<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/NCT04481568</url>
  </required_header>
  <id_info>
    <org_study_id>19-0800-FIMR-1</org_study_id>
    <secondary_id>1R21NR018500-01</secondary_id>
    <nct_id>NCT04481568</nct_id>
  </id_info>
  <brief_title>Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1)</brief_title>
  <official_title>Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Persons with Alzheimer's Disease and Related Dementias (ADRD) account for 3.2 million&#xD;
      hospital admissions per year and have over three times more hospitalizations than those&#xD;
      without cognitive impairment, yet hospital caregivers (HCGs) are ill-prepared to manage&#xD;
      patients with ADRD with less than 5% reporting mandatory dementia care training.&#xD;
      Three-quarters of hospitalized persons with ADRD display Behavioral and Psychological&#xD;
      Symptoms of Dementia (BPSD) associated with functional and cognitive decline, increased&#xD;
      resource consumption, institutionalization, premature death, and caregiver burden. The&#xD;
      overall objective is to test the preliminary efficacy of an innovative model of care,&#xD;
      PES-4-BPSD, for reducing BPSD by empowering Patient Engagement Specialists (PES) to deliver&#xD;
      dementia care for acutely-ill patients with ADRD. Traditionally, mental health assistants&#xD;
      with training in crisis-prevention techniques provide care to psychiatric patients. On the&#xD;
      intervention unit, these mental health assistants, as PES, purposefully engage patients with&#xD;
      BPSD. In the pilot study, investigators found patients with cognitive impairment admitted to&#xD;
      the PES unit were significantly less likely to require constant observation, chemical and&#xD;
      physical restraints, suggesting improved management of BPSD. The central hypothesis is that&#xD;
      PES-4-BPSD will improve the ability of PES to create an &quot;enabling&quot; milieu that addresses&#xD;
      factors leading to BPSD and improves the experience of hospital caregivers. Guided by a&#xD;
      social-ecological framework, PES-4-BPSD incorporates dementia education and training,&#xD;
      environmental modifications-cohorting, increased staffing-PES, and staff support. The&#xD;
      investigators' multidisciplinary research team is well-positioned to accomplish the&#xD;
      following: Aim 1) Determine the preliminary efficacy of PES-4-BPSD for reducing BPSD during&#xD;
      hospitalization, and Aim 2) Evaluate whether dementia care training improves the perceived&#xD;
      ability of PES staff (intervention) and nurse assistant staff (control) to care for&#xD;
      hospitalized persons with ADRD. For Aim 1, investigators will conduct a non-randomized&#xD;
      preliminary efficacy trial of the PES-4-BPSD intervention enrolling N=158 patients (79&#xD;
      control, 79 intervention). The primary outcome will be presence of BPSD during&#xD;
      hospitalization using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). In Aim 2,&#xD;
      investigators will use survey methodology in a repeated measures design to evaluate within&#xD;
      and between-group differences in attitudes, experience, and satisfaction toward managing&#xD;
      patients with ADRD. Measures will be completed at baseline (T1), immediately following&#xD;
      training (T2), and at the end of the intervention period (T3). This proposal will be the&#xD;
      first to study an innovative model of care utilizing PES as specialized hospital caregivers&#xD;
      for reducing BPSD in the hospital setting. The investigators' findings will lay the essential&#xD;
      groundwork for a multi-site trial of PES-4-BPSD and inform the development of a program that&#xD;
      can be easily implemented in other hospitals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to patient recruitment, a 3 month dementia training program will be implemented on both&#xD;
      the intervention and control units. On the intervention unit, training will target the&#xD;
      Patient Engagement Specialists (PES) and on the control to the nurse assistants (please refer&#xD;
      to NCT# 04179721 for more details on this aim). Following the implementation of the dementia&#xD;
      care training, eligible patients will be offered the opportunity to participate in the study.&#xD;
      A research coordinator will offer the information and opportunity to participate to the&#xD;
      patient's lawful caregiver. The signed consent forms will be stored in secured file cabinets.&#xD;
      Once a participant has been enrolled in the study, demographic information will be obtained&#xD;
      from the electronic medical records (EMR) and verified by Family Caregiver (FCG), including:&#xD;
      age, gender, race/ethnicity, marital status, education, work status, current living&#xD;
      situation, medical comorbidities, and reason for admission. A member of the research team&#xD;
      will conduct a short interview with the FCG to verify patient background information and&#xD;
      obtain baseline (1 month prior to admission) functional status (Barthel Index), dementia&#xD;
      severity cognitive (Clinical Dementia Rating Scale)(5 stages of severity: no 0, questionable&#xD;
      0.5, mild 1, moderate 2, and severe 3), and behavioral symptoms using the Neuropsychiatric&#xD;
      Inventory-Clinical version NPI-C.&#xD;
&#xD;
      A member of the research team will then complete daily NPI-Qs to determine the number of&#xD;
      behaviors and symptoms for each patient on a daily basis. The data collector will use a&#xD;
      multimodal approach drawing from electronic medical record (EMR) notes and interviews with&#xD;
      nursing staff regarding the patient's behavior and treatment over the past 24 hours. Delirium&#xD;
      will be assessed daily by the research coordinator using same multimodal approach and during&#xD;
      the time of NPI observation. A final EMR chart review will be conducted collecting&#xD;
      information such as length of stay, discharge disposition, in-hospital mortality as well as&#xD;
      total usage practices for management of BPSD: use of special observation (1:1 or enhanced),&#xD;
      restraints, psychoactive medications, psychiatric evaluation. Within 48 hours of discharge,&#xD;
      family caregivers will be interviewed regarding satisfaction with care using the Carer&#xD;
      Questionnaire Data from the National Audit of Dementia Round 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2020</start_date>
  <completion_date type="Actual">December 29, 2021</completion_date>
  <primary_completion_date type="Actual">December 29, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Nonrandom preliminary efficacy trial comparing 2 groups, intervention and control</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropsychiatric Inventory Questionnaire Average Score During Hospital Admission</measure>
    <time_frame>Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study</time_frame>
    <description>The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal approach, consisting of daily NPI-Q interviews with Hospital Caregivers and daily reviews of the patient's medical record, to provide a daily assessment of the 12 NPI-Q domains during hospitalization. Upon discharge, the average of each patient's daily NPI-Q total scores will be calculated, and this average will serve as the primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study</time_frame>
    <description>Collected via chart review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Practices for the Management of BPSD</measure>
    <time_frame>Outcomes vary by participant; will be assessed through duration of study for 1 year</time_frame>
    <description>Collected via chart review. Practices include orders placed for special observation (1:1 or enhanced), restraints, psychoactive medications, psychiatric evaluation, as well as adverse events (falls). Orders for constant observation are reported below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Caregiver (FCG) Satisfaction</measure>
    <time_frame>Collected within 48 hours of hospital discharge for the 1-year study duration</time_frame>
    <description>FCGs will be interviewed by research coordinator with a one-time telephone survey within 48 hours of discharge using the UK National Audit of Dementia Round 3, Caregiver Questionnaire. The survey consists of 10 items assessing perceptions of hospital quality of care provided by hospital staff. Responses of &quot;Excellent&quot; to the primary question assessed, &quot;overall, how would you rate the care received by your loved one during their hospital stay?&quot; is reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Alzheimer's Disease and Related Dementias</condition>
  <arm_group>
    <arm_group_label>The PES-4-BPSD Model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The attention control condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PES-4-BPSD Model</intervention_name>
    <description>We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
    <arm_group_label>The PES-4-BPSD Model</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The attention control condition</intervention_name>
    <description>On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</description>
    <arm_group_label>The attention control condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients who have an acute medical admission to either the control unit (Geriatric&#xD;
             Care Model) or intervention unit (PES-4-BPSD).&#xD;
&#xD;
          -  Patients age 65 and above&#xD;
&#xD;
          -  Documentation of dementia in the medical record (based on the International&#xD;
             Classification of Diseases, Ninth and Tenth Revision codes [ICD-9 and ICD-10])&#xD;
&#xD;
          -  AD8 score of 2 or greater (obtained from the family caregiver [FCG])&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are known to be terminally ill and/or receiving hospice or surgery&#xD;
&#xD;
          -  Patients with a length of stay of less than 48 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liron Sinvani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>Glen Oaks</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT04179721</url>
    <description>Please refer to NCT# 04179721 for more details on Aim 2: Hospital Caregivers</description>
  </link>
  <reference>
    <citation>Sampson EL, White N, Leurent B, Scott S, Lord K, Round J, Jones L. Behavioural and psychiatric symptoms in people with dementia admitted to the acute hospital: prospective cohort study. Br J Psychiatry. 2014 Sep;205(3):189-96. doi: 10.1192/bjp.bp.113.130948. Epub 2014 Jul 24.</citation>
    <PMID>25061120</PMID>
  </reference>
  <reference>
    <citation>Hessler JB, Schaufele M, Hendlmeier I, Junge MN, Leonhardt S, Weber J, Bickel H. Behavioural and psychological symptoms in general hospital patients with dementia, distress for nursing staff and complications in care: results of the General Hospital Study. Epidemiol Psychiatr Sci. 2018 Jun;27(3):278-287. doi: 10.1017/S2045796016001098. Epub 2017 Jan 9.</citation>
    <PMID>28065176</PMID>
  </reference>
  <reference>
    <citation>Astrom S, Nilsson M, Norberg A, Sandman PO, Winblad B. Staff burnout in dementia care--relations to empathy and attitudes. Int J Nurs Stud. 1991;28(1):65-75. doi: 10.1016/0020-7489(91)90051-4.</citation>
    <PMID>1856035</PMID>
  </reference>
  <reference>
    <citation>Dewing J, Dijk S. What is the current state of care for older people with dementia in general hospitals? A literature review. Dementia (London). 2016 Jan;15(1):106-24. doi: 10.1177/1471301213520172. Epub 2014 Jan 23.</citation>
    <PMID>24459188</PMID>
  </reference>
  <reference>
    <citation>Lintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. [PhD Thesis]. Prifysgol Bangor University; 2001</citation>
  </reference>
  <reference>
    <citation>Scerri A, Innes A, Scerri C. Dementia training programmes for staff working in general hospital settings - a systematic review of the literature. Aging Ment Health. 2017 Aug;21(8):783-796. doi: 10.1080/13607863.2016.1231170. Epub 2016 Sep 23.</citation>
    <PMID>27662075</PMID>
  </reference>
  <results_reference>
