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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
209
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.
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.
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
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.
Time frame: baseline and 7 days post-baseline and 30 days post-baseline
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.
Time frame: 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])
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.
Time frame: baseline and 7 days post-baseline
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.
Time frame: Baseline and 7 days post-Baseline
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).
Time frame: Baseline and 7 days post-Baseline
Resource Use
Patient resource use (e.g., number of hospital readmissions, and number of Emergency Department \[ED\] visits) within 30 days after enrollment.
Time frame: 30 days post-Baseline
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.
Time frame: Baseline and 7 days post-Baseline
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