Skip to content

Sight and Hearing Investigation Into Effects on Delirium

Prospective Initiative to Examine and Address Hearing Loss, Vision Loss, and Delirium in a Hospital Setting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06176625
Acronym
SHIELD
Enrollment
1543
Registered
2023-12-20
Start date
2023-01-11
Completion date
2023-12-15
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALCommunication Signage

Signage regarding effective communication strategies posted on door to patient's room.

BEHAVIORALAmplifier Use

Patient is provided amplification device and signage regarding effective communication strategies with reminder to utilize the amplification device posted on door to patient's room.

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium (4AT)Approximately daily during hospitalization up to 6 monthsDiagnosis of delirium using 4AT Rapid Clinical Test for Delirium (4AT). This test has a score range of 0 to 12, with a score of 4 or more indicating a positive delirium result. A score between 1 and 3 is indicative of possible cognitive impairment. Delirium symptom severity can be informally inferred from the test score, but the study will not be using the 4AT Rapid Clinical Test for Delirium (4AT) to measure delirium severity.
Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium in Proportion to Total Number of Patients ScreenedApproximately daily during hospitalization up to 6 monthsCounts of delirium diagnosed using 4AT Rapid Clinical Test for Delirium (4AT) score of 4 or greater, in comparison to the total number of patients screened. The 4AT Rapid Clinical Test for Delirium (4AT) has a score range of 0 to 12, with a score of 4 or more indicating a positive delirium result. A score between 1 and 3 is indicative of possible cognitive impairment. Delirium symptom severity can be informally inferred from the test score, but the study will not be using the 4AT Rapid Clinical Test for Delirium (4AT) to measure delirium severity.

Secondary

MeasureTime frameDescription
Severity of Delirium Quantified by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM)Approximately daily during hospitalization up to 6 monthsStudy participants who score a 1 or higher on the 4AT Rapid Clinical Test for Delirium (4AT) over the duration of time inpatient on the three hospital units of recruitment (Johns Hopkins Bayview Medicine A, Medicine B, and Carol Ball units). Quantification of delirium severity from 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium Severity (3D-CAM-S) score. The possible range of scores is from 0 to 20, with a larger number indicating the presence of more delirium signs and symptoms. However, the diagnosis of delirium using this metric depends on the presence of four characteristic features of delirium.
Satisfaction with Care Assessed Using the Questionnaire on the Quality of Physician-Patient Interaction (QQPI)Once during hospitalization up to 6 monthsSelf-reported satisfaction with hospital care from scores on Questionnaire on the Quality of Physician-Patient Interaction (QQPPI) and/or Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) measures. Possible scores on the QQPPI range from 14 to 70; higher scores indicate higher patient satisfaction.
Satisfaction with Care Assessed Using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)Once during hospitalization up to 6 monthsSelf-reported satisfaction with hospital care from scores on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) measures. Possible scores on the HCAHPS range from 11 to 62 regarding the hospital stay and between 1 and 5 on each of the two personal health questions. A higher score is consistent with better patient satisfaction and better subjective ratings of personal overall and mental health.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNicholas S Reed, Au.D., Ph.D.

Assistant Professor, Department of Epidemiology

PRINCIPAL_INVESTIGATOREsther Oh, MD, Ph.D.

Associate Professor, Departments of Medicine and Psychiatry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026