Clinical trial NCT05028972: Hearing Impairment, Strategies and Outcomes in VA Emergency Departments
Official title: Implementing HearVA (I-HearVA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Emergency Service
Hospital Readmission
Keywords: Hearing loss
Emergency service
ED Revisit
Communication
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: NYU Langone Health
First posted: 2021-08-31
Enrollment: 1050
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: ED 3-day Readmissions
timeFrame: 3-5 days after initial ED stay
Secondary outcomes:
measure: ED 30-day Readmissions
timeFrame: 30-35 days after initial ED stay
measure: Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
timeFrame: Duration of ED stay, average of 1 day
measure: Patient-Rated Quality of Post-Discharge Care
timeFrame: At time of discharge from ED, average 1 day
measure: Self-Reported Understanding of Discharge Instructions
timeFrame: 3-5 days after initial ED stay
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
Study officials:
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Joshua Chodosh, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References: