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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Discharge Care | No Intervention | Usual ED discharge care | |
| RECORD-ED Card | Experimental | Usual care, plus a physical greeting card-style card with audio discharge instructions (English or Spanish) recorded on it |
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| RECORD-ED Patient Portal | Experimental | Usual care, plus access to audio-recorded discharge instructions (English or Spanish) through the patient portal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECORD-ED Card | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol feasibility | [The protocol will be determined to be feasible if the following criteria are met:
| 3 months after ED visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Main pilot RCT: This study will enroll children and their parents who meet the following criteria:
Parent interviews: Parents will be eligible for the qualitative interviews if they meet the following criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42001451 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 15, 2023 | |
| Reset | Feb 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 15, 2023 | Feb 5, 2024 |
This is behavioral intervention
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| RECORD-ED Patient Portal | Other | Audio recorded, language concordant discharge instructions via patient portal |
|
| 2 days after |
| 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) | 2 days after ED visit |
| 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. | 1 week after ED visit |
| 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. | 1 week after ED visit |
| 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. | Within 3 days of ED visit |
| 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. | 3 months after ED visit |
| 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. | 3 months after ED visit |
| 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 | 2 days after ED visit |