<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/NCT02994979</url>
  </required_header>
  <id_info>
    <org_study_id>2016-04</org_study_id>
    <nct_id>NCT02994979</nct_id>
  </id_info>
  <brief_title>Nursing Assistant Intervention to Prevent Delirium in Nursing Homes</brief_title>
  <official_title>Multicomponent Intervention to Prevent Delirium in Nursing Homes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jewish Home &amp; Hospital Lifecare System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jewish Home &amp; Hospital Lifecare System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delirium is an acute confusion that occurs in one third of hospitalized older adults. As&#xD;
      compared to those without delirium, hospitalized patients with delirium have longer hospital&#xD;
      stays, higher mortality, and increased risk of nursing home utilization. Substantial&#xD;
      attention has been paid to developing, testing, and disseminating interventions to prevent&#xD;
      delirium in the hospital but, to date, not in the nursing home setting. In a previous study&#xD;
      we used known information on delirium risk factors to develop an intervention that can be&#xD;
      delivered at onset of acute illness in nursing home patients. The current study is designed&#xD;
      to test the effect of this intervention in a single-site clinical trial. Objectives: 1) to&#xD;
      determine, as compared to control, the effect of a multicomponent intervention targeting&#xD;
      delirium risk factors on delirium frequency, delirium severity, cognitive and physical&#xD;
      function decline, and hospitalization in nursing home patients with acute illness, and 2) to&#xD;
      identify features of the intervention associated with occurrence of delirium and other&#xD;
      outcomes. Approach: We will screen nursing home patients on 17 long-term care units at a&#xD;
      large, urban nursing home who experience onset of a change in condition according to&#xD;
      established criteria, and enroll and assign them to intervention or control in a 1:1 ratio.&#xD;
      Those assigned to intervention will receive daily visits from an Elder Life Specialist, a&#xD;
      mobile Certified Nursing Assistant trained to provide services to counter risks for delirium,&#xD;
      including dehydration, immobility, cognitive impairment, undernutrition, and sleep problems,&#xD;
      for the duration of the acute illness and for 1 week following. Patients assigned to control&#xD;
      will receive usual care from the unit-based nurses and the patient's primary team. Delirium&#xD;
      will be assessed 5 days a week by a research assistant. Cognitive and physical function&#xD;
      decline and hospital transfer will be ascertained during a 1 month follow-up period. We will&#xD;
      compare outcomes between intervention and control, as well as examine associations between&#xD;
      outcomes and intervention features such as number and duration of visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is an acute cognitive disorder with features of inattention, disorganized thinking,&#xD;
      and disordered consciousness that occurs in one third of hospitalized older adults. As&#xD;
      compared to those without delirium, hospitalized patients with delirium have longer hospital&#xD;
      stays, higher mortality, and increased risk of nursing home utilization. Substantial&#xD;
      attention has been paid to developing, testing, and disseminating interventions to prevent&#xD;
      delirium in the hospital but, to date, not in the nursing home setting. In a previous study&#xD;
      we used known information on delirium risk factors to develop a multicomponent intervention&#xD;
      that can be delivered at onset of acute illness in nursing home patients. We demonstrated the&#xD;
      intervention's feasibility, adherence, and acceptance by patients and staff. The current&#xD;
      study is designed to test the efficacy of this intervention in a single-site&#xD;
      cluster-randomized trial. Objectives: 1) to determine, as compared to control, the effect of&#xD;
      a multicomponent intervention targeting delirium risk factors (immobility, cognitive&#xD;
      impairment, dehydration, undernutrition, sleep, and medication use) on the primary outcome of&#xD;
      delirium frequency in nursing home patients with acute illness, and the secondary outcomes of&#xD;
      delirium severity, cognitive and physical function decline, and hospitalization associated&#xD;
      with acute illness, and 2) to identify features of the intervention, including &quot;dose&quot; and&#xD;
      components, associated with occurrence of delirium and its severity, cognitive and physical&#xD;
      function decline, and hospitalization associated with acute illness. Approach: We will screen&#xD;
      nursing home patients on 17 long-term care units at a large, urban nursing home who&#xD;
      experience onset of an acute change in condition according to established criteria, and&#xD;
      enroll and assign them to intervention or control in a 1:1 ratio. Those assigned to&#xD;
      intervention will receive daily visits from an Elder Life Specialist, a mobile Certified&#xD;
      Nursing Assistant trained to provide services to counter risks for delirium, including&#xD;
      dehydration, immobility, cognitive impairment, undernutrition, and sleep problems, for the&#xD;
      duration of the acute illness and for 1 week following, in collaboration with the patient's&#xD;
      primary medical and nursing team. Patients assigned to control will receive usual care from&#xD;
      the unit-based nurses and the patient's primary team. Delirium will be assessed 5 days a week&#xD;
      by a research assistant blinded to study hypotheses and group assignment. Cognitive and&#xD;
      physical function decline and hospital transfer will be ascertained during a 1 month&#xD;
      follow-up period. We will conduct analyses to compare outcomes between intervention and&#xD;
      control, as well as examine associations between outcomes and intervention features such as&#xD;
      number and duration of visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 28, 2018</completion_date>
  <primary_completion_date type="Actual">August 21, 2018</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Delirium</measure>
    <time_frame>During acute condition, up to 3 weeks</time_frame>
