Skip to main content
Clinical Trials/NCT03594500
NCT03594500
Completed
Not Applicable

Hearing Impairment, Strategies, and Outcomes in Emergency Departments

VA Office of Research and Development1 site in 1 country133 target enrollmentMarch 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
VA Office of Research and Development
Enrollment
133
Locations
1
Primary Endpoint
Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2019
End Date
January 2, 2020
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay

Time Frame: Duration of ED stay, average of 1-2 days

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.

Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay

Time Frame: Duration of ED stay, average of 1-2 days

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.

Patient-Rated Quality of Post-Discharge Care

Time Frame: At time of discharge from ED, average 1 day

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.

Secondary Outcomes

  • Number of Participants Who Live Alone or With Others(Duration of ED stay, average of 1-2 days)
  • Education Level(Duration of ED stay, average of 1-2 days)
  • Primary Language(Duration of ED stay, average of 1-2 days)
  • Number of Participants in the ED Alone or With Others(Duration of ED stay, average of 1-2 days)
  • Hospital Readmission(3-30 days after initial ED stay)

Study Sites (1)

Loading locations...

Similar Trials