Viewing Study NCT06176625



Ignite Creation Date: 2024-05-06 @ 7:53 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06176625
Status: COMPLETED
Last Update Posted: 2024-02-07
First Post: 2023-12-07

Brief Title: Sight and Hearing Investigation Into Effects on Delirium
Sponsor: Johns Hopkins University
Organization: Johns Hopkins University

Study Overview

Official Title: Prospective Initiative to Examine and Address Hearing Loss Vision Loss and Delirium in a Hospital Setting
Status: COMPLETED
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SHIELD
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 andor 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 andor 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 ie vision andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1K23AG065443-01 NIH None httpsreporternihgovquickSearch1K23AG065443-01