Enhancing Community Capacity to Improve Cancer Care Delivery: The Effect of a Lay Health Worker Intervention on Patient-reported Symptoms, Healthcare Use, Total Costs of Care, and End-of-life Care Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 832
- 试验地点
- 1
- 主要终点
- Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
研究概览
简要总结
Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a a lay health worker (LHW)-led symptom screening intervention was developed for patients with advanced cancer. This intervention will be expanded to all patients with cancer and the LHW will be trained to refer patients to palliative care and behavioral health. This intervention will evaluate the effect on symptom-burden, survival, healthcare use, and total costs.
详细描述
From 11/1/2016 - 9/30/2018, all newly diagnosed Medicare Advantage enrollees with solid or hematologic malignancies were enrolled in the intervention. Outcomes were compared outcomes to patients in the year prior (control arm). The primary outcome was change in symptoms using the Edmonton Symptom Assessment Scale (ESAS) and Personal Health Questionnaire-9 (PHQ-9) at baseline, 6- and 12-months post-enrollment. Secondary outcomes were between-group comparison of survival, 12-month healthcare use and costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 with cancer
- •Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- •Must be 18 years or older.
- •Must have 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.
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: proactive symptom assessments for patients for up to 12-months.
干预措施: Program participants (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: proactive symptom assessments for patients for up to 12-months.
干预措施: Usual Care (Other)
Control Group Arm
The control group arm will receive usual care as provided by their local oncologists.
干预措施: Usual Care (Other)
结局指标
主要结局
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
时间窗: 12 months after patient enrollment
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
时间窗: 12 months after patient enrollment
Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 12 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
时间窗: Baseline (at time of patient enrollment)
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
时间窗: 6 months after patient enrollment
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
时间窗: Baseline (at time of patient enrollment)
Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at baseline. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
时间窗: 6 months after patient enrollment
Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 6 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.
次要结局
- Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review)(12 months after patient enrollment)
- Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review)(12 months after patient enrollment)
- Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review)(12 months after patient enrollment)
- Total Health Care Costs (Claims Review)(12 months after patient enrollment)
- Number of Patients With an Acute Care Facility Death (Chart Review)(30 days prior to death for patients who died at 12-months follow-up)
- Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review)(30 days prior to death for patients who died at 12-months follow-up)
- Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review)(30 days prior to death for patients who died at 12-months follow-up)
- Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review)(30 days prior to death for patients who died at 12-months follow-up)
- Total Costs of Care (Claims Review)(30 days prior to death for patients who died at 12-months follow-up)
研究者
Manali Indravadan Patel
Assistant Professor
Stanford University