NCT03594500

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 18, 2021

Completed
Last Updated

November 5, 2025

Status Verified

October 1, 2025

Enrollment Period

8 months

First QC Date

July 11, 2018

Results QC Date

February 10, 2021

Last Update Submit

October 17, 2025

Conditions

Keywords

Emergency serviceHearing lossPatient readmissionCommunication

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay

    The investigators will observe and survey intervention participants to determine whether or not they use the hearing assistance device while they are in the ED. This will be measured on a yes/no basis.

    Duration of ED stay, average of 1-2 days

  • Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay

    Participants will self-rate their quality of hearing, understanding, and communication using a six item questionnaire. Scored on a 10-point Likert scale (1 = do not agree at all; 10 = completely agree) the questions will be: When I talked to the doctors and nurses today ... (1) their voices were very clear; (2) I was able to hear the sounds that I wanted to hear; (3) noises did not cause a problem for my hearing; and (4) listening did not make me tired. Two additional statements will explicitly capture understanding: (5) I was able to understand what they said; and (6) I was able to understand without making an effort. Higher scores will indicate better communication and understanding with providers.

    Duration of ED stay, average of 1-2 days

  • Patient-Rated Quality of Post-Discharge Care

    Patient-rated quality of post-discharge care using a three-item subset of the Care Transition Measure (CTM). The questions are scored on a 1-4 scale (1= strongly disagree; 4 = strongly agree): (1) The ED staff considered my preferences and those of my family or caregiver in deciding what my healthcare needs were for discharge; (2) Leaving the ED, I have a good understanding of the things I am responsible for in managing my health; (3) Leaving the ED, I clearly understand the purpose for each of my medications. Higher scores will indicate better discharge preparation.

    At time of discharge from ED, average 1 day

Secondary Outcomes (5)

  • Education Level

    Duration of ED stay, average of 1-2 days

  • Primary Language

    Duration of ED stay, average of 1-2 days

  • Number of Participants Who Live Alone or With Others

    Duration of ED stay, average of 1-2 days

  • Number of Participants in the ED Alone or With Others

    Duration of ED stay, average of 1-2 days

  • Hospital Readmission

    3-30 days after initial ED stay

Study Arms (2)

Intervention: PockeTalker

EXPERIMENTAL

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

Other: PockeTalker

Control: No PockeTalker

OTHER

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

Other: No PockeTalker

Interventions

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

Also known as: Hearing Assistance Device
Intervention: PockeTalker

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

Control: No PockeTalker

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

Location

MeSH Terms

Conditions

Hearing LossCommunication

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Dr. Joshua Chodosh
Organization
VA NY Harbor Healthcare System

Study Officials

  • Joshua Chodosh, MD MSHS

    VA NY Harbor Healthcare System, New York, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 20, 2018

Study Start

March 18, 2019

Primary Completion

November 26, 2019

Study Completion

January 2, 2020

Last Updated

November 5, 2025

Results First Posted

June 18, 2021

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations