Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Number of asthma-related hospitalizations and emergency department visits after discharge
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistants conducting telephone follow-up assessments 3, 6, 9, and 12 months after enrollment will be blinded to group allocation.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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).
排除标准
- •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.
研究组 & 干预措施
Telehealth-Enhanced Asthma Care for Home After the Emergency Room
New model of patient-centered asthma management.
干预措施: Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) (Behavioral)
Enhanced Care (EC) Comparison Group
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.
干预措施: Enhanced Care (EC) (Behavioral)
结局指标
主要结局
Number of asthma-related hospitalizations and emergency department visits after discharge
时间窗: 12 months
Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record
次要结局
- Caregiver-reported Asthma control (NHLBI)(Baseline, 3 months, 6 months, 9 months, 12 months)
- Missed school due to asthma in the past 2 weeks(Baseline, 3 months, 6 months, 9 months, 12 months)
- Caregiver quality of life([Time Frame: 2 months, 4 months, 6 months])
- Symptom-Free Days (SFD) in the past 2 weeks(Baseline, 3 months, 6 months, 9 months, 12 months)
- Missed work due to asthma in the past 2 weeks(Baseline, 3 months, 6 months, 9 months, 12 months)
- Caregiver-reported Medication adherence(Baseline, 3 months, 6 months, 9 months, 12 months)
研究者
Sean Frey
Associate Professor
University of Rochester