<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/NCT03244917</url>
  </required_header>
  <id_info>
    <org_study_id>TRAIN-AD</org_study_id>
    <nct_id>NCT03244917</nct_id>
  </id_info>
  <brief_title>Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias</brief_title>
  <acronym>TRAIN-AD</acronym>
  <official_title>Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebrew SeniorLife</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebrew SeniorLife</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>
      This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data&#xD;
      analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an&#xD;
      intervention to improve infection management for suspected UTIs and LRIs among residents with&#xD;
      advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of&#xD;
      randomization as the intervention must be delivered at the facility level to avoid&#xD;
      contamination and because this is how it would be employed in the real-world. Analyses will&#xD;
      be at the patient level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The final stage of dementia is characterized by recurrent suspected infections. Research has&#xD;
      shown these episodes are widely mismanaged, leading to adverse patient and public health&#xD;
      outcomes. Antimicrobials are extensively prescribed in advanced dementia, most often in the&#xD;
      absence of clinical evidence to support a bacterial infection. Antimicrobial exposure is the&#xD;
      main risk factor for multidrug-resistant organisms (MDROs). Nursing home (NH) residents with&#xD;
      advanced dementia are three times more likely to be colonized with MDROs compared to other&#xD;
      residents. Moreover, as these patients are in the terminal phase of dementia, evidence&#xD;
      suggests they may not clinically benefit from antimicrobials. Comfort is the stated goal of&#xD;
      care for 90% of advanced dementia patients, and the risks and burdens associated with work-up&#xD;
      and treatment of suspected infections generally do not promote that goal, particularly when&#xD;
      hospitalization is involved. Taken together, there is a clear need to improve infection&#xD;
      management in advanced dementia both to provide better end-of-life care to these patients and&#xD;
      reduce the public health threat of MDROs.&#xD;
&#xD;
      This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data&#xD;
      analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an&#xD;
      intervention to improve infection management for suspected UTIs and LRIs among residents with&#xD;
      advanced dementia (N=410; N=205/arm) living in NHs (N=28; N=14/arm). The NH is the unit of&#xD;
      randomization as the intervention must be delivered at the facility level to avoid&#xD;
      contamination and because this is how it would be employed in the real-world. Analyses will&#xD;
      be at the patient level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 2020</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>
    <intervention_model_description>Cluster Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The research assistants collecting outcome data through chart reviews and follow-up proxy interviews will be blinded to nursing home randomization. The Principal Investigator, data programmers, and statistician will be blinded to treatment assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total Antimicrobial Use for LRI and UTIs</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burdensome Interventions</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Antimicrobial Use</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">430</enrollment>
  <condition>Dementia</condition>
  <condition>Infection, Bacterial</condition>
  <arm_group>
    <arm_group_label>TRAIN-AD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia,</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TRAIN-AD</intervention_name>
    <description>The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. Intervention components aimed at the provider include: Professionally led infection management training seminars, online infection management course, and infection management guidance algorithms. Additionally participating prescribing providers will be sent bimonthly infection management feedback reports. Proxy Education is completed by providing an infection management in Advanced Dementia booklet to proxies of patients with AD upon resident enrollment in study.</description>
    <arm_group_label>TRAIN-AD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Facility inclusion criteria&#xD;
&#xD;
          1. More than 60 beds&#xD;
&#xD;
          2. Within 60 miles of Boston&#xD;
&#xD;
        Resident inclusion eligibility criteria&#xD;
&#xD;
          -  Age &gt; or = to 60 years&#xD;
&#xD;
          -  A diagnosis of dementia (any type)&#xD;
&#xD;
          -  Global Deterioration Scale (GDS) score of 7&#xD;
&#xD;
          -  NH length of stay &gt;90 days&#xD;
&#xD;
          -  An individual who can communicate in English has been formally or informally&#xD;
             designated as a health care proxy&#xD;
&#xD;
          -  Not comatose GDS stage 7 features include: profound memory deficits (cannot recognize&#xD;
             family), total functional dependence, speech &lt;= 5 words, incontinence, and&#xD;
             non-ambulatory. GDS 7 was chosen to define advanced dementia as it has been&#xD;
             successfully operationalized and validated in or prior studies, and experts agreed to&#xD;
             use this definition in research studies. A 90 day minimum length of stay was chosen to&#xD;
             exclude short-stay patients.&#xD;
&#xD;
        Provider inclusion criteria&#xD;
&#xD;
          -  Direct care provider of advanced dementia residents (a nurse, nurse practitioner,&#xD;
             physician or physician assistant identified by a senior administrator as an individual&#xD;
             who cares for residents with advanced dementia)&#xD;
&#xD;
          -  Can communicate in English (because intervention materials are all in English),&#xD;
&#xD;
          -  Over 21 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Residents with cognitive impairment due to causes other than dementia (e.g., head trauma&#xD;
        and in short-term, sub-acute SNFs) will be excluded.&#xD;
&#xD;
        Residents' whose proxies cannot communicate in English will be excluded from the study,&#xD;
        because the information directed to proxies are only in English.&#xD;
&#xD;
        Providers that do not provide direct care to residents with advanced dementia or who do not&#xD;
        speak English.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan L Mitchell, MD. MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebrew SeniorLife</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hebrew SeniorLife</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>July 19, 2021</results_first_submitted>
  <results_first_submitted_qc>July 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2021</results_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hebrew SeniorLife</investigator_affiliation>
    <investigator_full_name>Susan Mitchell, MD</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>Nursing home</keyword>
  <keyword>Palliative Care</keyword>
  <keyword>Dementia</keyword>
  <keyword>Infection</keyword>
  <keyword>Antimicrobials</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
    <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</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03244917/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03244917/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TRAIN-AD</title>
          <description>Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="201"/>
                <participants group_id="P2" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="199"/>
                <participants group_id="P2" count="227"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TRAIN-AD</title>
          <description>Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections</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="199"/>
            <count group_id="B2" value="227"/>
            <count group_id="B3" value="426"/>
          </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="87.7" spread="8.0"/>
