<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767517</url>
  </required_header>
  <id_info>
    <org_study_id>IRB300002420</org_study_id>
    <nct_id>NCT03767517</nct_id>
  </id_info>
  <brief_title>A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rural patients with life-limiting illness are at very high risk of not receiving appropriate&#xD;
      care due to a lack of health professionals, long distances to treatment centers, and limited&#xD;
      palliative care (PC) clinical expertise. Secondly, although culture strongly influences&#xD;
      people's response to diagnosis, illness and treatment preferences, culturally-based care&#xD;
      models are not currently available for most seriously-ill rural patients and their family&#xD;
      caregivers. Lack of sensitivity to cultural differences may compromise PC for minority&#xD;
      patients. The purpose of this study is to compare a culturally-based Tele-consult program to&#xD;
      usual hospital care to determine whether a culturally-based PC Tele-consult program leads to&#xD;
      lower symptom burden in hospitalized African American and White older adults with a&#xD;
      life-limiting illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The triple threat of rural geography, racial inequities, and older age hinders access to high&#xD;
      quality PC for a significant proportion of Americans. Rural patients with life-limiting&#xD;
      illness are at very high risk of not receiving appropriate care due to a lack of health&#xD;
      professionals, long distances to treatment centers, and limited PC clinical expertise.&#xD;
      Although culture strongly influences people's response to diagnosis, illness and treatment&#xD;
      preferences, culturally-based care models are not currently available for most seriously-ill&#xD;
      rural patients and their family caregivers. Lack of sensitivity to cultural differences may&#xD;
      compromise PC for minority patients. The two major public health consequences of these&#xD;
      problems are:&#xD;
&#xD;
        1. Access-Rural patients have sub-optimal or no access to PC. Despite significant&#xD;
           nationwide growth, access to PC is grossly inadequate for the 60 million US citizens who&#xD;
           live in rural or non-metropolitan areas. There is low PC use in rural and minority&#xD;
           populations. As a result, rural patients experience significant suffering from&#xD;
           uncontrolled symptoms that PC expertise could alleviate.&#xD;
&#xD;
        2. Acceptability-Even when palliative and hospice services are available, African Americans&#xD;
           (AA), compared to Whites (W) are more likely to receive medically-ineffective, poor&#xD;
           quality care due to a culturally-insensitive health care system and mistrust of health&#xD;
           care providers. Making culturally competent PC available for diverse underserved and&#xD;
           rural Americans is a national priority.&#xD;
&#xD;
      This community-developed, culturally based Teleconsult Intervention specifically targets the&#xD;
      gaps of PC access and acceptability. It was developed by and for rural, Deep South AA and W&#xD;
      patients and providers, and uses state-of-the-art telehealth methods, to provide PC&#xD;
      consultation to hospitalized seriously-ill patients and family. Using National Consensus&#xD;
      Project guidelines, and the culturally-based, community-developed PC Tele-consult&#xD;
      intervention, a remote PC expert conducts a comprehensive PC patient assessment, in&#xD;
      collaboration with local providers. Following interdisciplinary PC team review, the remote&#xD;
      clinician communicates recommendations. Two additional structured follow up contacts at Day 3&#xD;
      and 6 ensure care coordination and smooth transitions that enable patients to receive&#xD;
      guideline concurrent PC in their communities.&#xD;
&#xD;
      Aims of the study and Hypotheses:&#xD;
&#xD;
      Primary Aim: Determine whether a culturally-based PC Tele-consult program leads to lower&#xD;
      symptom burden in hospitalized AA and W older adults with a life-limiting illness.&#xD;
&#xD;
      Hypothesis 1: Intervention patient participants receiving a culturally-based PC Tele-consult&#xD;
      program will experience lower symptom burden on Day 7 post-consultation.&#xD;
&#xD;
      Secondary Aim: Determine whether a culturally-based PC Tele-consult program results in higher&#xD;
      patient and caregiver quality of life, care satisfaction, and lower caregiver burden at Day 7&#xD;
      post-consultation, and lower resource use (hospital readmission, emergency visits) 30-days&#xD;
      post-discharge.&#xD;
&#xD;
      Hypothesis 2: Intervention participants and their caregivers receiving a culturally-based PC&#xD;
      Tele-consult program will experience higher patient and caregiver quality of life, care&#xD;
      satisfaction, lower caregiver burden at Day 7 post consultation, and lower resource use (e.g.&#xD;
      hospital admission, emergency visits) at 30 days after discharge.&#xD;
&#xD;
      Exploratory Aim: Explore mediators and moderators of patient symptom and caregiver burden&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 20, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])</measure>
    <time_frame>baseline and 7 days post-baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Family satisfaction with care (FAMCARE-2)</measure>
    <time_frame>baseline and 7 days post-baseline</time_frame>
    <description>Change from baseline in family-reported satisfaction with care measured using the FAMCARE-2 scale at baseline; change from baseline measured using FAMCARE-2 at 7 days post-baseline. Each item is scored using: vs (very satisfied), s (satisfied), u (undecided), d (dissatisfied), vd (very dissatisfied), or NA (not applicable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])</measure>
