Hospital to Home Transition for Childhood Asthma

(H2H Trial)

Recruiting at 1 trial location

Overseen By Alicia Mathis

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Kavita Parikh

Disqualifiers: Diabetes, Sickle cell, Heart disease, others

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

Compensation: Varies

Number of Visits: 20

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to better support children with asthma after hospital discharge. It examines whether an "asthma navigator" can help families manage asthma care more effectively than standard support. Participants will receive either standard care or additional guidance through the Hospital to Home Transition (H2H) program, addressing asthma challenges at home and school over a year. Families with children aged 4-12 who have been hospitalized for asthma, reside in the DC, Maryland, or Virginia area, and speak English or Spanish may be eligible to join. As an unphased trial, this study offers families the chance to contribute to innovative asthma care strategies that could enhance daily life for children with asthma.

Do I need to stop my child's current medications for this asthma trial?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that this Hospital to Home Transition is safe for children with asthma?

A previous study showed that the Hospital to Home Transition (H2H) program is both practical and well-received, meaning it was easy to implement and appreciated by patients and families. Importantly, no reports of serious side effects emerged from the program.

The main feature of the H2H program is the use of asthma navigators. These trained professionals help families manage asthma care after leaving the hospital. They work closely with doctors, schools, and families to ensure children follow their asthma action plans.

Since the study is labeled "Not Applicable" for a specific phase, it likely focuses on testing the program's approach rather than a new drug. This suggests the intervention centers on coordinating care, which tends to be safer as it involves guidance rather than new medications.

Overall, the H2H program appears well-tolerated, with no major safety concerns identified so far. This could reassure families considering participation in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hospital to Home Transition (H2H) program for childhood asthma because it offers a personalized, hands-on approach that goes beyond the typical standard of care. Most current treatments focus on medication and in-hospital care, but H2H provides a multi-component support system that includes an asthma navigator. This navigator helps families manage asthma care at home and maintains communication with primary care doctors and school nurses. By addressing challenges in the child's daily environment, this approach aims to reduce hospital readmissions and improve overall asthma management for children.

What evidence suggests that the Hospital to Home Transition (H2H) intervention is effective for childhood asthma?

Research has shown that the Hospital to Home Transition (H2H) program, which participants in this trial may receive, can assist children with asthma after hospital discharge. Early studies indicate that initiating detailed care planning while a child is still hospitalized is feasible and appreciated by families. This approach aims to enhance children's healthcare use and asthma management at home, potentially reducing emergency visits and hospital readmissions. Evidence also suggests that home monitoring of asthma, a component of the H2H program, can cut emergency visits and hospital stays by about half. This improvement means children could manage their asthma better and enjoy a higher quality of life. ^{1 3 6 7 8}

Who Is on the Research Team?

Kavita Parikh, MD MSHS

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking caregivers living in DC, Maryland, or Virginia with a child aged 4-12 hospitalized due to asthma. Caregivers must be at least 18 years old.

Inclusion Criteria

My child, aged 4-12, is hospitalized for asthma.

Your residence is within the District of Columbia, Maryland, or Virginia area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During hospital admission

1 visit (in-person)

Baseline Data Collection

Baseline data will be collected from caregivers during the child's hospital admission for asthma exacerbation

During hospital admission

1 visit (in-person)

Intervention

Intervention arm receives standard of care plus asthma navigator support post-discharge

12 months

Up to 15 contacts (mixed in-person and virtual)

Control

Control arm receives standard of care post-discharge

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Data collection at 3, 6, 9, and 12 months (in-person or via telehealth)

What Are the Treatments Tested in This Trial?

Interventions

• Hospital to Home Transition (H2H)

Trial Overview The study tests a 'Hospital to Home' (H2H) program where after hospital discharge, one group gets standard care while the other also receives support from an asthma navigator. Participants are randomly assigned to these groups.

How Is the Trial Designed?

Group I: Hospital to Home Transition (H2H) Experimental Treatment 1 Intervention

The intervention for this study is a multi-component navigation-supported intervention for children hospitalized with asthma. Navigators will work with families for 12-months post-discharge. Trained asthma educator/navigators will work to address challenges with asthma care after discharge; will include maximum 15 contacts/12 months. The asthma navigators within this study will attempt to maintain direct contact with participants primary care doctors through email, fax, and/or postal mail as means for delivering asthma action plans, prescription updates, and patient appointment scheduling. The asthma navigators for intervention participants will attempt to maintain contact with the school nurse in efforts to have a line of communication with the school. Asthma navigators will assist families in all home-based needs pertaining to their child's asthma.

