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

NCT ID: NCT03767517

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2024-08-30

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.

Conditions

Cancer; Cardiac Disease; Pulmonary Disease; Neuro-Degenerative Disease; Renal Disease; Stroke; Sepsis; Hepatic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Active Intervention

Usual Care + Tele-consult Intervention

Group Type: EXPERIMENTAL

Active Intervention

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ronit Elk

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie A Bakitas, DNSc

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32703245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36871774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33393704 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35247583 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38641135 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

Bakitas MA, Gazaway S, Underwood F, Ekelem C, Heard VT, Kennedy R, Azuero A, Tucker R, McCammon S, Hauser JM, McElwain L, Elk R. Palliative Video Consultation and Symptom Distress Among Rural Inpatients: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519426. doi: 10.1001/jamanetworkopen.2025.19426.

Reference Type: DERIVED

PMID: 40632537 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01NR017181-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01NR017181-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB300002420

Identifier Type: -

Identifier Source: org_study_id