Hearing Impairment, Strategies, and Outcomes in Emergency Departments

NCT ID: NCT03594500

Last Updated: 2025-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2020-01-02

Brief Summary

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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

Detailed Description

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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.

Conditions

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Hearing Loss Emergency Service Hospital Readmission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Consenting participants will be randomly assigned to the control or intervention arm of the study. Participants in the intervention arm will receive PockeTalkers (hearing assistance devices) for the duration of their time in the emergency department. Participants in the control group will not receive hearing assistance devices during their time in the emergency department.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention: PockeTalker

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

Group Type EXPERIMENTAL

PockeTalker

Intervention Type OTHER

The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED

Control: No PockeTalker

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

Group Type OTHER

No PockeTalker

Intervention Type OTHER

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

Interventions

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PockeTalker

The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED

Intervention Type OTHER

No PockeTalker

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

Intervention Type OTHER

Other Intervention Names

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Hearing Assistance Device

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Chodosh, MD MSHS

Role: PRINCIPAL_INVESTIGATOR

VA NY Harbor Healthcare System, New York, NY

Locations

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VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HX002421-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIR 17-068

Identifier Type: -

Identifier Source: org_study_id

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