Limited English ProficiencyNCT05791240
Family-Initiated Interpretation in the PICU
A study testing Family Initiated Interpretation in people with Limited English Proficiency, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The goal of this study is to compare interpreter use rates before and after allowing non-English speaking families to call an interpreter themselves. The main questions it aims to answer are: Is it feasible for families to call an interpreter themselves? Will allowing families to call an interpreter themselves… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Limited English Proficiency
- What is being tested?
- Family Initiated Interpretation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 1 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients and families admitted to the pediatric intensive care unit (PICU) whose family requires an interpreter
Who cannot join
- Patients and families who do not require interpretation
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Family-Initiated Interpretation: A Novel Approach to Communication in the Pediatric Intensive Care Unit
The goal of this study is to compare interpreter use rates before and after allowing non-English speaking families to call an interpreter themselves. The main questions it aims to answer are:
Is it feasible for families to call an interpreter themselves? Will allowing families to call an interpreter themselves increase the rate of professional interpreter utilization?
Participants will be given an interpreting tablet and instructed to use the interpreter application whenever they would like to talk to the medical team. There will be a short survey on the feasibility and acceptability of the intervention for the patients and the medical team. The study team will then look at interpreter use rates before and after the intervention.
Read the detailed description
More than 25 million people in the United States have limited English proficiency. Patients with limited English proficiency face worse clinical outcomes than their English proficient counterparts, like longer length of stays, increased adverse events, and decreased understanding of their child's care. Language barriers may be particularly important in the pediatric intensive care unit (PICU), where parents encounter challenging medical decisions like choosing to pursue high-risk therapies or making end-of-life decisions.
Professional interpretation has been shown to mitigate negative outcomes for this population. For instance, one study showed decreased mortality in the pediatric intensive care unit (PICU) for Latino patients after in-person interpreter availability was increased; however, interpreters are still widely underutilized. One study in a PICU revealed that only 53% of doctors and 41% of nurses used an interpreter "often" for their patients who needed it. To improve clinical outcomes for this population, communication with patients with LEP needs to be improved.
Health disparities as a result of limited English proficiency are unjust, and a just medical system would allow patients with LEP to access the same quality of care as their English-proficiency counterparts. One way to improve communication may be to provide families with an opportunity to initiate interpreter use on their own. Although families have expressed a desire for this, no previous studies have examined the effects of this strategy.
Hypothesis:
The study team hypothesizes that implementing a novel family-initiated interpretation system will lead to greater use of interpreters, compared to the current standard of care. The investigators plan to test this hypothesis in the PICU. The specific aims are:
Explore the feasibility, usability, and acceptability of a family-initiated interpreter intervention among healthcare providers, and the acceptability of the intervention among families with limited English proficiency.
Examine the impact of family-initiated interpretation intervention on professional interpreter utilization by comparing pre and post-intervention professional interpreter utilization rates in the PICU.
By allowing families to initiate contact with an interpreter, the study team believe that interpreter utilization will increase, with the potential to decrease disparities in the limited English proficiency population. This work will inform future work to improve care for patients with limited English proficiency, and the investigators plan to investigate the clinical impact of this interpreter modality in future projects.
- Conditions
- Limited English Proficiency
- Being tested
- Family Initiated Interpretation
- Keywords
- limited English proficiency, interpretation, health equity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Initiated InterpretationBehavioural
Interpreter tablet will be given to families so they can contact an interpreter themselves.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | No intervention | The medical team will use standard interpreter practices with this group. |
| Interventional | Experimental | This arm will be given interpreter tablets in order to allow them to call interpreter themselves. Receives: Behavioral: Family Initiated Interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpreter Utilization
Number of interpreter encounters per limited English proficiency patient day
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start3 Apr 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Mary Pilarz, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791240
- Sponsor's protocol ID
- 2022-5221
- Status last verified
- Jan 2023
- First submitted
- 22 Feb 2023
- Last updated
- 3 Sep 2024
- Results posted
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Initiated Interpretation: A Novel Approach to Communication in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05791240
- Acronym / sponsor ID
- 2022-5221
- Conditions
- Limited English Proficiency
- Keywords
- limited English proficiency, interpretation, health equity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 30 Mar 2023 (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.
The goal of this study is to compare interpreter use rates before and after allowing non-English speaking families to call an interpreter themselves. The main questions it aims to answer are:
Is it feasible for families to call an interpreter themselves? Will allowing families to call an interpreter themselves increase the rate of professional interpreter utilization?
Participants will be given an interpreting tablet and instructed to use the interpreter application whenever they would like to talk to the medical team. There will be a short survey on the feasibility and acceptability of the intervention for the patients and the medical team. The study team will then look at interpreter use rates before and after the intervention.
Detailed description
More than 25 million people in the United States have limited English proficiency. Patients with limited English proficiency face worse clinical outcomes than their English proficient counterparts, like longer length of stays, increased adverse events, and decreased understanding of their child's care. Language barriers may be particularly important in the pediatric intensive care unit (PICU), where parents encounter challenging medical decisions like choosing to pursue high-risk therapies or making end-of-life decisions.
Professional interpretation has been shown to mitigate negative outcomes for this population. For instance, one study showed decreased mortality in the pediatric intensive care unit (PICU) for Latino patients after in-person interpreter availability was increased; however, interpreters are still widely underutilized. One study in a PICU revealed that only 53% of doctors and 41% of nurses used an interpreter "often" for their patients who needed it. To improve clinical outcomes for this population, communication with patients with LEP needs to be improved.
Health disparities as a result of limited English proficiency are unjust, and a just medical system would allow patients with LEP to access the same quality of care as their English-proficiency counterparts. One way to improve communication may be to provide families with an opportunity to initiate interpreter use on their own. Although families have expressed a desire for this, no previous studies have examined the effects of this strategy.
Hypothesis:
The study team hypothesizes that implementing a novel family-initiated interpretation system will lead to greater use of interpreters, compared to the current standard of care. The investigators plan to test this hypothesis in the PICU. The specific aims are:
Explore the feasibility, usability, and acceptability of a family-initiated interpreter intervention among healthcare providers, and the acceptability of the intervention among families with limited English proficiency.
Examine the impact of family-initiated interpretation intervention on professional interpreter utilization by comparing pre and post-intervention professional interpreter utilization rates in the PICU.
By allowing families to initiate contact with an interpreter, the study team believe that interpreter utilization will increase, with the potential to decrease disparities in the limited English proficiency population. This work will inform future work to improve care for patients with limited English proficiency, and the investigators plan to investigate the clinical impact of this interpreter modality in future projects.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | No intervention | –The medical team will use standard interpreter practices with this group. |
| Interventional | Experimental | Behavioral: Family Initiated InterpretationThis arm will be given interpreter tablets in order to allow them to call interpreter themselves. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients and families admitted to the pediatric intensive care unit (PICU) whose family requires an interpreter
Key exclusion criteria (1 listed)
- Patients and families who do not require interpretation
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 |
|---|---|---|
| Family Initiated InterpretationInterpreter tablet will be given to families so they can contact an interpreter themselves. | Behavioural | Interventional |
Primary outcome
Interpreter Utilization
Time frame: 12 months
Number of interpreter encounters per limited English proficiency patient day
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 3 Sep 2024.
- Individual participant dataSharing planned: No
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Promoting Equitable Access to Language Services in Health and Human Services
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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.
Mary Pilarz, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Initiated Interpretation in people with Limited English Proficiency, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Interpreter Utilization (time frame: 12 months). 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 3 Sep 2024.