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

NCT03181750 | Completed DMC

• 2 other identifiers: 16-1270R01NR016467
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 6

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.

Conditions

Palliative Care

Keywords

Palliative Care; Latino; Patient Navigation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Brief Pain Inventory

  3 months post enrollment

• Edmonton Symptom Assessment Scale

  3 months post enrollment

• Patient Navigation Process and Outcome Measure

  3 months post enrollment

• Advance Care Planning

  6 months post enrollment

• Hospice Utilization

  month 46 of the study

Other Outcomes (2)

• Cost Effectiveness of the Intervention

  6 months post intervention

• Cost Effectiveness of the Intervention for End of Life

  last 3 months of life

Study Arms (2)

Control

NO INTERVENTION

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.

Patient Navigator Intervention Group

EXPERIMENTAL

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

Interventions

Patient Navigator Intervention Group BEHAVIORAL

Bicultural, bilingual navigators conducting home visits with patients and caregivers.

Patient Navigator Intervention Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• If health care provider answers "no" to the question: "Would you be surprised if this patient died in the next year?"

You may not qualify if:

• Cancer diagnosis
• Referred or receiving hospice care
• Pregnant
• Incarcerated
• Lacking decisional capacity

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Kaiser Permanente: collaborator
• Denver Health Medical Center: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (6)

University of Colorado Health Central

Aurora, Colorado, 80045, United States

Location

University of Colorado Health

Colorado Springs, Colorado, 80909, United States

Location

Centura Health

Denver, Colorado, 80112, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Kaiser Permanente Colorado-N/S/W

Denver, Colorado, 80231, United States

Location

University of Colorado Health North

Fort Collins, Colorado, 80524, United States

Location

Related Publications (2)

• Fischer SM, Min SJ, Kline DM, Lester K, Gozansky W, Schifeling C, Himberger J, Lopez J, Fink RM. Patient Navigator Intervention to Improve Palliative Care Outcomes for Hispanic Patients With Serious Noncancer Illness: A Randomized Clinical Trial. JAMA Intern Med. 2024 Apr 1;184(4):384-393. doi: 10.1001/jamainternmed.2023.8145.

  PMID: 38345793 DERIVED

• Fink RM, Valenti KG, Kline DM, Fischer SM. Reality of Family Caregiving for Hispanics With Alzheimer's Disease and Related Dementias: A Qualitative Analysis. J Palliat Med. 2023 Dec;26(12):1618-1626. doi: 10.1089/jpm.2023.0008. Epub 2023 Jun 13.

  PMID: 37311202 DERIVED

Study Officials

• Stacy M Fischer, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principal Investigator and outcomes assessor blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-site Randomized Controlled Trial

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: June 2, 2017
• Primary Completion: December 9, 2020
• Study Completion: July 31, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)