Emergency Service, Hearing Loss, Hospital Readmission
Conditions
Keywords
Emergency service, Hearing loss, Patient readmission, Communication
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.
Interventions
OTHERPockeTalker
The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED
OTHERNo PockeTalker
The control group will not receive PockeTalkers while they receive care in the ED
Sponsors
NYU Langone Health
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in the ED Alone or With Others | Duration of ED stay, average of 1-2 days | The Investigators will code whether the Veteran came to the ED with others or alone. |
| Education Level | Duration of ED stay, average of 1-2 days | The Investigators will code what education level the Veterans have completed. |
| Hospital Readmission | 3-30 days after initial ED stay | 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. |
| Primary Language | Duration of ED stay, average of 1-2 days | The Investigators will code what language the Veterans speak when at home. |
| Number of Participants Who Live Alone or With Others | Duration of ED stay, average of 1-2 days | The Investigators will code whether the Veteran lives with others or alone. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention: PockeTalker Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department
PockeTalker: The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED | 66 |
| Control: No PockeTalker Consenting participants will be randomly assigned to the control group while receiving care in the emergency department
No PockeTalker: The control group will not receive PockeTalkers while they receive care in the ED | 67 |
| Total | 133 |
Baseline characteristics
| Characteristic | Intervention: PockeTalker | Total | Control: No PockeTalker |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 56 Participants | 118 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 15 Participants | 5 Participants |
| Age, Continuous | 76.6 years STANDARD_DEVIATION 9.36 | 76.4 years STANDARD_DEVIATION 9.22 | 76.2 years STANDARD_DEVIATION 9.09 |
| Education Level Completed college | 30 Participants | 58 Participants | 28 Participants |
| Education Level Completed high school | 12 Participants | 27 Participants | 15 Participants |
| Education Level Less than high school | 4 Participants | 9 Participants | 5 Participants |
| Education Level Missing | 3 Participants | 8 Participants | 5 Participants |
| Education Level Some college | 17 Participants | 31 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 20 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 111 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Primary Language English | 46 Participants | 103 Participants | 57 Participants |
| Primary Language Missing | 3 Participants | 8 Participants | 5 Participants |
| Primary Language Other | 12 Participants | 16 Participants | 4 Participants |
| Primary Language Spanish | 5 Participants | 6 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 19 Participants | 38 Participants | 19 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown/Other | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 43 Participants | 87 Participants | 44 Participants |
| Region of Enrollment United States | 66 Participants | 133 Participants | 67 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 65 Participants | 130 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 67 |
| other Total, other adverse events | 0 / 66 | 0 / 67 |
| serious Total, serious adverse events | 0 / 66 | 0 / 67 |
Outcome results
Primary
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.
Time frame: Duration of ED stay, average of 1-2 days
Population: Those randomized to receive the hearing assistance device, how many used the hearing assistance device in the ED
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention: received hearing assistance device | Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay | Yes (Used a hearing assistance device) | 38 Participants |
| Intervention: received hearing assistance device | Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay | No (Did not use a hearing assistance device) | 25 Participants |
Primary
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.
Time frame: Duration of ED stay, average of 1-2 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention: received hearing assistance device | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 3. Noises did not cause a problem for my hearing. | 69 Percent of participants |
| Intervention: received hearing assistance device | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 2. I was able to hear the sounds that I wanted to hear. | 81 Percent of participants |
| Intervention: received hearing assistance device | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 4. Listening did not make me tired. | 89 Percent of participants |
| Intervention: received hearing assistance device | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 5. I was able to understand what they said. | 90 Percent of participants |
| Intervention: received hearing assistance device | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 6. I was able to understand without making an effort. | 76 Percent of participants |
| Intervention: received hearing assistance device | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 1. Their voices were very clear. | 90 Percent of participants |
| Control | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 6. I was able to understand without making an effort. | 56 Percent of participants |
| Control | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 5. I was able to understand what they said. | 84 Percent of participants |
| Control | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 2. I was able to hear the sounds that I wanted to hear. | 79 Percent of participants |
| Control | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 3. Noises did not cause a problem for my hearing. | 66 Percent of participants |
| Control | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 1. Their voices were very clear. | 84 Percent of participants |
| Control | Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay | 4. Listening did not make me tired. | 74 Percent of participants |
Primary
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.
