The RECORD-ED Pilot Study

NCT04676490 | Completed

• 1 other identifier: STUDY00002727
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Protocol feasibility

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

  3 months after ED visit

Secondary Outcomes (8)

• Instruction recall

  2 days after

• Comfort with home care

  2 days after ED visit

• PCP follow-up

  1 week after ED visit

• Asthma Caregiver Quality of Life

  1 week after ED visit

• Provider-rated intervention acceptability

  Within 3 days of ED visit

Study Arms (3)

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

Other: RECORD-ED Card

RECORD-ED Patient Portal

EXPERIMENTAL

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

Other: RECORD-ED Patient Portal

Interventions

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.

RECORD-ED Card

RECORD-ED Patient Portal OTHER

Audio recorded, language concordant discharge instructions via patient portal

RECORD-ED Patient Portal

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's

Seattle, Washington, 98105, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is behavioral intervention

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 15, 2020
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)