Hearing Impairment, Strategies, and Outcomes in Emergency Departments

Hearing Loss Clinical Trial

— Hear-VA  

Official title:

Hearing Impairment, Strategies, and Outcomes in Emergency Departments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594500
• Other study ID #: IIR 17-068
• Secondary ID: HX002421-01
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The goal of this study is to test whether providing hearing assistance devices to older age hearing impaired patients in the ED setting will improve in-ED understanding and preparation for discharge. The proposed intervention, the Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED) will be conducted in the Emergency Departments of the Manhattan and Brooklyn VAs of the New York Harbor Healthcare System and will recruit hearing impaired ED patients who are 60 years and older and have been admitted to the ED with a low acuity triage score indicating a high likelihood of discharge home. The investigators will identify hearing impairment by using the Hearing Handicap Inventory for the Elderly survey (HHIE-S). The investigators will randomize consenting patients who fail the screening to either receipt of a simple hearing assistance device (a "PockeTalkerTM") during their ED stay or usual care. The investigators will test whether the provision of a PockeTalkerTM is feasible in this environment (by measuring the amount of device use), whether providing the device improves self-reported quality of hearing and understanding during the ED stay, and whether use of the device improves the quality of preparation for post-discharge care. If this randomized controlled trial demonstrates beneficial effects for in-ED use of a simple hearing assistance device for hearing impaired patients, this strategy can be disseminated throughout the VA healthcare system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 2, 2020
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Other:
• PockeTalker
The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED
• No PockeTalker
The control group will not receive PockeTalkers while they receive care in the ED

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Education Level	The Investigators will code what education level the Veterans have completed.	Duration of ED stay, average of 1-2 days
Secondary	Primary Language	The Investigators will code what language the Veterans speak when at home.	Duration of ED stay, average of 1-2 days
Secondary	Number of Participants Who Live Alone or With Others	The Investigators will code whether the Veteran lives with others or alone.	Duration of ED stay, average of 1-2 days
Secondary	Number of Participants in the ED Alone or With Others	The Investigators will code whether the Veteran came to the ED with others or alone.	Duration of ED stay, average of 1-2 days
Secondary	Hospital Readmission	The Investigators will determine whether patients have had an ED revisit within three and 30 days through CPRS review as well as a brief follow-up phone call four and 35 days after ED discharge.	3-30 days after initial ED stay