Sight and Hearing Investigation Into Effects on Delirium

Study 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.

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

Conditions
-----------------
Hearing Loss, Hearing Loss, Age-Related, Hearing Disability, Delirium, Delirium in Old Age, Delirium of Mixed Origin, Delirium With Dementia, Delirium on Emergence, Delirium, Cause Unknown, Delirium Superimposed on Dementia, Delirium Confusional State, Delirium;Non Alcoholic, Hearing Loss, Bilateral, Hearing Loss, Sensorineural, Hearing Loss, Functional, Hearing Loss, High-Frequency, Hearing

Intervention / Treatment
-----------------
* Behavioral: Communication Signage
* Behavioral: Communication Signage & Amplifier Use


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Initial portion of study is observational in nature. For the interventional portion, a baseline period of data collection will first be completed on all three hospital units. Intervention will be initially implemented in one unit and added in each subsequent unit in succession following equivalent time periods.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Delirium & Sensory Loss<br>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<br>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<br>For patients who report a little or moderate trouble hearing following the implementation of the intervention, a sign will be posted to prompt use of effective communication strategies by nursing staff. | Behavioral: Communication Signage<br>* Pink signage regarding effective communication strategies posted on door to patient's room.<br>|
| Active Comparator: Communication Signage & Amplifier<br>For patients who report a lot of trouble hearing following the implementation of the intervention, a sign will be posted to prompt nursing staff to implement effective communication strategies and make use of amplifier provided as part of the study. | Behavioral: Communication Signage & Amplifier Use<br>* Patient is provided amplification device and blue signage regarding effective communication strategies with reminder to utilize the amplification device posted on door to patient's room.<br>|

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) | 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 | 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) | 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) | 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) | 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 |