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临床试验/NCT04009798
NCT04009798Unknown不适用

Physician Intuition Versus Model Predicted Prognosis in Heart Failure

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2018年5月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,400
试验地点
1
主要终点
Heart Transplant

研究概览

简要总结

The purpose of the project is to conduct a physician-initiated Canadian multicentre observational research study that compares physician judgement and model prediction to estimate one-year survival in ambulatory heart failure (HF) patients and evaluate the use of resources according to physician intuitive risk. This study will evaluate the accuracy and impact of physician intuition and predictive models in the assessment of prognosis in ambulatory HF patients by: comparing 1-year physician predicted survival and 1-year observed survival to 1-year model predicted survival; evaluating whether model performance could be enhanced by incorporating physician intuition; evaluating the accuracy of physician intuition according to level of confidence in physician intuition (very low, low, moderate, high or very high); evaluating whether physician expertise impacts accuracy of physician intuition; and evaluating patient management and use of resources according to physician estimated survival.

详细描述

Heart failure (HF) is a large and growing medical and economic problem, with over 26 million people suffering worldwide. The prognosis associated with HF is poor. Optimal management of patients with HF, crucial to improve outcomes and minimize costs, depends on adequate assessment of prognosis to decide on appropriate testing and intervention.

There are predictive models, with satisfactory discrimination and calibration, that can accurately estimate mortality in HF patients. Despite their availability, physicians seldom use these models, instead relying on their informed intuition, which has proven to be limited. No studies have compared physician intuition (standard practice) and model predicted survival in patients with HF. The investigators therefore propose a Canadian multicentre study comparing physician intuition and model prediction to estimate one-year survival in ambulatory HF patients and secondly to assess the possible impact of intuition versus model prediction on the use of resources. Evaluating whether predictive models are more accurate than physician intuition will inform the best strategy to assess patient prognosis in HF. More accurate prognostic estimates will facilitate patient management by matching the need for further therapy or testing to patient risk thus offering greater clinical benefit and improving utilization of resources.

This study will evaluate the accuracy and impact of physician intuition and predictive models in the assessment of prognosis in ambulatory HF patients by: i. comparing the accuracy of 1-year physician predicted survival and 1-year model predicted survival to the true (observed) 1-year survival; ii. evaluating the accuracy of physician intuition according to physician's level of confidence in their intuition (very low, low, moderate, high or very high); iii. evaluating whether physician expertise impacts accuracy of physician intuition; iv. evaluating whether physician gender, patient gender and physician-patient gender concordance impact accuracy of physician intuition; and v. studying the association between physician estimated survival and resource use and related cost.

The investigators hypothesize that predictive models will more accurately predict mortality than physicians, with more marked differences in less experienced physicians or when physician confidence in estimate is low. Physicians will use more resources when they consider patients to be high risk. If these hypotheses prove correct, incorporation of user-friendly systems to estimate prognosis into clinical practice can offer clinical benefit, facilitate patient management and improve utilization of resources.

This is a Canadian multicentre prospective cohort study of consecutive consenting ambulatory adult heart failure (HF) patients followed in a HF clinic. Participating centers include tertiary care hospitals with dedicated HF clinics in British Columbia (St. Paul's Hospital, Providence Health Care Centre); Manitoba (St. Boniface General Hospital); Ontario (Toronto General Hospital, St. Michael's Hospital, Ottawa Heart Institute, Sunnybrook Hospital, Mount Sinai Hospital, Hamilton Health Science, Southlake Regional Health Centre); Quebec (McGill University Health Centre); and Nova Scotia (Nova Scotia Health Authority). These clinics attend to different HF populations permitting a wide representation of patient profiles.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ambulatory HF patients followed in a HF clinic
  • Adults (>18 years)
  • Have a left ventricular ejection fraction (LVEF) ≤40% by echocardiogram

排除标准

  • HF patients with preserved LVEF (>40%)
  • HF patients already on ventricular assist device support
  • Patients with acutely decompensated HF at the time of the clinic visit requiring admission or with a HF admission in the previous month to the index clinic visit.

结局指标

主要结局

Heart Transplant

时间窗: 1-year

Heart transplant within 1 year of study enrolment

Mortality

时间窗: 1-year

All-cause mortality

Left Ventricular Assist Device

时间窗: 1-year

Left ventricular assist device implant within 1 year of study enrolment

次要结局

  • Heart Failure Hospitalization(1-year)
  • Utilization of health resources and related costs(1-year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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