Delirium Clinical Trial
— SHIELDOfficial title:
Prospective Initiative to Examine and Address Hearing Loss, Vision Loss, and Delirium in a Hospital Setting
Verified date | February 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1500 |
Est. completion date | August 31, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Aging (NIA) |
United States,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. |
Once during hospitalization up to 6 months | |
Other | 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. |
Once during hospitalization up to 6 months | |
Other | 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. |
Once during hospitalization up to 6 months | |
Other | 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. |
Once during hospitalization up to 6 months | |
Primary | 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. | Approximately daily during hospitalization up to 6 months | |
Primary | 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. |
Approximately daily during hospitalization up to 6 months | |
Secondary | 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. |
Approximately daily during hospitalization up to 6 months | |
Secondary | 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. |
Once during hospitalization up to 6 months | |
Secondary | 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. |
Once during hospitalization up to 6 months |
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