Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 4:26 PM
Study NCT ID:
NCT03181750
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apoyo Con Carino: Patient Navigation for Palliative Care for Non-Cancer Illness
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Apoyo Con Carino: (Support With Caring) Improving Palliative Care Outcomes for Latinos With Advanced Medical Illness
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01NR016467 | NIH | None | https://reporter.nih.gov/quic… | View |