Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03626402 |
| Other study ID # |
STU 042016-050 |
| Secondary ID |
CCCDA-16-003-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Racial differences in health care are documented across the health care continuum and persist
in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented
minorities often choose more aggressive therapies in the terminal stages of illness. Main
reasons for these EOL disparities include: lack of knowledge of and misperceptions about
palliative and hospice care, spiritual beliefs, and mistrust in the health care system.
Despite the presence of national hospice guidelines, interventions addressing these
disparities have been limited and often not rigorously evaluated. Most interventions to
promote EOL care were done in majority populations and focused predominantly on trying to
change physician awareness of patient's pain, symptoms, and values or to change physician
communication behavior. While these early studies made tremendous contributions to the study
of EOL care and the needs of the terminally ill, the interventions associated with these
studies did not reach their desired effectiveness. The investigator proposes an innovative
strategy that would focus specifically on previously identified physician and patient
barriers to utilization of advance directives, palliative care, and hospice care among AA
cancer patients. The goal of this patient-centered project is to increase the awareness of
and willingness to discuss EOL care options among AAs with metastatic cancer. To overcome the
dual challenges of physicians' difficulty with prognostication and reluctance to discuss EOL
care, the investigator will harness data in the electronic medical record (EMR) to
automatically identify AA patients with metastatic breast, lung, colorectal, prostate and
other serious cancer who are eligible for counseling about palliative and EOL care options.
To change AA patients' knowledge and attitudes toward palliative and EOL care options, and
address issues of medical mistrust, the investigator will design and pilot test a culturally
sensitive, patient-targeted intervention that will combine multimedia materials and a
culturally concordant lay health advisor (LHA) who will deliver tailored education and
counseling. The investigator has chosen a LHA delivery strategy because past studies have
shown that they are best suited to address medical mistrust and perceived conflict between
spiritual beliefs and health care decisions.
Description:
The investigator proposes a three-phase project to improve awareness of use of advance
directives, palliative care and hospice services among patients with metastatic cancer by
creating and evaluating a multifaceted culturally sensitive intervention that targets
specific previously identified barriers to EOL care for AAs, including: knowledge, attitudes,
and awareness of options for care, conflict between patients' spiritual beliefs, and the
general hospice and palliative medicine philosophy of care, and medical mistrust. Aim 1 will
refine and validate the e-EOL computerized algorithm to identify persons with stage III and
IV breast, lung, colorectal, or other serious cancer who are appropriate candidates for
discussions about advance care planning, palliative care, and hospice in the outpatient
setting. The work in Aim 1 seeks to overcome the upstream barrier that physicians often have
difficulty with prognostication and are reluctant to discuss prognosis and EOL care options
with patients. Aim 2 will involve continued stakeholder engagement and the conduct of focus
groups with oncologists and primary care providers at Parkland Hospital and its affiliated
clinics to determine how to make the intervention feasible and acceptable to patients,
caregivers, and providers. The investigator also will obtain feedback on our newly developed
video and written educational materials that communicate key messages about EOL care options
and overcome common barriers. In Aim 3, the investigator will test the preliminary
feasibility, acceptability, and efficacy of the intervention that uses the e-EOL algorithm to
identify AA patients with advanced cancer who are eligible for care discussions and then
deploy a culturally concordant behavior change intervention that combines a Lay Health
Advisor (LHA) and video and written materials. Use of an LHA will help overcome the
providers' reluctance or lack of time to discuss EOL care issues and mitigate medical
mistrust. The three linked studies provide the necessary sequence of research projects and
multidisciplinary learning experiences needed to accomplish the PI's scientific and training
goals. It will also lay the groundwork for a fully powered RCT to test the efficacy of a
multifaceted EOL care counseling intervention vs. usual care.
Details of Research Design and Methods for Aim 1: Refine an e-EOL algorithm to identify
patients with metastatic cancer in the outpatient setting. Aim 1 will expand and validate the
e-EOL algorithm to identify patients with advanced cancer who are appropriate candidates for
discussions about EOL care options in the outpatient setting. The e-EOL algorithm will assist
physicians with determining prognosis more accurately and will provide a mechanism for
systematically identifying candidates for a subsequent EOL care counseling intervention
outlined in Aim 3.
Details of Research Design and Methods for Aim 2: The investigator will refine components of
a culturally sensitive intervention to improve knowledge of and intent to consider EOL care
options. Use of decision aids, educational videos, and LHAs has been shown to be effective in
improving medical knowledge and shared decision making and reducing racial disparities for
several clinical conditions. Though there have been few applications of these promising
approaches to palliative and EOL care, recent use of decision aids in improving knowledge
about the goals of care for persons with advanced dementia, have shown promise. Aim 2 will
iteratively refine the intervention messages delivered through a combination of novel DVD
segments that we have developed, print materials, and guided discussions by a culturally
concordant LHA. Through qualitative methods, the team will test the language, framing, and
communication strategies for conveying intervention messages and obtain feedback from primary
care and oncology providers at Parkland Hospital to verify the appropriateness of these
messages as intended by investigators.
