Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care

NCT05991115 | Recruiting DMC

• 1 other identifier: STUDY0699
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Caregiver-child dyads will be recruited during child's hospital admission for asthma exacerbation. Recruitment sites will be mainly Children's National Hospital Sheikh Zayed campus, as well as regional partners: Holy Cross Hospital, and Mary Washington Hospital. After enrollment, baseline data will be collected from caregiver. Caregiver-child dyads will be randomized (1:1 ratio) into the control arm or intervention arm. Control arm will receive the standard of care after hospital discharge. Intervention arm will receive the SOC plus an asthma navigator support after hospital discharge. Caregivers in both arms will complete data collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post enrollment.

Conditions

Asthma; Asthma in Children

Keywords

asthma; hospitalization; children

Outcome Measures

Primary Outcomes (1)

• Number of Re-admissions

  Asthma-related readmissions over 12-month follow-up period from index hospitalization

  3, 6, 9, 12 months

Secondary Outcomes (8)

• Number of Emergency Department (ED) Visit

  3, 6, 9, 12 months

• Asthma Control Test (ACT)

  3, 6, 9, 12 months

• Number of Household Triggers

  3, 6, 9, 12 months

• Caregiver quality of life

  3 ,6, 9, 12 months

• Symptom Free Days (SFD)

  3, 6, 9, 12 months

Other Outcomes (3)

• Sociodemographic factors

  Baseline

• Experience with Discrimination (EOD)

  Baseline

• Asthma severity

  Baseline

Study Arms (2)

Standard of Care

NO INTERVENTION

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

Hospital to Home Transition (H2H)

EXPERIMENTAL

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.

Behavioral: Hospital to Home Transition (H2H)

Interventions

Hospital to Home Transition (H2H) BEHAVIORAL

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.

Hospital to Home Transition (H2H)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• speak English or Spanish
• are at least 18 years old
• live in the District of Columbia, Maryland, or Virginia (DMV)
• have a child aged 4-12 years who is hospitalized due to asthma exacerbation.

You may not qualify if:

• Children ages 4-12 years with chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder
• Children ages 4-12 years involved in interventions with behavioral component and/or novel asthma therapeutics will be excluded given overlap with the current intervention
• Children ages 4-12 years in foster care
• Families not residing in the DMV
• Caregivers who do not speak English or Spanish

Sponsors & Collaborators

• Kavita Parikh: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Hospital to Home Transition

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kavita Parikh, MD MSHS

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kavita Parikh, MD MSHS

CONTACT

2024766366; kparikh@childrensnational.org

Alicia Mathis

CONTACT

2024764698; anewcome@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: January 22, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)