    <time_frame>baseline and 7 days post-baseline</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])</measure>
    <time_frame>Baseline and 7 days post-Baseline</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver burden scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])</measure>
    <time_frame>Baseline and 7 days post-Baseline</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource Use</measure>
    <time_frame>30 days post-Baseline</time_frame>
    <description>Patient resource use (e.g., number of hospital readmissions, number of hospital days, number of ICU days, number of Emergency Department [ED] visits, and hospice days during the 30 days following discharge) will be collected via electronic health records (eHR) 30 days post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with care (Feeling Heard and Understood)</measure>
    <time_frame>Baseline and 7 days post-Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Aim 1a. Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])</measure>
    <time_frame>Day 7</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Aim 1b. Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])</measure>
    <time_frame>Day 7</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Aim 1c. Caregiver burden (Montgomery Borgatta Caregiver Burden Scale [MBCB])</measure>
    <time_frame>Day 7</time_frame>
    <description>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). 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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Aim 1d. Caregiver burden (Montgomery Borgatta Caregiver Burden Scale [MBCB])</measure>
    <time_frame>Day 7</time_frame>
    <description>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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Aim 1e. Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL]</measure>
    <time_frame>2-3 Months after death of patient, if applicable</time_frame>
    <description>Caregiver evaluation of end-of-life care quality measured by Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL]</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Aim 1f. Caregiver bereavement (Caregiver Bereavement Items ([CBI])</measure>
    <time_frame>2-3 Months after death of patient, if applicable</time_frame>
    <description>Caregiver bereavement measured by Caregiver Bereavement Items ([CBI]</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">352</enrollment>
  <condition>Cancer</condition>
  <condition>Cardiac Disease</condition>
  <condition>Pulmonary Disease</condition>
  <condition>Neuro-Degenerative Disease</condition>
  <condition>Renal Disease</condition>
  <condition>Stroke</condition>
  <condition>Sepsis</condition>
  <condition>Hepatic Disease</condition>
  <arm_group>
    <arm_group_label>Active Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual Care + Tele-consult Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Active Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>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.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AA or W;&#xD;
&#xD;
          -  55 years old; has a condition which fits into one of 3 illness paradigms -cancer,&#xD;
             chronic progressive, frailty.&#xD;
&#xD;
          -  Clinician answers &quot;no&quot; to question: &quot;Would you be surprised if this person died in the&#xD;
             next 12 months?&quot;&#xD;
&#xD;
          -  Patient has a caregiver who has been involved in their care.&#xD;
&#xD;
          -  Able to complete baseline interviews&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to complete baseline interviews;&#xD;
&#xD;
          -  Currently receiving hospice care;&#xD;
&#xD;
          -  No family member/caregiver.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie A Bakitas, DNSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ronit Elk, PhD</last_name>
    <phone>205-996-1702</phone>
    <email>relk@uabmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Felicia Underwood, LICSW</last_name>
    <phone>205-934-7905</phone>
    <email>faunderwood@uabmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Russell Medical Center</name>
      <address>
        <city>Alexander City</city>
        <state>Alabama</state>
        <zip>35010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Anderson Regional Medical Center</name>
      <address>
        <city>Meridian</city>
        <state>Mississippi</state>
        <zip>39301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Prewitt, MD</last_name>
      <email>lprewitt@andersonregional.org</email>
    </contact>
    <contact_backup>
      <last_name>Lisa Massey, RN</last_name>
      <email>LMassey@andersonregional.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Highland Community Hospital</name>
      <address>
        <city>Picayune</city>
        <state>Mississippi</state>
        <zip>39466</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Aiken Regional Medical Center</name>
      <address>
        <city>Aiken</city>
        <state>South Carolina</state>
        <zip>29801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Greg Black</last_name>
      <phone>803-641-5608</phone>
      <email>gregory.black@uhsinc.com</email>
    </contact>
    <contact_backup>
      <last_name>Sheila McCormick</last_name>
      <email>sheila.mccormick@uhinc.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Ronit Elk</investigator_full_name>
    <investigator_title>Professor for the Division of Geriatrics, Gerontology, and Palliative Care; Associate Director for the Center for Palliative and Supportive Care</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767517
org study id: IRB300002420
nct id: NCT03767517
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])
time frame: baseline and 7 days post-baseline
description: 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.
measure: Family satisfaction with care (FAMCARE-2)
time frame: baseline and 7 days post-baseline
description: Change from baseline in family-reported satisfaction with care measured using the FAMCARE-2 scale at baseline; change from baseline measured using FAMCARE-2 at 7 days post-baseline. Each item is scored using: vs (very satisfied), s (satisfied), u (undecided), d (dissatisfied), vd (very dissatisfied), or NA (not applicable).
measure: Patient quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
time frame: baseline and 7 days post-baseline
description: 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).
measure: Caregiver quality of life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
time frame: Baseline and 7 days post-Baseline
description: 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).
measure: Caregiver burden scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
time frame: Baseline and 7 days post-Baseline
description: 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).
measure: Resource Use
time frame: 30 days post-Baseline
description: Patient resource use (e.g., number of hospital readmissions, number of hospital days, number of ICU days, number of Emergency Department [ED] visits, and hospice days during the 30 days following discharge) will be collected via electronic health records (eHR) 30 days post-discharge.
measure: Patient satisfaction with care (Feeling Heard and Understood)
time frame: Baseline and 7 days post-Baseline
description: 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.
measure: Exploratory Aim 1a. Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])
time frame: Day 7
description: 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.
measure: Exploratory Aim 1b. Patient symptom burden (Edmonton Symptom Assessment Scale [ESAS])
time frame: Day 7
description: 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.
measure: Exploratory Aim 1c. Caregiver burden (Montgomery Borgatta Caregiver Burden Scale [MBCB])
time frame: Day 7
description: 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). 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).
measure: Exploratory Aim 1d. Caregiver burden (Montgomery Borgatta Caregiver Burden Scale [MBCB])
time frame: Day 7
description: 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).
measure: Exploratory Aim 1e. Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL]
time frame: 2-3 Months after death of patient, if applicable
description: Caregiver evaluation of end-of-life care quality measured by Caregiver Evaluation of Quality of End-of-Life Care [CEQUEL]
measure: Exploratory Aim 1f. Caregiver bereavement (Caregiver Bereavement Items ([CBI])
time frame: 2-3 Months after death of patient, if applicable
description: Caregiver bereavement measured by Caregiver Bereavement Items ([CBI]
arm group label: Active Intervention
arm group type: Experimental
description: Usual Care + Tele-consult Intervention
arm group label: Usual Care
arm group type: Active Comparator
description: Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
intervention type: Other
intervention name: Active Intervention
description: 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.
arm group label: Active Intervention
intervention type: Other
intervention name: Usual Care
description: 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.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Marie A Bakitas, DNSc
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Ronit Elk, PhD
phone: 205-996-1702
email: relk@uabmc.edu
last name: Felicia Underwood, LICSW
phone: 205-934-7905
email: faunderwood@uabmc.edu
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Ronit Elk
investigator title: Professor for the Division of Geriatrics, Gerontology, and Palliative Care; Associate Director for the Center for Palliative and Supportive Care
mesh term: Liver Diseases
mesh term: Neurodegenerative Diseases
mesh term: Heart Diseases