Different Frailty Scores to Incidence of Post-operative Delirium and Cognitive Dysfunction

Postoperative Delirium Clinical Trial

Official title:

Comparing the Association of Different Frailty Scores to the Incidence of Post-operative Delirium and Cognitive Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056871
• Other study ID #: U1111-1237-9788
• Status: Completed
• Start date: August 20, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: April 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD).

So, it is crucial to find a suitable frailty assessment tool that can be incorporated into a guideline and reference for our local setting in geriatric peri-operative management. In the mean time, create awareness regarding the frailty elderly population with POD, POCD and other associated poor outcomes among our clinicians.

Description:

Increasing life expectancy has led to increase in elderly populations, thus the elderly patients amounting for greater proportion of surgical cases. But, most of them are frail with multiple co-morbidities and are exposed to adverse outcome post-operatively. The commonest adverse outcomes is post-operative delirium (POD) in which clinicians often miss and often take lightly. If it is not treated, it will progress to post-operative cognitive dysfunction (POCD).

So, it is crucial to identify the risk factors pre-operatively to minimize the risk of POD and POCD. The frail patients are more likely to have pre-existing cognitive impairment with reduced cognitive reserve, hence, they are the most vulnerable to POCD and POD. One of the most commonly used frailty screening tools is Fried Frailty criteria which is an easily accessible tool that mainly screens and scores the patients physically. However, the investigators propose to use the Groningen Frailty scale as it can assess the patients in a more holistic approach, not only in physical, but also vision, heating, nutritional, co-morbidities, cognition, psychosocial and mobility of the patients.

Method:

Elderly patients >65 years old undergoing elective surgery under general or local anaesthesia in University Malaya Medical Centre will be recruited for this study, over a 6 months period from August 2019 to January 2020. Patients will be assessed with baseline cognitive assessment, nutritional status, psychological status, and frailty scores prior to the surgery. After the operation, patients will be assessed using 4AT and CAM for at least 5 days or until patients discharged. Cognitive functions will be assessed on post-operative 7th day, 1 month and 3 months with T-MOCA via phone.

All data will be analyzed using SPSS.

Impact of research:

A suitable frailty assessment tool will be identified to be used pre-operatively for elderly patients undergoing elective surgery. This tool will then be incorporated into a guideline and reference in our local setting for geriatric peri-operative management protocol.

Moreover, with the results, investigators hope to create awareness within our multidisciplinary care of elderly surgical population on frailty assessment and its correlation to post-operative delirium, cognitive dysfunction and associated poor outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 20, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 years old and above

• ASA 1 - 3

• Full GCS

• Elective surgery

• Able to communicate well

• Consented

• Extubated at the end of surgery

Exclusion Criteria:

• Cardiac and neurosurgery

• On drugs affecting the central nervous system

• Admission to ICU intubated to continue ventilation.

• Refusal of consent

• Severe hearing loss

• Unable to use telephone/ mobile phone for communication

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Frail Elderly Syndrome
• Frailty
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Intervention

Diagnostic Test:
• Frailty Screening Tools
This is an observational and prospective study of patients who are going for elective surgery, thus no intervention will be given.

Locations

Country	Name	City	State
Malaysia	University Malaya	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (53)

Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25. Review. — View Citation

Bellelli G, Magnifico F, Trabucchi M. Outcomes at 12 months in a population of elderly patients discharged from a rehabilitation unit. J Am Med Dir Assoc. 2008 Jan;9(1):55-64. doi: 10.1016/j.jamda.2007.09.009. — View Citation

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. Corrigendum to 'Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people'. Age Ageing. 2015 Jan;44(1):175. doi: 10.1093/ageing/afu181. — View Citation

Bielderman A, van der Schans CP, van Lieshout MR, de Greef MH, Boersma F, Krijnen WP, Steverink N. Multidimensional structure of the Groningen Frailty Indicator in community-dwelling older people. BMC Geriatr. 2013 Aug 22;13:86. doi: 10.1186/1471-2318-13-86. — View Citation