Group II: Standard of Care Active Control 1 Intervention

Control arm will receive the standard of care (SOC) after hospital discharge.

Who Is Running the Clinical Trial?

Kavita Parikh

Lead Sponsor

Trials

1

Recruited

340+

Published Research Related to This Trial

From 2000 to 2016, the incidence of adverse drug events related to anti-asthmatic medications in hospitalized children increased significantly, from 5.3 to 21.6 per 1000 discharges, indicating a growing concern for safety in pediatric asthma treatment.

Children aged 0-4 years experienced the most dramatic rise in adverse events from bronchodilators, highlighting the need for careful monitoring and management of asthma medications in this vulnerable age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Drug Events Related to Common Asthma Medications in US Hospitalized Children, 2000-2016. Xie, L., Gelfand, A., Mathew, MS., et al.[2022]

Caregivers of children with asthma highlighted significant challenges in managing asthma care after hospital admissions, including unclear follow-up pathways and inconsistent advice, which can lead to readmissions.

They proposed effective solutions such as personalized Written Asthma Action Plans, early access to preventer medications, and improved community-based asthma support services to enhance care and potentially reduce future hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding caregiver perspectives on challenges and solutions to pediatric asthma care for children with a previous hospital admission: a multi-site qualitative study. Jones, R., Turner, B., Perera, P., et al.[2022]

A review of 71 studies found that pediatric discharge interventions, particularly those focusing on follow-up care, discharge planning, and parental education, can improve caregiver satisfaction and potentially reduce subsequent healthcare use.

Interventions that included bundled care coordination and family engagement were especially effective in lowering healthcare use for patients with chronic illnesses and neonates, suggesting targeted strategies can enhance hospital-to-home transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-to-Home Interventions, Use, and Satisfaction: A Meta-analysis. Hamline, MY., Speier, RL., Vu, PD., et al.[2023]

Home nebulisers for asthmatic children, used under hospital supervision, have led to fewer hospital admissions and a perceived improvement in asthma management by over two-thirds of parents, indicating their effectiveness.

However, there is a risk of excessive bronchodilator dosing, with some children receiving more than 10 mg of salbutamol daily; therefore, weight-related dosing and clear written instructions for parents are recommended to ensure safe use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home nebulisers in childhood asthma: survey of hospital supervised use. Bendefy, IM.[2021]

The multi-component hospital-to-home (H2H) transition program for children with asthma was found to be feasible and acceptable, with 100% of participants receiving medications at discharge and initiating school-based asthma therapy.

While the program showed high acceptability among families, it did not significantly reduce healthcare utilization compared to standard care, indicating the need for further research to assess its impact on reducing asthma-related healthcare needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes from a pilot patient-centered hospital-to-home transition program for children hospitalized with asthma. Parikh, K., Richmond, M., Lee, M., et al.[2021]

In a study of 601 children hospitalized for asthma exacerbations, the overall quality of the medical home did not correlate with readmission rates, indicating that other factors may play a more significant role in post-hospitalization outcomes.

However, children with poor access to their medical home had a higher risk of readmission, suggesting that improving access to healthcare could help reduce hospital readmissions for asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical home quality and readmission risk for children hospitalized with asthma exacerbations. Auger, KA., Kahn, RS., Davis, MM., et al.[2021]

The study successfully developed and pilot tested 8 new caregiver-reported quality measures to assess the transition of pediatric patients from hospital and emergency department to home, involving 2839 caregivers.

Results indicated that caregivers with lower educational attainment reported receiving better support for scheduling follow-up appointments, highlighting potential disparities in care transition experiences based on caregiver characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot Testing of Caregiver-Reported Pediatric Quality Measures for Transitions Between Sites of Care. Desai, AD., Burkhart, Q., Parast, L., et al.[2022]

Over 70% of children hospitalized for acute asthma exacerbations could potentially be treated successfully in alternative settings, such as short-stay units or at home, with appropriate care including supplemental oxygen and nebulized medications.