    <citation>Sinvani L, Warner-Cohen J, Strunk A, Halbert T, Harisingani R, Mulvany C, Qiu M, Kozikowski A, Patel V, Liberman T, Carney M, Pekmezaris R, Wolf-Klein G, Karlin-Zysman C. A Multicomponent Model to Improve Hospital Care of Older Adults with Cognitive Impairment: A Propensity Score-Matched Analysis. J Am Geriatr Soc. 2018 Sep;66(9):1700-1707. doi: 10.1111/jgs.15452. Epub 2018 Aug 11.</citation>
    <PMID>30098015</PMID>
  </results_reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <results_first_submitted>October 10, 2022</results_first_submitted>
  <results_first_submitted_qc>December 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2022</results_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Behavioral and Psychological Symptoms of Dementia</keyword>
  <keyword>Alzheimer's Disease and Related Dementias</keyword>
  <keyword>Hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <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>March 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT04481568/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>March 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT04481568/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>The PES-4-BPSD Model</title>
          <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).&#xD;
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
        </group>
        <group group_id="P2">
          <title>The Attention Control Condition</title>
          <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.&#xD;
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>The PES-4-BPSD Model</title>
          <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).&#xD;
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
        </group>
        <group group_id="B2">
          <title>The Attention Control Condition</title>
          <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.&#xD;
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</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="79"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="158"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.5" spread="8.44"/>
                    <measurement group_id="B2" value="86.9" spread="7.48"/>
                    <measurement group_id="B3" value="85.2" spread="8.13"/>
                  </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="48"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </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="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </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="27"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="93"/>
                  </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="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married/Domestic Partnership</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Separated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Widowed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Single/Never Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less than a high school diploma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school degree or equivalent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Associates degree (e.g., AA, AS)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bachelors degree (e.g. BA, BS)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Masters degree (e.g. MA, MS)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Doctorate (e.g. PhD, PsyD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Residence</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Still in own home</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caregivers home</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Assisted-living facility</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Independent living</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nursing home</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous history of dementia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Charlson Comorbidity Index</title>
          <description>The Charlson Comorbidity Index is a marker of baseline comorbid disease and is based on the presence and severity of 19 comorbidities. Age-adjusted results range from all participants range from 2 - 39, with higher scores indicating greater likelihood of mortality.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.09" spread="2.66"/>
                    <measurement group_id="B2" value="8.77" spread="2.65"/>
                    <measurement group_id="B3" value="8.43" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical Dementia Rating Worksheet final score</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 - No Impairment</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>0.5 - Questionable Impairment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 - Mild Impairment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 - Moderate Impairment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 - Severe Impairment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Neuropsychiatric inventory questionnaire</title>
          <description>The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.8" spread="7.49"/>
                    <measurement group_id="B2" value="10.5" spread="6.60"/>
                    <measurement group_id="B3" value="13.1" spread="7.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Neuropsychiatric Inventory Questionnaire Average Score During Hospital Admission</title>
        <description>The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal approach, consisting of daily NPI-Q interviews with Hospital Caregivers and daily reviews of the patient's medical record, to provide a daily assessment of the 12 NPI-Q domains during hospitalization. Upon discharge, the average of each patient's daily NPI-Q total scores will be calculated, and this average will serve as the primary outcome.</description>
        <time_frame>Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The PES-4-BPSD Model</title>
            <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).&#xD;
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
          </group>
          <group group_id="O2">
            <title>The Attention Control Condition</title>
            <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.&#xD;
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropsychiatric Inventory Questionnaire Average Score During Hospital Admission</title>
          <description>The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal approach, consisting of daily NPI-Q interviews with Hospital Caregivers and daily reviews of the patient's medical record, to provide a daily assessment of the 12 NPI-Q domains during hospitalization. Upon discharge, the average of each patient's daily NPI-Q total scores will be calculated, and this average will serve as the primary outcome.</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="79"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.36" spread="4.64"/>
                    <measurement group_id="O2" value="3.87" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay</title>
        <description>Collected via chart review.</description>
        <time_frame>Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The PES-4-BPSD Model</title>
            <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).&#xD;
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
          </group>
          <group group_id="O2">
            <title>The Attention Control Condition</title>
            <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.&#xD;
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay</title>
          <description>Collected via chart review.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" lower_limit="6.40" upper_limit="8.14"/>
                    <measurement group_id="O2" value="7.86" lower_limit="5.88" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Practices for the Management of BPSD</title>
        <description>Collected via chart review. Practices include orders placed for special observation (1:1 or enhanced), restraints, psychoactive medications, psychiatric evaluation, as well as adverse events (falls). Orders for constant observation are reported below.</description>
        <time_frame>Outcomes vary by participant; will be assessed through duration of study for 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The PES-4-BPSD Model</title>
            <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).&#xD;
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
          </group>
          <group group_id="O2">
            <title>The Attention Control Condition</title>
            <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.&#xD;
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</description>
          </group>
        </group_list>
        <measure>
          <title>Practices for the Management of BPSD</title>
          <description>Collected via chart review. Practices include orders placed for special observation (1:1 or enhanced), restraints, psychoactive medications, psychiatric evaluation, as well as adverse events (falls). Orders for constant observation are reported below.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Family Caregiver (FCG) Satisfaction</title>
        <description>FCGs will be interviewed by research coordinator with a one-time telephone survey within 48 hours of discharge using the UK National Audit of Dementia Round 3, Caregiver Questionnaire. The survey consists of 10 items assessing perceptions of hospital quality of care provided by hospital staff. Responses of &quot;Excellent&quot; to the primary question assessed, &quot;overall, how would you rate the care received by your loved one during their hospital stay?&quot; is reported.</description>
        <time_frame>Collected within 48 hours of hospital discharge for the 1-year study duration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The PES-4-BPSD Model</title>
            <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).&#xD;
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
          </group>
          <group group_id="O2">
            <title>The Attention Control Condition</title>
            <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.&#xD;
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</description>
          </group>
        </group_list>
        <measure>
          <title>Family Caregiver (FCG) Satisfaction</title>
          <description>FCGs will be interviewed by research coordinator with a one-time telephone survey within 48 hours of discharge using the UK National Audit of Dementia Round 3, Caregiver Questionnaire. The survey consists of 10 items assessing perceptions of hospital quality of care provided by hospital staff. Responses of &quot;Excellent&quot; to the primary question assessed, &quot;overall, how would you rate the care received by your loved one during their hospital stay?&quot; is reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Length of inpatient stay (median of 7 days) through 48 hours following hospital discharge; will be assessed for 1 year duration of study</time_frame>
      <group_list>
        <group group_id="E1">
          <title>The PES-4-BPSD Model</title>
          <description>The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).&#xD;
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.</description>
        </group>
        <group group_id="E2">
          <title>The Attention Control Condition</title>
          <description>The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.&#xD;
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).</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="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Liron Sinvani, Principal Investigator</name_or_title>
      <organization>Northwell Health</organization>
      <phone>646-766-7169</phone>
      <email>ldanay@northwell.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/NCT04481568
org study id: 19-0800-FIMR-1
secondary id: 1R21NR018500-01
nct id: NCT04481568
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Persons with Alzheimer's Disease and Related Dementias (ADRD) account for 3.2 million
      hospital admissions per year and have over three times more hospitalizations than those
      without cognitive impairment, yet hospital caregivers (HCGs) are ill-prepared to manage
      patients with ADRD with less than 5% reporting mandatory dementia care training.
      Three-quarters of hospitalized persons with ADRD display Behavioral and Psychological
      Symptoms of Dementia (BPSD) associated with functional and cognitive decline, increased
      resource consumption, institutionalization, premature death, and caregiver burden. The
      overall objective is to test the preliminary efficacy of an innovative model of care,
      PES-4-BPSD, for reducing BPSD by empowering Patient Engagement Specialists (PES) to deliver
      dementia care for acutely-ill patients with ADRD. Traditionally, mental health assistants
      with training in crisis-prevention techniques provide care to psychiatric patients. On the
      intervention unit, these mental health assistants, as PES, purposefully engage patients with
      BPSD. In the pilot study, investigators found patients with cognitive impairment admitted to
      the PES unit were significantly less likely to require constant observation, chemical and
      physical restraints, suggesting improved management of BPSD. The central hypothesis is that
      PES-4-BPSD will improve the ability of PES to create an "enabling" milieu that addresses
      factors leading to BPSD and improves the experience of hospital caregivers. Guided by a
      social-ecological framework, PES-4-BPSD incorporates dementia education and training,
      environmental modifications-cohorting, increased staffing-PES, and staff support. The
      investigators' multidisciplinary research team is well-positioned to accomplish the
      following: Aim 1) Determine the preliminary efficacy of PES-4-BPSD for reducing BPSD during
      hospitalization, and Aim 2) Evaluate whether dementia care training improves the perceived
      ability of PES staff (intervention) and nurse assistant staff (control) to care for
      hospitalized persons with ADRD. For Aim 1, investigators will conduct a non-randomized
      preliminary efficacy trial of the PES-4-BPSD intervention enrolling N=158 patients (79
      control, 79 intervention). The primary outcome will be presence of BPSD during
      hospitalization using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). In Aim 2,
      investigators will use survey methodology in a repeated measures design to evaluate within
      and between-group differences in attitudes, experience, and satisfaction toward managing
      patients with ADRD. Measures will be completed at baseline (T1), immediately following
      training (T2), and at the end of the intervention period (T3). This proposal will be the
      first to study an innovative model of care utilizing PES as specialized hospital caregivers
      for reducing BPSD in the hospital setting. The investigators' findings will lay the essential
      groundwork for a multi-site trial of PES-4-BPSD and inform the development of a program that
      can be easily implemented in other hospitals.
Prior to patient recruitment, a 3 month dementia training program will be implemented on both
      the intervention and control units. On the intervention unit, training will target the
      Patient Engagement Specialists (PES) and on the control to the nurse assistants (please refer
      to NCT# 04179721 for more details on this aim). Following the implementation of the dementia
      care training, eligible patients will be offered the opportunity to participate in the study.
      A research coordinator will offer the information and opportunity to participate to the
      patient's lawful caregiver. The signed consent forms will be stored in secured file cabinets.
      Once a participant has been enrolled in the study, demographic information will be obtained
      from the electronic medical records (EMR) and verified by Family Caregiver (FCG), including:
      age, gender, race/ethnicity, marital status, education, work status, current living
      situation, medical comorbidities, and reason for admission. A member of the research team
      will conduct a short interview with the FCG to verify patient background information and
      obtain baseline (1 month prior to admission) functional status (Barthel Index), dementia
      severity cognitive (Clinical Dementia Rating Scale)(5 stages of severity: no 0, questionable
      0.5, mild 1, moderate 2, and severe 3), and behavioral symptoms using the Neuropsychiatric
      Inventory-Clinical version NPI-C.

      A member of the research team will then complete daily NPI-Qs to determine the number of
      behaviors and symptoms for each patient on a daily basis. The data collector will use a
      multimodal approach drawing from electronic medical record (EMR) notes and interviews with
      nursing staff regarding the patient's behavior and treatment over the past 24 hours. Delirium
      will be assessed daily by the research coordinator using same multimodal approach and during
      the time of NPI observation. A final EMR chart review will be conducted collecting
      information such as length of stay, discharge disposition, in-hospital mortality as well as
      total usage practices for management of BPSD: use of special observation (1:1 or enhanced),
      restraints, psychoactive medications, psychiatric evaluation. Within 48 hours of discharge,
      family caregivers will be interviewed regarding satisfaction with care using the Carer
      Questionnaire Data from the National Audit of Dementia Round 3.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Nonrandom preliminary efficacy trial comparing 2 groups, intervention and control
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Neuropsychiatric Inventory Questionnaire Average Score During Hospital Admission
time frame: Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
description: The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal approach, consisting of daily NPI-Q interviews with Hospital Caregivers and daily reviews of the patient's medical record, to provide a daily assessment of the 12 NPI-Q domains during hospitalization. Upon discharge, the average of each patient's daily NPI-Q total scores will be calculated, and this average will serve as the primary outcome.
