综合可行的癌症患者老化评估试点
Aging is the greatest risk factor for cancer incidence and mortality. Geriatric screening is recommended to help with treatment discussions, inform intensity of treatment, and identify supportive care needs. Despite a strong evidence base, geriatric assessments are not implemented routinely in oncologic clinics. Similarly, important information on social determinants of health, mental health, and health behaviors are inconsistently assessed, and almost never in an integrated fashion. In an effort to support clinicians delivering the recommended goal-concordant care, the investigators will integrate assessment of geriatric issues, health behaviors, mental health, and social determinants of health into an efficient, actionable contextual assessment system for older cancer patients called Integrated Aging Assessment for Action for Cancer Patients (IA3-CP). The investigators will use D&I strategies including co-creation engagement approaches and form-function methods to develop workflow processes that feasibly integrate the IA3-CP into usual initial assessment with the oncology team. Our objective is to develop and conduct a randomized pilot of the IA3-CP system and hypothesize that our results will show it can be implemented consistently, acted on, improve quality of care, and enhance patient-provider interactions.
研究概览
地位
详细说明
Aging is the greatest risk factor for cancer incidence and mortality. Strong data and expert recommendations support the use of geriatric screening assessments to guide treatment for older adults (>65 years old). Geriatric assessment findings can help in treatment discussions, inform intensity of treatment, and identify supportive care needs. Yet, despite evidenced-based benefits, geriatric assessments are not implemented routinely in oncologic clinics. Similarly, there are strong data and expert recommendations for assessment of social determinants of health (SDoH) and health behaviors, but consistent assessment and action on SDoH and health behaviors is infrequent. Clinicians aiming to deliver recommended goal-concordant care to older patients - which is informed by a patient's frailty, SDoH, health behaviors, and mental health - must act without this important contextual information.
We have identified a pragmatic geriatric screening tool (the G8) and adapted it to a validated patient-reported measure. We aim to integrate the novel, validated, patient reported G8 with the NCI funded, theory driven, evidence-based My Own Health Report (MOHR) system that captures patient reported health behavior, mental health, and social determinants of health (SDoH) through a web-based portal. We will integrate assessment of geriatric issues, health behaviors, mental health, and SDoH into an efficient, actionable contextual assessment system for older cancer patients called Integrated Aging Assessment for Action for Cancer Patients (IA3-CP). We will use D&I strategies including co-creation engagement approaches and form-function methods to develop workflow processes that feasibly integrate the IA3-CP into usual initial assessment with the oncology team. Our objective is to develop and conduct a randomized pilot of the IA3-CP system to determine if it can be implemented consistently, acted on, improve quality of care, and enhance patient-provider interactions.
RATIONALE:
The phrase "you have cancer" lands differently with older patients than it does those younger. The issues of frailty, comorbidity, mental and behavioral health, and SDoH are critical to formulating a personalized cancer treatment approach with an older person as they can't put these conditions "on hold" to focus on a cancer diagnosis. Aging is the greatest risk factor for cancer incidence and mortality, with nearly half of all cancers diagnosed after age 65. There is a clear need to create patient-centered care plans that align care that is medically feasible and aligned with individual patient needs, environment, and preferences.
Geriatric screening and assessment is broadly recommended for the care of older persons with cancer. Similarly, there is strong consensus that SDoH (e.g., food scarcity, medical affordability, safe environments) and health behaviors are key drivers of health disparities. Validated, pragmatic patient-report measures of geriatric issues, health behaviors, and SDoH exist but are seldom consistently assessed in clinical practice, hardly ever in an integrated fashion, and even less seldom acted on. Clinics need efficient, cost-effective tools to screen for and address multiple risks at the same time - technology can provide important efficiencies.
SIGNIFICANCE:
Using age as a primary determinant for cancer treatment puts older adults at risk of under- or over-treatment of cancer. Failure to implement available tools that enhance our ability to tailor care planning to the unique needs of older adults represents a critical gap in patient-centered care.
Implementation of geriatric-specific measures: Oncologists recognize functional assessment as a predictor of future morbidity and mortality risk, so much so that it largely dictates oncology treatment selection, yet are using measures insensitive in an older population. Oncologists will often use clinical gestalt to recommend modified variants of standard treatment. An integrated assessment system can provide actionable, more comprehensive personalized data to the patient and care team.
Geriatric 8: The G8 is a brief geriatric assessment tool that has been broadly validated in the oncology setting to screen for potential frailty and need for a comprehensive assessment. It incorporates functional status, cognition and mental health, and nutritional feedback to form a clinic collected 8-item assessment. To address identified barriers to implementation, the investigators adapted the G8 with input from our Rural Cancer Advisory Board to a patient-reported version. The investigators then pilot tested implementation and validity of the modified G8 in seven clinical environments - primary care and oncology in community and academic settings with excellent results. In parallel, the investigators devised a way to integrate the patient-reported items into the UCHealth EHR for use in clinical care and documentation. The investigators now propose to use similar strategies to integrate the IA3-CP into the EHR.
