Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Audio-Recorded Discharge Instructions for LEP Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03195842
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
K. Casey Lion, Seattle Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Limited English Proficiency Disparities Other: Recordable card Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of Audio-Recorded Discharge Instructions on Confidence and Comprehension Among Limited English Proficient Parents: A Pilot Randomized Trial
Actual Study Start Date : March 10, 2016
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016

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.
Other: Recordable card

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Confidence in caring for the child post-discharge [ Time Frame: 2-7 days after discharge ]
    Using 7 health care transition measures

  2. Satisfaction with card [ Time Frame: 2-7 days after discharge ]
    Measures of satisfaction with the recordable card, asked of those who received one

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Layout table for additonal information
Responsible Party: K. Casey Lion, Assistant Professor of Pediatrics, Seattle Children's Hospital Identifier: NCT03195842    
Other Study ID Numbers: 00000016
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No