Hearing LossHear-VANCT03594500
Hearing Impairment, Strategies, and Outcomes in Emergency Departments
A study testing PockeTalker and No PockeTalker in people with Hearing Loss and Emergency Service, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Aim 1: Establish the feasibility of screening for hearing loss in the ED Aim 2: Determine the acceptability of the screening procedure (among the ED population) Aim 3: Derive a preliminary estimate of the effect size of primary outcomes Aim 4: Identify the evidence that decision makers in Veteran Affair Medical… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hearing Loss, Emergency Service, Hospital Readmission
- What is being tested?
- PockeTalker and No PockeTalker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 2 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish speaking
- Emergency severity index criterion of 4 or 5 (low acuity)
- Hearing Handicap Impairment Evaluation Screen greater than or equal to 24
- Capacity to consent to participate in research
Who cannot join
- Inability to consent to participate in research
- Emergency severity index criterion of 1-3 (high acuity)
- Hearing Handicap Impairment Evaluation Screen less than 24
- Inability to speak English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
About this study
Aim 1: Establish the feasibility of screening for hearing loss in the ED Aim 2: Determine the acceptability of the screening procedure (among the ED population) Aim 3: Derive a preliminary estimate of the effect size of primary outcomes Aim 4: Identify the evidence that decision makers in Veteran Affair Medical Centers, ED and Audiology Services need to commit to this approach
Read the detailed description
The goal of this study is to test whether providing hearing assistance devices to older age hearing impaired patients in the ED setting will improve in-ED understanding and preparation for discharge. The proposed intervention, the Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED) will be conducted in the Emergency Departments of the Manhattan and Brooklyn VAs of the New York Harbor Healthcare System and will recruit hearing impaired ED patients who are 60 years and older and have been admitted to the ED with a low acuity triage score indicating a high likelihood of discharge home. The investigators will identify hearing impairment by using the Hearing Handicap Inventory for the Elderly survey (HHIE-S). The investigators will randomize consenting patients who fail the screening to either receipt of a simple hearing assistance device (a "PockeTalkerTM") during their ED stay or usual care. The investigators will test whether the provision of a PockeTalkerTM is feasible in this environment (by measuring the amount of device use), whether providing the device improves self-reported quality of hearing and understanding during the ED stay, and whether use of the device improves the quality of preparation for post-discharge care. If this randomized controlled trial demonstrates beneficial effects for in-ED use of a simple hearing assistance device for hearing impaired patients, this strategy can be disseminated throughout the VA healthcare system.
- Conditions
- Hearing Loss, Emergency Service, Hospital Readmission
- Being tested
- PockeTalker, No PockeTalker
- Keywords
- Emergency service, Hearing loss, Patient readmission, Communication
- Medical subject headings
- Hearing Loss, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PockeTalkerOther
Also called Hearing Assistance Device
The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED
No PockeTalkerOther
The control group will not receive PockeTalkers while they receive care in the ED
| Study group | Role | What they receive |
|---|---|---|
| Intervention: PockeTalker | Experimental | Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department Receives: Other: PockeTalker |
| Control: No PockeTalker | Other | Consenting participants will be randomly assigned to the control group while receiving care in the emergency department Receives: Other: No PockeTalker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay
The investigators will observe and survey intervention participants to determine whether or not they use the hearing assistance device while they are in the ED. This will be measured on a yes/no basis.
Measured: Duration of ED stay, average of 1-2 days
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
Participants will self-rate their quality of hearing, understanding, and communication using a six item questionnaire. Scored on a 10-point Likert scale (1 = do not agree at all; 10 = completely agree) the questions will be: When I talked to the doctors and nurses today ... (1) their voices were very clear; (2) I was able to hear the sounds that I wanted to hear; (3) noises did not cause a problem for my hearing; and (4) listening did not make me tired. Two additional statements will explicitly capture understanding: (5) I was able to understand what they said; and (6) I was able to understand without making an effort. Higher scores will indicate better communication and understanding with providers.
Measured: Duration of ED stay, average of 1-2 days
Patient-Rated Quality of Post-Discharge Care
Patient-rated quality of post-discharge care using a three-item subset of the Care Transition Measure (CTM). The questions are scored on a 1-4 scale (1= strongly disagree; 4 = strongly agree): (1) The ED staff considered my preferences and those of my family or caregiver in deciding what my healthcare needs were for discharge; (2) Leaving the ED, I have a good understanding of the things I am responsible for in managing my health; (3) Leaving the ED, I clearly understand the purpose for each of my medications. Higher scores will indicate better discharge preparation.
Measured: At time of discharge from ED, average 1 day
Secondary outcomes (5)
Education Level
The Investigators will code what education level the Veterans have completed.
Measured: Duration of ED stay, average of 1-2 days
Primary Language
The Investigators will code what language the Veterans speak when at home.
Measured: Duration of ED stay, average of 1-2 days
Number of Participants Who Live Alone or With Others
The Investigators will code whether the Veteran lives with others or alone.
Measured: Duration of ED stay, average of 1-2 days
Number of Participants in the ED Alone or With Others
The Investigators will code whether the Veteran came to the ED with others or alone.
Measured: Duration of ED stay, average of 1-2 days
Hospital Readmission
The Investigators will determine whether patients have had an ED revisit within three and 30 days through CPRS review as well as a brief follow-up phone call four and 35 days after ED discharge.
Measured: 3-30 days after initial ED stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start18 Mar 2019
- Primary completion26 Nov 2019
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consenting participants will be randomly assigned to the control or intervention arm of the study. Participants in the intervention arm will receive PockeTalkers (hearing assistance devices) for the duration of their time in the emergency department. Participants in the control group will not receive hearing assistance devices during their time in the emergency department.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Joshua Chodosh, MD MSHS, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594500
- Sponsor's protocol ID
- IIR 17-068
- Other IDs
- HX002421-01
- Acronym
- Hear-VA
- Status last verified
- Oct 2025
- First submitted
- 11 Jul 2018
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Impairment, Strategies, and Outcomes in Emergency Departments
- ClinicalTrials.gov ID
- NCT03594500
- Acronym / sponsor ID
- Hear-VA / IIR 17-068
- Conditions
- Hearing Loss, Emergency Service, Hospital Readmission
- Keywords
- Emergency service, Hearing loss, Patient readmission, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- NYU Langone Health
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 1: Establish the feasibility of screening for hearing loss in the ED Aim 2: Determine the acceptability of the screening procedure (among the ED population) Aim 3: Derive a preliminary estimate of the effect size of primary outcomes Aim 4: Identify the evidence that decision makers in Veteran Affair Medical Centers, ED and Audiology Services need to commit to this approach
Detailed description
The goal of this study is to test whether providing hearing assistance devices to older age hearing impaired patients in the ED setting will improve in-ED understanding and preparation for discharge. The proposed intervention, the Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED) will be conducted in the Emergency Departments of the Manhattan and Brooklyn VAs of the New York Harbor Healthcare System and will recruit hearing impaired ED patients who are 60 years and older and have been admitted to the ED with a low acuity triage score indicating a high likelihood of discharge home. The investigators will identify hearing impairment by using the Hearing Handicap Inventory for the Elderly survey (HHIE-S). The investigators will randomize consenting patients who fail the screening to either receipt of a simple hearing assistance device (a "PockeTalkerTM") during their ED stay or usual care. The investigators will test whether the provision of a PockeTalkerTM is feasible in this environment (by measuring the amount of device use), whether providing the device improves self-reported quality of hearing and understanding during the ED stay, and whether use of the device improves the quality of preparation for post-discharge care. If this randomized controlled trial demonstrates beneficial effects for in-ED use of a simple hearing assistance device for hearing impaired patients, this strategy can be disseminated throughout the VA healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consenting participants will be randomly assigned to the control or intervention arm of the study. Participants in the intervention arm will receive PockeTalkers (hearing assistance devices) for the duration of their time in the emergency department. Participants in the control group will not receive hearing assistance devices during their time in the emergency department.
| Arm | Type | Receives |
|---|---|---|
| Intervention: PockeTalker | Experimental | Other: PockeTalkerConsenting participants will be randomly assigned to the intervention group while receiving care in the emergency department |
| Control: No PockeTalker | Other | Other: No PockeTalkerConsenting participants will be randomly assigned to the control group while receiving care in the emergency department |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaking
- Emergency severity index criterion of 4 or 5 (low acuity)
- Hearing Handicap Impairment Evaluation Screen greater than or equal to 24
- Capacity to consent to participate in research
Key exclusion criteria (4 listed)
- Inability to consent to participate in research
- Emergency severity index criterion of 1-3 (high acuity)
- Hearing Handicap Impairment Evaluation Screen less than 24
- Inability to speak English or Spanish
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 |
|---|---|---|
| PockeTalkerAlso: Hearing Assistance DeviceThe intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED | Other | Intervention: PockeTalker |
| No PockeTalkerThe control group will not receive PockeTalkers while they receive care in the ED | Other | Control: No PockeTalker |
Primary outcome
Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay
Time frame: Duration of ED stay, average of 1-2 days
The investigators will observe and survey intervention participants to determine whether or not they use the hearing assistance device while they are in the ED. This will be measured on a yes/no basis.
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
Time frame: Duration of ED stay, average of 1-2 days
Participants will self-rate their quality of hearing, understanding, and communication using a six item questionnaire. Scored on a 10-point Likert scale (1 = do not agree at all; 10 = completely agree) the questions will be: When I talked to the doctors and nurses today ... (1) their voices were very clear; (2) I was able to hear the sounds that I wanted to hear; (3) noises did not cause a problem for my hearing; and (4) listening did not make me tired. Two additional statements will explicitly capture understanding: (5) I was able to understand what they said; and (6) I was able to understand without making an effort. Higher scores will indicate better communication and understanding with providers.
Patient-Rated Quality of Post-Discharge Care
Time frame: At time of discharge from ED, average 1 day
Patient-rated quality of post-discharge care using a three-item subset of the Care Transition Measure (CTM). The questions are scored on a 1-4 scale (1= strongly disagree; 4 = strongly agree): (1) The ED staff considered my preferences and those of my family or caregiver in deciding what my healthcare needs were for discharge; (2) Leaving the ED, I have a good understanding of the things I am responsible for in managing my health; (3) Leaving the ED, I clearly understand the purpose for each of my medications. Higher scores will indicate better discharge preparation.
5 secondary outcomes
Education Level
Time frame: Duration of ED stay, average of 1-2 days
Primary Language
Time frame: Duration of ED stay, average of 1-2 days
Number of Participants Who Live Alone or With Others
Time frame: Duration of ED stay, average of 1-2 days
Number of Participants in the ED Alone or With Others
Time frame: Duration of ED stay, average of 1-2 days
Hospital Readmission
Time frame: 3-30 days after initial ED stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joshua Chodosh, MD MSHS principal investigator
VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PockeTalker and No PockeTalker in people with Hearing Loss and Emergency Service, run by VA Office of Research and Development 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 4 inclusion and 4 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 5 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay (time frame: Duration of ED stay, average of 1-2 days). The study lists 3 primary outcomes in all. 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 5 Nov 2025.