My Own Health Report (MOHR): MOHR is a patient-centered, web-based health risk assessment and feedback system for unhealthy behaviors, mental health status, and prioritizing patient concerns. MOHR has been used successfully in numerous primary care environments and its use has been found to result in patients feeling more cared for by their clinical team. Our randomized trial found that patients receiving MOHR improved physical activity (p < 0.001) and dietary behaviors (p < 0.001) that increase the risk for many oncology toxicities and significantly increased goal setting during primary care visits. The investigators have recently adapted MOHR to include SDoH such as transportation, food access, medication affordability, safety at home, housing, and financial stability. Much like the geriatric screen, MOHR provides information on health behaviors that may be at risk, especially in an older population more likely to face comorbid conditions.
This proposal will integrate our evidence-based health risk assessment (MOHR) with a geriatric health screener (G8) to assess and address the needs of older adults with cancer. Key challenges to assessment of SDoH and cancer risks are the nonsystematic and separate, non-integrated way these assessments are conducted and the limited time in clinic visits to identify risks, and tailor treatment and goal setting to patient context and priorities. When patients complete our MOHR web-based system, actionable information on health risks and SDoH along with patients' priorities provides for more informed and efficient patient-clinician interactions. This is an example of how well-designed, contextually-appropriate technology developed with patients and clinicians can provide important efficiencies to address clinical and implementation challenges.
In combining the extensive preliminary work in designing the modified G8 and the demonstrated success of the MOHR automated assessment and feedback system with the clinical and methodologic expertise of our team, the investigators are positioned to successfully pilot the IA3-CP in the UCCC. This proposal addresses a clear gap in the needs of older cancer patients and clinical teams and will lead to many future collaborations including a UG3/UH3 MPI pragmatic trial submission.
INNOVATION:
Our proposed feasibility pilot will accelerate the implementation of patient-reported measures to inform care planning for the diverse and at-risk population of older adults with cancer. It will also advance transdisciplinary cancer research by demonstrating integration of multiple risk issues in a pragmatic fashion using innovative D&I science and engagement methods.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Colorado
-
Aurora、Colorado、美国、80045
- University of Colorado Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age > /= 65
- Patient must agree to participate in all study-related activities
- English or Spanish speaking
- Attending initial visit to oncology
Exclusion criteria
- age < 65
- primary language other than English or Spanish
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:IA3-CP with SDoH
Assess IA3-CP with SDoH and provide feedback (provider & patient) |
Each patient randomly assigned to IA3-CP with SDoH study arm will complete a pre-visit assessment tool including SDoH. Feedback is provided to provider and patient. |
|
实验性的:IA3-CP only
Assess IA3-CP only without added SDoH and provide feedback (provider & patient) |
Each patient randomly assigned to IA3-CP only study arm will complete a pre-visit assessment tool excluding SDoH. Feedback is provided to provider and patient. |
|
无干预:Control - usual care
Usual care: Assess IA3-CP without providing the feedback report |
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 |
|---|---|---|
|
Patient reported receipt of quality illness care
大体时间:12 weeks
|
Measured by the Patient Assessment of Chronic illness Care (PACIC). The score ranges from 1-5 where higher scores mean a better outcome |
12 weeks
|
|
Number of referrals made and completed for geriatric, health behavior and SDoH issues
大体时间:16 weeks
|
Measured by data abstraction from EHR |
16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Discussion of IA3-CP related issues in oncologist-patient encounter
大体时间:7 months
|
Measured by checklist adapted from the Roter interaction analysis system (RIAS) completed from recorded observation of patient-oncologist meeting |
7 months
|
|
Oncologist utility
大体时间:7 months
|
Did IA3-CP change your care plan? (yes/no) How helpful was it? (6 pt. scale) |
7 months
|
|
Proportion of patients that use IA3-CP screening tool
大体时间:7 months
|
Measured by clinic leadership report & observation |
7 months
|
合作者和调查者
调查人员
- 首席研究员:Russell E Glasgow、University of Colorado, Denver
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
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
- 泌尿生殖系统疾病
- 生殖器疾病
- 血管疾病
- 心血管疾病
- 生殖器肿瘤,男性
- 泌尿生殖系统肿瘤
- 按部位分类的肿瘤
- 肿瘤
- 生殖器疾病,男性
- 前列腺疾病
- 男性泌尿生殖系统疾病
- 肾脏疾病
- 泌尿系统疾病
- 女性泌尿生殖系统疾病
- 女性泌尿生殖系统疾病和妊娠并发症
- 免疫系统疾病
- 组织学类型的肿瘤
- 血液病
- 皮肤病
- 乳腺疾病
- 淋巴系统疾病
- 淋巴增生性疾病
- 免疫增生性疾病
- 泌尿系肿瘤
- 淋巴瘤
- 肿瘤,浆细胞
- 止血障碍
- 副蛋白血症
- 血液蛋白失调
- 出血性疾病
- 膀胱疾病
- 白血病,骨髓,急性
- 皮肤和结缔组织疾病
- 半身和淋巴疾病
- 前列腺肿瘤
- 白血病
- 白血病,骨髓
- 乳腺肿瘤
- 白血病、淋巴细胞
- 多发性骨髓瘤
- 霍奇金病
- 膀胱肿瘤
- 肾脏肿瘤
- 白血病,单核细胞,急性
- 人口特征
- 健康状况
- 人口统计学
- 健康
- 健康的社会决定因素
其他研究编号
- 23-0440.cc
- P50CA244688 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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