The RECORD-ED Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-08-11

Brief Summary

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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.

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Detailed Description

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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

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is behavioral intervention

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Discharge Care

Usual ED discharge care

Group Type NO_INTERVENTION

No interventions assigned to this group

RECORD-ED Card

Usual care, plus a physical greeting card-style card with audio discharge instructions (English or Spanish) recorded on it

Group Type EXPERIMENTAL

RECORD-ED Card

Intervention Type 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.

RECORD-ED Patient Portal

Usual care, plus access to audio-recorded discharge instructions (English or Spanish) through the patient portal

Group Type EXPERIMENTAL

RECORD-ED Patient Portal

Intervention Type OTHER

Audio recorded, language concordant discharge instructions via patient portal

Interventions

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RECORD-ED Card

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.

Intervention Type OTHER

RECORD-ED Patient Portal

Audio recorded, language concordant discharge instructions via patient portal

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No