Clinical trial NCT03594500: Hearing Impairment, Strategies, and Outcomes in Emergency Departments
Official title: Hearing Impairment, Strategies, and Outcomes in Emergency Departments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Emergency Service
Hospital Readmission
Keywords: Emergency service
Hearing loss
Patient readmission
Communication
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: NYU Langone Health
First posted: 2018-07-20
Enrollment: 133
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 (hearing assistance devices) for the duration of their time in the emergency department. Participants in the control group will not receive hearing assistance devices during their time in the emergency department.
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay
timeFrame: Duration of ED stay, average of 1-2 days
measure: Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
timeFrame: Duration of ED stay, average of 1-2 days
measure: Patient-Rated Quality of Post-Discharge Care
timeFrame: At time of discharge from ED, average 1 day
Secondary outcomes:
measure: Education Level
timeFrame: Duration of ED stay, average of 1-2 days
measure: Primary Language
timeFrame: Duration of ED stay, average of 1-2 days
measure: Number of Participants Who Live Alone or With Others
timeFrame: Duration of ED stay, average of 1-2 days
measure: Number of Participants in the ED Alone or With Others
timeFrame: Duration of ED stay, average of 1-2 days
measure: Hospital Readmission
timeFrame: 3-30 days after initial ED stay
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
name: Joshua Chodosh, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References: