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临床试验/NCT01695382
NCT01695382已完成不适用

Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer

University of Colorado, Denver10 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
223
试验地点
10
主要终点
Hospice Utilization

研究概览

简要总结

Palliative care is a priority area of focus for health care in an aging population experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Cultural and linguistic barriers may also increase disparities in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and the unique cultural preferences and values of patients, the investigators are testing a patient navigator intervention to improve palliative care outcomes for Latinos with advanced cancer.

详细描述

This project uses a patient navigator to deliver a culturally tailored intervention to improve palliative care for Latinos with advanced cancer in urban and rural communities. The proposed research aims to improve palliative care with the goal of preventing and relieving suffering for people facing serious, complex illness. Palliative care, according to the National Quality Forum and Centers for Medicare and Medicaid, provides patient and family-centered care offered in conjunction with curative and all other appropriate forms of medical treatment. It addresses physical, intellectual, emotional, social, spiritual needs, and facilitates patients' understanding of illness and choice. There is emerging evidence that palliative care may also improve survival for cancer patients. The proposed research also focuses on reducing health disparities. Studies have shown that Latinos are more likely to die in a hospital, less likely to use hospice services, and more likely to have unmanaged pain. This study will recruit 240 Latino patients with advanced cancer from an urban safety net hospital, a National Cancer Institute-designated Comprehensive Cancer Center, and several rural communities (including some of the poorest, most underserved counties in Colorado). Patients will be randomized to either a control or intervention group. The control group will receive written materials covering three important palliative care domains -advance care planning, pain management, and hospice care. The materials, in English and Spanish, are appropriate for patients with low health literacy. Patients in the intervention group will receive the same written materials but will also have a patient navigator who will make 5 home visits to review materials, help patients and families talk about goals/values, and complete an advance directive, all in a culturally and linguistically appropriate manner. The navigator may also help with: accessing community resources, participating in family meetings with health care providers, and offering support to patients and families. The investigators hypothesize that the intervention will increase advance care planning, improve pain management, increase hospice referrals, and patients will have improved palliative care overall at the end of life. The patient navigator model has demonstrated an ability to improve cancer screening, early diagnosis, treatment, and survivorship. Once the investigators demonstrate the efficacy of a patient navigator intervention to improve palliative care for advanced cancer patients, they can disseminate the training and intervention to all patient navigators working with Latino cancer patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stage III or Stage IV cancer (all types)
  • Self-identify as Latino
  • 18 years of age or older
  • Speak English or Spanish

排除标准

  • Lacking decisional capacity
  • Incarcerated

结局指标

主要结局

Hospice Utilization

时间窗: 46 months after enrollment

Length of stay in hospice program in days. Data will be collected through follow up phone calls, medical records review, and death records review to determine date of admission into hospice program and date of discharge (through death or dis-enrollment)

Improvement in Palliative Care Overall

时间窗: 3 months after enrollment

Patient Navigator and Process Measure will capture the less tangible benefits of a patient navigator and help understand the effects of the many activities of the navigator beyond the scope of the prescribed intervention. The questions incorporate aspects of self-efficacy and patient activation (key concepts that patient navigators help improve).

Evidence of Advance Care Planning

时间窗: 6 months after enrollment

Chart review to determine if there is an advance directive in the medical record and classification of the type of advance directive (Medical Durable Power of Attorney (MDPOA), Advance Directive (AD), Living Will)

Assesment of Pain Management

时间窗: 3 months after enrollment

Pain management will be assessed through patient interviews utilizing the Brief Pain Inventory (BPI). The BPI Long Form (BPI-LF) is a 32-item self-report instrument that assesses the severity and impact of pain in patients with chronic diseases, e.g. cancer.

次要结局

  • Change in Quality of Life(Baseline and 3 months after enrollment)
  • Aggressiveness of Care at the End of Life(At month 46)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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