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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR017181-01A1 | U.S. NIH Grant/Contract | View source | |
| 5R01NR017181-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention | Experimental | Usual Care + Tele-consult Intervention |
|
| Usual Care | Active Comparator | Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Aim 1a. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS]) | Patient symptom burden measured by Edmonton Symptom Assessment Scale [ESAS] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record [eHR] documentation of recommendations by hospitalist/clinician at Day 7. Each item in the ESAS is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie A Bakitas, DNSc | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russell Medical Center | Alexander City | Alabama | 35010 | United States | ||
| Anderson Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32703245 | Background | 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. | |
| 36871774 | Background |
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Patient and Caregivers were considered enrolled. The patients were not enrolled without an active caregiver. They were only given one study Identification number.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Intervention | Usual Care + Tele-consult Intervention 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2022 |
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| 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. |
|
| 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. | 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. | 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). | 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. | 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. | Baseline and 7 days post-Baseline |
| Day 7 |
| Exploratory Aim 1b. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS]) | Patient symptom burden measured by Edmonton Symptom Assessment Scale [ESAS] mediated and/or moderated by patient/caregiver implementation of palliative care recommendations. Patient/caregiver implementation of palliative care recommendations are measured using patient/caregiver report at Day 7. Each item in the Edmonton Symptom Assessment Scale [ESAS] is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90. | Day 7 |
| Exploratory Aim 1c. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]). | Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale [MBCB] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record [eHR] documentation of recommendations by hospitalist/clinician at Day 7. 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) with higher scores indicating greater burden. 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). | Day 7 |
| Exploratory Aim 1d. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]). | Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale [MBCB] mediated and/or moderated by caregiver/patient implementation of palliative care recommendations. Caregiver/patient implementation of palliative care recommendations are measured using caregiver/patient report at Day 7. 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). Higher scores indicates greater burden. | Day 30 |
| Exploratory Aim 1e. Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL] | Caregiver evaluation of end-of-life care quality measured by Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL] | 2-3 Months after death of patient, if applicable |
| Exploratory Aim 1f. Caregiver Bereavement (Caregiver Bereavement Items ([CBI]) | Caregiver bereavement measured by Caregiver Bereavement Items ([CBI] | 2-3 Months after death of patient, if applicable |
| Meridian |
| Mississippi |
| 39301 |
| United States |
| Highland Community Hospital | Picayune | Mississippi | 39466 | United States |
| Aiken Regional Medical Center | Aiken | South Carolina | 29801 | United States |
| 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. |
| 33393704 | 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. |
| 35247583 | 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. |
| 38641135 | 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. |
| Result | 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. |
| 40632537 | Derived | 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. |
| FG001 |
| Usual Care |
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. 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. |
| Patient/Caregiver Breakdown |
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| COMPLETED |
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| NOT COMPLETED |
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There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Intervention | Usual Care + Tele-consult Intervention 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. |
| BG001 | Usual Care | Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups. | Mean | Standard Deviation | years |
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| Sex: Female, Male | # of caregivers in USUAL CARE were lost to f/u | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The ethnicity measure was assessed only for patients enrolled in the study. | There are 105 patient participants in the active intervention and There are 104 patient participants in usual care. | Count of Participants | Participants |
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| Race (NIH/OMB) | There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | score on a scale | baseline and 7 days post-baseline and 30 days post-baseline |
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| Secondary | 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. | The participants number analyzed in one or more rows differ from the overall number analyzed due to participants choosing not to answer certain questions from baseline to day 30. | Posted | Number | percentage of participants | baseline and 7 days post-baseline and 30 days post baseline |
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| Secondary | 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. | The number of patients changed because of not completing the study. | Posted | Mean | Standard Error | scaled to T-Scores | baseline and 7 days post-baseline |
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| Secondary | 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. | The number of Caregivers changed at Day 7. | Posted | Mean | Standard Error | score on a scale | Baseline and 7 days post-Baseline |
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| Secondary | 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). | The number analyzed in one or more rows differ from the overall number analyzed because some of the participants failed to answer questions during data collection. | Posted | Mean | Standard Error | score on a scale | Baseline and 7 days post-Baseline |
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| Secondary | Resource Use | Patient resource use (e.g., number of hospital readmissions, and number of Emergency Department [ED] visits) within 30 days after enrollment. | Some participants reported that they were not sure which was considered missing data for analysis. | Posted | Mean | Standard Error | count the number of visits | 30 days post-Baseline |
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| Secondary | 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. | Nine of the participants dropped out of the study by Day 7. | Posted | Mean | Standard Error | percentage of participants | Baseline and 7 days post-Baseline |
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| Other Pre-specified | Exploratory Aim 1a. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS]) | Patient symptom burden measured by Edmonton Symptom Assessment Scale [ESAS] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record [eHR] documentation of recommendations by hospitalist/clinician at Day 7. Each item in the ESAS is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90. | Posted | Mean | Standard Error | score on a scale | Day 7 |
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| Other Pre-specified | Exploratory Aim 1b. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS]) | Patient symptom burden measured by Edmonton Symptom Assessment Scale [ESAS] mediated and/or moderated by patient/caregiver implementation of palliative care recommendations. Patient/caregiver implementation of palliative care recommendations are measured using patient/caregiver report at Day 7. Each item in the Edmonton Symptom Assessment Scale [ESAS] is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90. | Posted | Mean | Standard Error | score on a scale | Day 7 |
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| Other Pre-specified | Exploratory Aim 1c. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]). | Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale [MBCB] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record [eHR] documentation of recommendations by hospitalist/clinician at Day 7. 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) with higher scores indicating greater burden. 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). | Some participants did not answer which resulted in missing data | Posted | Mean | Standard Error | score on a scale | Day 7 |
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| Other Pre-specified | Exploratory Aim 1d. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]). | Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale [MBCB] mediated and/or moderated by caregiver/patient implementation of palliative care recommendations. Caregiver/patient implementation of palliative care recommendations are measured using caregiver/patient report at Day 7. 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). Higher scores indicates greater burden. | Some participants did not answer which resulted in missing data | Posted | Mean | Standard Error | score on a scale | Day 30 |
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| Other Pre-specified | Exploratory Aim 1e. Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL] | Caregiver evaluation of end-of-life care quality measured by Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL] | This data was not collected. | Posted | 2-3 Months after death of patient, if applicable |
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| Other Pre-specified | Exploratory Aim 1f. Caregiver Bereavement (Caregiver Bereavement Items ([CBI]) | Caregiver bereavement measured by Caregiver Bereavement Items ([CBI] | This was not collected. | Posted | 2-3 Months after death of patient, if applicable |
|
|
30 days
Only patients were in both active intervention and usual care were monitored for adverse events. Caregivers were not monitored.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Intervention/Patients Only | Usual Care + Tele-consult Intervention 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. | 2 | 105 | 0 | 105 | 0 | 105 |
| EG001 | Usual Care/Patients Only | Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. 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. | 2 | 104 | 0 | 104 | 0 | 104 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronit Elk | University of Alabama at Birmingham | 205-996-1702 | relk@uabmc.edu |
| Dec 3, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006331 | Heart Diseases |
| D008171 | Lung Diseases |
| D007674 | Kidney Diseases |
| D020521 | Stroke |
| D018805 | Sepsis |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D012140 | Respiratory Tract Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. 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. |
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Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. 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. |
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Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. 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. |
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Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
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.
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