Clinical trial NCT03767517: A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cardiac Disease
Pulmonary Disease
Neuro-Degenerative Disease
Renal Disease
Stroke
Sepsis
Hepatic Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-12-06
Enrollment: 209
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
timeFrame: baseline and 7 days post-baseline and 30 days post-baseline
Secondary outcomes:
measure: The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
timeFrame: baseline and 7 days post-baseline and 30 days post baseline
measure: Patient Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
timeFrame: baseline and 7 days post-baseline
measure: Caregiver Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
timeFrame: Baseline and 7 days post-Baseline
measure: Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
timeFrame: Baseline and 7 days post-Baseline
measure: Resource Use
timeFrame: 30 days post-Baseline
measure: The Mean Percentage of Caregivers Who Responded Completely/Quite a Bit to the Patient Satisfaction With Care (Feeling Heard and Understood) Survey.
timeFrame: Baseline and 7 days post-Baseline
Other outcomes:
measure: Exploratory Aim 1a. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
timeFrame: Day 7
measure: Exploratory Aim 1b. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
timeFrame: Day 7
measure: Exploratory Aim 1c. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
timeFrame: Day 7
measure: Exploratory Aim 1d. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
timeFrame: Day 30
measure: Exploratory Aim 1e. Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL]
timeFrame: 2-3 Months after death of patient, if applicable
measure: Exploratory Aim 1f. Caregiver Bereavement (Caregiver Bereavement Items ([CBI])
timeFrame: 2-3 Months after death of patient, if applicable
Locations:
city: Alexander City
country: United States
facility: Russell Medical Center
state: Alabama
city: Meridian
country: United States
facility: Anderson Regional Medical Center
state: Mississippi
city: Picayune
country: United States
facility: Highland Community Hospital
state: Mississippi
city: Aiken
country: United States
facility: Aiken Regional Medical Center
state: South Carolina
Study officials:
affiliation: University of Alabama at Birmingham
name: Marie A Bakitas, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watts KA, Gazaway S, Malone E, Elk R, Tucker R, McCammon S, Goldhagen M, Graham J, Tassin V, Hauser J, Rhoades S, Kagawa-Singer M, Wallace E, McElligott J, Kennedy R, Bakitas M. Community Tele-pal: A community-developed, culturally based palliative care tele-consult randomized controlled trial for African American and White Rural southern elders with a life-limiting illness. Trials. 2020 Jul 23;21(1):672. doi: 10.1186/s13063-020-04567-w.
citation: Gazaway S, Bakitas M, Underwood F, Ekelem C, Duffie M, McCormick S, Heard V, Colvin A, Elk R. Community Informed Recruitment: A Promising Method to Enhance Clinical Trial Participation. J Pain Symptom Manage. 2023 Jun;65(6):e757-e764. doi: 10.1016/j.jpainsymman.2023.02.319. Epub 2023 Mar 5.
citation: Allen Watts K, Malone E, Dionne-Odom JN, McCammon S, Currie E, Hicks J, Tucker RO, Wallace E, Elk R, Bakitas M. Can you hear me now?: Improving palliative care access through telehealth. Res Nurs Health. 2021 Feb;44(1):226-237. doi: 10.1002/nur.22105. Epub 2021 Jan 4.
citation: Gazaway S, Bakitas MA, Elk R, Eneanya ND, Dionne-Odom JN. Engaging African American family Caregivers in Developing a Culturally-responsive Interview Guide: A Multiphase Process and Approach. J Pain Symptom Manage. 2022 Jun;63(6):e705-e711. doi: 10.1016/j.jpainsymman.2022.02.331. Epub 2022 Mar 3.
citation: Gazaway S, Odom JN, Herbey I, Armstrong M, Underwood F, Heard TV, Allen A, Ekelem C, Bakitas MA, Elk R. Cultural Values Influence on Rural Family Caregivers' Decision-Making for Ill Older Adult Loved Ones. J Pain Symptom Manage. 2024 Jul;68(1):86-95. doi: 10.1016/j.jpainsymman.2024.04.012. Epub 2024 Apr 18.
citation: Gazaway, S., Bakitas, MA., Underwood, F., Ekelem, C., Duffie, M., McCormick, S., Heard, V., Massey,. L., Allen, A., Tucker, R., McCammon, S., Goldhagen, M., Hauser, J., McElwain, L., Kennedy, R., Azuero, A., & Elk, R. Community Tele-Pal RCT Videoconsultation for Rural White and Black Inpatients: Caregiver Outcomes. American Association of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association Annual Assembly 2024.
citation: Bakitas, MA., Gazaway, S., Underwood, F., Ekelem, C., Duffie, M., McCormick, S., Heard, V., Massey,. L., Allen, A., Tucker, R., McCammon, S., Goldhagen, M., Hauser, J., McElwain, L., Kennedy, R., Azuero, A., & Elk, R. Community Tele-Pal RCT Videoconsultation for Rural White and Black Inpatients: Patient Outcomes. American Association of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association Annual Assembly 2024.