Clinical trial NCT06176625: Sight and Hearing Investigation Into Effects on Delirium
Official title: Prospective Initiative to Examine and Address Hearing Loss, Vision Loss, and Delirium in a Hospital Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Hearing Loss, Age-Related
Hearing Disability
Delirium
Delirium in Old Age
Delirium of Mixed Origin
Delirium With Dementia
Delirium on Emergence
Delirium, Cause Unknown
Delirium Superimposed on Dementia
Delirium Confusional State
Delirium;Non Alcoholic
Hearing Loss, Bilateral
Hearing Loss, Sensorineural
Hearing Loss, Functional
Hearing Loss, High-Frequency
Hearing
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-12-20
Enrollment: 1543
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Initial portion of study is observational in nature.

For the interventional portion, a baseline period of data collection will first be completed on all three hospital units. Intervention will be initially implemented in one unit and added in each subsequent unit in succession following equivalent time periods.
Primary purpose: PREVENTION

Brief summary: The goal of this observational study is to learn about sensory loss in hospital patients with delirium. The main questions it aims to answer are:

* Are hearing and vision loss related to increased risk of having delirium?
* Do hearing and vision loss contribute to more severe delirium?
* Do sensory loss and/or delirium affect patient satisfaction with hospital care?

Participants will be asked to:

* answer delirium screening questions,
* undergo hearing \& vision screenings, and
* complete questionnaires about the hospital stay.

The second part of this study is a clinical trial. Researchers will compare different hospital units to see if changing communication affects the number of patients with delirium. The main questions it aims to answer are:

• Does sharing information about communication and/or providing hearing devices change the number of hospital patients with delirium?

Participants in the study will be asked to complete delirium screenings and answer questions about their hearing and communication.

Detailed description: This is a prospective cohort study entitled Sight \& Hearing Investigation into Effects on Delirium (SHIELD), which aims of to characterize the impact of sensory impairment (i.e., vision and/or hearing loss) on inpatient delirium and experience. The initial phase of this research includes delirium, hearing, and vision screenings, as well as questionnaires regarding satisfaction with care, all of which are observational and do not constitute treatment or intervention. Researchers will conduct electronic medical record reviews to determine whether new patients have been admitted to the units of recruitment on a daily basis and collect relevant demographic and medical information. Eligible patients will be screened to with the 4AT identify delirium and the 3D-CAM-S to characterize delirium severity. After obtaining informed consent, patients will undergo bedside hearing and vision screenings, and complete patient satisfaction questionnaires.

The second phase of present study aims to determine the impact of improving communication on delirium in the hospital setting. Screenings will be used to identify delirium and measure severity and patients will be asked to report subjective hearing difficulty. Subsequent intervention will involve addressing communication barriers posed by hearing loss by providing training to clinical nursing staff, reinforcing strategies for effective communication through the use of posted signs, and providing amplification devices to eligible patients.

Eligibility criteria: Inclusion Criteria:

* inpatient on Johns Hopkins Bayview Medicine A, Medicine B, or Carol Ball unit
* communicates using speech and language
* able to converse in English

Exclusion Criteria:

* nonverbal
* unable to communicate using English language
* currently under airborne or droplet isolation precautions

Primary outcomes:
measure: Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium (4AT)
timeFrame: Approximately daily during hospitalization up to 6 months
measure: Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium in Proportion to Total Number of Patients Screened
timeFrame: Approximately daily during hospitalization up to 6 months
Secondary outcomes:
measure: Severity of Delirium Quantified by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM)
timeFrame: Approximately daily during hospitalization up to 6 months
measure: Satisfaction with Care Assessed Using the Questionnaire on the Quality of Physician-Patient Interaction (QQPI)
timeFrame: Once during hospitalization up to 6 months
measure: Satisfaction with Care Assessed Using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
timeFrame: Once during hospitalization up to 6 months
Other outcomes:
measure: Hearing Sensitivity as Quantified with Four-Frequency Pure Tone Average (PTA) for the Better-Hearing Ear
timeFrame: Once during hospitalization up to 6 months
measure: Binocular Distance Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
timeFrame: Once during hospitalization up to 6 months
measure: Binocular Contrast Sensitivity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
timeFrame: Once during hospitalization up to 6 months
measure: Binocular Near Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
timeFrame: Once during hospitalization up to 6 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Assistant Professor, Department of Epidemiology
name: Nicholas S Reed, Au.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Departments of Medicine and Psychiatry
name: Esther Oh, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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