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

NCT03053531 | Withdrawn FDA Device

• 1 other identifier: 16-01171
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

  5 Minutes

Study Arms (1)

HERO-ED RCT

EXPERIMENTAL

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.

Device: PockeTalker" Hearing Assistive Device (HAD)

Interventions

PockeTalker" Hearing Assistive Device (HAD) 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.

HERO-ED RCT

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Chodosh

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group study, with no control or comparison group.

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 15, 2017
• Study Start: February 3, 2017
• Primary Completion: November 30, 2017
• Study Completion: January 3, 2018
• Last Updated: January 5, 2018

Record last verified: 2018-01

Locations

US (1)