- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195842
Audio-Recorded Discharge Instructions for LEP Parents
June 20, 2017 updated by: K. Casey Lion, Seattle Children's Hospital
Impact of Audio-Recorded Discharge Instructions on Confidence and Comprehension Among Limited English Proficient Parents: A Pilot Randomized Trial
In this pilot study, limited English proficient (LEP) parents of children at Seattle Children's Hospital for day surgery will be randomized to usual discharge care or usual discharge plus language-concordant, audio-recorded instructions via recordable card.
these cards are similar to recordable greeting cards, and can record up to 180 seconds of information.
They can be played back over 100 times.
We will follow-up with families 2-7 days later to assess satisfaction and comprehension of discharge instructions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Limited English proficient (LEP) parents of day surgery patients at Seattle Children's Hospital (main campus) who prefer one of the following languages for care: Spanish, Somali, Russian, Ukrainian, Vietnamese, Mandarin, or Cantonese. Eligible parents are those receiving condition-specific discharge instructions about one or more of the following: a new medication, wound care, diet advancement, return precautions, or more than 1 follow-up appointment
Exclusion Criteria:
- Child being kept overnight at hospital following surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual discharge care
Standard discharge instructions, meaning conversation with physician, usually via interpreter, along with written instructions compiled by the nurse.
Written instructions include pre-translated handouts for common languages, and untranslated (English) patient-specific instructions.
|
|
|
Experimental: Recordable card
Usual care, as above, plus patient-specific and standard instructions recorded in the patient's preferred language for care and given to them on a card to take home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comprehension of discharge instructions
Time Frame: 2-7 days after discharge
|
Parent-reported instructions (medication, home care, follow-up, and return precautions) compared to documented instructions
|
2-7 days after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confidence in caring for the child post-discharge
Time Frame: 2-7 days after discharge
|
Using 7 health care transition measures
|
2-7 days after discharge
|
|
Satisfaction with card
Time Frame: 2-7 days after discharge
|
Measures of satisfaction with the recordable card, asked of those who received one
|
2-7 days after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2016
Primary Completion (Actual)
September 26, 2016
Study Completion (Actual)
September 26, 2016
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 20, 2017
First Posted (Actual)
June 22, 2017
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 20, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 00000016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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