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

NYU Langone Health

Status: Withdrawn

Conditions: Hearing Loss

Treatments: Device: PockeTalker" Hearing Assistive Device (HAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT03053531

16-01171

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 75+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

HERO-ED RCT

Experimental group

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.

Treatment:

Device: PockeTalker" Hearing Assistive Device (HAD)