with acute asthma in pediatric emergency department. [2007]