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Hearing LossSHIELDNCT06176625

Sight and Hearing Investigation Into Effects on Delirium

An observational study of Hearing Loss and Hearing Loss, Age-Related, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Communication Signage and Amplifier Use
How many people
1,543 participants
Where
1 siteUnited States
Study dates
11 Jan 2023to 15 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Participants over the age of 60 who was admitted to Bayview Medicine A, B, or C who meet inclusion criteria.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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

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?
Read more

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.

Read the 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.

Being tested
Communication Signage, Amplifier Use
Medical subject headings
Hearing Loss, Presbycusis, Delirium, Emergence Delirium, Confusion, Hearing Loss, Bilateral, Hearing Loss, Sensorineural, Hearing Loss, Functional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Communication SignageBehavioural

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

  • Amplifier UseBehavioural

    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.

Study groups in NCT06176625
Study groupRoleWhat they receive
Delirium & Sensory LossThe 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 PrevalenceThis 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 SignageFor 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.
Receives: Behavioral: Communication Signage
AmplifierFor 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.
Receives: Behavioral: Communication Signage; Behavioral: Amplifier Use

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately daily during hospitalization up to 6 months

  2. 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.

    Measured: Approximately daily during hospitalization up to 6 months

Secondary outcomes (3)

  1. 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.

    Measured: Approximately daily during hospitalization up to 6 months

  2. 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.

    Measured: Once during hospitalization up to 6 months

  3. 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.

    Measured: Once during hospitalization up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study start11 Jan 2023
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
1,543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06176625
Sponsor's protocol ID
IRB00306862
Other IDs
1K23AG065443-01
Acronym
SHIELD
Status last verified
Apr 2026
First submitted
7 Dec 2023
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Limited data sets of information may be available to other researchers, pending approval of the Johns Hopkins Medicine Institutional Review Board. For participants who have provided informed consent, this information includes demographics (age, sex, race), Charlson comorbidity index score, delirium screening and severity results, hearing screening results, vision screening results, and patient satisfaction data. For patients who qualified for study inclusion under waivers of documentation of informed consent and HIPAA, this information includes demographics (age, sex, race) and delirium screening and severity results.

Publications

  • 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.

    PubMed 21301940

  • 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.

    PubMed 32925460

  • 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.

    PubMed 25413192

  • 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.

    PubMed 26096388

  • 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.

    PubMed 33939509

  • 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.

    PubMed 22083573

  • Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.

    PubMed 15078664

  • 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.

    PubMed 23338042

  • 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.

    PubMed 23337978

  • 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.

    PubMed 35511175

  • 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.

    PubMed 19347026

  • 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.

    PubMed 20664045

  • 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.

    PubMed 31736109

  • 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.

    PubMed 29067347

  • 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.

    PubMed 26183518

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss and Hearing Loss, Age-Related, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium (4AT) (time frame: Approximately daily during hospitalization up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06176625, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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