Trial Outcomes & Findings for Hearing Impairment, Strategies, and Outcomes in Emergency Departments (NCT NCT03594500)
NCT ID: NCT03594500
Last Updated: 2025-11-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
133 participants
Primary outcome timeframe
Duration of ED stay, average of 1-2 days
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
|
Overall Study
COMPLETED
|
60
|
63
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hearing Impairment, Strategies, and Outcomes in Emergency Departments
Baseline characteristics by cohort
| Measure |
Intervention: PockeTalker
n=66 Participants
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
|
Control: No PockeTalker
n=67 Participants
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
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.6 years
STANDARD_DEVIATION 9.36 • n=15 Participants
|
76.2 years
STANDARD_DEVIATION 9.09 • n=161 Participants
|
76.4 years
STANDARD_DEVIATION 9.22 • n=100 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
15 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=15 Participants
|
62 Participants
n=161 Participants
|
118 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=15 Participants
|
65 Participants
n=161 Participants
|
130 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=15 Participants
|
6 Participants
n=161 Participants
|
20 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=15 Participants
|
61 Participants
n=161 Participants
|
111 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
43 Participants
n=15 Participants
|
44 Participants
n=161 Participants
|
87 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
19 Participants
n=15 Participants
|
19 Participants
n=161 Participants
|
38 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown/Other
|
3 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
66 Participants
n=15 Participants
|
67 Participants
n=161 Participants
|
133 Participants
n=100 Participants
|
|
Education Level
Less than high school
|
4 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
|
Education Level
Completed high school
|
12 Participants
n=15 Participants
|
15 Participants
n=161 Participants
|
27 Participants
n=100 Participants
|
|
Education Level
Some college
|
17 Participants
n=15 Participants
|
14 Participants
n=161 Participants
|
31 Participants
n=100 Participants
|
|
Education Level
Completed college
|
30 Participants
n=15 Participants
|
28 Participants
n=161 Participants
|
58 Participants
n=100 Participants
|
|
Education Level
Missing
|
3 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
8 Participants
n=100 Participants
|
|
Primary Language
English
|
46 Participants
n=15 Participants
|
57 Participants
n=161 Participants
|
103 Participants
n=100 Participants
|
|
Primary Language
Spanish
|
5 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
|
Primary Language
Other
|
12 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
16 Participants
n=100 Participants
|
|
Primary Language
Missing
|
3 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
8 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Duration of ED stay, average of 1-2 daysPopulation: Those randomized to receive the hearing assistance device, how many used the hearing assistance device in the ED
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.
Outcome measures
| Measure |
Intervention: PockeTalker
n=63 Participants
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
|
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
|
|---|---|---|
|
Number of Participants With Use of Hearing Assistance Device (HAD) During Emergency Department (ED) Stay
Yes (Used a hearing assistance device)
|
38 Participants
|
—
|
|
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 outcome
Timeframe: Duration of ED stay, average of 1-2 daysParticipants 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.
Outcome measures
| Measure |
Intervention: PockeTalker
n=60 Participants
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
|
Control: No PockeTalker
n=63 Participants
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
|
|---|---|---|
|
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
|
84 Percent of participants
|
|
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
1. Their voices were very clear.
|
90 Percent of participants
|
84 Percent of participants
|
|
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
|
79 Percent of participants
|
|
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
|
66 Percent of participants
|
|
Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay
4. Listening did not make me tired.
|
89 Percent of participants
|
74 Percent of participants
|
|
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
|
56 Percent of participants
|
PRIMARY outcome
Timeframe: At time of discharge from ED, average 1 dayPatient-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.
Outcome measures
| Measure |
Intervention: PockeTalker
n=60 Participants
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
|
Control: No PockeTalker
n=63 Participants
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
|
|---|---|---|
|
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
|
90 percentage of participants who agree
|
|
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
|
85 percentage of participants who agree
|
|
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
|
93 percentage of participants who agree
|
SECONDARY outcome
Timeframe: Duration of ED stay, average of 1-2 daysThe Investigators will code what education level the Veterans have completed.
Outcome measures
| Measure |
Intervention: PockeTalker
n=63 Participants
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
|
Control: No PockeTalker
n=62 Participants
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
|
|---|---|---|
|
Education Level
Education: Less than high school
|
4 Participants
|
5 Participants
|
|
Education Level
Education: Completed high school
|
12 Participants
|
15 Participants
|
|
Education Level
Education: Completed college
|
30 Participants
|
28 Participants
|
|
Education Level
Education: Some college
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Duration of ED stay, average of 1-2 daysThe Investigators will code what language the Veterans speak when at home.
Outcome measures
| Measure |
Intervention: PockeTalker
n=63 Participants
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
|
Control: No PockeTalker
n=62 Participants
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
|
|---|---|---|
|
Primary Language
Spanish
|
5 Participants
|
1 Participants
|
|
Primary Language
Other
|
12 Participants
|
4 Participants
|
|
Primary Language
English
|
46 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Duration of ED stay, average of 1-2 daysThe Investigators will code whether the Veteran lives with others or alone.
Outcome measures
| Measure |
Intervention: PockeTalker
n=63 Participants
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
|
Control: No PockeTalker
n=62 Participants
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
|
|---|---|---|
|
Number of Participants Who Live Alone or With Others
Yes (Lives Alone)
|
34 Participants
|
43 Participants
|
|
Number of Participants Who Live Alone or With Others
No (Lives with Others)
|
29 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Duration of ED stay, average of 1-2 daysThe Investigators will code whether the Veteran came to the ED with others or alone.
Outcome measures
| Measure |
Intervention: PockeTalker
n=66 Participants
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
|
Control: No PockeTalker
n=67 Participants
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
|
|---|---|---|
|
Number of Participants in the ED Alone or With Others
Yes (At ED Alone)
|
45 Participants
|
55 Participants
|
|
Number of Participants in the ED Alone or With Others
No (At ED with Others)
|
21 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3-30 days after initial ED stayPopulation: 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.
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.
Outcome measures
| Measure |
Intervention: PockeTalker
n=60 Participants
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
|
Control: No PockeTalker
n=63 Participants
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
|
|---|---|---|
|
Hospital Readmission
3-day readmissions
|
3 percentage of participants
|
9 percentage of participants
|
|
Hospital Readmission
30-day readmissions
|
23 percentage of participants
|
27 percentage of participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place