Hearing Resources and Outcomes in the Emergency Department (HERO-ED)

NCT ID: NCT03053531

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-03

Study Completion Date

2018-01-03

Brief Summary

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The Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot), gathers preliminary data and hones procedures and measures, prior to undertaking HERO-ED. Since the HERO-ED Pilot does not involve random assignment (no control group), it will not test device effectiveness. However, the HERO-ED Pilot will test device acceptability and use. It will also provide preliminary data on, and allow us to fine-tune, the measures of effectiveness that we plan to use in HERO-ED

Detailed Description

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The objectives are:

1. Measure the feasibility of in-ED hearing screening using HHIE-S and a handheld audiometer, among low-acuity11 ED patients age ≥75 years, by quantifying the proportion of eligible patients who complete hearing screening.
2. Test whether low-acuity older ED patients who screen positive for significant hearing loss (\> 40 dB HL bilaterally and HHIE-S \> 24) and are provided a hearing assistance device (HAD) use that device during the ED visit.
3. Test whether patients who are given a hearing assistance device will report ability as opposed to disability in hearing and understanding, using a six-item questionnaire adapted from a study by Cox et al.
4. Test whether those who are given a hearing assistance device will report being prepared for post-discharge care, using an adapted subset of the Care Transitions Measures (CTM).
5. Assess patient understanding of the HAD survey items within the post-use survey.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-group study, with no control or comparison group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HERO-ED RCT

Subjects will be instructed on use of the HAD. The model that we will use is the PockeTalker Mini-Cog. This is a small (9.0cm X 5.5cm X 2.0cm) battery-powered electronic box that can be worn around the neck which connects via wires to both earphones and headphones (we will supply both earpieces, and let the patient choose). The RA, trained on use of the HAD by an experienced research audiologist, will instruct the patient in use of the HAD, and test the device to ensure proper functioning. The patient will also receive an instruction sheet (Appendix 3). Subjects will be encouraged to use the HAD during any encounters with ED staff.

Group Type EXPERIMENTAL

PockeTalker" Hearing Assistive Device (HAD)

Intervention Type DEVICE

Investigators will test impacts of the provision of the HAD on hearing and understanding, and preparation for discharge. Just prior to going home, consented subjects will answer a set of survey questions, using an electronic tablet to support impaired hearing.

Interventions

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PockeTalker" Hearing Assistive Device (HAD)

Investigators will test impacts of the provision of the HAD on hearing and understanding, and preparation for discharge. Just prior to going home, consented subjects will answer a set of survey questions, using an electronic tablet to support impaired hearing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* low acuity clinical presentation (Emergency Severity Index11 triage criteria of 4 or 5, which indicates a high likelihood of being discharged home from the Emergency Department).
* Patients using hearing aids will not be excluded.

Exclusion Criteria

* Lack of capacity to consent, as defined by the patient's ability to satisfactorily answer the questions outlined in the Evaluation to Sign Consent form (ESC) mentioned in the protocol. A legal representative/family member will not be able to consent for the patient in this study.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Chodosh

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16-01171

Identifier Type: -

Identifier Source: org_study_id

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