NCT05028972

Brief Summary

HearVA involves six VA facility emergency departments (ED) over a 3-year intervention period. The first part of this study will test whether providing personal amplifiers to Veteran ED patients who self-report hearing difficulty is acceptable to these patients, can improve their hearing, enhance understanding of discharge instructions, and can reduce the risk of coming back to the ED in a short period of time (3 days and 30 days). The second part of the study will then identify whether ED staff can implement this program and achieve similar results. The second part will give ED staff increasing levels of responsibility for screening Veterans for hearing difficulty and providing personal amplifiers when such difficulty is detected.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Dec 2021Sep 2026

First Submitted

Initial submission to the registry

August 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 8, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

4.8 years

First QC Date

August 24, 2021

Last Update Submit

October 17, 2025

Conditions

Keywords

Hearing lossEmergency serviceED RevisitCommunication

Outcome Measures

Primary Outcomes (1)

  • ED 3-day Readmissions

    The Investigators will determine whether patients have had an ED revisit within three days through CPRS review as well as a brief follow-up phone call 3-5 days after ED discharge

    3-5 days after initial ED stay

Secondary Outcomes (4)

  • ED 30-day Readmissions

    30-35 days after initial ED stay

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

    Duration of ED stay, average of 1 day

  • Patient-Rated Quality of Post-Discharge Care

    At time of discharge from ED, average 1 day

  • Self-Reported Understanding of Discharge Instructions

    3-5 days after initial ED stay

Study Arms (2)

Intervention: Personal Amplifier

EXPERIMENTAL

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

Other: Personal Amplifier

Control: No Personal Amplifier

OTHER

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

Other: No Personal Amplifier

Interventions

The intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED

Also known as: Pocketalker
Intervention: Personal Amplifier

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

Control: No Personal Amplifier

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • Emergency severity index criterion of 3 (medium), 4, or 5 (low acuity)
  • Hearing Handicap Inventory-Screen greater than or equal to 10 or positive answer to a single-item screening question
  • Capacity to consent to participate in research

You may not qualify if:

  • Inability to consent to participate in research
  • Emergency severity index criterion of 1-2 (high acuity)
  • Hearing Handicap Inventory-Screen less than 10 and negative answer to single item screening question
  • Inability to speak English
  • Using cochlear implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

VA NY Harbor Healthcare System, New York, NY

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

RECRUITING

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

NOT YET RECRUITING

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

RECRUITING

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hearing LossCommunication

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joshua Chodosh, MD MSHS

    VA NY Harbor Healthcare System, New York, NY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Chodosh, MD MSHS

CONTACT

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 (personal amplifiers) for the duration of their time in the emergency department. Participants in the control group will not receive personal amplifiers during their time in the emergency department, but will receive one upon discharge from the emergency department. In later stages, there will be no control group and all participants will receive a personal amplifier during their time in the emergency department.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 31, 2021

Study Start

December 8, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations