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Clinical Trials/NCT04676490
NCT04676490CompletedNot Applicable

Recordable Cards for Optimizing Outcomes and Reducing Disparities After ED Discharge

Seattle Children's Hospital2 sites in 1 country160 target enrollmentStarted: December 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
160
Locations
2
Primary Endpoint
Protocol feasibility

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Protocol feasibility

Time Frame: 3 months after ED visit

\[The protocol will be determined to be feasible if the following criteria are met: * successful enrollment of 100 families over 15 months * participant retention \>70% through 3 follow-up surveys * successful ascertainment of parent, child, and utilization outcomes, with \<10% of data missing for each outcome (from among those who completed the relevant survey).\]

Secondary Outcomes

  • Provider-rated intervention acceptability(Within 3 days of ED visit)
  • Instruction recall(2 days after)
  • Child asthma control(3 months after ED visit)
  • Asthma Caregiver Quality of Life(1 week after ED visit)
  • Comfort with home care(2 days after ED visit)
  • PCP follow-up(1 week after ED visit)
  • ED and hospital re-visits(3 months after ED visit)
  • Medication adherence(2 days after ED visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

K. Casey Lion

Principal Investigator

Seattle Children's Hospital

Study Sites (2)

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