An observational study in Hearing Loss, Hearing Loss, Age-Related and Hearing Disability, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Johns Hopkins University · Observational
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:
Participants will be asked to:
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:
Participants in the study will be asked to complete delirium screenings and answer questions about their hearing and communication.
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 1,543 is above the median of 100 across 192 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Participants over the age of 60 who was admitted to Bayview Medicine A, B, or C who meet inclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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
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 · Behavioral: Amplifier Use
Signage regarding effective communication strategies posted on door to patient's room.
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.
Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium (4AT)
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.
Time frame: 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
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.
Time frame: Approximately daily during hospitalization up to 6 months
Severity of Delirium Quantified by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM)
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.
Time frame: Approximately daily during hospitalization up to 6 months
Satisfaction with Care Assessed Using the Questionnaire on the Quality of Physician-Patient Interaction (QQPI)
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.
Time frame: Once during hospitalization up to 6 months
Satisfaction with Care Assessed Using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
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.
Time frame: Once during hospitalization up to 6 months
Hearing Sensitivity as Quantified with Four-Frequency Pure Tone Average (PTA) for the Better-Hearing Ear
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.
Time frame: Once during hospitalization up to 6 months
Binocular Distance Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
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.
Time frame: Once during hospitalization up to 6 months
Binocular Contrast Sensitivity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
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.
Time frame: Once during hospitalization up to 6 months
Binocular Near Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
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.
Time frame: Once during hospitalization up to 6 months
Plan to share: No — 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.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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