Lay Health Worker Engage, Educate, and Encourage Patients to Share
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
研究概览
简要总结
The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.
详细描述
Unite Here Health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. The Lay Health Worker Engages, Educates, and Encourages Patients to Share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Unite Here Health members who are diagnosed with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with a cancer diagnosis.
- •Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- •The patients must be 18 years or older.
- •Patients must have the capacity to verbally consent.
排除标准
- •Inability to consent to the study due to lack of capacity as documented by the referring physician.
- •Patients without a newly diagnosed malignancy or patients without relapse of disease.
- •Patients not eligible for Fund benefits.
- •Patients without a newly diagnosed malignancy or patients without relapse of disease.
研究组 & 干预措施
Intervention Group Arm
Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice).
The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists.
干预措施: Lay Health Worker Intervention (Behavioral)
Intervention Group Arm
Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice).
The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists.
干预措施: Usual Care (Other)
Control Group Arm
The control group arm will receive usual care as provided by Unite Here Health and their local oncologists.
干预措施: Usual Care (Other)
结局指标
主要结局
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
时间窗: Change in Quality of Life from Baseline to 4 Months
Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at baseline and 4 months. We will measure the change in quality of life at baseline to 4 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.
次要结局
- Emergency Department Visit (Chart Review)(Last 30 days of life up to 12 months from patient enrollment)
- Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey(Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.)
- Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey(Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).)
- Hospitalization Visit (Chart Review)(4 months after patient enrollment)
- Palliative Care Use (Chart Review)(last 30 days of life)
- Physician Orders for Life Sustaining Treatment (Chart Review)(12 months after patient enrollment)
- Survival (Chart Review)(12 months after patient enrollment)
- Patient Activation Using the Patient Activation Measure Survey(Change in Patient Activation Measure from baseline to 12 months post-enrollment.)
- Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey(Health-related quality of life at 12 months)
- Goals of Care Documentation (Chart Review)(12 months after patient enrollment)
- Total Costs of Care End of Life(Last 30 days of life up to 12 months from patient enrollment)
- Hospitalization Visits (Chart Review)(last 30 days of life)
- Advance Directive Documentation (Chart Review)(12 months after patient enrollment)
- Total Costs of Care(12 months after patient enrollment)
- Hospice Use (Chart Review)(last 30 days of life)
- Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey(Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.)
- Patient Activation Using the Patient Activation Measure Survey(Change in Patient Activation Measure from baseline to 4 months post enrollment.)
- Emergency Department Visit (Chart Review)(4 months after patient enrollment)
- Emergency Department Visit (Chart Review)(12 months after patient enrollment)
- Hospitalization Visits (Chart Review)(12 months after study enrollment)
- Advance Directive Documentation (Chart Review)(4 months after patient enrollment)
- Physician Orders for Life Sustaining Treatment (Chart Review)(4 months after patient enrollment)
- Goals of Care Documentation (Chart Review)(4 months after patient enrollment)
- Palliative Care Use (Chart Review)(4 months after patient enrollment)
- Palliative Care Use (Chart Review)(12 months after patient enrollment)
- Hospice Use (Chart Review)(4 months after patient enrollment)
- Hospice Use (Chart Review)(12 months after patient enrollment)
- Survival (Chart Review)(4 months after patient enrollment)
研究者
Manali Indravadan Patel
Assistant Professor
Stanford University