<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/NCT02211274</url>
  </required_header>
  <id_info>
    <org_study_id>D1241-W</org_study_id>
    <nct_id>NCT02211274</nct_id>
  </id_info>
  <brief_title>VA Community Living Centers to Home</brief_title>
  <official_title>Improving Veteran Transitions From VA Community Living Centers to the Community</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Older adults prefer to live as in the community as long as possible. Creating a standardized&#xD;
      treatment planning process that includes assessments of everyday competence and goal-setting&#xD;
      techniques to help Veterans move from VA nursing homes back to the community can improve&#xD;
      functional health, well-being, and quality of life for older Veterans. Research has shown&#xD;
      that 29% of nursing home residents might be able to live safely in the community instead.&#xD;
      Currently, VA provides nursing home care to more than 13,000 Veterans across the country,&#xD;
      which costs about $3.3 billion a year. It is expensive for VA to provide nursing home care to&#xD;
      these inappropriate residents and they are using limited resources that could be given to&#xD;
      another Veteran with more urgent needs. The Everyday Competence Assessment and Planning for&#xD;
      Community Transitions (ECAP-CT) toolkit will help these Veterans to move back into the&#xD;
      community with the services and supports they need based on their individual level of&#xD;
      everyday competence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 29% of Community Living Center (CLC; VA nursing homes) residents may not require&#xD;
      nursing home levels of care and could successfully reside in the community with appropriate&#xD;
      rehabilitative services. Many older adults prefer to remain in their homes, though living&#xD;
      independently in the community is not always possible or safe. According to the model of&#xD;
      person-environment fit (P-E fit), older adults are at risk for poor outcomes when the demands&#xD;
      and resources available in the living environment are not in balance with the individual's&#xD;
      everyday competence (the ability to solve problems associated with everyday life).&#xD;
      Community-dwelling older adults with low levels of everyday competence and little support are&#xD;
      at risk for nursing home transition. Conversely, older adults with higher levels of everyday&#xD;
      competence who live in more restrictive environments (e.g., nursing home) may experience&#xD;
      declines in functioning resulting from a lack of stimulation. Often, transitions into nursing&#xD;
      homes occur during a time of crisis (e.g., after acute hospital stay), leaving little&#xD;
      opportunity for appropriate consideration of the individual's current and future level of&#xD;
      everyday competence.&#xD;
&#xD;
      In VA, a major focus is to minimize the time spent in the CLCs by providing rehabilitation&#xD;
      services and transitioning Veterans back into the community. The mission for the CLC program&#xD;
      is to return the Veteran to his or her highest level of well-being, thus maximizing P-E fit.&#xD;
      Despite this, CLC staff and Veterans face many barriers to facilitating transitions to the&#xD;
      community (e.g., caregiving needs, housing, etc.). Currently no standardized process exists&#xD;
      to assure that treatment planning includes processes to maximize P-E fit (e.g., assessing&#xD;
      everyday competence, setting resident-directed goals around rehabilitation needs, and&#xD;
      developing care plans to transition the Veteran to the community whenever possible).&#xD;
&#xD;
      The investigators' team has developed an instrument to allow providers to assess everyday&#xD;
      competence for safe and independent living in the community. However, to ensure successful&#xD;
      transitions, assessing everyday competence without intervention is not sufficient. Once CLC&#xD;
      interdisciplinary team members have an understanding of the resident's everyday competence&#xD;
      and barriers to transition, goal-setting must occur, focused on rehabilitation goals and care&#xD;
      planning around transitioning to the community.&#xD;
&#xD;
      The objective of the proposed research is to develop an effective and feasible toolkit the&#xD;
      CLC interdisciplinary team can use to 1) assess the Veteran's everyday competence for safe&#xD;
      and independent living; 2) develop personally meaningful rehabilitation goals that facilitate&#xD;
      successful transition out of the CLC based on everyday competence; and 3) conduct structured&#xD;
      care planning to support resident goals around transitioning back into the community. With&#xD;
      the innovative consideration of everyday competence and goal-setting in this context,&#xD;
      Veterans will have optimal P-E fit upon returning to the community, thus ensuring a&#xD;
      successful transition outcome (i.e., not readmitted to the CLC within 90 days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to issues with the study, we did not proceed with enrolling participants in the trial.&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transition Outcome</measure>
    <time_frame>90 days post-discharge</time_frame>
    <description>The primary outcome of interest for this pilot study will be transition outcome. Transitions will be &quot;successful&quot; if the resident leaves the CLC with a &quot;community&quot; destination and is not readmitted to the CLC within 90 days. For the purposes of this study, transitions to the &quot;community&quot; include any non-institutional environment that is more independent than the CLCs (e.g., single-family home, senior apartment, assisted living, medical foster home, etc.). For individuals who are unable to transition or who transition and are readmitted to the CLC within 90 days, these transitions will be &quot;unsuccessful&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Goal Attainment Scaling</measure>
    <time_frame>Baseline</time_frame>
    <description>An important outcome for participants at the intervention sites will be Goal Attainment Scaling64, which will allow us to identify if the resident was able to achieve the transition goals within the planned timeframe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multilevel Assessment Instrument - Environment Scale [MAI-ES]</measure>
    <time_frame>Baseline and 90 days</time_frame>
    <description>Measures person-environment fit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multilevel Assessment Instrument - Environment Scale [MAI-ES]</measure>
    <time_frame>90 days</time_frame>
    <description>Measures person-environment fit. Will be assessed at baseline and 90 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multilevel Assessment Instrument - Environment Scale</measure>
    <time_frame>Baseline and 90 days post discharge</time_frame>
    <description>Measures person-environment fit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Money Follows the Person - Quality of Life Scale</measure>
    <time_frame>Baseline and 90 days post discharge</time_frame>
    <description>Measures quality of life for individuals moving from a nursing home to the community.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Care Transitions Measure - 3</measure>
    <time_frame>Baseline and 90 days post discharge</time_frame>
    <description>Measures individual's preparation for transitioning out of a health care facility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale - Residential</measure>
    <time_frame>Baseline and 90 days post discharge</time_frame>
    <description>Measure of depression for older adults residing in residential care facilities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in CLC</measure>
    <time_frame>30 days and 90 days post discharge</time_frame>
    <description>Length of stay in the clc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Services Utilization</measure>
    <time_frame>30 days and 90 days post discharge</time_frame>
    <description>Identify health services (e.g., hospital admission, ER visit, etc.) utilization following transition from CLC.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Aged</condition>
  <condition>Frail Elderly</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals who want to leave the CLC will be allowed to participate in the study, there will be no assignment to groups. Individuals who want to leave the CLC will undergo transition care planning using the investigators' standardized toolkit. The investigators will compare outcomes to administrative data from other similar VA nursing homes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Everyday Competence Assessment and Planning for Community Transitions</intervention_name>
    <description>The Everyday Competence Assessment and Planning for Community Transitions (ECAP-CT) toolkit will allow CLC interdisciplinary team members to 1) assess the Veteran's everyday competence for safe and independent living; 2) develop personally meaningful rehabilitation goals that facilitate successful transition out of the CLC based on everyday competence; and 3) conduct structured treatment planning to support resident goals around transitioning back into the community. By considering everyday competence and goal-setting in this context, Veterans will have optimal P-E fit upon returning to the community, ensuring a successful transition.</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>ECAP - CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CLC residents will be included if they are able to demonstrate understanding of the&#xD;
             informed consent process through teach-back and to communicate verbally.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CLC residents will be excluded if they are too cognitively impaired or have serious&#xD;
             mental illness too severe to meaningfully participate in interviews (i.e., they are&#xD;
             not &quot;transition-capable&quot;).&#xD;
&#xD;
          -  No participants will be excluded based on gender, race, social class, or ethnicity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Whitney L. Mills, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Providence VA Medical Center, Providence, RI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Providence VA Medical Center, Providence, RI</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael E. DeBakey VA Medical Center, Houston, TX</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>April 8, 2020</last_update_submitted>
  <last_update_submitted_qc>April 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Nursing Homes</keyword>
  <keyword>Housing for the Elderly</keyword>
  <keyword>Homes for the Aged</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/NCT02211274
org study id: D1241-W
nct id: NCT02211274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Older adults prefer to live as in the community as long as possible. Creating a standardized
      treatment planning process that includes assessments of everyday competence and goal-setting
      techniques to help Veterans move from VA nursing homes back to the community can improve
      functional health, well-being, and quality of life for older Veterans. Research has shown
      that 29% of nursing home residents might be able to live safely in the community instead.
      Currently, VA provides nursing home care to more than 13,000 Veterans across the country,
      which costs about $3.3 billion a year. It is expensive for VA to provide nursing home care to
      these inappropriate residents and they are using limited resources that could be given to
      another Veteran with more urgent needs. The Everyday Competence Assessment and Planning for
      Community Transitions (ECAP-CT) toolkit will help these Veterans to move back into the
      community with the services and supports they need based on their individual level of
      everyday competence.
Up to 29% of Community Living Center (CLC; VA nursing homes) residents may not require
      nursing home levels of care and could successfully reside in the community with appropriate
      rehabilitative services. Many older adults prefer to remain in their homes, though living
      independently in the community is not always possible or safe. According to the model of
      person-environment fit (P-E fit), older adults are at risk for poor outcomes when the demands
      and resources available in the living environment are not in balance with the individual's
      everyday competence (the ability to solve problems associated with everyday life).
      Community-dwelling older adults with low levels of everyday competence and little support are
      at risk for nursing home transition. Conversely, older adults with higher levels of everyday
      competence who live in more restrictive environments (e.g., nursing home) may experience
      declines in functioning resulting from a lack of stimulation. Often, transitions into nursing
      homes occur during a time of crisis (e.g., after acute hospital stay), leaving little
      opportunity for appropriate consideration of the individual's current and future level of
      everyday competence.

      In VA, a major focus is to minimize the time spent in the CLCs by providing rehabilitation
      services and transitioning Veterans back into the community. The mission for the CLC program
      is to return the Veteran to his or her highest level of well-being, thus maximizing P-E fit.
      Despite this, CLC staff and Veterans face many barriers to facilitating transitions to the
      community (e.g., caregiving needs, housing, etc.). Currently no standardized process exists
      to assure that treatment planning includes processes to maximize P-E fit (e.g., assessing
      everyday competence, setting resident-directed goals around rehabilitation needs, and
      developing care plans to transition the Veteran to the community whenever possible).

      The investigators' team has developed an instrument to allow providers to assess everyday
      competence for safe and independent living in the community. However, to ensure successful
      transitions, assessing everyday competence without intervention is not sufficient. Once CLC
      interdisciplinary team members have an understanding of the resident's everyday competence
      and barriers to transition, goal-setting must occur, focused on rehabilitation goals and care
      planning around transitioning to the community.

      The objective of the proposed research is to develop an effective and feasible toolkit the
      CLC interdisciplinary team can use to 1) assess the Veteran's everyday competence for safe
      and independent living; 2) develop personally meaningful rehabilitation goals that facilitate
      successful transition out of the CLC based on everyday competence; and 3) conduct structured
      care planning to support resident goals around transitioning back into the community. With
      the innovative consideration of everyday competence and goal-setting in this context,
      Veterans will have optimal P-E fit upon returning to the community, thus ensuring a
      successful transition outcome (i.e., not readmitted to the CLC within 90 days).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Transition Outcome
time frame: 90 days post-discharge
description: The primary outcome of interest for this pilot study will be transition outcome. Transitions will be "successful" if the resident leaves the CLC with a "community" destination and is not readmitted to the CLC within 90 days. For the purposes of this study, transitions to the "community" include any non-institutional environment that is more independent than the CLCs (e.g., single-family home, senior apartment, assisted living, medical foster home, etc.). For individuals who are unable to transition or who transition and are readmitted to the CLC within 90 days, these transitions will be "unsuccessful".
measure: Goal Attainment Scaling
time frame: Baseline
description: An important outcome for participants at the intervention sites will be Goal Attainment Scaling64, which will allow us to identify if the resident was able to achieve the transition goals within the planned timeframe.
measure: Multilevel Assessment Instrument - Environment Scale [MAI-ES]
time frame: Baseline and 90 days
description: Measures person-environment fit
measure: Multilevel Assessment Instrument - Environment Scale [MAI-ES]
time frame: 90 days
description: Measures person-environment fit. Will be assessed at baseline and 90 days.
measure: Multilevel Assessment Instrument - Environment Scale
time frame: Baseline and 90 days post discharge
description: Measures person-environment fit.
measure: Money Follows the Person - Quality of Life Scale
time frame: Baseline and 90 days post discharge
description: Measures quality of life for individuals moving from a nursing home to the community.
measure: Care Transitions Measure - 3
time frame: Baseline and 90 days post discharge
description: Measures individual's preparation for transitioning out of a health care facility.
measure: Geriatric Depression Scale - Residential
time frame: Baseline and 90 days post discharge
description: Measure of depression for older adults residing in residential care facilities.
measure: Length of Stay in CLC
time frame: 30 days and 90 days post discharge
description: Length of stay in the clc
measure: Health Services Utilization
time frame: 30 days and 90 days post discharge
description: Identify health services (e.g., hospital admission, ER visit, etc.) utilization following transition from CLC.
arm group label: Study Group
arm group type: Experimental
description: Individuals who want to leave the CLC will be allowed to participate in the study, there will be no assignment to groups. Individuals who want to leave the CLC will undergo transition care planning using the investigators' standardized toolkit. The investigators will compare outcomes to administrative data from other similar VA nursing homes.
intervention type: Other
intervention name: Everyday Competence Assessment and Planning for Community Transitions
description: The Everyday Competence Assessment and Planning for Community Transitions (ECAP-CT) toolkit will allow CLC interdisciplinary team members to 1) assess the Veteran's everyday competence for safe and independent living; 2) develop personally meaningful rehabilitation goals that facilitate successful transition out of the CLC based on everyday competence; and 3) conduct structured treatment planning to support resident goals around transitioning back into the community. By considering everyday competence and goal-setting in this context, Veterans will have optimal P-E fit upon returning to the community, ensuring a successful transition.
arm group label: Study Group
other name: ECAP - CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Whitney L. Mills, PhD
role: Principal Investigator
affiliation: Providence VA Medical Center, Providence, RI
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No