Lay Health Worker Expanded Intervention in Community Oncology Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 2
- 主要终点
- % of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
研究概览
简要总结
Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.
详细描述
All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.
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
- 75 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed or relapsed cancer diagnosis.
- •75 years or older
- •Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- •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)
Behavioral:Program participants
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
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
时间窗: 12 months after patient enrollment
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the % of patients with emergency department visits between study arms.
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
时间窗: 12 months after patient enrollment
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms.
次要结局
- Total Health Care Costs (Claims Review)(12 months after patient enrollment)
- % of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)(12 months after patient enrollment)
- % of patients with an Acute Care Facility Death (Chart Review)(30 days prior to death for patients who died at 12-months follow-up)
- % of patients with 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)
- % of patients with 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)
- % 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)(Time of enrollment to 12 months followup or death, whichever is first)
研究者
Manali Indravadan Patel
Assistant Professor
Stanford University