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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
299

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
Kaiser Permanente
Denver Health Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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