The study analyzed 2028 asthma hospitalizations and found that most children had stable oxygen saturation levels (95% or greater in 21.3% of cases) and rarely deteriorated to critical levels, suggesting that many could be safely managed outside of traditional hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How commonly are children hospitalized for asthma eligible for care in alternative settings? McConnochie, KM., Russo, MJ., McBride, JT., et al.[2019]

Adverse asthma outcomes, such as intubation and cardiopulmonary arrest, occurred in 0.48% of pediatric asthma hospitalizations, with a notable increase in frequency during the 1990s compared to 1986.

Children aged 5 to 17 years, particularly those with pneumonia as a secondary diagnosis and Asian Pacific-American children, were at a higher risk for adverse outcomes, indicating the importance of age and specific health conditions in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse asthma outcomes among children hospitalized with asthma in California. Calmes, D., Leake, BD., Carlisle, DM.[2019]

A new health systems model was developed to improve the transition of children with complex healthcare needs from hospital to home, identifying seven critical factors necessary for successful discharge based on a review of 34 sources.

The model emphasizes the importance of dynamic communication and an integrated care pathway, highlighting that current discharge processes are often ineffective due to static responses and missing critical success factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconceptualizing children's complex discharge with health systems theory: novel integrative review with embedded expert consultation and theory development. Noyes, J., Brenner, M., Fox, P., et al.[2018]

Caregivers of children with congenital heart defects, particularly hypoplastic left heart syndrome (HLHS), experience significant stress and anxiety during the transition from hospital to home care, highlighting the emotional challenges they face.

Many parents reported difficulties with feeding their child and acquiring necessary medical skills, indicating a need for better support and resources to assist caregivers during these critical transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' perceptions during the transition to home for their child with a congenital heart defect: How can we support families of children with hypoplastic left heart syndrome? March, S.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32664809/

Outcomes from a pilot patient-centered hospital-to-home ... Conclusion: These pilot data suggest that comprehensive care coordination initiated during the inpatient stay is feasible and acceptable. A larger trial is ...

2. researchgate.net researchgate.net/publication/342959579_Outcomes_from_a_Pilot_Patient-Centered_Hospital-to-Home_Transition_Program_for_Children_Hospitalized_with_Asthma

Outcomes from a Pilot Patient-Centered Hospital-to-Home ... Primary outcomes included feasibility and acceptability. Secondary outcomes included healthcare utilization, asthma morbidity, and caregiver quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5327498/

Care transition interventions for children with asthma in the ... This review summarizes the evidence regarding care transition interventions originating in the ED for children with uncontrolled asthma.

4. publications.aap.org publications.aap.org/pediatrics/article/136/6/e1602/33889/Improving-Pediatric-Asthma-Care-and-Outcomes

Improving Pediatric Asthma Care and Outcomes Across ... Overall, improved asthma outcomes occurred without any increase in hospital resource use and no change in PICU transfer or death. At community ...

5. ersnet.org ersnet.org/news-and-features/news/children-with-asthma-who-use-at-home-monitoring-are-half-as-likely-to-need-hospital-care/

Children with asthma who use at-home monitoring are half ... Children with asthma who use at-home monitoring are around half as likely to visit the emergency department or be hospitalised, ...

6. withpower.com withpower.com/trial/hospital-to-home-transition-for-childhood-asthma-d624b

Hospital to Home Transition for Childhood Asthma (H2H Trial) The H2H medical study, being run by Kavita Parikh, is evaluating whether Hospital to Home Transition (H2H) will have tolerable side effects & efficacy for ...

7. policylab.chop.edu policylab.chop.edu/project/managing-health-children-asthma-hospital-community

Managing the Health of Children with Asthma from ... - PolicyLab Prior research has shown that only 60% to 75% of children with persistent asthma fill a prescription for controller medications over an entire year and the ...

8. publications.aap.org publications.aap.org/pediatrics/article/136/6/e1539/33897/The-Family-Perspective-on-Hospital-to-Home

The Family Perspective on Hospital to Home Transitions Hospital-level compliance with asthma care quality measures at children's hospitals and subsequent asthma-related outcomes. JAMA . 2011.