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

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181750
• Other study ID #: 16-1270
• Secondary ID: R01NR016467
• Status: Completed
• Phase: N/A
• Start date: June 2, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: July 31, 2021
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Patient Navigator Intervention Group
Bicultural, bilingual navigators conducting home visits with patients and caregivers.

Locations

Country	Name	City	State
United States	University of Colorado Health Central	Aurora	Colorado
United States	University of Colorado Health	Colorado Springs	Colorado
United States	Centura Health	Denver	Colorado
United States	Denver Health Medical Center	Denver	Colorado
United States	Kaiser Permanente Colorado-N/S/W	Denver	Colorado
United States	University of Colorado Health North	Fort Collins	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health Medical Center, Kaiser Permanente, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	FACIT-Quality of Life Assessment	Validated and responsive Quality of Life measure	3 months post enrollment
Primary	Caregiver Reaction Assessment	For caregivers: A validated measure of caregiver burden and positive meaning finding for caregivers	3 months post enrollment
Secondary	Brief Pain Inventory	A validated pain assessment measure	3 months post enrollment
Secondary	Edmonton Symptom Assessment Scale	A validated symptom assessment scale	3 months post enrollment
Secondary	Patient Navigation Process and Outcome Measure	A satisfaction and process measure developed for the patient navigator intervention	3 months post enrollment
Secondary	Advance Care Planning	chart review to document presence of advance directive	6 months post enrollment
Secondary	Hospice Utilization	hospice length of stay in days	month 46 of the study
Secondary	Advance Care Planning Engagement Survey	A validated measure of readiness to engage in advance care planning	3 months post enrollment