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临床试验/NCT03434561
NCT03434561已完成不适用

Comparing Different Methods for Collection of Comorbidity Data Per the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)

Fred Hutchinson Cancer Center1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2013年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
1
主要终点
Compare the rate of agreement on HCT-CI scores between 3 measures

研究概览

简要总结

Comorbidity assessment in the field of HCT might be a burden on the medical team at the clinic or the research staff. This research study aims to explore and validate new methods, Claims-based and patient questionnaire-based, as alternatives to the standard chart-based method in order to facilitate comorbidity coding. The study aims to save time and effort of medical personnel and to ensure the inclusion of comorbidity information in all clinical trials and outcome research studies in order to improve the accuracy of treatment decision-making, patient assignment to appropriate HCT strategy and hence HCT outcomes.

详细描述

Studies have shown the importance of pre-transplant comorbidities in predicting mortality after allogeneic HCT.

However, comorbidity assessment might be a burden on the medical team at the clinic or the research staff. This research study aims to explore and validate new methods as alternatives to the standard chart-based method in order to facilitate comorbidity coding. The study aims to save time and effort of medical personnel and to ensure the inclusion of comorbidity information in all clinical trials and outcome research studies in order to improve the accuracy of treatment decision-making, patient assignment to appropriate HCT strategy and hence HCT outcomes.

This study will investigate two parallel approaches aimed at simplifying comorbidity assessment and thereby facilitating wide-spread use of the HCT-CI. Patient questionnaire-based and Claims-based methods will be tested as possible alternative to the Chart-based method. primary outcome is prediction of non-relapse mortality. It is expected that once this method of comorbidity coding is validated, it will benefit physicians in non-academic institutions and community clinics.

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

入选标准

  • •Patients eligible for autologous or allogeneic HCT.
  • •Able to speak and read English.
  • •Willing and able to provide informed consent.
  • •There is no restriction based on diagnosis, intensity of conditioning regimen, type of donor graft, degree of HLA-matching, or stem cell source.
  • •Patients >20 years old
  • •Access to a telephone for study-related communications.

排除标准

  • •HCT candidates who cannot read, write, or speak English.
  • •Patients <20 years old

结局指标

主要结局

Compare the rate of agreement on HCT-CI scores between 3 measures

时间窗: 2 years

3 measures: the questionnaire-based and the claims-based methods versus the chart-based method.

次要结局

  • Assess the accuracy of predicting HCT outcomes and resource utilization (e.g., hospitalization) between the three methods of scoring(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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