Telehealth-Enhanced Asthma Care for Home After the Emergency Room

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)
  TEACH-ER aims to provide primary care management and educational support for families managing childhood asthma throughout the transition from emergency department to home, and includes several core components: 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 (when possible), featuring provider prompts for gu
• Поведенческое Enhanced Care (EC)
  Similar to children in the TEACH-ER group, participants in the EC group will receive a symptom assessment using NHLBI guidelines, a recommendation for appropriate preventive medications, and asthma education materials given at the time of the ED visit. After baseline and randomization, we will send the child's PCP a symptom report with guideline-based recommendations for preventive care and recommend a follow-up visit with the PCP. We will also give all providers a summary of the current nationa

Первичные конечные точки

• Number of asthma-related hospitalizations and emergency department visits after discharge [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Symptom-Free Days (SFD) in the past 2 weeks [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
• Caregiver-reported Asthma control (NHLBI) [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
• Missed school due to asthma in the past 2 weeks [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
• Missed work due to asthma in the past 2 weeks [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
• Caregiver-reported Medication adherence [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
• Caregiver quality of life [Срок оценки: [Time Frame: 2 months, 4 months, 6 months]]

Критерии участия

Inclusion Criteria (all criteria must be met):

• Physician diagnosis of asthma, based on review of medical records and/or caregiver report.
• Current emergency visit for an acute asthma exacerbation, requiring treatment with rescue medication.
• Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following:

• >2 days/wk with asthma symptoms in the past month,
• >2 days/wk with rescue medication use in the past month,
• >2 days/month with nighttime symptoms in the past month (vs. 1-2 nights per month if 3-4 years old), or
• ≥1 other episode of asthma during the past year that required systemic corticosteroids (vs. during the past 6 months if 3-4 years old).
• Child age between ≥3 and ≤12 years.
• Child and caregiver live in the greater Rochester, NY metropolitan area (Monroe, Wayne, Ontario, Livingston, Genesee, and Orleans Counties)
• Emergency severity index triage scores of 2-5 (total range 1-5; scores of 1 indicate the highest acuity and likelihood of hospitalization).

Критерии исключения

• An inability to speak and understand English. Parents (and children) with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.
• No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible location). If a subject does not have access to an appropriate device for Zoom visits at home, we will provide a device with required data plan.
• Other significant medical conditions, including cystic fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
• Children in foster care or other situations in which consent cannot be obtained from a legal guardian.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Rochester Medical Center — Rochester

Идентификаторы

NCT: NCT05844891 · 00008286 · R01HL169466

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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