- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03181750
Apoyo Con Carino: Patient Navigation for Palliative Care for Non-Cancer Illness
April 15, 2022 updated by: University of Colorado, Denver
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Health Central
-
Colorado Springs, Colorado, United States, 80909
- University of Colorado Health
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Denver, Colorado, United States, 80204
- Denver Health Medical Center
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Denver, Colorado, United States, 80231
- Kaiser Permanente Colorado-N/S/W
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Denver, Colorado, United States, 80112
- Centura Health
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Fort Collins, Colorado, United States, 80524
- University of Colorado Health North
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
|
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
Time Frame: 3 months post enrollment
|
Validated and responsive Quality of Life measure
|
3 months post enrollment
|
Caregiver Reaction Assessment
Time Frame: 3 months post enrollment
|
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
Time Frame: 3 months post enrollment
|
A validated pain assessment measure
|
3 months post enrollment
|
Edmonton Symptom Assessment Scale
Time Frame: 3 months post enrollment
|
A validated symptom assessment scale
|
3 months post enrollment
|
Patient Navigation Process and Outcome Measure
Time Frame: 3 months post enrollment
|
A satisfaction and process measure developed for the patient navigator intervention
|
3 months post enrollment
|
Advance Care Planning
Time Frame: 6 months post enrollment
|
chart review to document presence of advance directive
|
6 months post enrollment
|
Hospice Utilization
Time Frame: month 46 of the study
|
hospice length of stay in days
|
month 46 of the study
|
Advance Care Planning Engagement Survey
Time Frame: 3 months post enrollment
|
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
Time Frame: 6 months post 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
Time Frame: last 3 months 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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stacy M Fischer, MD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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