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Clinical Trials/NCT03767517
NCT03767517
Completed
Not Applicable

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 sites in 1 country209 target enrollmentAugust 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Alabama at Birmingham
Enrollment
209
Locations
4
Primary Endpoint
Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

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.

Detailed Description

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. Hypothesis 1: Intervention patient participants receiving a culturally-based PC Tele-consult program will experience lower symptom burden on Day 7 post-consultation. Secondary Aim: Determine whether a culturally-based PC Tele-consult program results in higher patient and caregiver quality of life, care satisfaction, and lower caregiver burden at Day 7 post-consultation, and lower resource use (hospital readmission, emergency visits) 30-days post-discharge. Hypothesis 2: Intervention participants and their caregivers receiving a culturally-based PC Tele-consult program will experience higher patient and caregiver quality of life, care satisfaction, lower caregiver burden at Day 7 post consultation, and lower resource use (e.g. hospital admission, emergency visits) at 30 days after discharge. Exploratory Aim: Explore mediators and moderators of patient symptom and caregiver burden outcomes.

Registry
clinicaltrials.gov
Start Date
August 24, 2020
End Date
August 30, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (4)

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