    <description>Confusion Assessment Method (CAM)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Function at 1 Month</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Minimum Data Set Activities of Daily Living scale; Scale range = 0-28; Higher score = Worse activities of daily living function; Outcome measure at 1 month may be adjusted for outcome measure at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function at 1 Month</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Minimum Data Set Cognitive Performance Scale; Scale range = 0-6; Higher scores = Worse cognitive performance; Outcome measure at 1 month may be adjusted for outcome measure at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Admitted to Hospital</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Delirium-prevention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Usual care plus a sham visit from the intervention CNA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Delirium-prevention</intervention_name>
    <description>Patients will be seen by an intervention CNA at least once daily 7 days a week. The CNA will be English/Spanish bilingual and will provide intervention components guided by structured protocols and a daily visit form. A typical visit lasts 30 minutes and begins with an introduction and orientation activity followed by provision of water, a reminiscence activity or game, a physical exercise, and a snack and second cup of water. Patients may also receive a relaxation visit at night and given a warm drink, a hand or foot massage, and quiet music. Daily visits will last for the duration of the illness and 7 days following the illness end. Illness end is defined as the last day of illness treatment (e.g., last day of antibiotics) or monitoring (e.g., last day on nursing &quot;24-hour report&quot;). During weekly intervention staff meetings patients will be discussed with the primary medical and nursing team. The planned intervention group sample size results in a case load of 4-8 patients.</description>
    <arm_group_label>Delirium-prevention group</arm_group_label>
    <other_name>HELP-LTC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham comparator</intervention_name>
    <description>Usual care plus sham visits by CNA</description>
    <arm_group_label>Usual care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Long-term care nursing home resident at The New Jewish Home&#xD;
&#xD;
          -  Acute change in condition or just returned from the hospital&#xD;
&#xD;
          -  Assent to participate in study&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Discharge or death expected before 2 months&#xD;
&#xD;
          -  Nonverbal or unable to follow simple commands&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Boockvar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai School of Medicine; The New Jewish Home</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The New Jewish Home</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <results_first_submitted>September 11, 2019</results_first_submitted>
  <results_first_submitted_qc>October 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 4, 2019</results_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <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>November 11, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02994979/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Delirium-prevention Group</title>
          <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.&#xD;
Delirium-prevention: Patients will be seen by an intervention CNA at least once daily 7 days a week. The CNA will be English/Spanish bilingual and will provide intervention components guided by structured protocols and a daily visit form. A typical visit lasts 30 minutes and begins with an introduction and orientation activity followed by provision of water, a reminiscence activity or game, a physical exercise, and a snack and second cup of water. Patients may also receive a relaxation visit at night and given a warm drink, a hand or foot massage, and quiet music. Daily visits will last for the duration of the illness and 7 days following the illness end. Illness end is defined as the last day of illness treatment (e.g., last day of antibiotics) or monitoring (e.g., last day on nursing &quot;24-hour report&quot;). During</description>
        </group>
        <group group_id="P2">
          <title>Usual Care Group</title>
          <description>Usual care plus a sham visit from the intervention CNA&#xD;
Sham comparator: Usual care plus sham visits by CNA</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="105"/>
              </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>Delirium-prevention Group</title>
          <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care Group</title>
          <description>Usual care plus a sham visit from the intervention CNA&#xD;
Sham comparator: Usual care plus sham visits by CNA</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="114"/>
            <count group_id="B2" value="105"/>
            <count group_id="B3" value="219"/>
          </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="82.67" spread="1.54"/>
                    <measurement group_id="B2" value="80.64" spread="1.34"/>
                    <measurement group_id="B3" value="81.69" spread="1.10"/>
                  </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="72"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="76"/>
                  </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="40"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="154"/>
                  </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>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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="117"/>
                  </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>Cognitive function</title>
          <description>Brief Interview of Mental Status; Score range = 0-15; Higher score = Better mental status function</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.95" spread=".49"/>
                    <measurement group_id="B2" value="9.70" spread=".44"/>
                    <measurement group_id="B3" value="8.79" spread=".44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Delirium</title>
        <description>Confusion Assessment Method (CAM)</description>
