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

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: Recruiting
• Conditions: Hearing Loss; Hospital Readmission; Emergency Service
• Intervention / Treatment: Other: Personal Amplifier; Other: No Personal Amplifier

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: Interventional
• Enrollment (Estimated): 1050
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Chodosh, MD MSHS; Phone Number: 48491 (310) 478-3711; Email: Joshua.Chodosh@va.gov
• Study Contact Backup: Name: Lin T Tun; Phone Number: (646) 501-4132; Email: lin.tun@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Recruiting
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Lauren Abbate, MD; Phone Number: 3177 303-399-8020; Email: Lauren.Abbate@va.gov
  • 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: Olga Dotsenko; Phone Number: 3323 (212) 686-7500; Email: olga.dotsenko@va.gov
      • Contact: Tali Finkelstein, MPA; Phone Number: 7386 (212) 686-7500; Email: Tali.Finkelstein2@va.gov
    • Syracuse, New York, United States, 13210
      • Not yet recruiting
      • Syracuse VA Medical Center, Syracuse, NY
      • Contact: Kevin Corcoran, DO; Phone Number: 315-425-4400; Email: Kevin.Corcoran@va.gov
    • The Bronx, New York, United States, 10468
      • Recruiting
      • James J. Peters VA Medical Center, Bronx, NY
      • Contact: Ula Hwang, MD; Phone Number: 3816 718-584-9000; Email: ula.hwang@va.gov
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Recruiting
      • Durham VA Medical Center, Durham, NC
      • Contact: Luna Ragsdale, MD; Email: luna.ragsdale@va.gov
  • Texas
    • Dallas, Texas, United States, 75216
      • Not yet recruiting
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
      • Contact: Rohit Manaktala, MD; Email: rohit.manaktala@va.gov

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	3-5 days after initial ED stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of discharge from ED, average 1 day
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	30-35 days after initial ED stay
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.	Duration of ED stay, average of 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.	3-5 days after initial ED stay

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: NYU Langone Health
• Investigators: Principal Investigator: Joshua Chodosh, MD MSHS, VA NY Harbor Healthcare System, New York, NY

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Communication; Hearing loss; Emergency service; ED Revisit
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Hearing Loss; Communication
• Other Study ID 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