Buigues C, Juarros-Folgado P, Fernández-Garrido J, Navarro-Martínez R, Cauli O. Frailty syndrome and pre-operative risk evaluation: A systematic review. Arch Gerontol Geriatr. 2015 Nov-Dec;61(3):309-21. doi: 10.1016/j.archger.2015.08.002. Epub 2015 Aug 4. Review. — View Citation

Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Review. Erratum in: Lancet. 2013 Oct 19;382(9901):1328. — View Citation

Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6. Review. — View Citation

Collins N, Blanchard MR, Tookman A, Sampson EL. Detection of delirium in the acute hospital. Age Ageing. 2010 Jan;39(1):131-5. doi: 10.1093/ageing/afp201. Epub 2009 Nov 16. — View Citation

Dasgupta M, Dumbrell AC. Preoperative risk assessment for delirium after noncardiac surgery: a systematic review. J Am Geriatr Soc. 2006 Oct;54(10):1578-89. Review. — View Citation

de Vries NM, Staal JB, van Ravensberg CD, Hobbelen JS, Olde Rikkert MG, Nijhuis-van der Sanden MW. Outcome instruments to measure frailty: a systematic review. Ageing Res Rev. 2011 Jan;10(1):104-14. doi: 10.1016/j.arr.2010.09.001. Epub 2010 Sep 17. Review. — View Citation

Desserud KF, Veen T, Søreide K. Emergency general surgery in the geriatric patient. Br J Surg. 2016 Jan;103(2):e52-61. doi: 10.1002/bjs.10044. Epub 2015 Dec 1. Review. — View Citation

Elie M, Rousseau F, Cole M, Primeau F, McCusker J, Bellavance F. Prevalence and detection of delirium in elderly emergency department patients. CMAJ. 2000 Oct 17;163(8):977-81. — View Citation

Etzioni DA, Liu JH, O'Connell JB, Maggard MA, Ko CY. Elderly patients in surgical workloads: a population-based analysis. Am Surg. 2003 Nov;69(11):961-5. — View Citation

Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. Review. — View Citation

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. — View Citation

Fried LP, Xue QL, Cappola AR, Ferrucci L, Chaves P, Varadhan R, Guralnik JM, Leng SX, Semba RD, Walston JD, Blaum CS, Bandeen-Roche K. Nonlinear multisystem physiological dysregulation associated with frailty in older women: implications for etiology and treatment. J Gerontol A Biol Sci Med Sci. 2009 Oct;64(10):1049-57. doi: 10.1093/gerona/glp076. Epub 2009 Jun 30. — View Citation

Fulop T, Larbi A, Witkowski JM, McElhaney J, Loeb M, Mitnitski A, Pawelec G. Aging, frailty and age-related diseases. Biogerontology. 2010 Oct;11(5):547-63. doi: 10.1007/s10522-010-9287-2. Epub 2010 Jun 18. Review. — View Citation

Gobbens RJ, Luijkx KG, Wijnen-Sponselee MT, Schols JM. Toward a conceptual definition of frail community dwelling older people. Nurs Outlook. 2010 Mar-Apr;58(2):76-86. doi: 10.1016/j.outlook.2009.09.005. Review. — View Citation

Hamel MB, Henderson WG, Khuri SF, Daley J. Surgical outcomes for patients aged 80 and older: morbidity and mortality from major noncardiac surgery. J Am Geriatr Soc. 2005 Mar;53(3):424-9. — View Citation

Hamilton GM, Wheeler K, Di Michele J, Lalu MM, McIsaac DI. A Systematic Review and Meta-analysis Examining the Impact of Incident Postoperative Delirium on Mortality. Anesthesiology. 2017 Jul;127(1):78-88. doi: 10.1097/ALN.0000000000001660. Review. — View Citation

Heymann A, Radtke F, Schiemann A, Lütz A, MacGuill M, Wernecke KD, Spies C. Delayed treatment of delirium increases mortality rate in intensive care unit patients. J Int Med Res. 2010 Sep-Oct;38(5):1584-95. — View Citation

