Telehealth Education for Asthma Connecting Hospital and Home (TEACHH) Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Asthma-related hospitalizations and emergency department visits after discharge
Study Overview
Brief Summary
The goal of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a technology-enhanced educational intervention for caregivers and children who are hospitalized due to asthma. We will conduct a pilot RCT with 60 children (5-13 yrs) hospitalized with asthma at the Golisano Children's Hospital in Rochester, NY. After baseline assessment, subjects will be randomized to either: 1) the Telehealth Education for Asthma Connecting Hospital and Home (TEACHH) intervention, which includes inpatient child/caregiver education using pictorial materials, color/shape labels for home medications (green star=controller, yellow/red circles=rescue), and a pair of in-home, smartphone-based telehealth visits after discharge to reinforce effective home management; or, 2) the standard care (SC) condition, which features standard inpatient education and routine outpatient follow-up. Patients in TEACHH will also receive all SC measures. All caregivers will complete blinded telephone follow-up assessments at 2, 4, and 6 months after discharge; children will be asked medication questions at baseline and 6 months. We will describe the feasibility and acceptability of implementing the TEACHH intervention by reviewing process measure data collected throughout the study; assess the preliminary efficacy of TEACHH in improving key clinical outcomes, including asthma-related ACU at 7 days, 30 days, and 6 months (per electronic health record documentation) and symptom-free days at each follow-up (reported by caregivers); and assess secondary clinical and functional outcomes including asthma-related quality of life, missed school or work due to asthma, caregiver and child medication knowledge, and reported adherence. We will also invite all caregivers to complete a semi-structured qualitative interview (1 month after baseline for the TEACHH group, 6 months after baseline for the SC group). Findings from this work will establish a strong foundation for a full-scale trial, and guide future efforts to deliver guideline-based asthma care to underserved children and families at the greatest risk for preventable morbidity.
Detailed Description
Study Design:
The investigators propose a 2-year pilot randomized trial of the TEACHH intervention vs. Standard Care (SC). We will enroll 60 children (5-13 years) with persistent asthma who are hospitalized at a tertiary care children's hospital with an acute asthma exacerbation. These children will be systematically screened, and those eligible approached for enrollment. After enrollment, participants will be randomly assigned to TEACHH or SC. We will measure feasibility continuously, and measure preliminary efficacy at 2, 4, and 6 months after enrollment. All caregivers will be invited to complete an additional in-depth interview to solicit feedback on the TEACHH intervention, and better understand family experiences with asthma management, educational support, and unmet home needs. We aim to conduct at least 20 interviews among caregivers in the TEACHH group, and 20 interviews among caregivers in the SC group.
Subjects and Setting:
Children aged 5-13 years will be screened for eligibility following admission to the Golisano Children's Hospital, a tertiary care institution in Rochester, NY. Eligibility will require persistent asthma severity (as per national guidelines) and a primary or secondary hospital diagnosis of asthma. We plan to enroll 60 children and caregiver dyads over a 12-month period. The mean length of stay at GCH for children with primary or secondary diagnoses of asthma is 3.8 days (1.9 days for primary diagnoses), ensuring ample time for study procedures. According to hospital census data, 386 children 5-13 years old with asthma are admitted for inpatient asthma care each year (128 primary diagnoses, 258 secondary diagnoses). We anticipate that at least 75% of these children (~290) will have persistent asthma symptoms and will be eligible for the pilot study, and we aim to enroll approximately 28% of the eligible children hospitalized within a 12-month timeframe.
These ages were chosen because: 1) younger children suffer the largest burden of asthma morbidity, 2) young children are at high risk for inadequate therapy for asthma, 3) children at age 5y are beginning to participate in medicine use, and 4) children in their mid-teenage have different medical and developmental needs compared to younger children, with different co-management roles with their parents that shift toward increased independence. The pictorial lessons, hands-on interactive demonstration of medication technique, and application of stickers to medications are all developmentally appropriate activities for this group of children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
Research assistants conducting telephone follow-up assessments 2, 4, and 6 months after enrollment will be blinded to group allocation.
Eligibility Criteria
- Ages
- 5 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(all 4 criteria must be met):
- •Physician diagnosis of asthma, based on review of medical records.
- •Inpatient admission to GCH with asthma as a primary or secondary diagnosis.
- •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 per week with asthma symptoms in the past month;
- •>2 days per week with rescue medication use in the past month;
- •>2 days per month with nighttime symptoms in the past month; or
- •≥1 other episode(s) of asthma during the past year that required systemic corticosteroids
- •Age between ≥5 and ≤11 years.
Exclusion Criteria
- •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 survey assessments.
- •No access to a smartphone (or other 'smart' device) for telehealth education.
- •Another significant medical condition, including Cystic Fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with assessment of asthma-related measures.
- •A diagnosed developmental condition (e.g. Autism spectrum disorder or significant developmental delay) identified in the child's medical record that could interfere with a child's ability to participate in teaching activities, and/or potentially delay the transition of responsibility for inhaled asthma medications from caregiver to child.
- •If the child or family is currently enrolled in a study conducted by The Preventive Care Program for Urban Children with Asthma (led by Dr. Jill Halterman).
Arms & Interventions
Telehealth Education for Asthma Connecting Hospital and Home (TEACHH)
New model of patient-centered asthma education
Intervention: Telehealth Education for Asthma Connecting Hospital and Home (Behavioral)
Standard Care (SC) Comparison Group
Standard inpatient asthma education per hospital protocol.
Intervention: Standard Care (SC) Comparison Group (Behavioral)
Outcomes
Primary Outcomes
Asthma-related hospitalizations and emergency department visits after discharge
Time Frame: 6 months after discharge
Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record.
Symptom-Free Days (SFD) in the past 2 weeks
Time Frame: 6 months
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 (2, 4, and 6 months after discharge)
Asthma-related hospitalizations and emergency department visits after discharge
Time Frame: 7 days after discharge
Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record.
Asthma-related hospitalizations and emergency department visits after discharge
Time Frame: 30 days after discharge
Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record.
Symptom-Free Days (SFD) in the past 2 weeks
Time Frame: 2 months
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 (2, 4, and 6 months after discharge)
Symptom-Free Days (SFD) in the past 2 weeks
Time Frame: 4 months
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 (2, 4, and 6 months after discharge)
Secondary Outcomes
- Caregiver quality of life(2 months, 4 months, 6 months)
- Missed school due to asthma in the past 2 weeks(2 months, 4 months, 6 months)
- Missed work due to asthma in the past 2 weeks(2 months, 4 months, 6 months)
- Caregiver-reported Asthma-related Acute Care Utilization (ACU)(7 days, 30 days, and 6 months after discharge)
- Caregiver-reported Asthma control (NHLBI)(2 months, 4 months, and 6 months)
- Caregiver-reported Medication adherence(2 months, 4 months, 6 months)
- Caregiver-reported Asthma-related outpatient care(2 months, 4 months, and 6 months)
Investigators
Sean Frey
Assistant Professor
University of Rochester
