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Recruiting NCT05028972

Hearing Impairment, Strategies and Outcomes in VA Emergency Departments

No phase Interventional Hearing Loss Emergency Service Hospital Readmission

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personal Amplifier, No Personal Amplifier.
Who it may be relevant to
Registry conditions: Hearing Loss, Emergency Service, Hospital Readmission. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Implementing HearVA (I-HearVA)

Overview

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.

Detailed description

HearVA is a randomized controlled trial to explore the utility and outcomes of providing point-of-care access to hearing-impaired Veterans, comparing an offer of personal amplifiers versus control in an environment where the clinical stakes are high. It addresses a knowledge gap about the utility of providing such hearing assistance during clinical encounters. The study measures whether providing personal amplifiers is acceptable to older patients, can improve hearing, enhance understanding of discharge instructions, and improve care transitions at discharge. If such a strategy is beneficial, this simple low-tech approach has great potential for implementation and wide dissemination. HearVA-ED has two phases - the first, which has been completed, established the feasibility and acceptability of research and procedures in the ED environment through a pilot efficacy study and the second phase will be to complete a larger more definitive efficacy study and a detailed implementation study resulting in a strategic approach that can be widely disseminated across all VA emergency departments throughout the United States. This second phase will use a mixed-methods, hybrid effectiveness-implementation design to implement and evaluate the hearing assistance intervention in six VA Emergency Department Sites (in different facilities across the country). Implementation will occur in four stages with variation in the starting sequence at each site: The first group of two VA emergency departments will initiate implementation with an efficacy trial; second group of two sites will initiate implementation with delivery and support of personal amplifiers after screening and randomization by a research assistant (Stage 1); the third group of two sites will initiate implementation with the entire implementation (Stage 2) and the presence of a research assistant to conduct discharge interviews; and all sites will progress from this sequence to Stage 3 - Sustainability - which is the full implementation without research assistant presence.

Interventions

  • Other Personal Amplifier
    The intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED
  • Other No Personal Amplifier
    The control group will not receive personal amplifiers while they receive care in the ED

Primary outcome measures

  • ED 3-day Readmissions [Time frame: 3-5 days after initial ED stay]
Secondary outcome measures (4)
  • ED 30-day Readmissions [Time frame: 30-35 days after initial ED stay]
  • Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay [Time frame: Duration of ED stay, average of 1 day]
  • Patient-Rated Quality of Post-Discharge Care [Time frame: At time of discharge from ED, average 1 day]
  • Self-Reported Understanding of Discharge Instructions [Time frame: 3-5 days after initial ED stay]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
  • VA NY Harbor Healthcare System, New York, NY — New York
  • Syracuse VA Medical Center, Syracuse, NY — Syracuse
  • James J. Peters VA Medical Center, Bronx, NY — The Bronx
  • Durham VA Medical Center, Durham, NC — Durham
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas

Identifiers

NCT: NCT05028972 · IIR 17-068-1 · HX002421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