Sight and Hearing Investigation Into Effects on Delirium (SHIELD)

Johns Hopkins University

Status: Completed

Conditions: Hearing Loss, Age-Related; Delirium Confusional State; Delirium;Non Alcoholic; Hearing Loss, High-Frequency; Hearing Loss; Delirium Superimposed on Dementia; Delirium, Cause Unknown; Delirium With Dementia; Hearing Disability; Hearing Loss, Sensorineural; Delirium; Hearing; Hearing Loss, Functional; Delirium on Emergence; Delirium in Old Age; Hearing Loss, Bilateral; Delirium of Mixed Origin

Treatments: Behavioral: Amplifier Use; Behavioral: Communication Signage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06176625

1K23AG065443-01 (U.S. NIH Grant/Contract)

IRB00306862

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,543 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,543 participants in 4 patient groups

Delirium & Sensory Loss

No Intervention group

Description:

The observational portion of the study, during which participants are screened for delirium. Consented individuals also complete bedside hearing and vision screenings, and provide information regarding care on patient satisfaction questionnaires.

Baseline Delirium Prevalence

No Intervention group

Description:

This arm of the interventional portion of the study will be used as baseline comparison data to determine whether implementation of the intervention impacted delirium outcomes. Baseline data collection will be collected for each of the units prior to implementation of the intervention.

Communication Signage

Active Comparator group

Description:

For patients who report a little or moderate trouble hearing following the implementation of the intervention, a pink sign will be posted to prompt use of effective communication strategies by nursing staff.

Treatment:

Behavioral: Communication Signage

Amplifier

Active Comparator group

Description:

For patients who report a lot of trouble hearing following the implementation of the intervention, a blue sign will be posted to prompt nursing staff to remind patient to make use of amplifier provided as part of the study.

Treatment:

Behavioral: Communication Signage

Behavioral: Amplifier Use