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Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients

2019年5月14日 更新者:UNC Lineberger Comprehensive Cancer Center
This study prospectively evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in a cohort of non-electively hospitalized older (> 70 years) adults with cancer.

研究概览

详细说明

This study evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in non-electively hospitalized older (> 70 years) adults with cancer. Participants will be randomly assigned to the GARRT group, or the control group. All participants will fill out user friendly questionnaire called the geriatric assessment. The results of the geriatric assessment will be given to the physicians of participants in the GARRT group in real-time. The physicians of participants in the control group will not receive real time results.

This study will compare the referral rates of participants in each group to determine if providing real-time results of the geriatric assessment impact referral rates.

研究类型

介入性

注册 (实际的)

148

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • UNC Lineberger Comprehensive Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

70年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 70 years or older.
  • English speaking.
  • Admitted to UNC Hospitals non-electively within 72 hours.
  • Biopsy proven solid tumor or myeloma or lymphoma.
  • Newly diagnosed cancer patients for whom active cancer directed therapy is planned within the next six months or patients on active cancer directed therapy either currently or within the previous 6 months.
  • Signed written IRB-approved informed consent.

Exclusion Criteria:

  • Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation. Patients with a life expectancy <6 weeks
  • Patients who are <48 hours post-surgery.
  • Patients who are admitted to an intensive care setting.
  • Patients with acute myeloma lymphoma (AML) or other high grade hematologic malignancies.
  • Patients undergoing bone marrow transplant or admitted to the bone marrow transplant unit.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:GARRT Arm
Participants in this arm complete an brief geriatric assessment, and the results of these assessments are given to providers with recommendations to address deficits identified by the geriatric assessment
Providers will receive results of the brief geriatric assessment with recommendations for address deficits identified through the results of the brief geriatric assessment
有源比较器:Control Arm
Providers of participants of this group will not receive the results of the brief geriatric assessments. These participants will receive standard of care treatment
Providers will not receive results of the brief geriatric assessment. Participants will receive standard of care treatment

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Referral rate for GA-identified deficits in intervention and control groups
大体时间:2 years
Number of participants with at least one referral for a GA-idenfied deficit
2 years

次要结果测量

结果测量
措施说明
大体时间
Referral to Physical and Occupational therapy
大体时间:2 years
Number of times physical and occupation therapy referral was given in Intervention and Control group
2 years
Referral to Geriatic Consultation
大体时间:2 years
Number of times a Geriatric Consultation referral was given in Intervention and Control group
2 years
Referral to Clinical Pharmacist
大体时间:2 years
Number of times Clinical Pharmacist referral was given in Intervention and Control group
2 years
Referral to Nutritionist
大体时间:2 years
Number of times Nutritionist referral was given in Intervention and Control group
2 years
Referral to psyhcosocial support team
大体时间:2 years
Number of times psychosocial support referral was given in Intervention and Control group
2 years
Physician Reported New information
大体时间:2 years
Number of times physicians answer "yes" to the questions "did report provide new information about patient deficits that would warrant a referral"
2 years
Physician Reported Satisfaction
大体时间:2 years
Number of times physician indicate "yes" report was helpful when asked "Is this report useful"
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Trevor Jolly, MBBS、UNC Lineberger Comprehensive Cancer Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年4月25日

初级完成 (实际的)

2018年4月24日

研究完成 (实际的)

2018年4月24日

研究注册日期

首次提交

2019年5月13日

首先提交符合 QC 标准的

2019年5月14日

首次发布 (实际的)

2019年5月15日

研究记录更新

最后更新发布 (实际的)

2019年5月15日

上次提交的符合 QC 标准的更新

2019年5月14日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LCCC 1538

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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