Hearing LossHearVA-EDNCT05028972
Hearing Impairment, Strategies and Outcomes in VA Emergency Departments
A study testing Personal Amplifier and No Personal Amplifier in people with Hearing Loss and Emergency Service, run by VA Office of Research and Development at 6 sites in United States.
Trial summary
HearVA involves six VA facility emergency departments (ED) over a 3-year intervention period. The first part of this study will test whether providing personal amplifiers to Veteran ED patients who self-report hearing difficulty is acceptable to these patients, can improve their hearing, enhance understanding of… 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?
- Personal Amplifier and No Personal Amplifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Dec 2021to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 speaking
- Emergency severity index criterion of 3 (medium), 4, or 5 (low acuity)
- Hearing Handicap Inventory-Screen greater than or equal to 10 or positive answer to a single-item screening question
- Capacity to consent to participate in research
Who cannot join
- Inability to consent to participate in research
- Emergency severity index criterion of 1-2 (high acuity)
- Hearing Handicap Inventory-Screen less than 10 and negative answer to single item screening question
- Inability to speak English
- Using cochlear implants
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Lauren Abbate, MD, 303-399-8020 ext. 3177, lauren.abbate@va.gov
- Recruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Rohit Manaktala, MD, Rohit.Manaktala@va.gov
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Luna Ragsdale, MD, luna.ragsdale@va.gov
- Recruiting
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Olga Dotsenko, (212) 686-7500 ext. 3323, olga.dotsenko@va.gov
Andrea M Aquines, (212) 686-7500, andrea.aquines@va.gov
- Active, not recruiting
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
- Recruiting
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
Ula Hwang, MD, 718-584-9000 ext. 3816, ula.hwang@va.gov
About this study
Official title: Implementing HearVA (I-HearVA)
HearVA involves six VA facility emergency departments (ED) over a 3-year intervention period. The first part of this study will test whether providing personal amplifiers to Veteran ED patients who self-report hearing difficulty is acceptable to these patients, can improve their hearing, enhance understanding of discharge instructions, and can reduce the risk of coming back to the ED in a short period of time (3 days and 30 days). The second part of the study will then identify whether ED staff can implement this program and achieve similar results. The second part will give ED staff increasing levels of responsibility for screening Veterans for hearing difficulty and providing personal amplifiers when such difficulty is detected.
Read the detailed description
HearVA is a randomized controlled trial to explore the utility and outcomes of providing point-of-care access to hearing-impaired Veterans, comparing an offer of personal amplifiers versus control in an environment where the clinical stakes are high. It addresses a knowledge gap about the utility of providing such hearing assistance during clinical encounters. The study measures whether providing personal amplifiers is acceptable to older patients, can improve hearing, enhance understanding of discharge instructions, and improve care transitions at discharge. If such a strategy is beneficial, this simple low-tech approach has great potential for implementation and wide dissemination. HearVA-ED has two phases - the first, which has been completed, established the feasibility and acceptability of research and procedures in the ED environment through a pilot efficacy study and the second phase will be to complete a larger more definitive efficacy study and a detailed implementation study resulting in a strategic approach that can be widely disseminated across all VA emergency departments throughout the United States. This second phase will use a mixed-methods, hybrid effectiveness-implementation design to implement and evaluate the hearing assistance intervention in six VA Emergency Department Sites (in different facilities across the country). Implementation will occur in four stages with variation in the starting sequence at each site: The first group of two VA emergency departments will initiate implementation with an efficacy trial; second group of two sites will initiate implementation with delivery and support of personal amplifiers after screening and randomization by a research assistant (Stage 1); the third group of two sites will initiate implementation with the entire implementation (Stage 2) and the presence of a research assistant to conduct discharge interviews; and all sites will progress from this sequence to Stage 3 - Sustainability - which is the full implementation without research assistant presence.
- Conditions
- Hearing Loss, Emergency Service, Hospital Readmission
- Being tested
- Personal Amplifier, No Personal Amplifier
- Keywords
- Hearing loss, Emergency service, ED Revisit, 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.
Personal AmplifierOther
Also called Pocketalker
The intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED
No Personal AmplifierOther
The control group will not receive personal amplifiers while they receive care in the ED
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Personal Amplifier | Experimental | Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department Receives: Other: Personal Amplifier |
| Control: No Personal Amplifier | Other | Consenting participants will be randomly assigned to the control group while receiving care in the emergency department Receives: Other: No Personal Amplifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency department (ED) 3-day Readmissions
The Investigators will determine whether patients have had an ED revisit within three days through CPRS review as well as a brief follow-up phone call 3-5 days after ED discharge
Measured: 3-5 days after initial ED stay
Secondary outcomes (4)
Emergency department (ED) 30-day Readmissions
The Investigators will determine whether patients have had an ED revisit within 30 days through CPRS review as well as a brief follow-up phone call 30-35 days after ED discharge
Measured: 30-35 days after initial ED stay
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During Emergency department (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 day
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
Self-Reported Understanding of Discharge Instructions
Investigators will gauge self-reported understanding of discharge instructions using semi-structured interview data compared to documented discharge data.
