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

Aim 1: Establish the feasibility of screening for hearing loss in the ED Aim 2: Determine the acceptability of the screening procedure (among the ED population) Aim 3: Derive a preliminary estimate of the effect size of primary outcomes Aim 4: Identify the evidence that decision makers in Veteran Affair Medical Centers, ED and Audiology Services need to commit to this approach

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Hospital Readmission; Emergency Service
• Intervention / Treatment: Other: PockeTalker; Other: No PockeTalker

Detailed Description

The goal of this study is to test whether providing hearing assistance devices to older age hearing impaired patients in the ED setting will improve in-ED understanding and preparation for discharge. The proposed intervention, the Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED) will be conducted in the Emergency Departments of the Manhattan and Brooklyn VAs of the New York Harbor Healthcare System and will recruit hearing impaired ED patients who are 60 years and older and have been admitted to the ED with a low acuity triage score indicating a high likelihood of discharge home. The investigators will identify hearing impairment by using the Hearing Handicap Inventory for the Elderly survey (HHIE-S). The investigators will randomize consenting patients who fail the screening to either receipt of a simple hearing assistance device (a "PockeTalkerTM") during their ED stay or usual care. The investigators will test whether the provision of a PockeTalkerTM is feasible in this environment (by measuring the amount of device use), whether providing the device improves self-reported quality of hearing and understanding during the ED stay, and whether use of the device improves the quality of preparation for post-discharge care. If this randomized controlled trial demonstrates beneficial effects for in-ED use of a simple hearing assistance device for hearing impaired patients, this strategy can be disseminated throughout the VA healthcare system.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010-5011
      • VA NY Harbor Healthcare System, New York, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English or Spanish speaking
• Emergency severity index criterion of 4 or 5 (low acuity)
• Hearing Handicap Impairment Evaluation Screen greater than or equal to 24
• Capacity to consent to participate in research

Exclusion Criteria:

• Inability to consent to participate in research
• Emergency severity index criterion of 1-3 (high acuity)
• Hearing Handicap Impairment Evaluation Screen less than 24
• Inability to speak English or Spanish

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: PockeTalker; Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department	Other: PockeTalker; The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED; Other Names: Hearing Assistance Device
Other: Control: No PockeTalker; Consenting participants will be randomly assigned to the control group while receiving care in the emergency department	Other: No PockeTalker; The control group will not receive PockeTalkers while they receive care in the ED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay	The investigators will observe and survey intervention participants to determine whether or not they use the hearing assistance device while they are in the ED. This will be measured on a yes/no basis.	Duration of ED stay, average of 1-2 days
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 1-2 days
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Education Level	The Investigators will code what education level the Veterans have completed.	Duration of ED stay, average of 1-2 days
Primary Language	The Investigators will code what language the Veterans speak when at home.	Duration of ED stay, average of 1-2 days
Number of Participants Who Live Alone or With Others	The Investigators will code whether the Veteran lives with others or alone.	Duration of ED stay, average of 1-2 days
Number of Participants in the ED Alone or With Others	The Investigators will code whether the Veteran came to the ED with others or alone.	Duration of ED stay, average of 1-2 days
Hospital Readmission	The Investigators will determine whether patients have had an ED revisit within three and 30 days through CPRS review as well as a brief follow-up phone call four and 35 days after ED discharge.	3-30 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): March 18, 2019
• Primary Completion (Actual): November 26, 2019
• Study Completion (Actual): January 2, 2020

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Estimated): November 5, 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; Patient readmission
• 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; HX002421-01 (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