A Randomized Controlled Trial of an Intervention Called "Algorithm-Enabled Patients Activated in Cancer Care Through Teams" (A-PACT) to Improve Goals of Care Communication for People With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- Proportion of patients with any hospitalization
研究概览
简要总结
This clinical trial evaluates an educational program called Algorithm-Enabled Patients Activated in Cancer Care Through Teams (A-PACT) for reducing unplanned hospital visits and improving goals of care conversations with providers among patients with solid cancers. A-PACT is an educational program where lay health workers (educators) help patients talk with their health care team about issues that matter most to them (goals of care). During A-PACT sessions, patients receive assistance in formulating health care and end of life care preferences, assistance in completing advance directives, guidance on how to engage in these conversations with family members, friends, and clinical teams, and encouragement to discuss these topics with their clinical team. A-PACT may reduce unplanned hospital visits and improve goals of care communication with providers among patients with solid cancers.
详细描述
PRIMARY OBJECTIVE:
I. To compare the proportion of participants who have any hospitalizations within 12 months after randomization between those receiving A-PACT (intervention arm) and those receiving usual care alone (control arm).
SECONDARY OBJECTIVES:
I. To compare the proportion of participants who report anxiety at 3 months compared to baseline between participants receiving A-PACT and participants receiving usual care.
II. To compare the proportion of participants who report depression at 3 months compared to baseline between participants receiving A-PACT and participants receiving usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
盲法说明
Randomization assignment is not revealed to clinicians and general staff.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must have a diagnosis of a solid tumor malignancy of any stage
- •Participants must be identified as high risk, defined as having 6 month mortality estimate from machine learning (ML) algorithm >= 20%
- •Participants must not be receiving or have pre-existing plans to enter hospice care at the time of study registration
- •Participant must be actively receiving or planning to receive systemic anti-cancer therapy (defined as any oral, injection, or intravenous therapy against cancer) within 3 months after registration
- •NOTE: This includes chemotherapy (conventional or cytotoxic chemotherapy), hormone therapy, targeted therapy, and immunotherapy
- •NOTE: Participants are allowed to be co-enrolled on other clinical trials including trials using investigational agents
- •Participants must be >= 18 years of age at the time of study enrollment
- •Participants who can complete Patient Reported Outcome (PRO) questionnaires in English or Spanish must be willing to 1) complete PROs at all scheduled assessments; and 2) complete the pre-registration (baseline) PRO forms within 14 days prior to registration
- •Participants must be able to provide a valid telephone number for the purpose of being contacted by the lay health worker
- •NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- •Patient and clinician participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative NOTE: For this study, in the OPEN registration, clinician participants will be listed as their own treating investigator. However, clinician participants must not consent themselves or sign their own eligibility criteria forms
排除标准
- 未提供
研究组 & 干预措施
Group 1 (Usual care + A-PACT)
Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care.
干预措施: Electronic Health Record Review (Other)
Group 2 (Usual care)
Patients receive usual care for 6 months.
干预措施: Electronic Health Record Review (Other)
Group 2 (Usual care)
Patients receive usual care for 6 months.
干预措施: Questionnaire Administration (Other)
Group 1 (Usual care + A-PACT)
Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care.
干预措施: Interview (Other)
Group 1 (Usual care + A-PACT)
Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care.
干预措施: Best Practice (Other)
Group 1 (Usual care + A-PACT)
Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care.
干预措施: Educational Intervention (Other)
Group 1 (Usual care + A-PACT)
Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care.
干预措施: Questionnaire Administration (Other)
Group 2 (Usual care)
Patients receive usual care for 6 months.
干预措施: Best Practice (Other)
Group 1 (Usual care + A-PACT)
Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care.
干预措施: Telephone-Based Intervention (Behavioral)
结局指标
主要结局
Proportion of patients with any hospitalization
时间窗: Within 12 months of enrollment
The primary analysis will be conducted using multivariable logistic regression, adjusting for stratification factors as covariates.
次要结局
- Number of hospitalizations as a continuous outcome(Up to 12 months)
- Intensive end-of-life care(Up to 12 months)
- Anxiety(At 3 months after enrollment)
- Proportion of patients with 0 versus >= 1 of the combined endpoint of hospitalizations or emergency room (ER) visits(Up to 12 months)
- Number of hospitalizations or ER visits(Up to 12 months)
- Depression(At 3 months after enrollment)