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

Primary Purpose

Asthma in Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)
Enhanced Care (EC)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma in Children

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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 Monroe County, NY. Exclusion Criteria: An inability to speak and understand either English or Spanish. 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.

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telehealth-Enhanced Asthma Care for Home After the Emergency Room

Enhanced Care (EC) Comparison Group

Arm Description

New model of patient-centered asthma management.

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.

Outcomes

Primary Outcome Measures

Number of asthma-related hospitalizations and emergency department visits after discharge
Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record

Secondary Outcome Measures

Symptom-Free Days (SFD) in the past 2 weeks
The number of 24-hour periods within the previous 14 days that a child remained free of asthma symptoms (range: 0-14 days); a higher score indicates more days without symptoms. Reported by caregivers during scheduled telephone assessments.
Caregiver-reported Asthma control (NHLBI)
Asthma control over the past 1 month, as based on caregiver report of recent symptoms, activity limitation, and medication use during scheduled telephone assessments.
Missed school due to asthma in the past 2 weeks
We will ask caregivers to report how many days of school the child missed (if any) during the previous 2 weeks due to their asthma (range: 0-14 days).
Missed work due to asthma in the past 2 weeks
We will ask caregivers to report how many days of work the caregiver missed (if any) during the previous 2 weeks due to their child's asthma (range: 0-14 days).
Caregiver-reported Medication adherence
Recent adherence with prescribed controller therapy as reported by caregivers during scheduled telephone assessments using the Medication Adherence Report Scale (5-25 points; higher scores indicate higher levels of reported adherence).
Caregiver quality of life
The Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ) is a well-established, validated measure of caregiver quality of life over the previous 1 week, as reported by caregivers during scheduled telephone assessments (score range: 1-7 points; 1 indicates severe impairment, 7 indicates no impairment).

Full Information

First Posted
April 21, 2023
Last Updated
August 15, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT05844891
Brief Title
Telehealth-Enhanced Asthma Care for Home After the Emergency Room
Acronym
TEACH-ER
Official Title
Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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), 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Research assistants conducting telephone follow-up assessments 3, 6, 9, and 12 months after enrollment will be blinded to group allocation.
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth-Enhanced Asthma Care for Home After the Emergency Room
Arm Type
Experimental
Arm Description
New model of patient-centered asthma management.
Arm Title
Enhanced Care (EC) Comparison Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)
Intervention Description
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, 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. Virtual visits will be completed using the Zoom platform on smartphones or other compatible devices. We anticipate that all three telehealth visits (1 provider visit, 2 educator visits) will be completed within 2 months of enrollment.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Care (EC)
Intervention Description
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 national guidelines. We will provide systematic feedback to the family and child's PCP at intervals that parallel the TEACH-ER group's telemedicine assessments. This feedback will include prompting caregivers to schedule a recommended follow-up appointment with the PCP, and encouraging providers to adhere to the NHLBI guidelines. While participants will not be blinded to their group allocation, they will be told that they are randomly assigned to two different ways of approaching asthma management.
Primary Outcome Measure Information:
Title
Number of asthma-related hospitalizations and emergency department visits after discharge
Description
Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Symptom-Free Days (SFD) in the past 2 weeks
Description
The number of 24-hour periods within the previous 14 days that a child remained free of asthma symptoms (range: 0-14 days); a higher score indicates more days without symptoms. Reported by caregivers during scheduled telephone assessments.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Caregiver-reported Asthma control (NHLBI)
Description
Asthma control over the past 1 month, as based on caregiver report of recent symptoms, activity limitation, and medication use during scheduled telephone assessments.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Missed school due to asthma in the past 2 weeks
Description
We will ask caregivers to report how many days of school the child missed (if any) during the previous 2 weeks due to their asthma (range: 0-14 days).
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Missed work due to asthma in the past 2 weeks
Description
We will ask caregivers to report how many days of work the caregiver missed (if any) during the previous 2 weeks due to their child's asthma (range: 0-14 days).
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Caregiver-reported Medication adherence
Description
Recent adherence with prescribed controller therapy as reported by caregivers during scheduled telephone assessments using the Medication Adherence Report Scale (5-25 points; higher scores indicate higher levels of reported adherence).
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Caregiver quality of life
Description
The Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ) is a well-established, validated measure of caregiver quality of life over the previous 1 week, as reported by caregivers during scheduled telephone assessments (score range: 1-7 points; 1 indicates severe impairment, 7 indicates no impairment).
Time Frame
[Time Frame: 2 months, 4 months, 6 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Monroe County, NY. Exclusion Criteria: An inability to speak and understand either English or Spanish. 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.
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telehealth-Enhanced Asthma Care for Home After the Emergency Room

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