Hearing Impairment, Strategies, and Outcomes in Emergency Departments (Hear-VA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03594500|
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss Emergency Service Hospital Readmission||Other: PockeTalker Other: No PockeTalker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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)|
|Official Title:||Hearing Impairment, Strategies, and Outcomes in Emergency Departments|
|Actual Study Start Date :||March 18, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||February 28, 2020|
Experimental: Intervention: PockeTalker
Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department
The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED
Other Name: Hearing Assistance Device
Control: No PockeTalker
Consenting participants will be randomly assigned to the control group while receiving care in the emergency department
Other: No PockeTalker
The control group will not receive PockeTalkers while they receive care in the ED
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594500
|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|
|United States, New York|
|Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY||Recruiting|
|New York, New York, United States, 10010|
|Contact: John G Hay, MD 212-686-7500 ext 3860 email@example.com|
|Contact: Romaine Johnson (718) 439-4355 Romaine.Johnson@va.gov|
|Principal Investigator: Joshua Chodosh, MD MSHS|
|Principal Investigator:||Joshua Chodosh, MD MSHS||Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY|