Parkinson's Disease: Risk Assessment of Persistent Delirium and Its Management

NCT05437458 | Unknown

• 1 other identifier: 293560
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

Background: delirium describes the change in people's behaviour and thinking when they are unwell. People with delirium may appear confused, have difficulty with organisation and can be different to their usual personality. Older people with Parkinson's are particularly susceptible to persistent delirium, which can last over 14 days. They are more likely to need increased community support and they have a greater risk of death and dementia. However, there is limited research for people with Parkinson's on how to effectively manage persistent delirium and how to identify those at risk of persistent delirium. Community support may not sufficiently support the care needs of people with Parkinson's, and this is expected to be more detrimental for people also affected by persistent delirium Study Design: retrospective case note review with qualitative interviews. Study participants: older people (≥65 years old) with Parkinson's disease, previously affected by either persistent delirium or another form of delirium (e.g. hyperactive, hypoactive, mixed). 207 participants with Parkinson's for quantitative data collection. The qualitative study will include up to 10 participants with Parkinson's from the quantitative part of this study. An additional maximum of 10 more carers for people with Parkinson's may also be interviewed. Research Aims:

1. 1.To develop and estimate the assessment tool's sensitivity and specificity to predict persistent delirium in older people with Parkinson's in the outpatient setting. Persistent delirium in this study will be initially defined as a delirium lasting ≥14 days. An associated secondary objective will be to develop a scoring system that allocates an increasing number of points to risk factors that have a stronger association for predicting delirium.
2. 2.To evaluate the management strategies used for persistent delirium.
3. 3.To determine what are the community care needs for people recovering from persistent delirium.

Conditions

Parkinson Disease; Delirium in Old Age

Keywords

Parkinson's; Delirium; Older

Outcome Measures

Primary Outcomes (2)

• The incidence and prevalence of delirium in older people with Parkinson's, measured by the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorders 5th edition).

  DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th edition) will be used to confirm the diagnosis of delirium.

  Time frame: measured when the participant has previously encountered healthcare professionals during 2015-2019.

• The duration of delirium will be measured in days.

  Once delirium is confirmed by the DSM-V criteria, then the number of days that participants are affected by delirium will be inferred from medical notes.

  Time frame: measured when the participant has previously encountered healthcare professionals during 2015-2019.

Study Arms (4)

Persistent delirium

People with Parkinson's who have experienced persistent delirium (delirium lasting for ≥14 days) and will also be invited to interview.

Other: Delirium (exposure)

Non-persistent delirium

People with Parkinson's who have experienced non-persistent delirium (delirium lasting \<14 days).

Other: Delirium (exposure)

No delirium (Control group)

People with Parkinson's who have never experienced delirium

Carers for Qualitative Interview

Carers of people with Parkinson's who have consented to being interviewed.

Other: Delirium (exposure)

Interventions

Delirium (exposure) OTHER

No interventions.

Carers for Qualitative Interview; Non-persistent delirium; Persistent delirium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. People aged 65 years or older in 2015, with a diagnosis of idiopathic Parkinson's, who attend the outpatient clinic at Airedale Hospital and have had a hospital admission of at least 24 hours during 2015-2019. 2. A carer (aged 18 years and older) for a person with Parkinson's, who has experienced persistent delirium.

You may qualify if:

• Participants must be aged at least 65 years old in 2015.
• Participants must have a diagnosis of idiopathic Parkinson's disease using Queen's Square Brain Bank criteria (32) diagnosed by a movement disorders expert.
• Admitted patients must have stayed in hospital \>24 hours for at least one hospital admission.
• Participants must have had previous admissions/attendance to the hospital between 2015-2019.
• An appropriate consultee must be available and willing to be involved in this study for potential participants without the mental capacity to consent to the extraction of information from their medical records.
• For the qualitative study, participants must have the mental capacity to consent and must have been affected by persistent delirium. The participant must be able to understand, write and speak English.
• Participants must be aged 18 or over.
• Participants must have the mental capacity to consent.
• Participants must have been a primary carer for someone living with Parkinson's, who has had a previous experience of persistent delirium, during 2015-2020.
• Participants must be able to understand, write and speak English.

You may not qualify if:

• Aged less than 65 years old in 2015.
• Diagnosed with drug-induced parkinsonism, vascular parkinsonism, atypical Parkinsonian disorder (e.g. progressive supranuclear palsy, multiple systems atrophy, corticobasal syndrome) or dementia (e.g. dementia with Lewy bodies, vascular dementia, Alzheimer's disease).
• Potential participants will be excluded from the interview if they cannot communicate verbally or cannot read/write in English.
• The potential participant's medical records are incomplete and no alternate strategies are appropriate to account for the missing data, without introducing significant study bias or inaccuracy in statistical findings. Criteria for when the medical records will be excluded in the analysis will be:
• \. There is uncertainty regarding the identity of the medical records. 2. Documentation for the admission of interest is missing to the extent that researchers are unable to extract the relevant data required for the aims of this study.
• \) For the qualitative study, potential participants will be excluded if they do not have the mental capacity to consent.
• \) Potential participants without a consultee and also do not have the mental capacity to consent to this study.
• \) Potential deceased participants will be excluded if there is previous documentation that the person would not have wanted to participate in research studies.
• The potential participant is aged less than 18 years old.
• The potential participant does not have the mental capacity to consent to this study.
• The potential participant is not the primary carer for someone with Parkinson's and has been affected by persistent delirium, during 2015-2020.
• The potential participant does not understand, write and/or speak English.
• The potential participant has a severe speech impairment to the extent that the audio recording of the interview is unintelligible.

Sponsors & Collaborators

• Newcastle University: lead

Study Sites (1)

Airedale Hospital

Keighley, West Yorkshire, BD20 6TD, United Kingdom

RECRUITING

Related Publications (20)

• AMERICAN PSYCHIATRIC ASSOCIATION 2013. Delirium. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC.

  BACKGROUND

• Billings J, Mijanovich T. Improving the management of care for high-cost Medicaid patients. Health Aff (Millwood). 2007 Nov-Dec;26(6):1643-54. doi: 10.1377/hlthaff.26.6.1643.

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• BRAUN, V. & CLARKE, V. 2006. Using thematic analysis in psychology. Qualitative research in psychology, 3, 77-101.

  BACKGROUND

• Cole MG, Ciampi A, Belzile E, Zhong L. Persistent delirium in older hospital patients: a systematic review of frequency and prognosis. Age Ageing. 2009 Jan;38(1):19-26. doi: 10.1093/ageing/afn253. Epub 2008 Nov 18.

  PMID: 19017678 BACKGROUND

• Davis DH, Muniz Terrera G, Keage H, Rahkonen T, Oinas M, Matthews FE, Cunningham C, Polvikoski T, Sulkava R, MacLullich AM, Brayne C. Delirium is a strong risk factor for dementia in the oldest-old: a population-based cohort study. Brain. 2012 Sep;135(Pt 9):2809-16. doi: 10.1093/brain/aws190. Epub 2012 Aug 9.

  PMID: 22879644 BACKGROUND

• Kakuma R, du Fort GG, Arsenault L, Perrault A, Platt RW, Monette J, Moride Y, Wolfson C. Delirium in older emergency department patients discharged home: effect on survival. J Am Geriatr Soc. 2003 Apr;51(4):443-50. doi: 10.1046/j.1532-5415.2003.51151.x.

  PMID: 12657062 BACKGROUND

• Kouli A, Torsney KM, Kuan WL. Parkinson's Disease: Etiology, Neuropathology, and Pathogenesis. In: Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK536722/

  PMID: 30702842 BACKGROUND

• Lawson RA, McDonald C, Burn DJ. Defining delirium in idiopathic Parkinson's disease: A systematic review. Parkinsonism Relat Disord. 2019 Jul;64:29-39. doi: 10.1016/j.parkreldis.2018.09.025. Epub 2018 Sep 26.

  PMID: 30279060 BACKGROUND

• Lubomski M, Rushworth RL, Tisch S. Hospitalisation and comorbidities in Parkinson's disease: a large Australian retrospective study. J Neurol Neurosurg Psychiatry. 2015 Mar;86(3):324-30. doi: 10.1136/jnnp-2014-307822. Epub 2014 May 29.

  PMID: 24876185 BACKGROUND

• MEHRA, A., SURENDRAN, I., SURI, V. & GROVER, S. 2014. Missed diagnosis-persistent delirium. Journal of Geriatric Mental Health, 1, 118.

  BACKGROUND

• Read J, Cable S, Lofqvist C, Iwarsson S, Bartl G, Schrag A. Experiences of health services and unmet care needs of people with late-stage Parkinson's in England: A qualitative study. PLoS One. 2019 Dec 30;14(12):e0226916. doi: 10.1371/journal.pone.0226916. eCollection 2019.

  PMID: 31887175 BACKGROUND

• Siddiqi N, House AO, Holmes JD. Occurrence and outcome of delirium in medical in-patients: a systematic literature review. Age Ageing. 2006 Jul;35(4):350-64. doi: 10.1093/ageing/afl005. Epub 2006 Apr 28.

  PMID: 16648149 BACKGROUND

• ROSNER, B. 2015. Fundamentals of biostatistics, Cengage learning.

  BACKGROUND

• TAYLOR, S. J. & BOGDAN, R. 1984. Introduction to qualitative research methods: The search for meanings, Wiley-Interscience.

  BACKGROUND

• Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.

  PMID: 17872937 BACKGROUND

• 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

• Frank M, Sivagnanaratnam A, Bernstein J. Nutritional assessment in elderly care: a MUST! BMJ Qual Improv Rep. 2015 Jan 22;4(1):u204810.w2031. doi: 10.1136/bmjquality.u204810.w2031. eCollection 2015.

  PMID: 26734346 BACKGROUND

• Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.

  PMID: 6067254 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Kuhn E, Du X, McGrath K, Coveney S, O'Regan N, Richardson S, Teodorczuk A, Allan L, Wilson D, Inouye SK, MacLullich AM, Meagher D, Brayne C, Timmons S, Davis D. Validation of a consensus method for identifying delirium from hospital records. PLoS One. 2014 Nov 4;9(11):e111823. doi: 10.1371/journal.pone.0111823. eCollection 2014.

  PMID: 25369057 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Delirium

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• William Lee, MB/BS

  Airedale Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Lee, MB/BS

CONTACT

01535 652511; william.lee4@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: June 29, 2022
• Study Start: February 6, 2022
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At after 2025 for at least 5 years.
• Access Criteria: By written request to principal investigator.

Locations

GB (1)