跳至主要内容
临床试验/NCT03181750
NCT03181750已完成不适用

Apoyo Con Carino: (Support With Caring) Improving Palliative Care Outcomes for Latinos With Advanced Medical Illness

University of Colorado, Denver12 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2017年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
299
试验地点
12
主要终点
FACIT-Quality of Life Assessment

研究概览

简要总结

Palliative care is a priority area of focus for the National Institute of Nursing Research. 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, our innovative study has the potential to improve palliative care outcomes and reduce health disparities in both urban and rural underserved communities.

详细描述

Latinos are more likely to experience uncontrolled pain, institutional death, and are less likely to engage in advance care planning. Efforts to increase access to palliative care must maximize primary palliative care and community based models to meet the ever growing need in a culturally-sensitive and congruent manner. Patient navigator interventions are community based, culturally tailored models of care and have been successfully implemented to improve disease prevention, early diagnosis and treatment. The investigators have developed and implemented a patient navigation intervention to improve palliative care outcomes for seriously ill hospitalized Latinos. They have demonstrated feasibility and early findings suggest this intervention can improve palliative care outcomes for Latinos with advanced cancer. Building on this prior research, the investigators propose a fully powered randomized controlled trial to determine the effectiveness of the manualized patient navigator intervention in a non-cancer population. A total of 240 Latino adults with non-cancer, advanced medical illness enrolled from 8 urban and 4 rural clinical sites will be randomized to the intervention group (5 palliative care-related patient navigator visits plus educational materials) or control group (usual care plus educational materials). Participants randomized to the intervention group will demonstrate better quality of life, will be more likely to have a palliative approach to their care, have higher rates of advance care planning, better pain and symptom control, and higher rates of hospice utilization compared to the control group). They will conduct a cost analysis of the patient navigator intervention by comparing direct costs of the intervention and cost and utilization of health care system resources across the study arms. Participants randomized to the intervention will have lower costs in the 6 months following study enrollment compared to participants in the control arm. Decedent participants randomized to the intervention will have lower costs in the last 3 months of life compared to decedent participants in the control arm. For the intervention visits, bicultural, bilingual navigators (guias) integrate core Latino values, while addressing barriers to a palliative approach through education, culturally tailored messaging, and patient activation. Patients will be interviewed at baseline and 3 months using the QUAL-E quality of life scale, Brief Pain Inventory, Edmonton Symptom Assessment Scale, and the Patient Navigator Process and Outcomes Measure. Medical records will be reviewed to assess advance directive completion, hospice and health care utilization and intensity of care at the end of life. This culturally tailored, evidence-based, theory driven, highly innovative patient navigation intervention has significant potential to improve palliative care for Latinos, and facilitate true health equity in palliative and end of life care.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Principal Investigator and outcomes assessor blinded to group allocation.

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

  • Self-identify as Latino
  • Age 18-90 years
  • Not referred or enrolled in hospice care
  • Meeting medium to high risk for death at 1 year using the CARING criteria (although excluding patients with cancer diagnosis)
  • If health care provider answers "no" to the question: "Would you be surprised if this patient died in the next year?"

排除标准

  • Cancer diagnosis
  • Referred or receiving hospice care
  • Incarcerated
  • Lacking decisional capacity

结局指标

主要结局

FACIT-Quality of Life Assessment

时间窗: 3 months post enrollment

Validated and responsive Quality of Life measure

Caregiver Reaction Assessment

时间窗: 3 months post enrollment

For caregivers: A validated measure of caregiver burden and positive meaning finding for caregivers

次要结局

  • Brief Pain Inventory(3 months post enrollment)
  • Edmonton Symptom Assessment Scale(3 months post enrollment)
  • Patient Navigation Process and Outcome Measure(3 months post enrollment)
  • Advance Care Planning(6 months post enrollment)
  • Hospice Utilization(month 46 of the study)
  • Advance Care Planning Engagement Survey(3 months post enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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