Sight and Hearing Investigation Into Effects on Delirium
NCT ID: NCT06176625
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1543 participants
INTERVENTIONAL
2023-01-11
2023-12-15
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
PREVENTION
NONE
Study Groups
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Delirium & Sensory Loss
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 interventions assigned to this group
Baseline Delirium Prevalence
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.
No interventions assigned to this group
Communication Signage
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.
Communication Signage
Signage regarding effective communication strategies posted on door to patient's room.
Amplifier
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.
Communication Signage
Signage regarding effective communication strategies posted on door to patient's room.
Amplifier Use
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.
Interventions
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Communication Signage
Signage regarding effective communication strategies posted on door to patient's room.
Amplifier Use
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.
Eligibility Criteria
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Inclusion Criteria
* communicates using speech and language
* able to converse in English
Exclusion Criteria
* unable to communicate using English language
* currently under airborne or droplet isolation precautions
65 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Nicholas S Reed, Au.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor, Department of Epidemiology
Esther Oh, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Associate Professor, Departments of Medicine and Psychiatry
Locations
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Countries
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References
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Pandhi N, Schumacher JR, Barnett S, Smith MA. Hearing loss and older adults' perceptions of access to care. J Community Health. 2011 Oct;36(5):748-55. doi: 10.1007/s10900-011-9369-3.
Reed NS, Boss EF, Lin FR, Oh ES, Willink A. Satisfaction With Quality of Health Care Among Medicare Beneficiaries With Functional Hearing Loss. Med Care. 2021 Jan;59(1):22-28. doi: 10.1097/MLR.0000000000001419.
Mick P, Foley DM, Lin FR. Hearing loss is associated with poorer ratings of patient-physician communication and healthcare quality. J Am Geriatr Soc. 2014 Nov;62(11):2207-9. doi: 10.1111/jgs.13113. No abstract available.
Genther DJ, Betz J, Pratt S, Martin KR, Harris TB, Satterfield S, Bauer DC, Newman AB, Simonsick EM, Lin FR; Health, Aging and Body Composition Study. Association Between Hearing Impairment and Risk of Hospitalization in Older Adults. J Am Geriatr Soc. 2015 Jun;63(6):1146-52. doi: 10.1111/jgs.13456. Epub 2015 Jun 11.
Reed NS, Assi L, Horiuchi W, Hoover-Fong JE, Lin FR, Ferrante LE, Inouye SK, Miller Iii ER, Boss EF, Oh ES, Willink A. Medicare Beneficiaries With Self-Reported Functional Hearing Difficulty Have Unmet Health Care Needs. Health Aff (Millwood). 2021 May;40(5):786-794. doi: 10.1377/hlthaff.2020.02371.
Lin FR, Niparko JK, Ferrucci L. Hearing loss prevalence in the United States. Arch Intern Med. 2011 Nov 14;171(20):1851-2. doi: 10.1001/archinternmed.2011.506. No abstract available.
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Swenor BK, Ramulu PY, Willis JR, Friedman D, Lin FR. The prevalence of concurrent hearing and vision impairment in the United States. JAMA Intern Med. 2013 Feb 25;173(4):312-3. doi: 10.1001/jamainternmed.2013.1880. No abstract available.
Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.
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.
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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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.
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.
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.
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.
Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, MacLullich AM. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing. 2014 Jul;43(4):496-502. doi: 10.1093/ageing/afu021. Epub 2014 Mar 2.
Inouye SK, Kosar CM, Tommet D, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Jones RN. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014 Apr 15;160(8):526-533. doi: 10.7326/M13-1927.
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.
Lin FR, Ferrucci L, An Y, Goh JO, Doshi J, Metter EJ, Davatzikos C, Kraut MA, Resnick SM. Association of hearing impairment with brain volume changes in older adults. Neuroimage. 2014 Apr 15;90:84-92. doi: 10.1016/j.neuroimage.2013.12.059. Epub 2014 Jan 9.
Cudmore V, Henn P, O'Tuathaigh CMP, Smith S. Age-Related Hearing Loss and Communication Breakdown in the Clinical Setting. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1054-1055. doi: 10.1001/jamaoto.2017.1248.
Pope DS, Gallun FJ, Kampel S. Effect of hospital noise on patients' ability to hear, understand, and recall speech. Res Nurs Health. 2013 Jun;36(3):228-41. doi: 10.1002/nur.21540. Epub 2013 Apr 19.
Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
Fick DM, Steis MR, Waller JL, Inouye SK. Delirium superimposed on dementia is associated with prolonged length of stay and poor outcomes in hospitalized older adults. J Hosp Med. 2013 Sep;8(9):500-5. doi: 10.1002/jhm.2077. Epub 2013 Aug 19.
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.
Other Identifiers
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IRB00306862
Identifier Type: -
Identifier Source: org_study_id
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