Developing Pilot Postoperative Guidelines for Improved Functional Outcomes After High-Risk Cancer Surgery
Development and Implementation of Pilot Postoperative Guidelines to Improve Functional Outcomes Following High-Risk Surgery for Cancer: A North American Prospective Feasibility Study
研究概览
地位
详细说明
This is a prospective, feasibility, and effectiveness trial to be conducted at The University of Alabama at Birmingham. We plan to develop algorithmic guidelines focused on proactive support of surgical recovery and will then recruit surgeons who care for adults undergoing high-risk abdominal surgery for cancer to study the preliminary effectiveness of implementing the algorithmic guidelines into postoperative care workflows at 4 pre-determined timepoints. A modified Delphi process will be used to ensure an expert consensus on the algorithmic guideline content is achieved through a rigorous and consensus-driven process. Two rounds of structured online voting will be conducted to rate and refine each algorithmic guideline component.
Key feasibility outcomes include recruitment and retention rates, surgeon adherence, data completeness, and integration into routine workflows. Preliminary effectiveness will be measured using patient-reported outcomes, timeliness of referral to supportive providers and resources, use of supportive services, rates of surgical regret, and measures of functional recovery.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Amber N Taylor (Clinical Research Regulatory Coordinator I), BS, MA
- 电话号码:(205)996-4611
- 邮箱:amberntaylor@uabmc.edu
学习地点
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Alabama
-
Birmingham、Alabama、美国、35233
- University of Alabama at Birmingham
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接触:
- Amber Taylor, BS, MA
- 电话号码:2059964611
- 邮箱:amberntaylor@uabmc.edu
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Surgeons who perform abdominal surgery for cancer at the study institution
Exclusion Criteria:
- Surgeons who do not perform abdominal surgery for cancer
- Surgeons who are external to the study institution
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 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:Surgeons
Surgeons will be given a postoperative decision support guideline for assessment of functional recovery
|
This is a pilot feasibility study to test the clinical use of a novel algorithmic guideline to support patient functional recovery following cancer surgery.
To date, no algorithmic guideline exists to support functional recovery as a primary postoperative outcome.
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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 |
|---|---|---|
|
Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery
大体时间:6 months
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The primary outcome is surgeon use of the novel guideline to guide the postoperative clinical care of patients recovering from GI cancer surgery.
This will be measured by in-clinic fidelity monitoring, i.e. researcher monitoring of clinical use of the developed guideline.
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6 months
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合作者和调查者
调查人员
- 首席研究员:Kimberly E Kopecky, MD,MSCI、University of Alabama at Birmingham
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- IRB-300016448
- UAB (其他标识符:UAB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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
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