Hogue CW Jr, Palin CA, Arrowsmith JE. Cardiopulmonary bypass management and neurologic outcomes: an evidence-based appraisal of current practices. Anesth Analg. 2006 Jul;103(1):21-37. Review. — View Citation

Inouye SK, Charpentier PA. Precipitating factors for delirium in hospitalized elderly persons. Predictive model and interrelationship with baseline vulnerability. JAMA. 1996 Mar 20;275(11):852-7. — View Citation

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. Review. — View Citation

Ismail Z, Rajji TK, Shulman KI. Brief cognitive screening instruments: an update. Int J Geriatr Psychiatry. 2010 Feb;25(2):111-20. doi: 10.1002/gps.2306. Review. — View Citation

Jones DM, Song X, Rockwood K. Operationalizing a frailty index from a standardized comprehensive geriatric assessment. J Am Geriatr Soc. 2004 Nov;52(11):1929-33. — View Citation

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. — View Citation

Lin HS, McBride RL, Hubbard RE. Frailty and anesthesia - risks during and post-surgery. Local Reg Anesth. 2018 Oct 5;11:61-73. doi: 10.2147/LRA.S142996. eCollection 2018. Review. — View Citation

Lin HS, Watts JN, Peel NM, Hubbard RE. Frailty and post-operative outcomes in older surgical patients: a systematic review. BMC Geriatr. 2016 Aug 31;16(1):157. doi: 10.1186/s12877-016-0329-8. Review. — View Citation

Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28. — View Citation

Marcantonio ER, Juarez G, Goldman L, Mangione CM, Ludwig LE, Lind L, Katz N, Cook EF, Orav EJ, Lee TH. The relationship of postoperative delirium with psychoactive medications. JAMA. 1994 Nov 16;272(19):1518-22. — View Citation

Markle-Reid M, Browne G. Conceptualizations of frailty in relation to older adults. J Adv Nurs. 2003 Oct;44(1):58-68. Review. — View Citation

Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. — View Citation

Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. Erratum in: Lancet 1998 Jun 6;351(9117):1742. — View Citation

Moug SJ, Stechman M, McCarthy K, Pearce L, Myint PK, Hewitt J; Older Persons Surgical Outcomes Collaboration. Frailty and cognitive impairment: Unique challenges in the older emergency surgical patient. Ann R Coll Surg Engl. 2016 Mar;98(3):165-9. doi: 10.1308/rcsann.2016.0087. Review. — View Citation

Oakland K, Nadler R, Cresswell L, Jackson D, Coughlin PA. Systematic review and meta-analysis of the association between frailty and outcome in surgical patients. Ann R Coll Surg Engl. 2016 Feb;98(2):80-5. doi: 10.1308/rcsann.2016.0048. Epub 2016 Jan 7. Review. — View Citation

Partridge JS, Martin FC, Harari D, Dhesi JK. The delirium experience: what is the effect on patients, relatives and staff and what can be done to modify this? Int J Geriatr Psychiatry. 2013 Aug;28(8):804-12. doi: 10.1002/gps.3900. Epub 2012 Oct 30. Review. — View Citation

Pendlebury ST, Welch SJ, Cuthbertson FC, Mariz J, Mehta Z, Rothwell PM. Telephone assessment of cognition after transient ischemic attack and stroke: modified telephone interview of cognitive status and telephone Montreal Cognitive Assessment versus face-to-face Montreal Cognitive Assessment and neuropsychological battery. Stroke. 2013 Jan;44(1):227-9. doi: 10.1161/STROKEAHA.112.673384. Epub 2012 Nov 8. — View Citation

Peri-operative Care for Older Patients Undergoing Surgery. British Geriatrics Society. http://www.bgs.org.uk/index.php/topresources/publicationfind/goodpractice/2402-bpg-pops (cited November 2015

