Sight and Hearing Investigation Into Effects on Delirium (SHIELD)

February 5, 2024 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elizabeth R Kolberg, Au.D.
  • Phone Number: 443-717-2269
  • Email: ekolber1@jhmi.edu

Study Contact Backup

  • Name: Nicholas S Reed, Au.D., Ph.D.
  • Phone Number: 317-694-2488
  • Email: nreed9@jhmi.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Delirium & Sensory Loss
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.
No Intervention: Baseline Delirium Prevalence
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.
Active Comparator: Communication Signage
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.
Behavioral: Communication Signage
Signage regarding effective communication strategies posted on door to patient's room.
Active Comparator: Amplifier
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.
Behavioral: Communication Signage
Signage regarding effective communication strategies posted on door to patient's room.
Behavioral: Amplifier 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately daily during hospitalization up to 6 months
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.
Approximately daily during hospitalization up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Delirium Quantified by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM)
Time Frame: Approximately daily during hospitalization up to 6 months

Study 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.
Approximately daily during hospitalization up to 6 months
Satisfaction with Care Assessed Using the Questionnaire on the Quality of Physician-Patient Interaction (QQPI)
Time Frame: Once during hospitalization up to 6 months

Self-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.
Once during hospitalization up to 6 months
Satisfaction with Care Assessed Using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
Time Frame: Once during hospitalization up to 6 months

Self-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.
Once during hospitalization up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Sensitivity as Quantified with Four-Frequency Pure Tone Average (PTA) for the Better-Hearing Ear
Time Frame: Once during hospitalization up to 6 months

Hearing sensitivity will be quantified based on the average of thresholds measured for four pure tone frequencies (500, 1000, 2000, and 4000 Hz). Thresholds will be measured under earphones during an iPad-based SHOEBOX audiometric screening. PTA values range from -20 to 90 decibels hearing level (dB HL). A higher pure tone average (PTA) suggests that higher signal intensities were necessary for the participant to hear and respond to the stimuli, which also suggests poorer hearing.

World Health Organization categories for PTA are include 25 or less: no impairment, 26 to 40: slight impairment, 41 to 60: moderate impairment, 61 to 80: severe impairment, and 81 or greater: profound impairment including deafness.
Once during hospitalization up to 6 months
Binocular Distance Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
Time Frame: Once during hospitalization up to 6 months

Vision screenings will be performed using the National Health and Aging Trends Study (NHATS) Vision e-book developed by Ridgevue Vision on an iPad. Participants will not use glasses or contacts during the testing.

Distance visual acuity will be measured at 5 feet. Scores range from 50/20 to 4/20, with smaller numbers indicating better distance visual acuity.
Once during hospitalization up to 6 months
Binocular Contrast Sensitivity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
Time Frame: Once during hospitalization up to 6 months

Vision screenings will be performed using the National Health and Aging Trends Study (NHATS) Vision e-book developed by Ridgevue Vision on an iPad. Participants will not use glasses or contacts during the testing.

Contrast sensitivity will also be measured at a distance of 5 feet. Scores for this test range from 0.5 to 2.0 with a larger score indicating better contrast sensitivity.
Once during hospitalization up to 6 months
Binocular Near Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
Time Frame: Once during hospitalization up to 6 months

Vision screenings will be performed using the National Health and Aging Trends Study (NHATS) Vision e-book developed by Ridgevue Vision on an iPad. Participants will not use glasses or contacts during the testing.

Near visual acuity will be measured at usual reading distance. Scores for this test range from 32/20 to 2.5/20, with smaller numbers indicating better near visual acuity.
Once during hospitalization up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Nicholas S Reed, Au.D., Ph.D., Assistant Professor, Department of Epidemiology
  • Principal Investigator: Esther Oh, MD, Ph.D., Associate Professor, Departments of Medicine and Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 20, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00306862
  • 1K23AG065443-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Limited data sets of information may be available to other researchers, pending approval of the Johns Hopkins Medicine Institutional Review Board.

For participants who have provided informed consent, this information includes demographics (age, sex, race), Charlson comorbidity index score, delirium screening and severity results, hearing screening results, vision screening results, and patient satisfaction data.

For patients who qualified for study inclusion under waivers of documentation of informed consent and HIPAA, this information includes demographics (age, sex, race) and delirium screening and severity results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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