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Asthma in ChildrenNCT04676490

The RECORD-ED Pilot Study

A study testing RECORD-ED Card and RECORD-ED Patient Portal in people with Asthma in Children, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this pilot randomized trial, the investigators will evaluate the feasibility, acceptability, and potential family-centered outcomes associated with providing asthma discharge instructions in audio-recorded format in addition to written format, compared to written instructions alone. Read more about this study

Who is it for?
Any age
Conditions the study is for
Asthma in Children
What is being tested?
RECORD-ED Card and RECORD-ED Patient Portal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
15 Dec 2020to 11 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Main pilot RCT: This study will enroll children and their parents who meet the following criteria:

  • child age 10 years old or younger
  • child with public or no insurance
  • child being discharged home from the ED with discharge instructions for asthma/reactive airways disease
  • parent with a preferred language for medical care of English or Spanish
  • parent/caregiver present in the ED is child's legal guardian
  • parent reports access to a telephone (including landline or non-smartphone) for completing follow-up surveys

Parent interviews: Parents will be eligible for the qualitative interviews if they meet the following criteria:

  • enrolled in pilot RCT
  • randomized to RECORD-ED arm
  • completed second follow-up survey within 10 days of ED visit and can complete interview within 14 days of visit
  • parent language, literacy (based on single item literacy screener question), and previous experience with ED visits for asthma will be used to purposively sample an even number of English- and Spanish-speaking parents

Provider and nurse surveys: Providers and nurses in the ED will be eligible for the post-visit survey if they meet the following criteria:

-involved in caring for an enrolled patient, randomized to either intervention arm, around the time of discharge

Provider and nurse interviews: Providers and nurses will be eligible for an interview if they meet the following criteria:

-involved in discharge for 1 or more patients in either intervention arm over the past month, with at least one in the past 14 days

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Seattle Children's

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Recordable Cards for Optimizing Outcomes and Reducing Disparities After ED Discharge

In this pilot randomized trial, the investigators will evaluate the feasibility, acceptability, and potential family-centered outcomes associated with providing asthma discharge instructions in audio-recorded format in addition to written format, compared to written instructions alone. The study will enroll 100 families of children being discharged home from an emergency department visit, who prefer either English or Spanish for medical care, and assess outcomes at 3 time-points.

Read the detailed description

This pilot randomized controlled trial seeks to test the feasibility and acceptability of providing and evaluating outcomes associated with audio-recorded, language concordant ED discharge instructions (the RECORD-ED intervention) among low-income parents of children treated for an asthma exacerbation. The study will enroll 100 children and their parent/caregiver with low income and/or limited English proficiency (LEP) who are being discharged home from the emergency department (ED) with a diagnosis of asthma; 20 will be randomized to receive usual discharge care, 40 will receive a physical card with audio-recorded discharge instructions, in addition to usual care, and another 40 will receive access to audio-recorded instructions through the patient portal in addition to usual care. The study team will also send a brief survey to providers and nurses in the ED about the intervention, and conduct qualitative interviews with parents and nurses about their experiences using the recordable cards for discharge instructions. Primary outcomes will focus on feasibility and acceptability of the intervention and outcome ascertainment protocols, as recommended for pilot studies. Parents will complete surveys at 3 time points. Parent outcomes (instruction recall, adherence, comfort with home care, caregiver quality of life), child outcomes (asthma control, including rescue medication use and school absence if age-appropriate), and follow-up utilization (primary care follow-up, 3-month ED and hospital re-visits) will be collected to inform planning for the subsequent R01 proposal.

Being tested
RECORD-ED Card, RECORD-ED Patient Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RECORD-ED CardOther

    Low-cost and low-tech recordable audio card containing language-concordant discharge instructions for families of children under age 10 presenting to the ED for asthma exacerbations with no or public insurance and a preference for English or Spanish. Recordable cards allow for multiple audio reviews of the instructions by multiple caregivers without dependence on access to the internet or smartphone technologies.

  • RECORD-ED Patient PortalOther

    Audio recorded, language concordant discharge instructions via patient portal

Study groups in NCT04676490
Study groupRoleWhat they receive
Usual Discharge CareNo interventionUsual ED discharge care
RECORD-ED CardExperimentalUsual care, plus a physical greeting card-style card with audio discharge instructions (English or Spanish) recorded on it
Receives: Other: RECORD-ED Card
RECORD-ED Patient PortalExperimentalUsual care, plus access to audio-recorded discharge instructions (English or Spanish) through the patient portal
Receives: Other: RECORD-ED Patient Portal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Protocol feasibility

    [The protocol will be determined to be feasible if the following criteria are met:

    • successful enrollment of 100 families over 15 months
    • participant retention >70% through 3 follow-up surveys
    • successful ascertainment of parent, child, and utilization outcomes, with <10% of data missing for each outcome (from among those who completed the relevant survey).]

