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

NCT03767517 | Completed Results DMC

• 3 other identifiers: IRB3000024201R01NR017181-01A15R01NR017181-05
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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. A higher value represents the worse possible outcome. Higher score indicates higher symptom burden.

  baseline and 7 days post-baseline and 30 days post-baseline

Secondary Outcomes (6)

• 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

• Resource Use

  30 days post-Baseline

Other Outcomes (6)

• Exploratory Aim 1a. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])

  Day 7

• Exploratory Aim 1b. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])

  Day 7

• Exploratory Aim 1c. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).

  Day 7

Study Arms (2)

Active Intervention

EXPERIMENTAL

Usual Care + Tele-consult Intervention

Other: Active Intervention

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Active Intervention 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.

Active Intervention

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AA or W;
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (4)

Russell Medical Center

Alexander City, Alabama, 35010, United States

Location

Anderson Regional Medical Center

Meridian, Mississippi, 39301, United States

Location

Highland Community Hospital

Picayune, Mississippi, 39466, United States

Location

Aiken Regional Medical Center

Aiken, South Carolina, 29801, United States

Location

Related Publications (8)

• 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.

  PMID: 32703245 BACKGROUND

• 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.

  PMID: 36871774 BACKGROUND

• 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.

  PMID: 33393704 BACKGROUND

• 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.

  PMID: 35247583 BACKGROUND

• 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.

  PMID: 38641135 BACKGROUND

• 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.

  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.

  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.

  PMID: 40632537 DERIVED

MeSH Terms

Conditions

Neoplasms; Heart Diseases; Lung Diseases; Kidney Diseases; Stroke; Sepsis; Digestive System Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The hospital sites restricted recruitment practices due to COVID-19. Therefore, recruitment was delayed one year. The delay resulted in not reaching the target number of participants. We reached saturation at 209 participants.

Results Point of Contact

• Title: Dr. Ronit Elk
• Organization: University of Alabama at Birmingham

relk@uabmc.edu

205-996-1702

Study Officials

• Marie A Bakitas, DNSc

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for the Division of Geriatrics, Gerontology, and Palliative Care; Associate Director for the Center for Palliative and Supportive Care

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: December 6, 2018
• Study Start: August 24, 2020
• Primary Completion: December 7, 2023
• Study Completion: August 30, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Locations

US (4)