Care Transition Intervention for Hospitalized Patients With Advanced Cancer
Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer
研究概览
详细说明
To address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology NP within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.
From 01/07/21 to 05/28/21, the investigators conducted a pilot trial of CONTINUUM in 48 patients with advanced cancer recently discharged from the Massachusetts General Hospital Cancer Center (NCT04640714). The investigators found that the intervention was feasible and acceptable in our population.
The investigators are now conducting a randomized controlled trial of the CONTINUUM intervention versus standard of care, to study whether CONTINUUM improves patients' confidence in managing their health condition, as measured by the Patient Activation Measure-13. The investigators will also assess the efficacy of CONTINUUM for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. Lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days.
Study procedures include random assignment to either the CONTINUUM intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection.
Participants are expected to be on the study for up to 40 days after hospital discharge.
It is anticipated that about 286 people will take part in this research study.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jennifer S Temel, MD
- 电话号码：(617) 724-4000
- 邮箱：jtemel@partners.org
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- 招聘中
- Massachusetts General Hospital Cancer Center
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接触：
- Jennifer S Temel, MD
- 电话号码：617-724-4000
- 邮箱：jtemel@mgh.harvard.edu
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首席研究员：
- Jennifer S Temel, MD
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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 >= 18 years
- First unplanned admission to the oncology service at Massachusetts General Hospital (MGH) since diagnosis of advanced cancer
- Known diagnosis of advanced breast, thoracic, genitourinary, or gastrointestinal cancer
- Receiving ongoing oncology care at MGH
- Verbal fluency in English
- Internet/wifi or telephone access
- Residing in Massachusetts at the time of hospital discharge
Exclusion Criteria:
- Admitted electively
- Discharged to a location other than home or expired during admission
- Discharged with hospice services
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：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 |
|---|---|
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实验性的：CONTINUUM Intervention Post-Hospital Discharge
Participants will receive CONTINUUM intervention visit with a nurse practitioner within three business days of hospital discharge and complete questionnaires about their cancer and care.
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The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology nurse practitioner within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.
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有源比较器：Usual Care Post-Hospital Discharge
Participants will receive standard oncology care following hospital discharge with follow-up appointments scheduled per primary team and participant preferences.
Participants will complete questionnaires about their cancer and care.
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Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.
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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 |
|---|---|---|
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Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
大体时间：Baseline to 10-15 days after hospital discharge
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Compare change in the PAM-13 from baseline to 10-15 days post-discharge between study groups.
The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition.
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Baseline to 10-15 days after hospital discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale
大体时间：Up to 10-15 days after hospital discharge
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Compare differences in CAHPS-Communication at up to 10-15 days post-discharge between study groups.
CAHPS-Communication has a composite score (score range 0-20) with higher scores indicating better satisfaction.
As recommended by CAHPS, we will also analyze specific differences in CAHPS-Communication individual items, which relate to patients' assessment of whether clinicians discussed 1) illness course expectations, 2) what is most important to the patient, and 3) how the treatment plan should match what is most important to the patient.
These items are scored as "Yes" vs. "No" responses.
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Up to 10-15 days after hospital discharge
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Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)
大体时间：Baseline to 10-15 days after hospital discharge
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Compare change in the Edmonton Symptom Assessment System-Revised (ESAS-r) total score and physical sub-scale between baseline and 10-15 days of discharge between study groups.
Scores on the ESAS-r range from 0-100 with higher scores indicating worse symptom burden.
Scores on the ESAS-Physical sub-scale range from 0-70 with higher scores indicating worse symptom burden.
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Baseline to 10-15 days after hospital discharge
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Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)
大体时间：Baseline to 10-15 days after hospital discharge
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Compare change in the Patient Health Questionnaire-4 (PHQ-4) between baseline and 10-15 days of discharge between study groups.
The PHQ-4 is a 4-item tool that contains two 2-item subscales assessing depression and anxiety symptoms.
Both subscales and the composite PHQ-4 score can also be evaluated continuously, with higher scores indicating worse psychological distress.
Scores on each subscale range from 0 to 6.
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Baseline to 10-15 days after hospital discharge
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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30-day Hospital Readmissions
大体时间：Up to 30 days after discharge
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Compare hospital readmissions within 30 days of discharge between study groups.
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Up to 30 days after discharge
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合作者和调查者
调查人员
- 首席研究员：Jennifer S Temel, MD、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
- 21-501
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
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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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CONTINUUM Intervention的临床试验
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Centre hospitalier de l'Université de Montréal...Boehringer Ingelheim; Greybox主动，不招人
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Institut de cancérologie Strasbourg EuropeContinuum Plus Santé; Plateforme nationale qualité de vie et cancer; WeShare尚未招聘
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人