Telehealth Education for Asthma Connecting Hospital and Home
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

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 Procedures:

      Screening Procedures: Screening will occur in a rolling fashion from November 2021 through
      the end of October 2022. The investigators will identify potentially eligible children
      through a daily review of the inpatient census at the Golisano Children's Hospital. To be
      included in this study, children (5-13 years old) need to have (1) a physician diagnosis of
      asthma; (2) inpatient admission to the Golisano Children's Hospital with asthma as a primary
      or secondary diagnosis; and (3) persistent asthma or poor asthma control for which daily
      controller therapy is recommended by NHLBI guidelines. Caregivers will also need to have
      access to a smartphone (or similar device) for telehealth education. Dr. Frey will conduct a
      brief review of the patient's chart to determine whether key eligibility criteria are met (no
      known language barriers, no other significant medical or developmental conditions). Remaining
      eligibility criteria outlined above will be assessed during a brief screening visit with
      caregivers in the hospital.

      Baseline Assessment: The baseline survey assessment will be conducted following enrollment by
      Dr. Frey or his research assistant within the child's hospital room or another comfortable,
      private inpatient setting. All survey instruments will be available in English, and questions
      will be read aloud to the caregiver and child. Although most questions will be posed to
      caregivers, children will also be asked several questions about their medications.

      Randomization: After the baseline assessment, children will be randomly assigned to TEACHH or
      SC using a permuted block design to ensure an equal balance of children in each group over
      time. The URMC Biostatistics Center will develop the randomization scheme independently, and
      randomization will be implemented electronically via REDCapTM. All families will receive
      information on community resources for asthma management, addressing home asthma triggers,
      and smoking cessation. A letter describing study participation will be sent to each child's
      PCP.

      TEACHH Intervention

      Medicine Availability: All patients will have an albuterol MDI and spacer at the bedside per
      inpatient protocol. All subjects will have persistent asthma and should also be treated with
      a daily controller medication. We will ask inpatient providers to transmit controller
      prescriptions to the hospital outpatient pharmacy, which can send filled prescriptions to
      inpatient wards for labeling and teaching. If no prescriptions are needed, we will ask
      caregivers to bring controller medications from home. If controller medications are not
      available in the hospital, we will use practice inhalers for inpatient TEACHH activities and
      ensure proper medication labeling at the first virtual follow-up (below).

      Inpatient asthma education, medication labeling, and smartphone set-up: A dedicated asthma
      educator will deliver inpatient education prior to discharge. We will use Zoom, an encrypted,
      HIPAA-compliant web-based program, for follow-up education and home management support. All
      major elements (teaching materials, medication labels, Zoom telehealth visits) have been
      successfully field tested. The inpatient session will include:

        1. "Let's Take Control of Asthma," a brief, scripted overview of asthma, medications, and
           action plans that uses visual imagery to communicate essential teaching points.

        2. Written information to support home management, including: a) pictorial instructions for
           using MDIs with a spacer; and b) a pictorial asthma action plan.

        3. Color- and shape-coded stickers to distinguish controller and rescue medications (green
           star=controller, yellow/red circles=rescue). Labels will be applied by patients with
           caregiver assistance. Caregivers will apply matching labels to action plans for home
           reference when labeling refills. Additional labels will be provided for home. Teach-back
           will be used to ensure caregiver and child understanding of when to use each medicine.

        4. A demonstration of correct technique for using inhaled medications. Teach-back and
           show-back methods will be used to verify comprehension.

        5. Prior to discharge, the educator will help families download, install, and log in to
           Zoom from a smartphone or other available smart device (e.g., tablet).

      Two videoconferencing sessions will be completed 2-4 days and 3 weeks after discharge by the
      same inpatient educator; timing will align with guideline recommendations for follow-up after
      hospitalization. Preferred times for visits will be reviewed prior to discharge. These visits
      are meant to supplement, not replace, recommended PCP follow-up visits.

      First visit (2-4 days after discharge): This visit will reinforce key points of home
      management. The educator will show digital images from "Let's Take Control of Asthma," and
      review action plans, color/shape labels (including any medicines that were not available
      during hospitalization), and inhalation technique. Teach back will be used.

      Second visit (3 weeks after discharge): This visit will emphasize ongoing management after an
      acute exacerbation, including continued use of controller medication and how to request and
      label refills. Session checklists will ensure that all components are delivered; ≥20% of
      sessions will be recorded and reviewed by the PI to assure fidelity and provide feedback.

      Standard Care (SC) comparison condition:

      Patients in the SC group will receive standard impatient management, including pre-recorded
      asthma education videos shown prior to discharge and the hospital action plan. PCP follow-up
      with be scheduled within a week of discharge. All SC measures will also be provided to
      subjects randomized to TEACHH.

      Follow-Up Assessments:

      The study, including all follow-up assessments, will continue throughout the 2022 calendar
      year and the first several months of 2023. We will follow subjects for a total of 6 months.
      After the baseline assessment, caregivers will complete 3 telephone-based surveys conducted
      2-, 4-, and 6-months after discharge by a research assistant who is blinded to group
      allocation. Each assessment will repeat key measures from the baseline. We will use the
      electronic medical record (EMR) to review ACU and prescription fill data. To maintain
      blinding, we will not ask children about medications (indications for use, techniques) until
      the 6-month follow-up.

      In-Depth Interviews:

      Caregivers in both arms will also be invited to participate in semi-structured interviews.
      All caregivers will be eligible to participate in this, however we aim to complete 40
      interviews altogether. The interview guide will explore family experiences with managing
      asthma at home, experiences with asthma education and management support before the index
      hospitalization, and caregiver opinions on support received during the index hospitalization
      with specific emphasis on components of the TEACHH intervention. Interviews will be conducted
      over Zoom (or by telephone if preferred), and audio recordings will be transcribed. Thematic
      analysis will be conducted on interview transcripts until saturation is achieved within both
      the TEACHH and SC groups; we anticipate completing 20 interviews in each group, that will
      take approximately 30-45 minutes to complete. In order to best capture feedback on the TEACHH
      intervention, we will interview caregivers randomized to this group approximately 1 month
      after enrollment (about 1 week after the second virtual visit). We plan to interview
      caregivers in the SC group after the final follow-up assessment, approximately 6 months after
      enrollment. During interviews with the SC group, we will show educational materials from the
      TEACHH intervention to solicit feedback.
    

Intervention name(s): Telehealth Education for Asthma Connecting Hospital and Home; Standard Care (SC) Comparison Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): TEACHH aims to provide educational support to families managing childhood asthma throughout the transition from hospital to home, and includes several core components: 1) Health literacy-informed inpatient teaching for child and caregiver including pictorial materials, hands-on demonstration, and use of teach-back/show-back techniques; 2) Facilitated identification of rescue and controller medications using color- and shape-coded medication labels and a pictorial asthma action plan; and 3) A pair of virtual follow-up visits after discharge to reinforce inpatient teaching and support families during the shift from acute exacerbation to preventive care management. Virtual visits will be completed using the Zoom platform on smartphones or other compatible devices, 2-4 days after discharge (first visit) and 3 weeks after discharge (second visit). All intervention activities will be completed within 1 month of discharge.; Patients in the SC group will receive standard impatient management, including pre-recorded asthma education videos shown prior to discharge and the hospital action plan. PCP follow-up with be scheduled within a week of discharge. All SC measures will also be provided to subjects randomized to TEACHH.
Other intervention name(s): TEACHH
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot randomized controlled trial using a parallel design, in which subjects are randomized to one of two different arms
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research