Apoyo Con Carino: Patient Navigation for Palliative Care

February 1, 2017 updated by: University of Colorado, Denver

Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer

Palliative care is a priority area of focus for health care in an aging population experiencing burdens of chronic illness. 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, the investigators are testing a patient navigator intervention to improve palliative care outcomes for Latinos with advanced cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project uses a patient navigator to deliver a culturally tailored intervention to improve palliative care for Latinos with advanced cancer in urban and rural communities. The proposed research aims to improve palliative care with the goal of preventing and relieving suffering for people facing serious, complex illness. Palliative care, according to the National Quality Forum and Centers for Medicare and Medicaid, provides patient and family-centered care offered in conjunction with curative and all other appropriate forms of medical treatment. It addresses physical, intellectual, emotional, social, spiritual needs, and facilitates patients' understanding of illness and choice. There is emerging evidence that palliative care may also improve survival for cancer patients. The proposed research also focuses on reducing health disparities. Studies have shown that Latinos are more likely to die in a hospital, less likely to use hospice services, and more likely to have unmanaged pain. This study will recruit 240 Latino patients with advanced cancer from an urban safety net hospital, a National Cancer Institute-designated Comprehensive Cancer Center, and several rural communities (including some of the poorest, most underserved counties in Colorado). Patients will be randomized to either a control or intervention group. The control group will receive written materials covering three important palliative care domains -advance care planning, pain management, and hospice care. The materials, in English and Spanish, are appropriate for patients with low health literacy. Patients in the intervention group will receive the same written materials but will also have a patient navigator who will make 5 home visits to review materials, help patients and families talk about goals/values, and complete an advance directive, all in a culturally and linguistically appropriate manner. The navigator may also help with: accessing community resources, participating in family meetings with health care providers, and offering support to patients and families. The investigators hypothesize that the intervention will increase advance care planning, improve pain management, increase hospice referrals, and patients will have improved palliative care overall at the end of life. The patient navigator model has demonstrated an ability to improve cancer screening, early diagnosis, treatment, and survivorship. Once the investigators demonstrate the efficacy of a patient navigator intervention to improve palliative care for advanced cancer patients, they can disseminate the training and intervention to all patient navigators working with Latino cancer patients.

Study Type

Interventional

Enrollment (Actual)

223

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

  • United States
    • Colorado
      • Alamosa, Colorado, United States, 81101
        • San Luis Valley Regional Medical Center
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Denver, Colorado, United States, 80202
        • Denver Health and Hospital Authority
      • Eagle, Colorado, United States, 81632
        • Shaw Cancer Center
      • Glenwood Springs, Colorado, United States, 81601
        • Valley View Medical Center

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

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage III or Stage IV cancer (all types)
  • Self-identify as Latino
  • 18 years of age or older
  • Speak English or Spanish

Exclusion Criteria:

  • Lacking decisional capacity
  • Incarcerated

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navigation
Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy. In addition they will have 5 navigator initiated home visits to review the educational materials and help patients and families address barriers to palliative care through education, advocacy, and activation.
Behavioral: Navigation
As per Arm description
No Intervention: Control
Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Palliative Care Overall
Time Frame: 3 months after enrollment
Patient Navigator and Process Measure will capture the less tangible benefits of a patient navigator and help understand the effects of the many activities of the navigator beyond the scope of the prescribed intervention. The questions incorporate aspects of self-efficacy and patient activation (key concepts that patient navigators help improve).
3 months after enrollment
Evidence of Advance Care Planning
Time Frame: 6 months after enrollment
Chart review to determine if there is an advance directive in the medical record and classification of the type of advance directive (Medical Durable Power of Attorney (MDPOA), Advance Directive (AD), Living Will)
6 months after enrollment
Assesment of Pain Management
Time Frame: 3 months after enrollment
Pain management will be assessed through patient interviews utilizing the Brief Pain Inventory (BPI). The BPI Long Form (BPI-LF) is a 32-item self-report instrument that assesses the severity and impact of pain in patients with chronic diseases, e.g. cancer.
3 months after enrollment
Hospice Utilization
Time Frame: 46 months after enrollment
Length of stay in hospice program in days. Data will be collected through follow up phone calls, medical records review, and death records review to determine date of admission into hospice program and date of discharge (through death or dis-enrollment)
46 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aggressiveness of Care at the End of Life
Time Frame: At month 46
For patients who have died within the follow up period this outcome assesses aggressiveness of care at the end of life using a composite measure comprised of the following: chemotherapy within 14 days of death no hospice hospice within 3 days of death
At month 46
Change in Quality of Life
Time Frame: Baseline and 3 months after enrollment
McGill Quality of Life questionnaire (MQOL) will be used at baseline and at 3 months after enrollment. The MQOL is specifically designed for a palliative care population, measuring whole-person concerns magnified by advanced life-limiting illness. It is short, reliable, repeatable, and can be used to determine changes in QOL of groups.
Baseline and 3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Stacy M Fischer, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-0592

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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