Apoyo Con Carino: Patient Navigation for Palliative Care for Non-Cancer Illness
Condition: Palliative Care
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Patient Navigator Intervention Group
Intervention type(s): Behavioral
Intervention description(s): Bicultural, bilingual navigators conducting home visits with patients and caregivers.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-site Randomized Controlled Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Palliative Care; Latino; Patient Navigation