- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07760545
Reliability In Neurocognitive Telemedicine Screening (RING)
Perioperative neurocognitive disorders are common after surgery and pre-existing cognitive impairment is an important risk factor. Current guidelines recommend identifying cognitive impairment before surgery; however, screening remains inconsistent, particularly when preoperative assessments are performed remotely.
This prospective observational diagnostic validation study aims to determine whether a modified Mini-Cog cognitive screening tool administered by telephone can reliably identify cognitive impairment in patients aged 65 years and older undergoing preoperative assessment. Telephone-based modified Mini-Cog results will be compared with standard in-person Mini-Cog assessments to evaluate agreement and feasibility. This study may improve access to preoperative cognitive screening and support optimization of surgical care for older adults.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Perioperative neurocognitive disorders (PND) are common and associated with significant morbidity and economic costs. One of the dominant risk factors for PND is pre-existing cognitive impairment (CI). The importance of detecting CI pre-operatively to facilitate patient selection for optimisation pathways and informed risk assessments is stressed in recent joint guidelines by the American College of Surgeons and the American Geriatrics Society.
Despite these recommendations, screening for pre-operative CI is inconsistently performed. One systematic barrier to CI screening is telemedicine, the use of which has recently seen an inflection point partly precipitated by the Coronavirus pandemic. Telemedicine enables the delivery of tertiary level patient-centred care over expanding geographical catchments, and is likely here to stay.
To date, no brief CI screening tool has been validated for perioperative use via telemedicine.
The Mini-Cog is a brief CI screening tool that is uniquely familiar to perioperative healthcare providers. It is validated in preoperative patients and performs favourably compared to other screening tools in the detection of CI. A Mini-Cog result consistent with CI is strongly associated with postoperative delirium, and is widely used as a trigger for geriatric optimization referral.
Validation of the Mini-Cog delivered via telemedicine is an important step towards improving patient access to CI screening.
Although video pre-operative assessments have been shown to promote high levels of patient and anesthesiologist satisfaction6, it is our local experience that video call technology is less frequently available to older patients, can pose operational challenges for either participant, and reduces workflow flexibility.
Clock Drawing Test (CDT) is an integral part of the Mini-Cog, testing multiple domains of executive function and motor skills, and functioning as a 'distractor' between the registration and recall of three items.
A modified Mini-Cog has been used with illiterate patients unable to use an analogue clock. The CDT was replaced with a serial subtraction task (SST) as an alternate distractor. One study found the modified Mini-Cog correlates with a proxy-rated CI screening tool similarly to the standard Mini-Cog.
Whilst it not feasible to perform a Mini-Cog assessment during a telephone interview, the modified Mini-Cog is an attractive alternative. We therefore aim to validate the modified Mini-Cog assessment for use over the telephone.
Our study involves comparing the validated Mini-Cog with the modified Mini-Cog. Patients awaiting surgery performed the Modified-Mini-Cog with telemedicine and on a later date subsequently performed the validated standard Mini-Cog. We plan to analyse the concordance of the results.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Donald Young, MD
- Telefonnummer: 54304 800-604-875-4304
- E-post: donald.young@vch.ca
Studer Kontakt Backup
- Navn: Shirley Lim, BSN, BS-HRIM
- Telefonnummer: 66378 604-875-4111
- E-post: shirley.lim@vch.ca
Studiesteder
-
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British Columbia
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Vancouver, British Columbia, Canada, BC V5Z 1M9
- Rekruttering
- Vancouver General Hospital
-
Ta kontakt med:
- Stewart Brown, MD
- E-post: stewart.brown@vch.ca
-
Ta kontakt med:
- Shirley Lim, BSN, BS-HRIM
- Telefonnummer: 66378 800-604-875-4111
-
Hovedetterforsker:
- Donald Young, MD
-
Underetterforsker:
- Stewart Brown, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients with age >65 at time of listing for pre-operative assessment.
- Patients with a conversational understanding of English language.
- Patients scheduled for in-person consult with an anaesthesiologist.
- Patients awaiting surgery at Vancouver General Hospital or University of British Columbia Hospital.
Exclusion Criteria:
1. Patients with known cognitive impairment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Concordance between telephone-administered modified Mini-Cog and standard in-person Mini-Cog assessment
Tidsramme: Within 1-2 weeks of telephone assessment
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Agreement between modified Mini-Cog scores obtained by telephone and standard in-person Mini-Cog scores in identifying cognitive impairment using the established Mini-Cog cutoff score.
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Within 1-2 weeks of telephone assessment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity and specificity of telephone modified Mini-Cog
Tidsramme: Within 1-2 weeks of telephone assessment
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Sensitivity and specificity of the telephone-administered modified Mini-Cog for detection of cognitive impairment compared with the in-person Mini-Cog assessment.
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Within 1-2 weeks of telephone assessment
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Completion time of modified Mini-Cog assessment
Tidsramme: During each assessment
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Time required to complete the telephone and in-person Mini-Cog assessments.
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During each assessment
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Feasibility of telephone-based cognitive screening
Tidsramme: During telephone assessment
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Proportion of participants able to complete the telephone-administered modified Mini-Cog assessment.
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During telephone assessment
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Stewart Brown, MD, University of British Columbia
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Long LS, Shapiro WA, Leung JM. A brief review of practical preoperative cognitive screening tools. Can J Anaesth. 2012 Aug;59(8):798-804. doi: 10.1007/s12630-012-9737-1. Epub 2012 May 26.
- Culley DJ, Flaherty D, Fahey MC, Rudolph JL, Javedan H, Huang CC, Wright J, Bader AM, Hyman BT, Blacker D, Crosby G. Poor Performance on a Preoperative Cognitive Screening Test Predicts Postoperative Complications in Older Orthopedic Surgical Patients. Anesthesiology. 2017 Nov;127(5):765-774. doi: 10.1097/ALN.0000000000001859.
- R Core Team (2022). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.
- Rotondi MA (2018). _kappaSize: Sample Size Estimation Functions for Studies of Interobserver Agreement_. R package version 1.2, <https://CRAN.R-project.org/package=kappaSize>.
- Graham JE, Rockwood K, Beattie BL, Eastwood R, Gauthier S, Tuokko H, McDowell I. Prevalence and severity of cognitive impairment with and without dementia in an elderly population. Lancet. 1997 Jun 21;349(9068):1793-6. doi: 10.1016/S0140-6736(97)01007-6.
- Donner A, Rotondi MA. Sample size requirements for interval estimation of the kappa statistic for interobserver agreement studies with a binary outcome and multiple raters. Int J Biostat. 2010;6(1):Article 31. doi: 10.2202/1557-4679.1275.
- Rezaei M, Rashedi V, Lotfi G, Shirinbayan P, Foroughan M. Psychometric Properties of the Persian Adaptation of Mini-Cog Test in Iranian Older Adults. Int J Aging Hum Dev. 2018 Apr;86(3):266-280. doi: 10.1177/0091415017724547. Epub 2017 Aug 31.
- Tiwary N, Treggiari MM, Yanez ND, Kirsch JR, Tekkali P, Taylor CC, Schenning KJ. Agreement Between the Mini-Cog in the Preoperative Clinic and on the Day of Surgery and Association With Postanesthesia Care Unit Delirium: A Cohort Study of Cognitive Screening in Older Adults. Anesth Analg. 2021 Apr 1;132(4):1112-1119. doi: 10.1213/ANE.0000000000005197.
- Adhikari SP, Dev R, Borson S. Modifying the Mini-Cog to Screen for Cognitive Impairment in Nonliterate Individuals. Int J Alzheimers Dis. 2021 Aug 16;2021:5510093. doi: 10.1155/2021/5510093. eCollection 2021.
- Wong DT, Kamming D, Salenieks ME, Go K, Kohm C, Chung F. Preadmission anesthesia consultation using telemedicine technology: a pilot study. Anesthesiology. 2004 Jun;100(6):1605-7. doi: 10.1097/00000542-200406000-00038. No abstract available.
- Decker J, Kaloostian CL, Gurvich T, Nguyen P, Widjaja W, Cardona H, Pagan V, Motamed A, Peden CJ. Beyond Cognitive Screening: Establishing an Interprofessional Perioperative Brain Health Initiative. J Am Geriatr Soc. 2020 Oct;68(10):2359-2364. doi: 10.1111/jgs.16720. Epub 2020 Aug 3.
- Mohanty S, Rosenthal RA, Russell MM, Neuman MD, Ko CY, Esnaola NF. Optimal Perioperative Management of the Geriatric Patient: A Best Practices Guideline from the American College of Surgeons NSQIP and the American Geriatrics Society. J Am Coll Surg. 2016 May;222(5):930-47. doi: 10.1016/j.jamcollsurg.2015.12.026. Epub 2016 Jan 4. No abstract available.
- Dworkin A, Lee DS, An AR, Goodlin SJ. A Simple Tool to Predict Development of Delirium After Elective Surgery. J Am Geriatr Soc. 2016 Nov;64(11):e149-e153. doi: 10.1111/jgs.14428. Epub 2016 Sep 21.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H22-03455
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