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Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED)

Primary Purpose

Hearing Loss, Emergency Service, Hospital Readmission

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personal Amplifier
No Personal Amplifier
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing loss, Emergency service, ED Revisit, Communication

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English or Spanish 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 or Spanish

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO
  • James J. Peters VA Medical Center, Bronx, NYRecruiting
  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NYRecruiting
  • Syracuse VA Medical Center, Syracuse, NY
  • Durham VA Medical Center, Durham, NC
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention: Personal Amplifier

Control: No Personal Amplifier

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

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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
August 24, 2021
Last Updated
January 4, 2023
Sponsor
VA Office of Research and Development
Collaborators
New York University Grossman School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05028972
Brief Title
Hearing Impairment, Strategies and Outcomes in VA Emergency Departments
Acronym
HearVA-ED
Official Title
Implementing HearVA (I-HearVA)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
New York University Grossman School of Medicine

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
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.
Detailed 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.

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
Hearing loss, Emergency service, ED Revisit, 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 (personal amplifiers) for the duration of their time in the emergency department. Participants in the control group will not receive personal amplifiers during their time in the emergency department, but will receive one upon discharge from the emergency department. In later stages, there will be no control group and all participants will receive a personal amplifier during their time in the emergency department.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Personal Amplifier
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 Personal Amplifier
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)
Personal Amplifier
Other Intervention Name(s)
Pocketalker
Intervention Description
The intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED
Intervention Type
Other
Intervention Name(s)
No Personal Amplifier
Intervention Description
The control group will not receive personal amplifiers while they receive care in the ED
Primary Outcome Measure Information:
Title
ED 3-day Readmissions
Description
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
Time Frame
3-5 days after initial ED stay
Secondary Outcome Measure Information:
Title
ED 30-day Readmissions
Description
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
Time Frame
30-35 days after initial ED stay
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 day
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
Title
Self-Reported Understanding of Discharge Instructions
Description
Investigators will gauge self-reported understanding of discharge instructions using semi-structured interview data compared to documented discharge data.
Time Frame
3-5 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Chodosh, MD MSHS
Phone
(310) 478-3711
Ext
48491
Email
Joshua.Chodosh@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricio Arcila-mesa
Phone
(646) 501-4660
Email
mauricio.arcila-mesa@va.gov
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
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Abbate, MD
Phone
303-399-8020
Ext
3177
Email
lauren.abbate@va.gov
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ula Hwang, MD
Phone
718-584-9000
Ext
3816
Email
ula.hwang@va.gov
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
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Benouaguef
Phone
212-686-7500
Email
Elizabeth.Benouaguef@va.gov
First Name & Middle Initial & Last Name & Degree
Kayla G Raizner, MHA BS
Phone
(212) 686-7500
Ext
3131
Email
Kayla.Raizner@va.gov
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD MSHS
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Corcoran, DO
Phone
315-425-4400
Email
Kevin.Corcoran@va.gov
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luna Ragsdale, MD
Email
luna.ragsdale@va.gov
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Manaktala, MD
Email
rohit.manaktala@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Hearing Impairment, Strategies and Outcomes in VA Emergency Departments

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