- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04792983
Cognition and the Immunology of Postoperative Outcomes
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This project is designed as a prospective, single-center observational study. The cohort will consist of 600 consenting subjects ≥ 65 years of age that agree to have a study investigator speak with them during their preoperative evaluation prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 65 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spinal surgery. Exclusion criteria will include history of stroke (not including transient ischemic attacks, or TIAs) or brain tumor, a history of autoimmune disorders, medications likely to significantly impact inflammation (e.g. steroids), current infection, uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions); limited use of the dominant hand (limited ability to draw); and or inability to speak, read, or understand English.
Patients will be introduced to the study through a flyer provided to them as part of a packet from their surgeon's office. A study team member will speak with those who have agreed during their preoperative evaluation to discuss studies from the department of Anesthesiology and satisfy eligibility criteria. After obtaining informed verbal consent over the telephone, study staff will gain information about the patient's age and years of education. Study staff will conduct the following preoperative measures over the telephone: the Geriatric Depression Scale-Short (GDS), the Beck Anxiety Inventory (BAI), the Visual Analog Scale for Pain (VAS), the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale (FRAIL), Instrumental Activities of daily living (IADLs), the Brief Pain Inventory (BPI), the World Health Organization Disability Assessment Schedule (WHODAS). In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members), and whether they have ever tested positive for COVID-19 in a patient survey. The study staff will administer the Montreal Cognitive Assessment (MOCA) simple cognitive screening tool that takes less than 10 minutes to complete and has little or no education, language, or race bias. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will be advised to expect a follow up telephone up to 3, 6, and 12- months after surgery to verify data elements and reassess functional outcome.
Delirium will be assessed prospectively once per day on postoperative days 1, 2, and/or 3 by a trained study team member using the Confusion Assessment Method [CAM] if the patient remains in the hospital and agrees to the evaluation. Delirium by chart review and CAM-ICU scores from the nursing staff will also be documented. Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. To evaluate cognition and functional status, the MOCA and the WHODAS will be administered 3, 6, and 12- months postoperatively by study staff over the telephone if the patient can be contacted and continue to agree to participate. The investigators will also collect information on secondary outcomes including whether they had a surgical procedure, time to postoperative anesthesia care unit (PACU) discharge, discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day, 6-month, and 1-year mortality when available. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Gregory J Crosby, MD
- Número de telefone: 617-732-7398
- E-mail: gcrosby@bwh.harvard.edu
Estude backup de contato
- Nome: Erin J Kim, BA
- Número de telefone: 7034088957
- E-mail: ekim56@bwh.harvard.edu
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Recrutamento
- Brigham & Women's Hospital
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Contato:
- Sierra J Loomis, BA
- Número de telefone: 617-278-0949
- E-mail: saloomis@bwh.harvard.edu
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Contato:
- Erin J Kim, BA
- Número de telefone: 6177320949
- E-mail: ekim56@bwh.harvard.edu
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Investigador principal:
- Gregory J Crosby, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients ≥ 65 years of age
- American Society of Anesthesiologists (ASA) physical status of I-III
- Scheduled for elective spine surgery.
Exclusion Criteria:
- History of stroke (not including transient ischemic attacks, or TIAs)
- History of brain tumor
- History of autoimmune disorders
- Medications likely to significantly impact inflammation (e.g. steroids)
- Current infection
- Uncorrected vision or hearing impairment
- limited use of the dominant hand (limited ability to draw)
- inability to speak, read, or understand English.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Older (≥ 65 years of age)
Older surgical patients presenting for elective spine surgery.
|
This is an observational study with no interventions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
MOCA Score, Delirium, and Plasma Inflammatory Mediators
Prazo: 5 years
|
The investigators will evaluate correlations between preoperative cognition, as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative plasma inflammatory markers by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
|
5 years
|
MOCA Score, Delirium, and the Cellular Immune Response
Prazo: 5 years
|
The investigators will evaluate correlations between preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative monocyte immune gene transcriptome ex vivo to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
|
5 years
|
MOCA Score, Delirium and Extracellular Vesicle Immune Responses to Surgery.
Prazo: 5 years
|
The investigators will evaluate correlations between poor preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative proteins found in circulating extracellular vesicles by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
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5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Newly diagnosed perioperative health complications
Prazo: Up to 30 days after the surgical procedure
|
Newly diagnosed Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission following the subjects initial surgical procedure.
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Up to 30 days after the surgical procedure
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Discharge location (Home vs. other than home) on the day of patient discharge from hospital
Prazo: Up to 30 days after the surgical procedure
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Whether the patient was discharge to their home or discharged to a place other than home such as rehabilitation center or skilled nursing facility.
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Up to 30 days after the surgical procedure
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30 day mortality
Prazo: 30 days after surgical procedure
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Patient mortality 30 days after surgical procedure
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30 days after surgical procedure
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30 day re-operation or readmission
Prazo: 30 days after surgical procedure
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Patient readmission to the hospital or reoperation 30 days after surgical procedure
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30 days after surgical procedure
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6 month mortality
Prazo: 6 months after surgical procedure
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Patient mortality 6 months after surgical procedure
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6 months after surgical procedure
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1 year mortality
Prazo: 1 year after surgical procedure
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Patient mortality 1 year after surgical procedure
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1 year after surgical procedure
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Cognitive health outcome
Prazo: 3, 6, and 12-months after surgical procedure.
|
Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) measured approximately 3, 6, and 12-months following the patient's surgical procedure if the participant is willing to participate.
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3, 6, and 12-months after surgical procedure.
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Functional health outcome
Prazo: Between 6 and 12-months after surgical procedure.
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Functional health outcome measured with the World Health Organization Disability Assessment Score (WHODAS, 12-item, minimum score 0 maximum score 110 with higher score reflecting more disability) approximately 6 months to 1 year following the patient's surgical procedure if the participant can be contacted by followup phone call and is willing to participate.
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Between 6 and 12-months after surgical procedure.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gregory J Crosby, MD, Brigham & Women's Hospital; Harvard Medical School
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
- 2019P000577
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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