Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
NCT Number: NCT06176625
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.
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Notify Me65 year and older
All sexes
Observational
Baltimore, Maryland, 21224, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Johns Hopkins University
Other
Prospective Initiative to Examine and Address Hearing Loss, Vision Loss, and Delirium in a Hospital Setting
Acronym: SHIELD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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