        <time_frame>During acute condition, up to 3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Delirium-prevention Group</title>
            <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Usual care plus a sham visit from the intervention CNA&#xD;
Sham comparator: Usual care plus sham visits by CNA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Delirium</title>
          <description>Confusion Assessment Method (CAM)</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="114"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Function at 1 Month</title>
        <description>Minimum Data Set Activities of Daily Living scale; Scale range = 0-28; Higher score = Worse activities of daily living function; Outcome measure at 1 month may be adjusted for outcome measure at baseline</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Delirium-prevention Group</title>
            <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Usual care plus a sham visit from the intervention CNA&#xD;
Sham comparator: Usual care plus sham visits by CNA</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Function at 1 Month</title>
          <description>Minimum Data Set Activities of Daily Living scale; Scale range = 0-28; Higher score = Worse activities of daily living function; Outcome measure at 1 month may be adjusted for outcome measure at baseline</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.05" spread="1.13"/>
                    <measurement group_id="O2" value="14.27" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function at 1 Month</title>
        <description>Minimum Data Set Cognitive Performance Scale; Scale range = 0-6; Higher scores = Worse cognitive performance; Outcome measure at 1 month may be adjusted for outcome measure at baseline</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Delirium-prevention Group</title>
            <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Usual care plus a sham visit from the intervention CNA&#xD;
Sham comparator: Usual care plus sham visits by CNA</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function at 1 Month</title>
          <description>Minimum Data Set Cognitive Performance Scale; Scale range = 0-6; Higher scores = Worse cognitive performance; Outcome measure at 1 month may be adjusted for outcome measure at baseline</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.06" spread=".20"/>
                    <measurement group_id="O2" value="1.47" spread=".13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Admitted to Hospital</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Delirium-prevention Group</title>
            <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Usual care plus a sham visit from the intervention CNA&#xD;
Sham comparator: Usual care plus sham visits by CNA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Admitted to Hospital</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <desc>Fall</desc>
      <group_list>
        <group group_id="E1">
          <title>Delirium-prevention Group</title>
          <description>Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care Group</title>
          <description>Usual care plus a sham visit from the intervention CNA&#xD;
Sham comparator: Usual care plus sham visits by CNA</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="114"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="114"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital admission</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="114"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="114"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="47" subjects_affected="30" subjects_at_risk="114"/>
                <counts group_id="E2" events="26" subjects_affected="16" subjects_at_risk="105"/>
              </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>Dr. Kenneth Boockvar</name_or_title>
      <organization>The New Jewish Home</organization>
      <phone>212-870-5062</phone>
      <email>kenneth.boockvar@mssm.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/NCT02994979
org study id: 2016-04
nct id: NCT02994979
lead sponsor: 
has dmc: Yes
Delirium is an acute confusion that occurs in one third of hospitalized older adults. As
      compared to those without delirium, hospitalized patients with delirium have longer hospital
      stays, higher mortality, and increased risk of nursing home utilization. Substantial
      attention has been paid to developing, testing, and disseminating interventions to prevent
      delirium in the hospital but, to date, not in the nursing home setting. In a previous study
      we used known information on delirium risk factors to develop an intervention that can be
      delivered at onset of acute illness in nursing home patients. The current study is designed
      to test the effect of this intervention in a single-site clinical trial. Objectives: 1) to
      determine, as compared to control, the effect of a multicomponent intervention targeting
      delirium risk factors on delirium frequency, delirium severity, cognitive and physical
      function decline, and hospitalization in nursing home patients with acute illness, and 2) to
      identify features of the intervention associated with occurrence of delirium and other
      outcomes. Approach: We will screen nursing home patients on 17 long-term care units at a
      large, urban nursing home who experience onset of a change in condition according to
      established criteria, and enroll and assign them to intervention or control in a 1:1 ratio.
      Those assigned to intervention will receive daily visits from an Elder Life Specialist, a
      mobile Certified Nursing Assistant trained to provide services to counter risks for delirium,
      including dehydration, immobility, cognitive impairment, undernutrition, and sleep problems,
      for the duration of the acute illness and for 1 week following. Patients assigned to control
      will receive usual care from the unit-based nurses and the patient's primary team. Delirium
      will be assessed 5 days a week by a research assistant. Cognitive and physical function
      decline and hospital transfer will be ascertained during a 1 month follow-up period. We will
      compare outcomes between intervention and control, as well as examine associations between
      outcomes and intervention features such as number and duration of visits.
