Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study: an Observational Cohort Study in Patients Undergoing Non-cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Degree of agreement in screening results (Cohen's Kappa (κ) coefficients)
研究概览
简要总结
This is a prospective multicenter cohort study, which will determine the prevalence of preoperative cognitive impairment (CI) using the Modified Telephone Interview for Cognitive Status (TICS-M), Eight-items interview to Differentiate Aging and Dementia (AD8), Telephone Montreal Cognitive Assessment (T-MoCA), and a single cognitive question from the Centers for Disease Control and Prevention (CDC). We would also determine the (1) the degree of agreement in screening results between each cognitive screening tool, (2) risk factors associated with screening positive for CI on each tool, and (3) the prevalence and/or trajectory of postoperative delirium, sleep disturbances, functional disability, instrumental activities of daily living (IADL), depression, quality of health, frailty, and pain in older surgical patients and its association with CI. This study will target older patients from the pre-operative clinics at Toronto Western Hospital and Mount Sinai Hospital (MSH), Toronto. Research staff will identify eligible patients who are scheduled for elective non-cardiac surgery. Written informed consent to participate in the study will be obtained from all patients.
详细描述
The primary aim of this study is to (1) determine the prevalence of CI preoperatively in older surgical adults using virtual or telephone cognitive instruments, (2) determine the degree of agreement in screening results between each cognitive screening tool, and (3) explore the prevalence and trajectory of preoperative and postoperative outcomes and its association with CI. The outcomes include functional disability, IADL, sleep disturbances, quality of health, frailty, pain and depression.
In a preoperative assessment 1-30 days prior to their scheduled surgery, patients will be asked via telephone to complete TICS-M and T-MoCA and an online questionnaire, including the AD8, CDC single cognitive question, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), IADL, EuroQol 5 Dimension (EQ-5D-5L), Geriatric Depression Scale (GDS), 5-item FRAIL questionnaire, (FRAIL), visual analog pain scale (VAS pain), Single-item Sleep Quality Scale (SQS), Pittsburgh Sleep Quality Index (PSQI), and STOP questionnaire. These questionnaires will be repeated at follow-up visits at 30-, 90-, and 180-days post-surgery. At the hospital on post-operatively days 1-3, the Confusion Assessment Method (CAM), SQS, and VAS pain will be administered during the in-person visit. Chart review of delirium will also be conducted during patients' stay at the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ≥ 65 years old;
- •patients scheduled for elective non-cardiac surgery
- •able to be contacted by telephone for follow up.
排除标准
- •patients with previous dementia diagnosis,
- •patients scheduled for outpatient surgery,
结局指标
主要结局
Degree of agreement in screening results (Cohen's Kappa (κ) coefficients)
时间窗: Pre-surgery
The degree of agreement in screening results among the screening tools by calculating Cohen's Kappa (κ) coefficients.
Prevalence of cognitive impairment via remote (virtual/telephone) assessment
时间窗: Pre-surgery, 30-, 90- and 180-days post-surgery
Prevalence of cognitive impairment via remote (virtual/telephone) assessment as detected by the CDC Single Cognitive Question. The CDC Single Cognitive Question is a yes/no question where answers of yes indicate cognitive impairment.
The trajectories and prevalence or incidence of patient-reported outcomes
时间窗: Pre-surgery, 30-, 90- and 180-days post-surgery
The trajectories and prevalence or incidence of quality of health as measured through the EQ5D5L (EuroQol 5 Dimension) in participants with CI vs those without. Each dimension on the tool has five response levels and one level from each dimension is combined to give a health state ranging from 11111 (full health) to 55555 (worst health). The health states are converted into a single index utility where lower values indicate worse quality of health
次要结局
- Hospital length of stay (LOS) of participants post-surgery(Post-op day 1-3)
- Number of participants who have been re-admitted to the hospital post-surgery(30-, 90- and 180-days post-surgery)
- The incidence of postoperative delirium post-surgery(Post-op day 1-3)
- Days spent at home (DAH30) of participants post-surgery(30-days post-surgery)
- Incidence of postoperative complications of participants post-surgery(30-, 90- and 180-days post-surgery)
- Discharge destination of participants from chart review post-surgery(Post-op day 1-3)
- Mortality (number of participants who have died) post-surgery(30-, 90- and 180-days post-surgery)
- Number of participants who have visited the emergency department post-surgery(30-, 90- and 180-days post-surgery)
- Incidence of re-operation or revision surgery post-surgery(30-, 90- and 180-days post-surgery)
- Risk factors for screening positive on each cognitive screening tool(Pre-surgery)