Clinical Trials Directory

Trials / Completed

CompletedNCT04676490

The RECORD-ED Pilot Study

Recordable Cards for Optimizing Outcomes and Reducing Disparities After ED Discharge

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
160 (actual)
Sponsor
Seattle Children's Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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. 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.

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.

Conditions

Interventions

TypeNameDescription
OTHERRECORD-ED CardLow-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.
OTHERRECORD-ED Patient PortalAudio recorded, language concordant discharge instructions via patient portal

Timeline

Start date
2020-12-15
Primary completion
2022-08-11
Completion
2022-08-11
First posted
2020-12-21
Last updated
2023-11-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04676490. Inclusion in this directory is not an endorsement.