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NCT Number: NCT05028972

Hearing Impairment, Strategies and Outcomes in VA Emergency Departments

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personal Amplifier

Other

The intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED

Other names: Pocketalker

No Personal Amplifier

Other

The control group will not receive personal amplifiers while they receive care in the ED

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Chodosh, MD MSHS

CONTACT

[email protected]

(310) 478-3711 ext. 48491

Lin T Tun

CONTACT

[email protected]

(646) 501-4132

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • NYU Langone Health

Registry information

Official study title

Implementing HearVA (I-HearVA)

Acronym: HearVA-ED

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2021
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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