measure: Length of Stay
time frame: Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
description: Collected via chart review.
measure: Practices for the Management of BPSD
time frame: Outcomes vary by participant; will be assessed through duration of study for 1 year
description: Collected via chart review. Practices include orders placed for special observation (1:1 or enhanced), restraints, psychoactive medications, psychiatric evaluation, as well as adverse events (falls). Orders for constant observation are reported below.
measure: Family Caregiver (FCG) Satisfaction
time frame: Collected within 48 hours of hospital discharge for the 1-year study duration
description: FCGs will be interviewed by research coordinator with a one-time telephone survey within 48 hours of discharge using the UK National Audit of Dementia Round 3, Caregiver Questionnaire. The survey consists of 10 items assessing perceptions of hospital quality of care provided by hospital staff. Responses of "Excellent" to the primary question assessed, "overall, how would you rate the care received by your loved one during their hospital stay?" is reported.
arm group label: The PES-4-BPSD Model
arm group type: Experimental
description: The intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES staff: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Staff Support: The PI will hold monthly 20 minute group sessions to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
arm group label: The attention control condition
arm group type: Active Comparator
description: The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
intervention type: Behavioral
intervention name: PES-4-BPSD Model
description: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
arm group label: The PES-4-BPSD Model
intervention type: Behavioral
intervention name: The attention control condition
description: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
arm group label: The attention control condition
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Liron Sinvani, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
facility: 
country: United States
url: https://clinicaltrials.gov/ct2/show/NCT04179721
description: Please refer to NCT# 04179721 for more details on Aim 2: Hospital Caregivers
citation: Sampson EL, White N, Leurent B, Scott S, Lord K, Round J, Jones L. Behavioural and psychiatric symptoms in people with dementia admitted to the acute hospital: prospective cohort study. Br J Psychiatry. 2014 Sep;205(3):189-96. doi: 10.1192/bjp.bp.113.130948. Epub 2014 Jul 24.
PMID: 25061120
citation: Hessler JB, Schaufele M, Hendlmeier I, Junge MN, Leonhardt S, Weber J, Bickel H. Behavioural and psychological symptoms in general hospital patients with dementia, distress for nursing staff and complications in care: results of the General Hospital Study. Epidemiol Psychiatr Sci. 2018 Jun;27(3):278-287. doi: 10.1017/S2045796016001098. Epub 2017 Jan 9.
PMID: 28065176
citation: Astrom S, Nilsson M, Norberg A, Sandman PO, Winblad B. Staff burnout in dementia care--relations to empathy and attitudes. Int J Nurs Stud. 1991;28(1):65-75. doi: 10.1016/0020-7489(91)90051-4.
PMID: 1856035
citation: Dewing J, Dijk S. What is the current state of care for older people with dementia in general hospitals? A literature review. Dementia (London). 2016 Jan;15(1):106-24. doi: 10.1177/1471301213520172. Epub 2014 Jan 23.
PMID: 24459188
citation: Lintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. [PhD Thesis]. Prifysgol Bangor University; 2001
citation: Scerri A, Innes A, Scerri C. Dementia training programmes for staff working in general hospital settings - a systematic review of the literature. Aging Ment Health. 2017 Aug;21(8):783-796. doi: 10.1080/13607863.2016.1231170. Epub 2016 Sep 23.
PMID: 27662075
citation: Sinvani L, Warner-Cohen J, Strunk A, Halbert T, Harisingani R, Mulvany C, Qiu M, Kozikowski A, Patel V, Liberman T, Carney M, Pekmezaris R, Wolf-Klein G, Karlin-Zysman C. A Multicomponent Model to Improve Hospital Care of Older Adults with Cognitive Impairment: A Propensity Score-Matched Analysis. J Am Geriatr Soc. 2018 Sep;66(9):1700-1707. doi: 10.1111/jgs.15452. Epub 2018 Aug 11.
PMID: 30098015
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 