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

ConditionsAsthma Asthma in Children

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age4-12

SponsorKavita Parikh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

. 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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

340 Participants

are divided into 2 treatment groups

Group A: Standard of CareNo intervention 0 interventions

Group B: Hospital to Home Transition (H2H)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of Re-admissions

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

Time frame

3, 6, 9, 12 months

Secondary outcomes

Number of Emergency Department (ED) Visit

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

Time frame

3, 6, 9, 12 months

Asthma Control Test (ACT)

Asthma Control Test (ACT) which is 7 questions with scores ranging from 0 to 27. Score less than 19 means that asthma is not well-controlled.

Time frame

3, 6, 9, 12 months

Number of Household Triggers

Questionnaire from home visit program. Includes exposures in the home, specifically: birds, cats, dogs, dust, eats in Bedroom, tobacco smoke, fireplace/wood burning stove/heat source, incense/candles, mice/rats, roaches/waterbugs, mold/mildew smell;water damage, perfume, other.

Time frame

3, 6, 9, 12 months

Caregiver quality of life

Pediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ) which includes 13-items; includes feelings about child's asthma symptoms (9 items), level of concern about child's asthma (4 items); uses a 7-point Likert scale.Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. The result will be expressed as a mean score per item for each of the domains, as well as for the overall quality of life. Higher score means better outcome.

Time frame

3 ,6, 9, 12 months

Other outcomes

Sociodemographic factors

Age, Gender, Martial Status, Race, Ethnicity, Socioeconomic status, Occupation, Education, Household size, Number of asthma caregivers, English Proficiency, and Health Literacy

Time frame

Baseline

Experience with Discrimination (EOD)

Survey includes experiences with discrimination and situations of unfair treatment asking about frequency as well as the specific situation. Validated close-format questions used in diverse racial/ethnic groups.

Time frame

Baseline

Asthma severity

Asthma severity will be measured by NIH classification of Intermittent, Persistent mild, Persistent moderate, Persistent severe.

Time frame

Baseline