End-of-Life Care for African Americans: An Outpatient Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Feasibility of relying upon the intervention algorithm to identify eligible patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •breast, lung, colon, prostate or other advanced cancer diagnosis
- •English proficient
- •African American
- •mentally competent
排除标准
- •not currently receiving palliative or hospice care
结局指标
主要结局
Feasibility of relying upon the intervention algorithm to identify eligible patients
时间窗: This will be assessed from the time of initiating patient recruitment (April 2017) through completion of recruitment of new patients (April 2018), up to 56 weeks.
This will be assessed by the principal investigator reviewing the medical records of patients flagged by the algorithm as eligible for participation to verify their eligibility and confirming those who meet study inclusion criteria.
Acceptability of intervention among patients randomized to the intervention arm
时间窗: Assessed at the end of the intervention, which occurs approximately two weeks after the baseline survey with those patients randomized to receive the intervention. This will be assessed beginning in April 2017 and ending in April 2018, up to 52 weeks.
Patient acceptability will be determined by the lay health advisor asking the patient, "Is this video something that you would recommend that your family and/or friends watch?" Responses will be noted "yes, no, refused, or don't know." Then they will be asked, "Why/why not?" and their responses written verbatim.
Participant change in intent to discuss EOL care options
时间窗: Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.
Changes in intention to discuss EOL care options will be assessed for all patients in both arms of the study by using the Transtheoretical Stages of Change Model.
次要结局
- Decisional conflict about preferences for EOL care(Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.)
- Knowledge of prognosis and EOL care options(Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.)
- Patient healthcare utilization(Assessed at 1, 3, and 6 months of baseline beginning May 2017 and ending October 2018, up to 74 weeks.)
- Participant perceptions about their quality of life(Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.)
- Date and place of death(Assessed at 1, 3, and 6 months of baseline beginning May 2017 and ending October 2018, up to 74 weeks.)
研究者
Ramona L. Rhodes
Associate Professor of Medicine
University of Texas Southwestern Medical Center