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

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

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.

Study Overview

• Status: Completed
• Conditions: Palliative Care
• Intervention / Treatment: Behavioral: Patient Navigator Intervention Group

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.

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Central
    • Colorado Springs, Colorado, United States, 80909
      • University of Colorado Health
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
    • Denver, Colorado, United States, 80231
      • Kaiser Permanente Colorado-N/S/W
    • Denver, Colorado, United States, 80112
      • Centura Health
    • Fort Collins, Colorado, United States, 80524
      • University of Colorado Health North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; 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; Bicultural, bilingual navigators conducting home visits with patients and caregivers.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effectiveness of the Intervention	costs of providing the intervention versus costs of utilization of health care with and without intervention	6 months post intervention
Cost Effectiveness of the Intervention for End of Life	costs of providing the intervention versus costs of utilization of health care with and without intervention for those patients who die during the study period	last 3 months of life

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Nursing Research (NINR); Kaiser Permanente; Denver Health Medical Center
• Investigators: Principal Investigator: Stacy M Fischer, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Patient Navigation; Palliative Care; Latino
• Other Study ID Numbers: 16-1270; R01NR016467 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No