- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Donald Young, MD
- Número de telefone: 54304 800-604-875-4304
- E-mail: donald.young@vch.ca
Estude backup de contato
- Nome: Shirley Lim, BSN, BS-HRIM
- Número de telefone: 66378 604-875-4111
- E-mail: shirley.lim@vch.ca
Locais de estudo
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, BC V5Z 1M9
- Recrutamento
- Vancouver General Hospital
-
Contato:
- Stewart Brown, MD
- E-mail: stewart.brown@vch.ca
-
Contato:
- Shirley Lim, BSN, BS-HRIM
- Número de telefone: 66378 800-604-875-4111
-
Investigador principal:
- Donald Young, MD
-
Subinvestigador:
- Stewart Brown, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concordance between telephone-administered modified Mini-Cog and standard in-person Mini-Cog assessment
Prazo: Within 1-2 weeks of telephone assessment
|
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.
|
Within 1-2 weeks of telephone assessment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sensitivity and specificity of telephone modified Mini-Cog
Prazo: Within 1-2 weeks of telephone assessment
|
Sensitivity and specificity of the telephone-administered modified Mini-Cog for detection of cognitive impairment compared with the in-person Mini-Cog assessment.
|
Within 1-2 weeks of telephone assessment
|
|
Completion time of modified Mini-Cog assessment
Prazo: During each assessment
|
Time required to complete the telephone and in-person Mini-Cog assessments.
|
During each assessment
|
|
Feasibility of telephone-based cognitive screening
Prazo: During telephone assessment
|
Proportion of participants able to complete the telephone-administered modified Mini-Cog assessment.
|
During telephone assessment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Stewart Brown, MD, University of British Columbia
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H22-03455
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .