Hearing Impairment, Strategies, and Outcomes in Emergency Departments (Hear-VA)
Primary Purpose
Hearing Loss, Emergency Service, Hospital Readmission
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PockeTalker
No PockeTalker
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Emergency service, Hearing loss, Patient readmission, Communication
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
Sites / Locations
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention: PockeTalker
Control: No PockeTalker
Arm Description
Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department
Consenting participants will be randomly assigned to the control group while receiving care in the emergency department
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Education Level
The Investigators will code what education level the Veterans have completed.
Primary Language
The Investigators will code what language the Veterans speak when at home.
Number of Participants Who Live Alone or With Others
The Investigators will code whether the Veteran lives with others or alone.
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.
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.
Full Information
NCT ID
NCT03594500
First Posted
July 11, 2018
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
Collaborators
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT03594500
Brief Title
Hearing Impairment, Strategies, and Outcomes in Emergency Departments
Acronym
Hear-VA
Official Title
Hearing Impairment, Strategies, and Outcomes in Emergency Departments
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
January 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Emergency Service, Hospital Readmission
Keywords
Emergency service, Hearing loss, Patient readmission, Communication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: PockeTalker
Arm Type
Experimental
Arm Description
Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department
Arm Title
Control: No PockeTalker
Arm Type
Other
Arm Description
Consenting participants will be randomly assigned to the control group while receiving care in the emergency department
Intervention Type
Other
Intervention Name(s)
PockeTalker
Other Intervention Name(s)
Hearing Assistance Device
Intervention Description
The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED
Intervention Type
Other
Intervention Name(s)
No PockeTalker
Intervention Description
The control group will not receive PockeTalkers while they receive care in the ED
Primary Outcome Measure Information:
Title
Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay
Description
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.
Time Frame
Duration of ED stay, average of 1-2 days
Title
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
Description
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.
Time Frame
Duration of ED stay, average of 1-2 days
Title
Patient-Rated Quality of Post-Discharge Care
Description
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.
Time Frame
At time of discharge from ED, average 1 day
Secondary Outcome Measure Information:
Title
Education Level
Description
The Investigators will code what education level the Veterans have completed.
Time Frame
Duration of ED stay, average of 1-2 days
Title
Primary Language
Description
The Investigators will code what language the Veterans speak when at home.
Time Frame
Duration of ED stay, average of 1-2 days
Title
Number of Participants Who Live Alone or With Others
Description
The Investigators will code whether the Veteran lives with others or alone.
Time Frame
Duration of ED stay, average of 1-2 days
Title
Number of Participants in the ED Alone or With Others
Description
The Investigators will code whether the Veteran came to the ED with others or alone.
Time Frame
Duration of ED stay, average of 1-2 days
Title
Hospital Readmission
Description
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.
Time Frame
3-30 days after initial ED stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD MSHS
Organizational Affiliation
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010-5011
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Hearing Impairment, Strategies, and Outcomes in Emergency Departments
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