Clinical trial NCT03181750: Apoyo Con Carino: Patient Navigation for Palliative Care for Non-Cancer Illness
Official title: Apoyo Con Carino: (Support With Caring) Improving Palliative Care Outcomes for Latinos With Advanced Medical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: Palliative Care
Latino
Patient Navigation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: Denver Health Medical Center
name: National Institute of Nursing Research (NINR)
First posted: 2017-06-09
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-site Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: FACIT-Quality of Life Assessment
timeFrame: 3 months post enrollment
measure: Caregiver Reaction Assessment
timeFrame: 3 months post enrollment
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: 3 months post enrollment
measure: Edmonton Symptom Assessment Scale
timeFrame: 3 months post enrollment
measure: Patient Navigation Process and Outcome Measure
timeFrame: 3 months post enrollment
measure: Advance Care Planning
timeFrame: 6 months post enrollment
measure: Hospice Utilization
timeFrame: month 46 of the study
measure: Advance Care Planning Engagement Survey
timeFrame: 3 months post enrollment
Other outcomes:
measure: Cost Effectiveness of the Intervention
timeFrame: 6 months post intervention
measure: Cost Effectiveness of the Intervention for End of Life
timeFrame: last 3 months of life
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Central
state: Colorado
city: Colorado Springs
country: United States
facility: University of Colorado Health
state: Colorado
city: Denver
country: United States
facility: Centura Health
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente Colorado-N/S/W
state: Colorado
city: Fort Collins
country: United States
facility: University of Colorado Health North
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Stacy M Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References: