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Clinical Trials/NCT06176625
NCT06176625
Active, Not Recruiting
N/A

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

Johns Hopkins University1 site in 1 country1,500 target enrollmentJanuary 11, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Johns Hopkins University
Enrollment
1500
Locations
1
Primary Endpoint
Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium (4AT)
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 11, 2023
End Date
August 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium (4AT)

Time Frame: Approximately daily during hospitalization up to 6 months

Diagnosis 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 Screened

Time Frame: Approximately daily during hospitalization up to 6 months

Counts 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 Outcomes

  • Satisfaction with Care Assessed Using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)(Once during hospitalization up to 6 months)
  • 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 months)
  • Satisfaction with Care Assessed Using the Questionnaire on the Quality of Physician-Patient Interaction (QQPI)(Once during hospitalization up to 6 months)

Study Sites (1)

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