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临床试验/NCT03767517
NCT03767517已完成不适用

A Community Developed, Culturally-Based Palliative Care Tele-Consult Program for African American and White Rural Southern Elders With a Life Limiting Illness

University of Alabama at Birmingham4 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2020年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
209
试验地点
4
主要终点
Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])

研究概览

简要总结

Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited palliative care (PC) clinical expertise. Secondly, although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The purpose of this study is to compare a culturally-based Tele-consult program to usual hospital care to determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized African American and White older adults with a life-limiting illness.

详细描述

The triple threat of rural geography, racial inequities, and older age hinders access to high quality PC for a significant proportion of Americans. Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited PC clinical expertise. Although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The two major public health consequences of these problems are:

  1. Access-Rural patients have sub-optimal or no access to PC. Despite significant nationwide growth, access to PC is grossly inadequate for the 60 million US citizens who live in rural or non-metropolitan areas. There is low PC use in rural and minority populations. As a result, rural patients experience significant suffering from uncontrolled symptoms that PC expertise could alleviate.
  2. Acceptability-Even when palliative and hospice services are available, African Americans (AA), compared to Whites (W) are more likely to receive medically-ineffective, poor quality care due to a culturally-insensitive health care system and mistrust of health care providers. Making culturally competent PC available for diverse underserved and rural Americans is a national priority.

This community-developed, culturally based Teleconsult Intervention specifically targets the gaps of PC access and acceptability. It was developed by and for rural, Deep South AA and W patients and providers, and uses state-of-the-art telehealth methods, to provide PC consultation to hospitalized seriously-ill patients and family. Using National Consensus Project guidelines, and the culturally-based, community-developed PC Tele-consult intervention, a remote PC expert conducts a comprehensive PC patient assessment, in collaboration with local providers. Following interdisciplinary PC team review, the remote clinician communicates recommendations. Two additional structured follow up contacts at Day 3 and 6 ensure care coordination and smooth transitions that enable patients to receive guideline concurrent PC in their communities.

Aims of the study and Hypotheses:

Primary Aim: Determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized AA and W older adults with a life-limiting illness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •55 years old; has a condition which fits into one of 3 illness paradigms -cancer, chronic progressive, frailty.
  • •Clinician answers "no" to question: "Would you be surprised if this person died in the next 12 months?"
  • •Patient has a caregiver who has been involved in their care.
  • •Able to complete baseline interviews

排除标准

  • •Unable to complete baseline interviews;
  • •Currently receiving hospice care;
  • •No family member/caregiver.

研究组 & 干预措施

Active Intervention

Experimental

Usual Care + Tele-consult Intervention

干预措施: Active Intervention (Other)

Usual Care

Active Comparator

Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.

干预措施: Usual Care (Other)

结局指标

主要结局

Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])

时间窗: baseline and 7 days post-baseline and 30 days post-baseline

Change from baseline in patient-reported symptom burden measured using the Edmonton Symptom Assessment Scale (ESAS) at baseline; change from baseline measured using the ESAS at 7 days post-baseline. Each item is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90. A higher value represents the worse possible outcome. Higher score indicates higher symptom burden.

次要结局

  • Resource Use(30 days post-Baseline)
  • The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.(baseline and 7 days post-baseline and 30 days post baseline)
  • Patient Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])(baseline and 7 days post-baseline)
  • Caregiver Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])(Baseline and 7 days post-Baseline)
  • Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])(Baseline and 7 days post-Baseline)
  • The Mean Percentage of Caregivers Who Responded Completely/Quite a Bit to the Patient Satisfaction With Care (Feeling Heard and Understood) Survey.(Baseline and 7 days post-Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronit Elk

Professor for the Division of Geriatrics, Gerontology, and Palliative Care; Associate Director for the Center for Palliative and Supportive Care

University of Alabama at Birmingham

研究点 (4)

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