<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/NCT03014570</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00069354</org_study_id>
    <nct_id>NCT03014570</nct_id>
  </id_info>
  <brief_title>Testing the Implementation of EIT-4-BPSD</brief_title>
  <acronym>EIT-4_BPSD</acronym>
  <official_title>Testing the Implementation of EIT-4-BPSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pragmatic trial focuses on implementation of an evidence based process to increase&#xD;
      person-centered management of behavioral and psychological symptoms of dementia (BPSD) in&#xD;
      nursing homes, referred to as EIT-4-BPSD. The findings from this study will add to what is&#xD;
      known about implementation of effective interventions in nursing homes, will serve as a model&#xD;
      for other programs and care approaches, and will help facilities and staff implement quality&#xD;
      person-centered care, which is the goal of the National Partnership to Improve Dementia Care&#xD;
      and Reduce Antipsychotic Use in Nursing Homes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavioral and Psychological Symptoms of Dementia (BPSD) include aggression, agitation,&#xD;
      depression, anxiety, apathy and hallucinations and are exhibited by up to 90% of nursing&#xD;
      facility residents with dementia. BPSD result in negative health outcomes decline in physical&#xD;
      functioning and high cost of care. In addition, BPSD put residents at risk for inappropriate&#xD;
      use of antipsychotic drugs and other restraining methods that reduce function, increase&#xD;
      social isolation, and increase risk of physical abuse. Prior NIH-funded clinical trials show&#xD;
      that behavioral approaches reduce BPSD. These behavioral approaches are endorsed as the first&#xD;
      line of treatment for BPSD. In fact, the Centers for Medicare and Medicaid Services (CMS)&#xD;
      National Partnership to Improve Dementia Care and Reduce Antipsychotic Use in Nursing Homes&#xD;
      requires that care for residents with dementia be delivered using person-centered behavioral&#xD;
      approaches. Despite regulatory requirements, less than 2% of nursing homes (also referred to&#xD;
      as facilities) consistently implement these approaches. Established barriers to use of&#xD;
      behavioral approaches include limited knowledge, skills, and experience with&#xD;
      non-pharmacological approaches, beliefs in the superiority of psychotropic medications over&#xD;
      behavioral interventions, and lack of staff motivation to use non-pharmacologic strategies&#xD;
      consistently. The proposed project responds to this gap between knowledge and practice. A&#xD;
      novel implementation approach will be tested to assure that staff in nursing homes [i.e.,&#xD;
      those who provide direct care to residents] use non-pharmacologic, behavioral approaches for&#xD;
      the management of BPSD.&#xD;
&#xD;
      To advance the CMS National Partnership, a comprehensive compendium of&#xD;
      peer-reviewed/expert-endorsed resources was developed for utilizing person-centered,&#xD;
      behavioral approaches for BPSD (the Nursing Home Toolkit: www.nursinghometoolkit.com). The&#xD;
      Toolkit has resources that support a theoretically-based 4-step approach that we found&#xD;
      effective in prior implementation work. The four steps include: 1. Assessment of the&#xD;
      environment and policies; 2. Education of staff; 3. Establishing person-centered care plans;&#xD;
      and 4. Mentoring and motivating staff. While the Toolkit is free and accessible, staff in&#xD;
      nursing homes need help with implementation. Implementation of the theoretically based 4-step&#xD;
      approach is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings&#xD;
      together evidence and key stakeholders from the facility to influence care practices. EIT&#xD;
      includes: participatory implementation processes, provision of practical evidence-based&#xD;
      interventions, and pragmatic measures of progress toward goals. This implementation framework&#xD;
      was merged with the 4-step approach and the Nursing Home Toolkit resources to develop the&#xD;
      intervention, EIT-4-BPSD. The goal is to demonstrate that EIT-4-BPSD is an implementation&#xD;
      strategy that enables staff in nursing homes to reduce BPSD using behavioral approaches while&#xD;
      optimizing function, preventing adverse events and improving quality of life of residents. A&#xD;
      Hybrid III cluster randomized trial will be done with 50 nursing facilities randomized to&#xD;
      EIT-4-BPSD or Education Only (EO). The aims are:&#xD;
&#xD;
      Primary Aim 1: To implement and test the implementation of EIT-4-BPSD. Facility Level&#xD;
      Outcome: Research question: Do facilities exposed to EIT-4-BPSD demonstrate evidence of&#xD;
      implementation at 12 months evaluated by the Reach, Effectiveness, Adoption, Implementation,&#xD;
      and Maintenance (RE-AIM) criteria? For evaluation of Effectiveness within RE-AIM: Resident&#xD;
      Level Outcomes: Hypothesis: Residents in EIT-4-BPSD facilities will experience less BPSD,&#xD;
      maintain or improve function, have reduced use of psychotropic medications, experience fewer&#xD;
      adverse events, and have improved quality of life compared to residents in EO facilities. We&#xD;
      will measure these outcomes at baseline, 4 and 12 months post implementation of the&#xD;
      intervention. Facility Level Outcomes: Hypotheses: (1) EIT-4-BPSD facilities will demonstrate&#xD;
      improvements in Environment and Policy assessments that reflect support for behavioral&#xD;
      approaches for BPSD, and will have a greater percentage of residents with behavioral&#xD;
      approaches incorporated into their care plans at 12 months post-implementation when compared&#xD;
      to EO facilities; (2) We will examine Maintenance of EIT-4-BPSD facility outcomes at 12&#xD;
      months and then at 24 months post-implementation.&#xD;
&#xD;
      Primary Aim 2: Evaluation of the Feasibility, Utility and Cost of EIT Approach in EIT-4-BPSD&#xD;
      Facilities. Using descriptive and qualitative data captured during the intervention and from&#xD;
      focus groups at 12 months,use of the EIT strategy and the participatory implementation&#xD;
      process with the Stakeholder Team and facility staff will be evaluated. In addition a&#xD;
      description of the costs of implementation using an activity-based costing method will be&#xD;
      completed.&#xD;
&#xD;
      This study will add critical knowledge to what little is known about implementation of&#xD;
      effective interventions in nursing facilities. It will serve as an implementation model with&#xD;
      potential to be widely disseminated. In addition, the study will demonstrate how facilities&#xD;
      can implement person-centered dementia care and decrease BPSD, the ultimate goal of the CMS&#xD;
      National Partnership.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Function as Determined by Barthel Index</measure>
    <time_frame>Baseline, 4 months and 12 months</time_frame>
    <description>The Barthel index has a score range of 0-100 with higher scores indicating higher physical function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression as Determined by the Cornell Scale for Depression in Dementia</measure>
    <time_frame>Baseline, 4 months, 12 months</time_frame>
    <description>The Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)</measure>
    <time_frame>Baseline, 4 months, 12 months</time_frame>
    <description>The CMAI score ranges from 0-70 with higher scores indicating more agitation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">553</enrollment>
  <condition>Dementia</condition>
  <condition>Behavioral and Psychological Symptoms of Dementia (BPSD)</condition>
  <arm_group>
    <arm_group_label>Education-Only Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EIT-4-BPSD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EIT-4-BPSD</intervention_name>
    <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.</description>
    <arm_group_label>EIT-4-BPSD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education-only Control</intervention_name>
    <description>This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.</description>
    <arm_group_label>Education-Only Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Living in the nursing home; 55 years of age or older; score 0-12 on the Brief Interview of&#xD;
        Mental Status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrolled in hospice&#xD;
&#xD;
          -  in the nursing home for short stay rehabilitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>January 27, 2022</results_first_submitted>
  <results_first_submitted_qc>March 5, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2023</results_first_posted>
  <last_update_submitted>March 5, 2023</last_update_submitted>
  <last_update_submitted_qc>March 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Barbara Resnick</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>behavior,</keyword>
  <keyword>apathy</keyword>
  <keyword>mood</keyword>
  <keyword>function</keyword>
  <keyword>cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 23, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03014570/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03014570/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>There were 553 residents enrolled into the study from 55 care communities from Maryland and Pennsylvania .</recruitment_details>
      <pre_assignment_details>there were no significant events prior to the implementation of the study. No one was excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Education-Only Control</title>
          <description>This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention).&#xD;
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.&#xD;
There were 27 sites randomized to control which included 248 participants.</description>
        </group>
        <group group_id="P2">
          <title>EIT-4-BPSD</title>
          <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.&#xD;
There were 28 sites randomized to treatment which included 305 participants.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="248">All of the intervention activities have been completed the date of completion was March 2020</participants>
                <participants group_id="P2" count="305">all of the intervention activities have been completed. the date of completion was march 2020</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123">All intervention activities were completed March 2020.</participants>
                <participants group_id="P2" count="174">all intervention activities were completed march 2020</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="131"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>COVID-19 Restrictions</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transfer from facility</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hospitalized</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transfer within facility</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site refusal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Education-Only Control</title>
          <description>This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.&#xD;
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.</description>
        </group>
        <group group_id="B2">
          <title>EIT-4-BPSD</title>
          <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="248"/>
            <count group_id="B2" value="305"/>
            <count group_id="B3" value="553"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="248"/>
                    <measurement group_id="B2" value="305"/>
                    <measurement group_id="B3" value="553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years of age</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84" spread="10"/>
                    <measurement group_id="B2" value="82" spread="7"/>
                    <measurement group_id="B3" value="83" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="225"/>
                    <measurement group_id="B3" value="398"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="222"/>
                    <measurement group_id="B3" value="419"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="248"/>
                    <measurement group_id="B2" value="305"/>
                    <measurement group_id="B3" value="553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Physical Function as Determined by Barthel Index</title>
        <description>The Barthel index has a score range of 0-100 with higher scores indicating higher physical function</description>
        <time_frame>Baseline, 4 months and 12 months</time_frame>
        <population>Older adults in nursing analysis was a repeated measures</population>
        <group_list>
          <group group_id="O1">
            <title>Education-Only Control</title>
            <description>This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.&#xD;
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.</description>
          </group>
          <group group_id="O2">
            <title>EIT-4-BPSD</title>
            <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Function as Determined by Barthel Index</title>
          <description>The Barthel index has a score range of 0-100 with higher scores indicating higher physical function</description>
          <population>Older adults in nursing analysis was a repeated measures</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.82" spread="27.75"/>
                    <measurement group_id="O2" value="31.36" spread="26.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.63" spread="30.33"/>
                    <measurement group_id="O2" value="33.93" spread="28.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.52" spread="30.72"/>
                    <measurement group_id="O2" value="36.56" spread="29.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Depression as Determined by the Cornell Scale for Depression in Dementia</title>
        <description>The Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms</description>
        <time_frame>Baseline, 4 months, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Education-Only Control</title>
            <description>This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.&#xD;
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.</description>
          </group>
          <group group_id="O2">
            <title>EIT-4-BPSD</title>
            <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression as Determined by the Cornell Scale for Depression in Dementia</title>
          <description>The Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72" spread="2.5"/>
                    <measurement group_id="O2" value="1.86" spread="3.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="4.58"/>
                    <measurement group_id="O2" value="3.81" spread="4.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="4.57"/>
                    <measurement group_id="O2" value="4.39" spread="3.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)</title>
        <description>The CMAI score ranges from 0-70 with higher scores indicating more agitation</description>
        <time_frame>Baseline, 4 months, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Education-Only Control</title>
            <description>This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.&#xD;
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.</description>
          </group>
          <group group_id="O2">
            <title>EIT-4-BPSD</title>
            <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps.&#xD;
EIT-4-BPSD: This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps.</description>
          </group>
        </group_list>
        <measure>
          <title>Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)</title>
          <description>The CMAI score ranges from 0-70 with higher scores indicating more agitation</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.42" spread="7.73"/>
                    <measurement group_id="O2" value="19.68" spread="6.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.54" spread="7.74"/>
                    <measurement group_id="O2" value="20.24" spread="7.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.66" spread="8.34"/>
                    <measurement group_id="O2" value="21.32" spread="8.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over 12 months</time_frame>
      <desc>There were no adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Education-Only Control</title>
          <description>This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.&#xD;
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.</description>
        </group>
        <group group_id="E2">
          <title>EIT-4-BPSD</title>
          <description>This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="79" subjects_at_risk="305"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="305"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="305"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Barbara Resnick PhD, CRNP Professor and PI among MPIs of the trial</name_or_title>
      <organization>University of Maryland School of Nursing</organization>
      <phone>410 706 5178</phone>
      <email>resnick@umaryland.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03014570
org study id: HP-00069354
nct id: NCT03014570
lead sponsor: 
collaborator: 
has dmc: Yes
This pragmatic trial focuses on implementation of an evidence based process to increase
      person-centered management of behavioral and psychological symptoms of dementia (BPSD) in
      nursing homes, referred to as EIT-4-BPSD. The findings from this study will add to what is
      known about implementation of effective interventions in nursing homes, will serve as a model
      for other programs and care approaches, and will help facilities and staff implement quality
      person-centered care, which is the goal of the National Partnership to Improve Dementia Care
      and Reduce Antipsychotic Use in Nursing Homes.
Behavioral and Psychological Symptoms of Dementia (BPSD) include aggression, agitation,
      depression, anxiety, apathy and hallucinations and are exhibited by up to 90% of nursing
      facility residents with dementia. BPSD result in negative health outcomes decline in physical
      functioning and high cost of care. In addition, BPSD put residents at risk for inappropriate
      use of antipsychotic drugs and other restraining methods that reduce function, increase
      social isolation, and increase risk of physical abuse. Prior NIH-funded clinical trials show
      that behavioral approaches reduce BPSD. These behavioral approaches are endorsed as the first
      line of treatment for BPSD. In fact, the Centers for Medicare and Medicaid Services (CMS)
      National Partnership to Improve Dementia Care and Reduce Antipsychotic Use in Nursing Homes
      requires that care for residents with dementia be delivered using person-centered behavioral
      approaches. Despite regulatory requirements, less than 2% of nursing homes (also referred to
      as facilities) consistently implement these approaches. Established barriers to use of
      behavioral approaches include limited knowledge, skills, and experience with
      non-pharmacological approaches, beliefs in the superiority of psychotropic medications over
      behavioral interventions, and lack of staff motivation to use non-pharmacologic strategies
      consistently. The proposed project responds to this gap between knowledge and practice. A
      novel implementation approach will be tested to assure that staff in nursing homes [i.e.,
      those who provide direct care to residents] use non-pharmacologic, behavioral approaches for
      the management of BPSD.

      To advance the CMS National Partnership, a comprehensive compendium of
      peer-reviewed/expert-endorsed resources was developed for utilizing person-centered,
      behavioral approaches for BPSD (the Nursing Home Toolkit: www.nursinghometoolkit.com). The
      Toolkit has resources that support a theoretically-based 4-step approach that we found
      effective in prior implementation work. The four steps include: 1. Assessment of the
      environment and policies; 2. Education of staff; 3. Establishing person-centered care plans;
      and 4. Mentoring and motivating staff. While the Toolkit is free and accessible, staff in
      nursing homes need help with implementation. Implementation of the theoretically based 4-step
      approach is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings
      together evidence and key stakeholders from the facility to influence care practices. EIT
      includes: participatory implementation processes, provision of practical evidence-based
      interventions, and pragmatic measures of progress toward goals. This implementation framework
      was merged with the 4-step approach and the Nursing Home Toolkit resources to develop the
      intervention, EIT-4-BPSD. The goal is to demonstrate that EIT-4-BPSD is an implementation
      strategy that enables staff in nursing homes to reduce BPSD using behavioral approaches while
      optimizing function, preventing adverse events and improving quality of life of residents. A
      Hybrid III cluster randomized trial will be done with 50 nursing facilities randomized to
      EIT-4-BPSD or Education Only (EO). The aims are:

      Primary Aim 1: To implement and test the implementation of EIT-4-BPSD. Facility Level
      Outcome: Research question: Do facilities exposed to EIT-4-BPSD demonstrate evidence of
      implementation at 12 months evaluated by the Reach, Effectiveness, Adoption, Implementation,
      and Maintenance (RE-AIM) criteria? For evaluation of Effectiveness within RE-AIM: Resident
      Level Outcomes: Hypothesis: Residents in EIT-4-BPSD facilities will experience less BPSD,
      maintain or improve function, have reduced use of psychotropic medications, experience fewer
      adverse events, and have improved quality of life compared to residents in EO facilities. We
      will measure these outcomes at baseline, 4 and 12 months post implementation of the
      intervention. Facility Level Outcomes: Hypotheses: (1) EIT-4-BPSD facilities will demonstrate
      improvements in Environment and Policy assessments that reflect support for behavioral
      approaches for BPSD, and will have a greater percentage of residents with behavioral
      approaches incorporated into their care plans at 12 months post-implementation when compared
      to EO facilities; (2) We will examine Maintenance of EIT-4-BPSD facility outcomes at 12
      months and then at 24 months post-implementation.

      Primary Aim 2: Evaluation of the Feasibility, Utility and Cost of EIT Approach in EIT-4-BPSD
      Facilities. Using descriptive and qualitative data captured during the intervention and from
      focus groups at 12 months,use of the EIT strategy and the participatory implementation
      process with the Stakeholder Team and facility staff will be evaluated. In addition a
      description of the costs of implementation using an activity-based costing method will be
      completed.

      This study will add critical knowledge to what little is known about implementation of
      effective interventions in nursing facilities. It will serve as an implementation model with
      potential to be widely disseminated. In addition, the study will demonstrate how facilities
      can implement person-centered dementia care and decrease BPSD, the ultimate goal of the CMS
      National Partnership.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Physical Function as Determined by Barthel Index
time frame: Baseline, 4 months and 12 months
description: The Barthel index has a score range of 0-100 with higher scores indicating higher physical function
measure: Depression as Determined by the Cornell Scale for Depression in Dementia
time frame: Baseline, 4 months, 12 months
description: The Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms
measure: Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)
time frame: Baseline, 4 months, 12 months
description: The CMAI score ranges from 0-70 with higher scores indicating more agitation
arm group label: Education-Only Control
arm group type: Active Comparator
description: This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.
arm group label: EIT-4-BPSD
arm group type: Experimental
description: This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
intervention type: Behavioral
intervention name: EIT-4-BPSD
description: This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
arm group label: EIT-4-BPSD
intervention type: Behavioral
intervention name: Education-only Control
description: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
arm group label: Education-Only Control
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Barbara Resnick
investigator title: Professor
mesh term: Dementia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 