Peters LL, Boter H, Buskens E, Slaets JP. Measurement properties of the Groningen Frailty Indicator in home-dwelling and institutionalized elderly people. J Am Med Dir Assoc. 2012 Jul;13(6):546-51. doi: 10.1016/j.jamda.2012.04.007. Epub 2012 May 12. — View Citation

Polanczyk CA, Marcantonio E, Goldman L, Rohde LE, Orav J, Mangione CM, Lee TH. Impact of age on perioperative complications and length of stay in patients undergoing noncardiac surgery. Ann Intern Med. 2001 Apr 17;134(8):637-43. — View Citation

Radtke FM, Franck M, Schneider M, Luetz A, Seeling M, Heinz A, Wernecke KD, Spies CD. Comparison of three scores to screen for delirium in the recovery room. Br J Anaesth. 2008 Sep;101(3):338-43. doi: 10.1093/bja/aen193. Epub 2008 Jul 3. — View Citation

Robinson TN, Wu DS, Pointer LF, Dunn CL, Moss M. Preoperative cognitive dysfunction is related to adverse postoperative outcomes in the elderly. J Am Coll Surg. 2012 Jul;215(1):12-7; discussion 17-8. doi: 10.1016/j.jamcollsurg.2012.02.007. Epub 2012 May 22. — View Citation

Rockwood K. Educational interventions in delirium. Dement Geriatr Cogn Disord. 1999 Sep-Oct;10(5):426-9. Review. — View Citation

Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923. — View Citation

Sepehri A, Beggs T, Hassan A, Rigatto C, Shaw-Daigle C, Tangri N, Arora RC. The impact of frailty on outcomes after cardiac surgery: a systematic review. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3110-7. doi: 10.1016/j.jtcvs.2014.07.087. Epub 2014 Aug 7. Review. — View Citation

Shem Tov L, Matot I. Frailty and anesthesia. Curr Opin Anaesthesiol. 2017 Jun;30(3):409-417. doi: 10.1097/ACO.0000000000000456. Review. — View Citation

Slaets JP. Vulnerability in the elderly: frailty. Med Clin North Am. 2006 Jul;90(4):593-601. Review. — View Citation

Steverink N, Slaets J, Schuurmans H, van Lis M. Measuring frailty: developing and testing of the Groningen frailty indicator (GFI). Gerontologist. 2001;41:236-237

Verloo H, Goulet C, Morin D, von Gunten A. Association between frailty and delirium in older adult patients discharged from hospital. Clin Interv Aging. 2016 Jan 18;11:55-63. doi: 10.2147/CIA.S100576. eCollection 2016. — View Citation

Walston J, Hadley EC, Ferrucci L, Guralnik JM, Newman AB, Studenski SA, Ershler WB, Harris T, Fried LP. Research agenda for frailty in older adults: toward a better understanding of physiology and etiology: summary from the American Geriatrics Society/National Institute on Aging Research Conference on Frailty in Older Adults. J Am Geriatr Soc. 2006 Jun;54(6):991-1001. Review. — View Citation

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. — View Citation

Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009. Review. — View Citation

* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of confusion using Confusion Assessment Method (CAM) scores	Delirium is present if the following are present: Feature 1-Acute Change or/and Fluctuation (any symptom) AND Feature 2-Inattention AND EITHER Feature 3-Disorganized Thinking OR Feature 4-Altered Level of Consciousness	Within 5 days after surgery
Primary	Change in cognitive function using Telephone-Montreal Cognitive Assessment (T-MOCA)	Cognitive function of the patients will be assessed after discharged and must achieved post-operative day 7 with T-MOCA via phone, subsequently assessed at 1 month and 3 month later.	Within 1 month
Primary	Occurence of delirium using 4AT scores	A score of 4 or more suggests delirium but is not diagnostic: more detailed assessment of mental status may be required to reach a diagnosis. A score of 1-3 suggests cognitive impairment and more detailed cognitive testing and informant history-taking are required. A score of 0 does not definitively exclude delirium or cognitive impairment: more detailed testing may be required depending on the clinical context.	Within 5 days after surgery