Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED)

October 17, 2025 updated by: VA Office of Research and Development

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1050

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045-7211
        • Recruiting
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
    • New York
      • New York, New York, United States, 10010-5011
        • Recruiting
        • VA NY Harbor Healthcare System, New York, NY
        • Principal Investigator:
          • Joshua Chodosh, MD MSHS
        • Contact:
        • Contact:
      • Syracuse, New York, United States, 13210
        • Not yet recruiting
        • Syracuse VA Medical Center, Syracuse, NY
        • Contact:
      • The Bronx, New York, United States, 10468
        • Recruiting
        • James J. Peters VA Medical Center, Bronx, NY
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Recruiting
        • Durham VA Medical Center, Durham, NC
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216
        • Not yet recruiting
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention: Personal Amplifier
Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department
Other: Personal Amplifier
The intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED
Other Names:
  • Pocketalker
Other: Control: No Personal Amplifier
Consenting participants will be randomly assigned to the control group while receiving care in the emergency department
Other: No Personal Amplifier
The control group will not receive personal amplifiers while they receive care in the ED

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3-5 days after initial ED stay

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At time of discharge from ED, average 1 day
ED 30-day Readmissions
Time Frame: 30-35 days after initial ED stay
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
30-35 days after initial ED stay
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
Time Frame: Duration of ED stay, average of 1 day
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.
Duration of ED stay, average of 1 day
Self-Reported Understanding of Discharge Instructions
Time Frame: 3-5 days after initial ED stay
Investigators will gauge self-reported understanding of discharge instructions using semi-structured interview data compared to documented discharge data.
3-5 days after initial ED stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joshua Chodosh, MD MSHS, VA NY Harbor Healthcare System, New York, NY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIR 17-068-1
  • HX002421 (Other Grant/Funding Number: VA HSR&D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings