<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/NCT01672398</url>
  </required_header>
  <id_info>
    <org_study_id>R18HS019625-01A1</org_study_id>
    <nct_id>NCT01672398</nct_id>
  </id_info>
  <brief_title>Trial of the CarePartner Program for Improving the Quality of Transition Support</brief_title>
  <official_title>Trial of the CarePartner Program for Improving the Quality of Transition 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: Patients hospitalized with complex chronic conditions frequently experience&#xD;
      preventable short-term readmissions due to inadequate transition support. Although structured&#xD;
      discharge planning with telephone follow-up improves transition outcomes, these services&#xD;
      often are unavailable, and proactive outreach is often inadequate once the patient returns&#xD;
      home. Informal caregivers are invaluable for ensuring successful transitions, but many&#xD;
      patients live alone, have an in-home caregiver who is struggling with competing demands, or&#xD;
      live at a distance from adult children or other potential sources of support. New models are&#xD;
      needed for transition support that include low-cost technologies and more structured&#xD;
      assistance for patients' informal caregiving network, while providing patients' clinical&#xD;
      teams with the information they need to avert health crises.&#xD;
&#xD;
      Objectives: Consistent with Agency for Healthcare Research and Quality goals to improve&#xD;
      transitions using accessible health IT, we will evaluate a novel intervention designed to&#xD;
      improve the effectiveness of transition support for common chronic conditions via three&#xD;
      mechanisms of action: (a) direct tailored communication to patients via automated calls post&#xD;
      discharge, (b) support for informal caregivers via structured feedback about the patient's&#xD;
      status and advice about how they can help, and (c) support for proactive care management&#xD;
      including a web-based disease management tool, automated alerts about potential problems, and&#xD;
      the capacity for asynchronous communication with patients and their caregivers. Specifically,&#xD;
      the trial will determine: 1) whether the CarePartner intervention improves patients'&#xD;
      readmission risk and functional status; 2) the impact of the intervention on patients'&#xD;
      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: 422 adults with complex chronic conditions will be identified upon admission to a&#xD;
      university-based acute care general medical service. Patients will be asked to identify a&#xD;
      CarePartner (CP) living outside their household; CPs will be spouses, adult children, and&#xD;
      others in their social network willing to play an active role in their transition support.&#xD;
      Patients will be randomized to the intervention or usual care. Intervention patients will&#xD;
      receive automated assessment and behavior change calls, and their CPs will receive structured&#xD;
      feedback and advice following each assessment. Patients' clinical team will have access to&#xD;
      patients' assessment results via the web, will receive automated reports about urgent health&#xD;
      problems, and will be able to communicate asynchronously with patients and CPs using a secure&#xD;
      web page and a specially designed voicemail service. Patients will complete surveys at&#xD;
      baseline, 30- and 90- days post discharge; utilization data will be obtained from hospital&#xD;
      records. CPs and clinicians will be interviewed to evaluate intervention effects on processes&#xD;
      of self-care support, caregiver stress and communication, and the intervention's potential&#xD;
      for broader implementation. The primary outcome will be 30 day readmission rates; 2ndary&#xD;
      outcomes include functional status, self-care behaviors, and mortality 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 short-term readmission rates, emergency department visits, and patients' 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 CarePartner intervention on process measures of transition quality and on patients' medication-related self-management.</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 stress and increases activation levels among CarePartners.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">271</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 21 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/NCT01672398
org study id: R18HS019625-01A1
nct id: NCT01672398
lead sponsor: 
has dmc: Yes
Background: Patients hospitalized with complex chronic conditions frequently experience
      preventable short-term readmissions due to inadequate transition support. Although structured
      discharge planning with telephone follow-up improves transition outcomes, these services
      often are unavailable, and proactive outreach is often inadequate once the patient returns
      home. 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 Agency for Healthcare Research and Quality goals to improve
      transitions using accessible health IT, we will evaluate a novel intervention designed to
      improve the effectiveness of transition support for common chronic conditions via three
      mechanisms of action: (a) direct tailored communication to patients via automated calls post
      discharge, (b) support for informal caregivers 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: 422 adults with complex chronic conditions will be identified upon admission to a
      university-based acute care general medical service. Patients will be asked to identify a
      CarePartner (CP) living outside their household; CPs will be spouses, adult children, and
      others in their social network willing to play an active role in their transition support.
      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 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 outcome will be 30 day readmission rates; 2ndary
      outcomes 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 short-term readmission rates, emergency department visits, and patients' 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 CarePartner intervention on process measures of transition quality and on patients' medication-related self-management.
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 stress and increases activation levels among CarePartners.
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