Details of Research Design and Methods for Aim 3: Assess the feasibility and acceptability of
a multifaceted EOL care behavior change pilot intervention. The pilot intervention will
combine the refined elements from Aims 1 and 2, to conduct a small pilot RCT comparing the
intervention group to a usual care control group. All of these aims taken together lay the
groundwork for a future, fully powered RCT.
Description of the Pilot Intervention: The EOL LHA will meet with eligible patients and their
caregivers to tell them their doctor approved of them receiving more information about their
treatment options. The LHA will then assist the eligible patients and caregivers in watching
the EOL care DVD segments (the video modules described in Aim 2 targeted to their
pre-intervention survey needs assessment). After the patients and caregivers watch the DVD,
the LHA will answer questions and provide additional information. They will then use
counseling scripts created by the PI and research team to probe in more depth the patient's
goals of care, and understanding of their clinical condition, prognosis, and treatment
options. They will tailor the discussion to the patient's values, preferences, concerns, and
clinical circumstances. Those who express interest in hearing more about EOL care options
will be encouraged to discuss this with their doctor. The counselor will offer to update
their physician on their discussion and help communicate the patient's desire for a
palliative care consult or advance directive (if that is something they wanted). Specific
questions about prognosis will be referred to the treating physician. Formal palliative care
referrals will be ordered and performed in the usual fashion with the exception that the
patient may ask the LHA to update the palliative care team on their prior discussions,
concerns, and preferences. The LHA will follow up with patients the day after they view the
educational video to answer any additional questions and again within one week to assist
patients with advance care planning questions and referrals. All intervention sessions will
be audiotaped to ensure intervention fidelity.
Usual Care: Participants randomized to usual care will proceed with clinical care as already
routinely implemented by their physicians. At the time of recruitment, they will be asked to
identify their primary caregiver who will also be contacted. Patient-caregiver pairs who are
randomized to usual care will also be asked if they would be willing to be contacted at 1, 3
and 6-month intervals to complete the post-study assessment. All participants will be mailed
a reminder letter that study staff will be contacting them to participate in follow-up
surveys a couple of weeks prior to the 1-month surveys. The reminder letter will include an
informational brochure that briefly and simply summarizes advance care planning options.
Primary Outcomes: Feasibility and acceptability are the main process outcomes. Feasibility is
success in accurately identifying eligible patients via the e-EOL algorithm (number flagged,
specificity, positive predictive value), and numbers and rates of patients completing the
pilot intervention and follow-up interviews. Acceptability will be measured with Likert scale
items rating "understandability, informativeness, balance, right amount of information,
helpfulness, and "recommending this to others" used in published trials of decision aids. The
LHA will also ask open-ended questions on things patients did or did not like about the
intervention. The primary decision making outcome is change in intent to discuss EOL care
options based on the Transtheoretical Stages of Change Model, an approach used in many other
realms. The investigator will categorize patients into the following stages: 1)
Pre-contemplation: is unaware of EOL care options/has not thought about discussing this with
a provider; 2) Contemplation: is aware of EOL care options/thinking about discussing options;
3) Preparation: intends to discuss EOL care issues with the doctor/has a plan for talking
about it; 4) Action: has a discussion with the provider about EOL care. The completion stage
is not applicable in this medical situation because the goal of the intervention is for the
patient to have an informed discussion about benefits and harms of all treatment options
including EOL care. The intent is NOT to get all patients to choose palliative care or
hospice, or complete and an advance directive, but for them to understand how palliative care
may benefit them now or in the future, and how it can be combined with curative care. The
goal is for the patient to make "the right decision for them" based on knowing all of the
facts and options.
Secondary Outcomes will measure: 1) Knowledge of prognosis and EOL care options: will be
measured by a questionnaire from prior NCI-funded palliative care studies; 2) Decisional
conflict will be assessed by the Decisional Conflict Scale, a validated 16 item scale
measuring uncertainty about the best course of action and factors contributing to
uncertainty. Scores <25 (on this 100-point scale) are associated with implementing decisions,
and scores >38 with decisional delay; 3) Quality of life (QOL): will be assessed with the
McGill QOL Questionnaire, a well-validated 20-item scale developed to measure QOL at the EOL;
4) Healthcare utilization will include: outpatient visits (incl. palliative care), ED visits,
hospitalizations, total hospital days, and use of hospice services (type and time to hospice
initiation); 5) Date and place (hospital, hospice, home) of deaths within a 6 month follow-up
period will also be recorded.