Measured: 3-5 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 posted31 Aug 2021
- Study start8 Dec 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 (personal amplifiers) for the duration of their time in the emergency department. Participants in the control group will not receive personal amplifiers during their time in the emergency department, but will receive one upon discharge from the emergency department. In later stages, there will be no control group and all participants will receive a personal amplifier during their time in the emergency department.
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
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
- NCT05028972
- Sponsor's protocol ID
- IIR 17-068-1
- Other IDs
- 5I01HX002421-08, HX002421
- Acronym
- HearVA-ED
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2021
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing HearVA (I-HearVA)
- ClinicalTrials.gov ID
- NCT05028972
- Acronym / sponsor ID
- HearVA-ED / IIR 17-068-1
- Conditions
- Hearing Loss, Emergency Service, Hospital Readmission
- Keywords
- Hearing loss, Emergency service, ED Revisit, Communication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- NYU Langone Health
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 31 Aug 2021 (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.
HearVA involves six VA facility emergency departments (ED) over a 3-year intervention period. The first part of this study will test whether providing personal amplifiers to Veteran ED patients who self-report hearing difficulty is acceptable to these patients, can improve their hearing, enhance understanding of discharge instructions, and can reduce the risk of coming back to the ED in a short period of time (3 days and 30 days). The second part of the study will then identify whether ED staff can implement this program and achieve similar results. The second part will give ED staff increasing levels of responsibility for screening Veterans for hearing difficulty and providing personal amplifiers when such difficulty is detected.
Detailed description
HearVA is a randomized controlled trial to explore the utility and outcomes of providing point-of-care access to hearing-impaired Veterans, comparing an offer of personal amplifiers versus control in an environment where the clinical stakes are high. It addresses a knowledge gap about the utility of providing such hearing assistance during clinical encounters. The study measures whether providing personal amplifiers is acceptable to older patients, can improve hearing, enhance understanding of discharge instructions, and improve care transitions at discharge. If such a strategy is beneficial, this simple low-tech approach has great potential for implementation and wide dissemination. HearVA-ED has two phases - the first, which has been completed, established the feasibility and acceptability of research and procedures in the ED environment through a pilot efficacy study and the second phase will be to complete a larger more definitive efficacy study and a detailed implementation study resulting in a strategic approach that can be widely disseminated across all VA emergency departments throughout the United States. This second phase will use a mixed-methods, hybrid effectiveness-implementation design to implement and evaluate the hearing assistance intervention in six VA Emergency Department Sites (in different facilities across the country). Implementation will occur in four stages with variation in the starting sequence at each site: The first group of two VA emergency departments will initiate implementation with an efficacy trial; second group of two sites will initiate implementation with delivery and support of personal amplifiers after screening and randomization by a research assistant (Stage 1); the third group of two sites will initiate implementation with the entire implementation (Stage 2) and the presence of a research assistant to conduct discharge interviews; and all sites will progress from this sequence to Stage 3 - Sustainability - which is the full implementation without research assistant presence.
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 (personal amplifiers) for the duration of their time in the emergency department. Participants in the control group will not receive personal amplifiers during their time in the emergency department, but will receive one upon discharge from the emergency department. In later stages, there will be no control group and all participants will receive a personal amplifier during their time in the emergency department.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Personal Amplifier | Experimental | Other: Personal AmplifierConsenting participants will be randomly assigned to the intervention group while receiving care in the emergency department |
| Control: No Personal Amplifier | Other | Other: No Personal AmplifierConsenting 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 speaking
- Emergency severity index criterion of 3 (medium), 4, or 5 (low acuity)
- Hearing Handicap Inventory-Screen greater than or equal to 10 or positive answer to a single-item screening question
- Capacity to consent to participate in research
Key exclusion criteria (5 listed)
- Inability to consent to participate in research
- Emergency severity index criterion of 1-2 (high acuity)
- Hearing Handicap Inventory-Screen less than 10 and negative answer to single item screening question
- Inability to speak English
- Using cochlear implants
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 |
|---|---|---|
| Personal AmplifierAlso: PocketalkerThe intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED | Other | Intervention: Personal Amplifier |
| No Personal AmplifierThe control group will not receive personal amplifiers while they receive care in the ED | Other | Control: No Personal Amplifier |
Primary outcome
Emergency department (ED) 3-day Readmissions
Time frame: 3-5 days after initial ED stay
The Investigators will determine whether patients have had an ED revisit within three days through CPRS review as well as a brief follow-up phone call 3-5 days after ED discharge
4 secondary outcomes
Emergency department (ED) 30-day Readmissions
Time frame: 30-35 days after initial ED stay
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During Emergency department (ED) Stay
Time frame: Duration of ED stay, average of 1 day
Patient-Rated Quality of Post-Discharge Care
Time frame: At time of discharge from ED, average 1 day
Self-Reported Understanding of Discharge Instructions
Time frame: 3-5 days after initial ED stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- 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.
Joshua Chodosh, MD MSHS principal investigator
VA NY Harbor Healthcare System, New York, NY
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Amplifier and No Personal Amplifier in people with Hearing Loss and Emergency Service, run by VA Office of Research and Development at 6 sites 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 5 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Chodosh, MD MSHS ((310) 478-3711 ext. 48491, Joshua.Chodosh@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency department (ED) 3-day Readmissions (time frame: 3-5 days after initial ED stay). 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 Oct 2026.