NCT03195842

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 20, 2017

Last Update Submit

June 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comprehension of discharge instructions

    Parent-reported instructions (medication, home care, follow-up, and return precautions) compared to documented instructions

    2-7 days after discharge

Secondary Outcomes (2)

  • Confidence in caring for the child post-discharge

    2-7 days after discharge

  • Satisfaction with card

    2-7 days after discharge

Study Arms (2)

Usual discharge care

NO INTERVENTION

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.

Recordable card

EXPERIMENTAL

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

Interventions

Recordable card

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Child being kept overnight at hospital following surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 22, 2017

Study Start

March 10, 2016

Primary Completion

September 26, 2016

Study Completion

September 26, 2016

Last Updated

June 22, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share