Clinical trial NCT04676490: The RECORD-ED Pilot Study
Official title: Recordable Cards for Optimizing Outcomes and Reducing Disparities After ED Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is behavioral intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol feasibility
timeFrame: 3 months after ED visit
Secondary outcomes:
measure: Instruction recall
timeFrame: 2 days after
measure: Comfort with home care
timeFrame: 2 days after ED visit
measure: PCP follow-up
timeFrame: 1 week after ED visit
measure: Asthma Caregiver Quality of Life
timeFrame: 1 week after ED visit
measure: Provider-rated intervention acceptability
timeFrame: Within 3 days of ED visit
measure: Child asthma control
timeFrame: 3 months after ED visit
measure: ED and hospital re-visits
timeFrame: 3 months after ED visit
measure: Medication adherence
timeFrame: 2 days after ED visit
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
References: