<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/NCT01672385</url>
  </required_header>
  <id_info>
    <org_study_id>R01AG039474-01</org_study_id>
    <nct_id>NCT01672385</nct_id>
  </id_info>
  <brief_title>Improving Transition Outcomes Through Accessible Health IT and Caregiver Support</brief_title>
  <official_title>Improving Transition Outcomes Through Accessible Health IT and Caregiver Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Older hospitalized adults frequently experience preventable short-term&#xD;
      readmissions due to inadequate transition support. Although proactive telephone follow-up&#xD;
      improves transition outcomes, these services often are unsystematic and of low intensity.&#xD;
      Informal caregivers are invaluable for ensuring successful transitions, but many patients&#xD;
      live alone, have an in-home caregiver who is struggling with competing demands, or live at a&#xD;
      distance from adult children or other potential sources of support. New models are needed for&#xD;
      transition support that include low-cost technologies and more structured assistance for&#xD;
      patients' informal caregiving network, while providing patients' clinical teams with the&#xD;
      information they need to avert health crises.&#xD;
&#xD;
      Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a&#xD;
      novel intervention designed to improve the effectiveness of transition support for older&#xD;
      adults with common chronic conditions via three mechanisms of action: (a) direct tailored&#xD;
      communication to patients via regular automated calls post discharge, (b) support for&#xD;
      informal caregivers living outside of the patient's household via structured feedback about&#xD;
      the patient's status and advice about how they can help, and (c) support for proactive care&#xD;
      management including a web-based disease management tool, automated alerts about potential&#xD;
      problems, and the capacity for asynchronous communication with patients and their caregivers.&#xD;
      Specifically, the trial will determine: 1) whether the CarePartner intervention improves&#xD;
      patients' readmission risk and functional status; 2) the impact of the intervention on&#xD;
      patients' self-care behaviors and the quality of the transition process; and 3) whether the&#xD;
      intervention improves caregiver burden and stress levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: 846 older adults with complex chronic conditions will be identified upon admission&#xD;
      to two community-based acute care medical services. Patients will be asked to identify a&#xD;
      CarePartner (CP) living outside their household, i.e., an adult child or other social network&#xD;
      member willing to play an active role in their transition support and organizing their&#xD;
      broader network of informal caregivers. Patients will be randomized to the intervention or&#xD;
      usual care. Intervention patients will receive automated assessment and behavior change&#xD;
      calls, and their CPs will receive structured feedback and advice following each assessment.&#xD;
      Patients' clinical team will have access to patients' assessment results via the web, will&#xD;
      receive automated reports about urgent health problems, and will be able to communicate&#xD;
      asynchronously with patients and CPs using a secure web page and a specially designed&#xD;
      voicemail service. Patients will complete surveys at baseline, 30- and 90- days post&#xD;
      discharge; utilization data will be obtained from hospital records. CPs, other caregivers,&#xD;
      and clinicians will be interviewed to evaluate intervention effects on processes of self-care&#xD;
      support, caregiver stress and communication, and the intervention's potential for broader&#xD;
      implementation. The primary outcomes will be 30 day readmission rates; 2ndary outcomes&#xD;
      measured at 30 and 90 days include functional status, self-care behaviors, and mortality&#xD;
      risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Specific Aim 1</measure>
    <time_frame>Outcomes will be measured at 30- and 90-days post discharge.</time_frame>
    <description>To determine the extent to which the CarePartner model for supporting effective transitions from hospital to home improves outcomes of care, including lower readmission rates, emergency department visits, and improved patient functional status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specific Aim 2</measure>
    <time_frame>Outcomes will be measured at 30- and 90-days post discharge.</time_frame>
    <description>To evaluate the impact of the intervention on process measures of transition quality (e.g., attendance at post-discharge appointments and patients' understanding of their personal health record), as well as on patients' medication-related self-management (e.g., adherence and medication beliefs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specific Aim 3</measure>
    <time_frame>Outcomes will be measured at 30- and 90-days post discharge.</time_frame>
    <description>To determine the extent to which the intervention increases the quality and quantity of support for patients' self-care using a mixed methods approach to identify whether the service reduces caregivers' stress and increases their activation levels (e.g., by increasing their disease-specific communication with the patient and successful problem solving).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">246</enrollment>
  <condition>Post-discharge</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telemonitoring plus self-management support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemonitoring plus self-management support</intervention_name>
    <description>Patients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being discharged from study site with any diagnoses that indicate a chronic condition&#xD;
             with a high risk of short-term readmission, for example: stroke, heart failure,&#xD;
             coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease,&#xD;
             peripheral vascular disease, deep venous thrombosis, pulmonary embolism, pneumonia,&#xD;
             diabetes, urinary tract infection, cellulitis, gastroenteritis, fevers, and other&#xD;
             infections&#xD;
&#xD;
          -  At least 50 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious mental illness, e.g., psychosis&#xD;
&#xD;
          -  Are in hospice care&#xD;
&#xD;
          -  Do not speak English&#xD;
&#xD;
          -  Are unable to use a telephone&#xD;
&#xD;
          -  Have a non-health system-affiliated primary care provider&#xD;
&#xD;
          -  Are unable to nominate a potentially eligible CarePartner&#xD;
&#xD;
          -  Are cognitively impaired as determined by a validate screener&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John D. Piette, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Center for Clinical Management Research &amp; the University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>November 4, 2016</last_update_submitted>
  <last_update_submitted_qc>November 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>John Piette</investigator_full_name>
    <investigator_title>VA Senior Research Career Scientist and Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>CarePartner</keyword>
  <keyword>informal caregiver</keyword>
  <keyword>interactive voice response</keyword>
  <keyword>transition</keyword>
  <keyword>post-discharge</keyword>
  <keyword>chronic illness</keyword>
  <keyword>readmission</keyword>
  <keyword>self-care</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01672385
org study id: R01AG039474-01
nct id: NCT01672385
lead sponsor: 
has dmc: Yes
Background: Older hospitalized adults frequently experience preventable short-term
      readmissions due to inadequate transition support. Although proactive telephone follow-up
      improves transition outcomes, these services often are unsystematic and of low intensity.
      Informal caregivers are invaluable for ensuring successful transitions, but many patients
      live alone, have an in-home caregiver who is struggling with competing demands, or live at a
      distance from adult children or other potential sources of support. New models are needed for
      transition support that include low-cost technologies and more structured assistance for
      patients' informal caregiving network, while providing patients' clinical teams with the
      information they need to avert health crises.

      Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a
      novel intervention designed to improve the effectiveness of transition support for older
      adults with common chronic conditions via three mechanisms of action: (a) direct tailored
      communication to patients via regular automated calls post discharge, (b) support for
      informal caregivers living outside of the patient's household via structured feedback about
      the patient's status and advice about how they can help, and (c) support for proactive care
      management including a web-based disease management tool, automated alerts about potential
      problems, and the capacity for asynchronous communication with patients and their caregivers.
      Specifically, the trial will determine: 1) whether the CarePartner intervention improves
      patients' readmission risk and functional status; 2) the impact of the intervention on
      patients' self-care behaviors and the quality of the transition process; and 3) whether the
      intervention improves caregiver burden and stress levels.
Methods: 846 older adults with complex chronic conditions will be identified upon admission
      to two community-based acute care medical services. Patients will be asked to identify a
      CarePartner (CP) living outside their household, i.e., an adult child or other social network
      member willing to play an active role in their transition support and organizing their
      broader network of informal caregivers. Patients will be randomized to the intervention or
      usual care. Intervention patients will receive automated assessment and behavior change
      calls, and their CPs will receive structured feedback and advice following each assessment.
      Patients' clinical team will have access to patients' assessment results via the web, will
      receive automated reports about urgent health problems, and will be able to communicate
      asynchronously with patients and CPs using a secure web page and a specially designed
      voicemail service. Patients will complete surveys at baseline, 30- and 90- days post
      discharge; utilization data will be obtained from hospital records. CPs, other caregivers,
      and clinicians will be interviewed to evaluate intervention effects on processes of self-care
      support, caregiver stress and communication, and the intervention's potential for broader
      implementation. The primary outcomes will be 30 day readmission rates; 2ndary outcomes
      measured at 30 and 90 days include functional status, self-care behaviors, and mortality
      risk.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Specific Aim 1
time frame: Outcomes will be measured at 30- and 90-days post discharge.
description: To determine the extent to which the CarePartner model for supporting effective transitions from hospital to home improves outcomes of care, including lower readmission rates, emergency department visits, and improved patient functional status.
measure: Specific Aim 2
time frame: Outcomes will be measured at 30- and 90-days post discharge.
description: To evaluate the impact of the intervention on process measures of transition quality (e.g., attendance at post-discharge appointments and patients' understanding of their personal health record), as well as on patients' medication-related self-management (e.g., adherence and medication beliefs).
measure: Specific Aim 3
time frame: Outcomes will be measured at 30- and 90-days post discharge.
description: To determine the extent to which the intervention increases the quality and quantity of support for patients' self-care using a mixed methods approach to identify whether the service reduces caregivers' stress and increases their activation levels (e.g., by increasing their disease-specific communication with the patient and successful problem solving).
arm group label: Intervention Group
arm group type: Experimental
description: Telemonitoring plus self-management support
arm group label: Usual Care Group
arm group type: No Intervention
description: Usual Care
intervention type: Other
intervention name: Telemonitoring plus self-management support
description: Patients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: John D. Piette, Ph.D.
role: Principal Investigator
affiliation: VA Center for Clinical Management Research & the University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: John Piette
investigator title: VA Senior Research Career Scientist and Professor of Internal Medicine
sharing ipd: No