Delirium is an acute cognitive disorder with features of inattention, disorganized thinking,
      and disordered consciousness that occurs in one third of hospitalized older adults. As
      compared to those without delirium, hospitalized patients with delirium have longer hospital
      stays, higher mortality, and increased risk of nursing home utilization. Substantial
      attention has been paid to developing, testing, and disseminating interventions to prevent
      delirium in the hospital but, to date, not in the nursing home setting. In a previous study
      we used known information on delirium risk factors to develop a multicomponent intervention
      that can be delivered at onset of acute illness in nursing home patients. We demonstrated the
      intervention's feasibility, adherence, and acceptance by patients and staff. The current
      study is designed to test the efficacy of this intervention in a single-site
      cluster-randomized trial. Objectives: 1) to determine, as compared to control, the effect of
      a multicomponent intervention targeting delirium risk factors (immobility, cognitive
      impairment, dehydration, undernutrition, sleep, and medication use) on the primary outcome of
      delirium frequency in nursing home patients with acute illness, and the secondary outcomes of
      delirium severity, cognitive and physical function decline, and hospitalization associated
      with acute illness, and 2) to identify features of the intervention, including "dose" and
      components, associated with occurrence of delirium and its severity, cognitive and physical
      function decline, and hospitalization associated with acute illness. Approach: We will screen
      nursing home patients on 17 long-term care units at a large, urban nursing home who
      experience onset of an acute change in condition according to established criteria, and
      enroll and assign them to intervention or control in a 1:1 ratio. Those assigned to
      intervention will receive daily visits from an Elder Life Specialist, a mobile Certified
      Nursing Assistant trained to provide services to counter risks for delirium, including
      dehydration, immobility, cognitive impairment, undernutrition, and sleep problems, for the
      duration of the acute illness and for 1 week following, in collaboration with the patient's
      primary medical and nursing team. Patients assigned to control will receive usual care from
      the unit-based nurses and the patient's primary team. Delirium will be assessed 5 days a week
      by a research assistant blinded to study hypotheses and group assignment. Cognitive and
      physical function decline and hospital transfer will be ascertained during a 1 month
      follow-up period. We will conduct analyses to compare outcomes between intervention and
      control, as well as examine associations between outcomes and intervention features such as
      number and duration of visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Number of Participants With Delirium
time frame: During acute condition, up to 3 weeks
description: Confusion Assessment Method (CAM)
measure: Physical Function at 1 Month
time frame: Baseline and 1 month
description: Minimum Data Set Activities of Daily Living scale; Scale range = 0-28; Higher score = Worse activities of daily living function; Outcome measure at 1 month may be adjusted for outcome measure at baseline
measure: Cognitive Function at 1 Month
time frame: Baseline and 1 month
description: Minimum Data Set Cognitive Performance Scale; Scale range = 0-6; Higher scores = Worse cognitive performance; Outcome measure at 1 month may be adjusted for outcome measure at baseline
measure: Number of Participants Admitted to Hospital
time frame: Up to 1 month
arm group label: Delirium-prevention group
arm group type: Experimental
description: Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.
arm group label: Usual care group
arm group type: Sham Comparator
description: Usual care plus a sham visit from the intervention CNA
intervention type: Other
intervention name: Delirium-prevention
description: Patients will be seen by an intervention CNA at least once daily 7 days a week. The CNA will be English/Spanish bilingual and will provide intervention components guided by structured protocols and a daily visit form. A typical visit lasts 30 minutes and begins with an introduction and orientation activity followed by provision of water, a reminiscence activity or game, a physical exercise, and a snack and second cup of water. Patients may also receive a relaxation visit at night and given a warm drink, a hand or foot massage, and quiet music. Daily visits will last for the duration of the illness and 7 days following the illness end. Illness end is defined as the last day of illness treatment (e.g., last day of antibiotics) or monitoring (e.g., last day on nursing "24-hour report"). During weekly intervention staff meetings patients will be discussed with the primary medical and nursing team. The planned intervention group sample size results in a case load of 4-8 patients.
arm group label: Delirium-prevention group
other name: HELP-LTC
intervention type: Other
intervention name: Sham comparator
description: Usual care plus sham visits by CNA
arm group label: Usual care group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth Boockvar, MD
role: Principal Investigator
affiliation: Mount Sinai School of Medicine; The New Jewish Home
facility: 
country: United States
responsible party type: Sponsor
mesh term: Delirium
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 