    Measured: 3 months after ED visit

Secondary outcomes (8)
  1. Instruction recall

    Caregiver-reported discharge instructions, in 5 domains (home care, medications [including over-the-counter], expected illness progression, follow-up, and return precautions), will be compared to chart-abstracted instructions and coded for concordance (fully or mostly concordant (3), partially concordant (2), minimally concordant (1), or wrong/ not concordant (0)). Overall instruction recall concordance will be calculated as the percent of domains that were fully or mostly concordant.

    Measured: 2 days after

  2. Comfort with home care

    These 8 caregiver-reported care transition items pertain to having received enough information; knowing warning signs; understanding how to manage the child's care; knowing who to call; the child being healthy enough to go home; having an easily understood plan; understanding the purpose of each medication; and understanding how much and how often to give each medication. Responses are on a Likert scale, from "strongly disagree" (1) to "strongly agree" (5)

    Measured: 2 days after ED visit

  3. PCP follow-up

    Caregivers will be asked to report on any visits to the PCP since the ED visit, and whether the visit was specifically for the condition that prompted the initial ED visit. The response will be coded as yes or no.

    Measured: 1 week after ED visit

  4. Asthma Caregiver Quality of Life

    We will use the Pediatric Asthma Caregiver's Quality of Life Questionnaire to measure the current impact of the child's asthma symptoms and management on caregiver QoL. This 13-item measure captures asthma-related caregiver stress, uncertainty, sleep disruption and activity limitation; it is associated with child asthma control and life stress, and exhibits good responsiveness to intervention.

    Measured: 1 week after ED visit

  5. Provider-rated intervention acceptability

    We will use the 4-item Acceptability of Intervention measure to capture nurses' and providers' assessment of the acceptability of a recordable card for discharge instructions. Responses are using a 5-point Likert scale. The survey to assess this measure will be brief and anonymous, sent to nurses and providers recorded as having been part of discharge for families randomized to the intervention arm.

    Measured: Within 3 days of ED visit

  6. Child asthma control

    Child asthma control will be measured using the Test for Respiratory and Asthma Control in Kids (TRACK, age <=4 years) or the Asthma Therapy Assessment Questionnaire (ATAQ, age 5-10 years) control domain, depending on child age at enrollment. The TRACK includes 5 questions assessing parent-reported symptoms, nighttime awakenings, activity interference, rescue medication use, and oral corticosteroid use. It produces a scale score (0-100), with scores <80 indicating poorly controlled asthma. The ATAQ control domain includes 7 questions, each dichotomously scored and summed, assessing parent-reported symptoms, nighttime awakenings, activity interference, rescue medication use, and missed school. It produces scores 0-7, with higher scores reflecting worse asthma control.

    Measured: 3 months after ED visit

  7. ED and hospital re-visits

    Number of visits to ED and/or overnight hospital stays since index ED visit; collected via parent-report and from administrative data.

    Measured: 3 months after ED visit

  8. Medication adherence

    This outcome is coded as correct or incorrect, based on comparing parent-reported actual medication administration (elicited through detailed interview prompts) to EMR-abstracted instructions

    Measured: 2 days after ED visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completion11 Aug 2022
  4. Study completion11 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is behavioral intervention
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04676490
Sponsor's protocol ID
STUDY00002727
Status last verified
Nov 2023
First submitted
15 Dec 2020
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Burns B, Senturia K, Garcia Y, Hartford E, Brown JC, Wingfield E, Lion KC, O'Connor MR. Equitable Discharge Teaching During COVID-19: Paediatric Emergency Nurses' Perspectives From Qualitative Interviews. J Adv Nurs. 2026 Apr 19:10.1111/jan.70604. doi: 10.1111/jan.70604. Online ahead of print.

    PubMed 42001451

Questions about this trial

What is this clinical trial studying?

A study testing RECORD-ED Card and RECORD-ED Patient Portal in people with Asthma in Children, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protocol feasibility (time frame: 3 months after ED visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04676490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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