Sight and Hearing Investigation Into Effects on Delirium

NCT06176625 | Completed

• 2 other identifiers: IRB003068621K23AG065443-01
• Study Type: interventional
• Target: 1,543
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Severity of Delirium Quantified by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM)

  Approximately daily during hospitalization up to 6 months

• Satisfaction with Care Assessed Using the Questionnaire on the Quality of Physician-Patient Interaction (QQPI)

  Once during hospitalization up to 6 months

• Satisfaction with Care Assessed Using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)

  Once during hospitalization up to 6 months

Other Outcomes (4)

• Hearing Sensitivity as Quantified with Four-Frequency Pure Tone Average (PTA) for the Better-Hearing Ear

  Once during hospitalization up to 6 months

• Binocular Distance Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)

  Once during hospitalization up to 6 months

• Binocular Contrast Sensitivity Quantified with E-Book from National Health and Aging Trends Study (NHATS)

  Once during hospitalization up to 6 months

Study Arms (4)

Delirium & Sensory Loss

NO INTERVENTION

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.

Baseline Delirium Prevalence

NO INTERVENTION

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.

Communication Signage

ACTIVE COMPARATOR

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

Amplifier

ACTIVE COMPARATOR

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

Interventions

Communication Signage BEHAVIORAL

Signage regarding effective communication strategies posted on door to patient's room.

Amplifier; Communication Signage

Amplifier Use BEHAVIORAL

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.

Amplifier

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• inpatient on Johns Hopkins Bayview Medicine A, Medicine B, or Carol Ball unit
• communicates using speech and language
• able to converse in English

You may not qualify if:

• nonverbal
• unable to communicate using English language
• currently under airborne or droplet isolation precautions

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (27)

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• Hwang PH, Longstreth WT Jr, Thielke SM, Francis CE, Carone M, Kuller LH, Fitzpatrick AL. Longitudinal Changes in Hearing and Visual Impairments and Risk of Dementia in Older Adults in the United States. JAMA Netw Open. 2022 May 2;5(5):e2210734. doi: 10.1001/jamanetworkopen.2022.10734.

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• Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.

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• Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.

  PMID: 20664045 BACKGROUND

• Harithasan D, Mukari SZS, Ishak WS, Shahar S, Yeong WL. The impact of sensory impairment on cognitive performance, quality of life, depression, and loneliness in older adults. Int J Geriatr Psychiatry. 2020 Apr;35(4):358-364. doi: 10.1002/gps.5237. Epub 2019 Dec 5.

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• Deal JA, Albert MS, Arnold M, Bangdiwala SI, Chisolm T, Davis S, Eddins A, Glynn NW, Goman AM, Minotti M, Mosley T, Rebok GW, Reed N, Rodgers E, Sanchez V, Sharrett AR, Coresh J, Lin FR. A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. Alzheimers Dement (N Y). 2017 Jun 21;3(3):410-415. doi: 10.1016/j.trci.2017.06.003. eCollection 2017 Sep.

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• Thompson GP, Sladen DP, Borst BJ, Still OL. Accuracy of a Tablet Audiometer for Measuring Behavioral Hearing Thresholds in a Clinical Population. Otolaryngol Head Neck Surg. 2015 Nov;153(5):838-42. doi: 10.1177/0194599815593737. Epub 2015 Jul 16.

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• Varadaraj V, Assi L, Gajwani P, Wahl M, David J, Swenor BK, Ehrlich JR. Evaluation of Tablet-Based Tests of Visual Acuity and Contrast Sensitivity in Older Adults. Ophthalmic Epidemiol. 2021 Aug;28(4):293-300. doi: 10.1080/09286586.2020.1846758. Epub 2020 Nov 13.

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• Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.

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• Mohanty S, Gillio A, Lindroth H, Ortiz D, Holler E, Azar J, Boustani M, Zarzaur B. Major Surgery and Long Term Cognitive Outcomes: The Effect of Postoperative Delirium on Dementia in the Year Following Discharge. J Surg Res. 2022 Feb;270:327-334. doi: 10.1016/j.jss.2021.08.043. Epub 2021 Oct 29.

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MeSH Terms

Conditions

Hearing Loss; Presbycusis; Delirium; Emergence Delirium; Confusion; Hearing Loss, Bilateral; Hearing Loss, Sensorineural; Hearing Loss, Functional; Hearing Loss, High-Frequency

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 20, 2023
• Study Start: January 11, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)