Hearing Impairment, Strategies and Outcomes in VA Emergency Departments

NCT ID: NCT05028972

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-08
• Study Completion Date: 2026-09-30

Brief 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 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.

Conditions

Hearing Loss; Emergency Service; Hospital Readmission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Personal Amplifier

Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department

Group Type: EXPERIMENTAL

Personal Amplifier

Intervention Type: OTHER

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

Control: No Personal Amplifier

Consenting participants will be randomly assigned to the control group while receiving care in the emergency department

Group Type: OTHER

No Personal Amplifier

Intervention Type: OTHER

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

Interventions

Personal Amplifier

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

Intervention Type: OTHER

No Personal Amplifier

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

Intervention Type: OTHER

Other Intervention Names

Pocketalker

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Chodosh, MD MSHS

Role: PRINCIPAL_INVESTIGATOR

VA NY Harbor Healthcare System, New York, NY

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status: RECRUITING

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Site Status: RECRUITING

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States

Site Status: NOT_YET_RECRUITING

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Site Status: RECRUITING

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Site Status: RECRUITING

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Joshua Chodosh, MD MSHS

Role: CONTACT

Joshua.Chodosh@va.gov

(310) 478-3711 ext. 48491

Lin T Tun

Role: CONTACT

lin.tun@va.gov

(646) 501-4132

Facility Contacts

Lauren Abbate, MD

Role: primary

lauren.abbate@va.gov

303-399-8020 ext. 3177

Tali Finkelstein, MPA

Role: primary

Tali.Finkelstein2@va.gov

(212) 686-7500 ext. 7386

Olga Dotsenko

Role: backup

olga.dotsenko@va.gov

(212) 686-7500 ext. 3323

Kevin Corcoran, DO

Role: primary

Kevin.Corcoran@va.gov

315-425-4400

Ula Hwang, MD

Role: primary

ula.hwang@va.gov

718-584-9000 ext. 3816

Luna Ragsdale, MD

Role: primary

luna.ragsdale@va.gov

Rohit Manaktala, MD

Role: primary

rohit.manaktala@va.gov

Other Identifiers

HX002421

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIR 17-068-1

Identifier Type: -

Identifier Source: org_study_id