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CancerNCT03767517

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

A study testing Active Intervention in people with Cancer and Cardiac Disease, run by University of Alabama at Birmingham at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Cancer, Cardiac Disease, Pulmonary Disease
What is being tested?
Active Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
4 sitesUnited States
Study dates
24 Aug 2020to 30 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Aiken Regional Medical Center

    Aiken, South Carolina, 29801

  • Russell Medical Center

    Alexander City, Alabama, 35010

  • Anderson Regional Medical Center

    Meridian, Mississippi, 39301

  • Highland Community Hospital

    Picayune, Mississippi, 39466

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Active Intervention, Usual Care
Medical subject headings
Neoplasms, Heart Diseases, Lung Diseases, Kidney Diseases, Stroke, Sepsis, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active InterventionOther

    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 CareOther

    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.

Study groups in NCT03767517
Study groupRoleWhat they receive
Active InterventionExperimentalUsual Care + Tele-consult Intervention
Receives: Other: Active Intervention
Usual CareActive comparatorUsual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline and 7 days post-baseline and 30 days post-baseline

Secondary outcomes (6)

  1. The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.

    Change from baseline measured using FAMCARE-2 at 7 days post-baseline. Each item was scored on a Likert scale of VS (very satisfied), S (satisfied), U (undecided), D (dissatisfied), VD (very dissatisfied), or NA (not applicable), which was then dichotomized into very satisfied/satisfied and undecided/dissatisfied/very dissatisfied. The mean percentages in these dichotomized categories was calculated along with the standard error of the mean. A repeated measures generalized linear mixed model was used to calculate the estimated marginal means (least squares means) and associated standard errors at each time point for the intervention and usual care groups. The higher mean percentage of the population that responded very satisfied/ satisfied equals a better outcome.

    Measured: baseline and 7 days post-baseline and 30 days post baseline

  2. 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).Items were summed , then scaled to T-scores (which would have a mean of 50 and standard deviation of 10 in the general adult population) using published procedures from Health Measures, with higher scores representing better health. As the PROMIS Global Health is scaled relative to the referent general population, there are no minimum and maximum values published.

    Measured: baseline and 7 days post-baseline

  3. 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).Items were summed , then scaled to T-scores (which would have a mean of 50 and standard deviation of 10 in the general adult population) using published procedures from Health Measures, with higher scores representing better health. As the PROMIS Global Health is scaled relative to the referent general population, there are no minimum and maximum values published.

    Measured: Baseline and 7 days post-Baseline

  4. 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).

    Measured: Baseline and 7 days post-Baseline

  5. Resource Use

    Patient resource use (e.g., number of hospital readmissions, and number of Emergency Department [ED] visits) within 30 days after enrollment.

    Measured: 30 days post-Baseline

  6. The Mean Percentage of Caregivers Who Responded Completely/Quite a Bit to the Patient Satisfaction With Care (Feeling Heard and Understood) Survey.

    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. Which was then dichotomized into completely/quite-a-bit and moderately/slightly/not at all. The mean percentage of participants in these dichotomized categories were calculated along with the standard error of the mean. The higher mean percentage of the population that responded completely/ quite a bit equals a better outcome.

    Measured: Baseline and 7 days post-Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2018
  2. Study start24 Aug 2020
  3. Primary completion7 Dec 2023
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03767517
Sponsor's protocol ID
IRB300002420
Other IDs
1R01NR017181-01A1, 5R01NR017181-05
Status last verified
May 2025
First submitted
29 Oct 2018
Last updated
23 May 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32703245

  • 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.

    PubMed 36871774

  • 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.

    PubMed 33393704

  • 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.

    PubMed 35247583

  • 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.

    PubMed 38641135

  • 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.

  • 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.

  • 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.

    PubMed 40632537

Questions about this trial

What is this clinical trial studying?

A study testing Active Intervention in people with Cancer and Cardiac Disease, run by University of Alabama at Birmingham at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS]) (time frame: baseline and 7 days post-baseline and 30 days post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03767517, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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