Limited English ProficiencyNCT03195842
Audio-Recorded Discharge Instructions for LEP Parents
A study testing Recordable card in people with Limited English Proficiency and Disparities, run by Seattle Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Limited English Proficiency, Disparities
- What is being tested?
- Recordable card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2016to 26 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Child being kept overnight at hospital following surgery
About this study
Official title: 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.
- Conditions
- Limited English Proficiency, Disparities
- Being tested
- Recordable card
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recordable cardOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Recordable card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of discharge instructions
Parent-reported instructions (medication, home care, follow-up, and return precautions) compared to documented instructions
Measured: 2-7 days after discharge
Secondary outcomes (2)
Confidence in caring for the child post-discharge
Using 7 health care transition measures
Measured: 2-7 days after discharge
Satisfaction with card
Measures of satisfaction with the recordable card, asked of those who received one
Measured: 2-7 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start10 Mar 2016
- Primary completion26 Sep 2016
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited English ProficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Casey Lion, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195842
- Sponsor's protocol ID
- 00000016
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Audio-Recorded Discharge Instructions on Confidence and Comprehension Among Limited English Proficient Parents: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT03195842
- Acronym / sponsor ID
- 00000016
- Conditions
- Limited English Proficiency, Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Recordable cardUsual 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Child being kept overnight at hospital following surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recordable card | Other | Recordable card |
Primary outcome
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 secondary outcomes
Confidence in caring for the child post-discharge
Time frame: 2-7 days after discharge
Satisfaction with card
Time frame: 2-7 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Recordable card in people with Limited English Proficiency and Disparities, run by Seattle Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of discharge instructions (time frame: 2-7 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.