Hearing Impairment, Strategies and Outcomes in VA Emergency Departments

Hearing Loss Clinical Trial

— HearVA-ED  

Official title:

Implementing HearVA (I-HearVA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028972
• Other study ID #: IIR 17-068-1
• Secondary ID: HX002421
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Joshua Chodosh, MD MSHS
• Phone: (310) 478-3711
• Email: Joshua.Chodosh[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Emergencies
• Emergency Service
• Hearing Loss
• Hospital Readmission

Intervention

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

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	New York University Grossman School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ED 30-day Readmissions	The Investigators will determine whether patients have had an ED revisit within 30 days through CPRS review as well as a brief follow-up phone call 30-35 days after ED discharge	30-35 days after initial ED stay
Secondary	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 day
Secondary	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	Self-Reported Understanding of Discharge Instructions	Investigators will gauge self-reported understanding of discharge instructions using semi-structured interview data compared to documented discharge data.	3-5 days after initial ED stay