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

Primary Purpose

Hearing Loss

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PockeTalker" Hearing Assistive Device (HAD)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HERO-ED RCT

Arm Description

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.

Outcomes

Primary Outcome Measures

Measure the feasibility of in-ED hearing screening using HHIE-S
The HHIE-S is a ten-item survey and takes five minutes to complete. Responses to the HHIE reflect the extent to which hearing loss "feels" like a problem. Each response is scored on a 4, 2, or 0 point scale (4 = yes, 2 = sometimes, and 0 = no) for a maximum score of 40. A high score indicates high likelihood of hearing loss. Scores above 24 indicate a high likelihood of hearing loss and high adherence to HAD use

Secondary Outcome Measures

Full Information

First Posted
February 3, 2017
Last Updated
January 3, 2018
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03053531
Brief Title
Hearing Resources and Outcomes in the Emergency Department (HERO-ED)
Acronym
HERO-ED
Official Title
Hearing Resources and Outcomes in the Emergency Department (HERO-ED)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Did not meet enrollment
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
January 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
The objectives are: 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. 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. 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. 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). Assess patient understanding of the HAD survey items within the post-use survey.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-group study, with no control or comparison group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HERO-ED RCT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PockeTalker" Hearing Assistive Device (HAD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure the feasibility of in-ED hearing screening using HHIE-S
Description
The HHIE-S is a ten-item survey and takes five minutes to complete. Responses to the HHIE reflect the extent to which hearing loss "feels" like a problem. Each response is scored on a 4, 2, or 0 point scale (4 = yes, 2 = sometimes, and 0 = no) for a maximum score of 40. A high score indicates high likelihood of hearing loss. Scores above 24 indicate a high likelihood of hearing loss and high adherence to HAD use
Time Frame
5 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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