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

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ClinicalTrials.gov Identifier: NCT03594500
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
New York University School of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Use of hearing assistance device during ED stay [ Time Frame: Duration of ED stay, average of 1-2 days ]
    The investigators will observe and survey 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.
  • 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.
  • Discharge preparation (survey) [ 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.
  • Barriers/facilitators to hearing assistance device use in the ED [ Time Frame: At time of discharge from ED, average 1 day ]
    The interviews will obtain a more detailed understanding of patients' ED experience, barriers and facilitators of hearing assistance device (HAD) use, and anticipated future use of a hearing device in medical and other settings. Brief semi-structured interviews with ED nurses and physicians (providers) around the time of patient discharge will be used to assess providers' experiences interacting with hearing-impaired patients with and without HADs to evaluate, from the provider's view, the benefits and feasibility of use of the PockeTalker in the ED.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03594500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Demographic and health data [ Time Frame: Duration of ED stay, average of 1-2 days ]
    Using administrative and CPRS data, we will abstract demographic data, the presenting complaint, all diagnoses (including cognitive diagnoses) prior to and during the ED stay, medications at ED admission and discharge, and discharge diagnoses and plans. Included in Veteran surveys, we will inquire about primary spoken language, prior non-VA ED experience, years of education, mood (using the Patient Heath Questionaire-2).
  • Social support [ Time Frame: Duration of ED stay, average of 1-2 days ]
    We will code whether the Veteran came to the ED alone or with others and whether they live with others or alone.
  • Hospital readmission [ Time Frame: 3-30 days after initial ED stay ]
    We 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hearing Impairment, Strategies, and Outcomes in Emergency Departments
Official Title  ICMJE Hearing Impairment, Strategies, and Outcomes in Emergency Departments
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 VAMCs, 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hearing Loss
  • Emergency Service
  • Hospital Readmission
Intervention  ICMJE
  • Other: PockeTalker
    The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED
    Other Name: Hearing Assistance Device
  • Other: No PockeTalker
    The control group will not receive PockeTalkers while they receive care in the ED
Study Arms  ICMJE
  • Experimental: Intervention: PockeTalker
    Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department
    Intervention: Other: PockeTalker
  • Control: No PockeTalker
    Consenting participants will be randomly assigned to the control group while receiving care in the emergency department
    Intervention: Other: No PockeTalker
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
150
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
1800
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joshua Chodosh, MD MSHS (310) 478-3711 ext 48491 Joshua.Chodosh@va.gov
Contact: Hilary F Oliphant, MHA MA BA (212) 686-7500 ext 3131 Hilary.Oliphant@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03594500
Other Study ID Numbers  ICMJE IIR 17-068
HX002421-01 ( Other Grant/Funding Number: VA HSR&D )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE New York University School of Medicine
Investigators  ICMJE
Principal Investigator: Joshua Chodosh, MD MSHS Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
PRS Account VA Office of Research and Development
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP