A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders

Not Applicable

Completed

• Conditions: Renal Disease; Cardiac Disease; Pulmonary Disease; Hepatic Disease; Cancer; Neuro-Degenerative Disease; Stroke; Sepsis
• Interventions: Other: Active Intervention; Other: Usual Care

• Registration Number: NCT03767517
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Study Start: 2020-08-24
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• AA or W;
• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Intervention	Active Intervention	Usual Care + Tele-consult Intervention
Usual Care	Usual Care	Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.

Primary Outcome Measures

Name	Time	Method
Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])	baseline and 7 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.

Secondary Outcome Measures

Name	Time	Method
Caregiver quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])	Baseline and 7 days post-Baseline	Change from baseline in caregiver-reported quality of life using the Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS Global Health-10) at baseline; change from baseline measured using the PROMIS Global Health-10 at 7 days post-baseline. Items 1-6 are scored using: 1-5 (1=poor; 5=excellent). Item 7 is scored using 1-5 (1= not at all; 5= completely). Item 8 is scored using 1-5 (1= always; 5=never). Item 9 is scored using 1-5 (1=very severe; 5=none). Item 10 is scored using 0-10 (0=no pain; 10=worst pain imaginable).
Family satisfaction with care (FAMCARE-2)	baseline and 7 days post-baseline	Change from baseline in family-reported satisfaction with care measured using the FAMCARE-2 scale at baseline; change from baseline measured using FAMCARE-2 at 7 days post-baseline. Each item is scored using: vs (very satisfied), s (satisfied), u (undecided), d (dissatisfied), vd (very dissatisfied), or NA (not applicable).
Resource Use	30 days post-Baseline	Patient resource use (e.g., number of hospital readmissions, number of hospital days, number of ICU days, number of Emergency Department \[ED\] visits, and hospice days during the 30 days following discharge) will be collected via electronic health records (eHR) 30 days post-discharge.
Patient quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])	baseline and 7 days post-baseline	Change from baseline in patient-reported quality of life using the Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS Global Health-10) at baseline; change from baseline measured using the PROMIS Health-10 at 7 days post-baseline. Items 1-6 are scored using: 1-5 (1=poor; 5=excellent). Item 7 is scored using 1-5 (1= not at all; 5= completely). Item 8 is scored using 1-5 (1= always; 5=never). Item 9 is scored using 1-5 (1=very severe; 5=none). Item 10 is scored using 0-10 (0=no pain; 10=worst pain imaginable).
Caregiver burden scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])	Baseline and 7 days post-Baseline	Change from baseline in caregiver-reported burden using the Montgomery Borgatta Caregiver Burden Scale (MBCB) at baseline; change from baseline measured using the MBCB at 7 days post-baseline. This scale contains a total of 14 questions and 5 Likert scale responses (a lot less, a little less, the same, a little more, or a lot more). Caregiver burden will be quantified by three subscales; objective, subjective and demand burdens. Objective burden is measured by 6 questions (total score between 0-30), subjective burden is measured by 4 questions (total score between 4-20), and demand burden is measured by 4 questions (total score between 4-20).
Patient satisfaction with care (Feeling Heard and Understood)	Baseline and 7 days post-Baseline	Change from baseline in patient-reported satisfaction with care using the Feeling Heard and Understood questionnaire at baseline; change from baseline using the Feeling Heard and Understood questionnaire at 7 days post-baseline. Likert scale using: completely, quite a bit, moderately, slightly, not at all.

Trial Locations

Locations (4)

Russell Medical Center; 🇺🇸 Alexander City, Alabama, United States

Anderson Regional Medical Center; 🇺🇸 Meridian, Mississippi, United States

Highland Community Hospital; 🇺🇸 Picayune, Mississippi, United States

Aiken Regional Medical Center; 🇺🇸 Aiken, South Carolina, United States