Apoyo Con Carino: Patient Navigation for Palliative Care for Non-Cancer Illness

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Palliative Care

Intervention / Treatment
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* Behavioral: Patient Navigator Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) OR If health care provider answers no to the question: Would you be surprised if this patient died in the next year? Exclusion Criteria: Cancer diagnosis Referred or receiving hospice care Pregnant Incarcerated Lacking decisional capacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-site Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients and caregivers randomized to this arm will receive a packet of educational materials in English or Spanish. These materials are written at 5-6th grade reading level. The materials focus on advance care planning, pain and symptom management, and hospice care. | |
| Experimental: Patient Navigator Intervention Group<br>Patient and caregivers randomized to this arm will receive the same packet of educational materials. They will also receive at least 5 visits from a bicultural bilingual patient navigator. The navigator will utilize a annualized visit guide manual to lead discussions on advance care planning, pain and symptom management, and hospice care. | Behavioral: Patient Navigator Intervention Group<br>* Bicultural, bilingual navigators conducting home visits with patients and caregivers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACIT-Quality of Life Assessment | Validated and responsive Quality of Life measure | 3 months post enrollment | 
| Caregiver Reaction Assessment | For caregivers: A validated measure of caregiver burden and positive meaning finding for caregivers | 3 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory | A validated pain assessment measure | 3 months post enrollment | 
| Edmonton Symptom Assessment Scale | A validated symptom assessment scale | 3 months post enrollment | 
| Patient Navigation Process and Outcome Measure | A satisfaction and process measure developed for the patient navigator intervention | 3 months post enrollment | 
| Advance Care Planning | chart review to document presence of advance directive | 6 months post enrollment | 
| Hospice Utilization | hospice length of stay in days | month 46 of the study | 
| Advance Care Planning Engagement Survey | A validated measure of readiness to engage in advance care planning | 3 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Latino, Patient Navigation