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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767517
• Other study ID #: IRB300002420
• Secondary ID: 1R01NR017181-01A
• Status: Completed
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 30, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Exclusion Criteria:

• Unable to complete baseline interviews;

• Currently receiving hospice care;

• No family member/caregiver.

Related Conditions & MeSH terms

• Cancer
• Cardiac Disease
• Heart Diseases
• Hepatic Disease
• Liver Diseases
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Pulmonary Disease
• Renal Disease
• Sepsis
• Stroke

Intervention

Other:
• Active Intervention
Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
• Usual Care
Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.

Locations

Country	Name	City	State
United States	Aiken Regional Medical Center	Aiken	South Carolina
United States	Russell Medical Center	Alexander City	Alabama
United States	Anderson Regional Medical Center	Meridian	Mississippi
United States	Highland Community Hospital	Picayune	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Aim 1a. Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])	Patient symptom burden measured by Edmonton Symptom Assessment Scale [ESAS] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record [eHR] documentation of recommendations by hospitalist/clinician at Day 7. Each item in the ESAS is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90.	Day 7
Other	Exploratory Aim 1b. Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])	Patient symptom burden measured by Edmonton Symptom Assessment Scale [ESAS] mediated and/or moderated by patient/caregiver implementation of palliative care recommendations. Patient/caregiver implementation of palliative care recommendations are measured using patient/caregiver report at Day 7. Each item in the Edmonton Symptom Assessment Scale [ESAS] is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90.	Day 7
Other	Exploratory Aim 1c. Caregiver burden (Montgomery Borgatta Caregiver Burden Scale [MBCB])	Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale [MBCB] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record [eHR] documentation of recommendations by hospitalist/clinician at Day 7. 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).	Day 7
Other	Exploratory Aim 1d. Caregiver burden (Montgomery Borgatta Caregiver Burden Scale [MBCB])	Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale [MBCB] mediated and/or moderated by caregiver/patient implementation of palliative care recommendations. Caregiver/patient implementation of palliative care recommendations are measured using caregiver/patient report at Day 7. 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).	Day 7
Other	Exploratory Aim 1e. Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL]	Caregiver evaluation of end-of-life care quality measured by Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL]	2-3 Months after death of patient, if applicable
Other	Exploratory Aim 1f. Caregiver bereavement (Caregiver Bereavement Items ([CBI])	Caregiver bereavement measured by Caregiver Bereavement Items ([CBI]	2-3 Months after death of patient, if applicable
Primary	Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])	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.	baseline and 7 days post-baseline
Secondary	Family satisfaction with care (FAMCARE-2)	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).	baseline and 7 days post-baseline
Secondary	Patient quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])	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).	baseline and 7 days post-baseline
Secondary	Caregiver quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])	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).	Baseline and 7 days post-Baseline
Secondary	Caregiver burden scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])	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).	Baseline and 7 days post-Baseline
Secondary	Resource Use	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.	30 days post-Baseline
Secondary	Patient satisfaction with care (Feeling Heard and Understood)	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.	Baseline and 7 days post-Baseline