Time frame: At time of discharge from ED, average 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention: received hearing assistance device | Patient-Rated Quality of Post-Discharge Care | 2. I have a good understanding of my responsibilities for managing my health. | 97 percentage of participants who agree |
| Intervention: received hearing assistance device | Patient-Rated Quality of Post-Discharge Care | 3. When leaving, I clearly understood the purpose for taking each of my medications. | 97 percentage of participants who agree |
| Intervention: received hearing assistance device | Patient-Rated Quality of Post-Discharge Care | 1. ED staff took my preferences into account in deciding my health care needs when I left. | 95 percentage of participants who agree |
| Control | Patient-Rated Quality of Post-Discharge Care | 1. ED staff took my preferences into account in deciding my health care needs when I left. | 90 percentage of participants who agree |
| Control | Patient-Rated Quality of Post-Discharge Care | 2. I have a good understanding of my responsibilities for managing my health. | 85 percentage of participants who agree |
| Control | Patient-Rated Quality of Post-Discharge Care | 3. When leaving, I clearly understood the purpose for taking each of my medications. | 93 percentage of participants who agree |
Secondary
Education Level
The Investigators will code what education level the Veterans have completed.
Time frame: Duration of ED stay, average of 1-2 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention: received hearing assistance device | Education Level | Education: Completed high school | 12 Participants |
| Intervention: received hearing assistance device | Education Level | Education: Completed college | 30 Participants |
| Intervention: received hearing assistance device | Education Level | Education: Some college | 17 Participants |
| Intervention: received hearing assistance device | Education Level | Education: Less than high school | 4 Participants |
| Control | Education Level | Education: Less than high school | 5 Participants |
| Control | Education Level | Education: Completed high school | 15 Participants |
| Control | Education Level | Education: Some college | 14 Participants |
| Control | Education Level | Education: Completed college | 28 Participants |
Secondary
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.
Time frame: 3-30 days after initial ED stay
Population: 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 at the conclusion of phase 2 of the project.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention: received hearing assistance device | Hospital Readmission | 3-day readmissions | 3 percentage of participants |
| Intervention: received hearing assistance device | Hospital Readmission | 30-day readmissions | 23 percentage of participants |
| Control | Hospital Readmission | 3-day readmissions | 9 percentage of participants |
| Control | Hospital Readmission | 30-day readmissions | 27 percentage of participants |
Secondary
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.
Time frame: Duration of ED stay, average of 1-2 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention: received hearing assistance device | Number of Participants in the ED Alone or With Others | Yes (At ED Alone) | 45 Participants |
| Intervention: received hearing assistance device | Number of Participants in the ED Alone or With Others | No (At ED with Others) | 21 Participants |
| Control | Number of Participants in the ED Alone or With Others | Yes (At ED Alone) | 55 Participants |
| Control | Number of Participants in the ED Alone or With Others | No (At ED with Others) | 12 Participants |
Secondary
Number of Participants Who Live Alone or With Others
The Investigators will code whether the Veteran lives with others or alone.
Time frame: Duration of ED stay, average of 1-2 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention: received hearing assistance device | Number of Participants Who Live Alone or With Others | Yes (Lives Alone) | 34 Participants |
| Intervention: received hearing assistance device | Number of Participants Who Live Alone or With Others | No (Lives with Others) | 29 Participants |
| Control | Number of Participants Who Live Alone or With Others | Yes (Lives Alone) | 43 Participants |
| Control | Number of Participants Who Live Alone or With Others | No (Lives with Others) | 19 Participants |
Secondary
Primary Language
The Investigators will code what language the Veterans speak when at home.
Time frame: Duration of ED stay, average of 1-2 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention: received hearing assistance device | Primary Language | English | 46 Participants |
| Intervention: received hearing assistance device | Primary Language | Spanish | 5 Participants |
| Intervention: received hearing assistance device | Primary Language | Other | 12 Participants |
| Control | Primary Language | English | 57 Participants |
| Control | Primary Language | Spanish | 1 Participants |
| Control | Primary Language | Other | 4 Participants |