                    <measurement group_id="B2" value="85.3" spread="8.6"/>
                    <measurement group_id="B3" value="86.3" spread="8.4"/>
                  </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="163"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="353"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="73"/>
                  </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="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </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="22"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="366"/>
                  </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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Antimicrobial Use for LRI and UTIs</title>
        <description>The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TRAIN-AD</title>
            <description>Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections</description>
          </group>
        </group_list>
        <measure>
          <title>Total Antimicrobial Use for LRI and UTIs</title>
          <description>The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months</description>
          <units>antimicrobial courses per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="0.25" upper_limit="0.84"/>
                    <measurement group_id="O2" value="0.82" lower_limit="0.49" upper_limit="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs</title>
        <description>The investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TRAIN-AD</title>
            <description>Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections</description>
          </group>
        </group_list>
        <measure>
          <title>Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs</title>
          <description>The investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.</description>
          <units>antimicrobial courses per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" lower_limit="0.15" upper_limit="0.60"/>
                    <measurement group_id="O2" value="0.43" lower_limit="0.23" upper_limit="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Burdensome Interventions</title>
        <description>The investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TRAIN-AD</title>
            <description>Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections</description>
          </group>
        </group_list>
        <measure>
          <title>Burdensome Interventions</title>
          <description>The investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm</description>
          <units>interventions per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" lower_limit="0.54" upper_limit="1.60"/>
                    <measurement group_id="O2" value="1.69" lower_limit="0.87" upper_limit="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Antimicrobial Use</title>
        <description>The investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TRAIN-AD</title>
            <description>Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections</description>
          </group>
        </group_list>
        <measure>
          <title>Total Antimicrobial Use</title>
          <description>The investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months</description>
          <units>antimicrobial courses per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" lower_limit="0.52" upper_limit="1.13"/>
                    <measurement group_id="O2" value="1.19" lower_limit="0.83" upper_limit="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each residents was followed for up to one year</time_frame>
      <desc>There were no pre-specified adverse events in this minimal risk study</desc>
      <group_list>
        <group group_id="E1">
          <title>TRAIN-AD</title>
          <description>Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections</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="82" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="227"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="227"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="227"/>
              </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>Susan Mitchell MD, MPH</name_or_title>
      <organization>Hebrew SeniorLife</organization>
      <phone>6172813669</phone>
      <email>smitchell@hsl.harvard.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/NCT03244917
org study id: TRAIN-AD
nct id: NCT03244917
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data
      analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an
      intervention to improve infection management for suspected UTIs and LRIs among residents with
      advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of
      randomization as the intervention must be delivered at the facility level to avoid
      contamination and because this is how it would be employed in the real-world. Analyses will
      be at the patient level.
The final stage of dementia is characterized by recurrent suspected infections. Research has
      shown these episodes are widely mismanaged, leading to adverse patient and public health
      outcomes. Antimicrobials are extensively prescribed in advanced dementia, most often in the
      absence of clinical evidence to support a bacterial infection. Antimicrobial exposure is the
      main risk factor for multidrug-resistant organisms (MDROs). Nursing home (NH) residents with
      advanced dementia are three times more likely to be colonized with MDROs compared to other
      residents. Moreover, as these patients are in the terminal phase of dementia, evidence
      suggests they may not clinically benefit from antimicrobials. Comfort is the stated goal of
      care for 90% of advanced dementia patients, and the risks and burdens associated with work-up
      and treatment of suspected infections generally do not promote that goal, particularly when
      hospitalization is involved. Taken together, there is a clear need to improve infection
      management in advanced dementia both to provide better end-of-life care to these patients and
      reduce the public health threat of MDROs.

      This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data
      analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an
      intervention to improve infection management for suspected UTIs and LRIs among residents with
      advanced dementia (N=410; N=205/arm) living in NHs (N=28; N=14/arm). The NH is the unit of
      randomization as the intervention must be delivered at the facility level to avoid
      contamination and because this is how it would be employed in the real-world. Analyses will
      be at the patient level.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster Randomized Clinical Trial
primary purpose: Health Services Research
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The research assistants collecting outcome data through chart reviews and follow-up proxy interviews will be blinded to nursing home randomization. The Principal Investigator, data programmers, and statistician will be blinded to treatment assignment
measure: Total Antimicrobial Use for LRI and UTIs
time frame: 12 months
description: The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
measure: Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs
time frame: 12 months
description: The investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.
measure: Burdensome Interventions
time frame: 12 months
description: The investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm
measure: Total Antimicrobial Use
time frame: 12 months
description: The investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
arm group label: TRAIN-AD
arm group type: Experimental
description: The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education.
arm group label: CONTROL
arm group type: No Intervention
description: Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia,
intervention type: Behavioral
intervention name: TRAIN-AD
description: The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. Intervention components aimed at the provider include: Professionally led infection management training seminars, online infection management course, and infection management guidance algorithms. Additionally participating prescribing providers will be sent bimonthly infection management feedback reports. Proxy Education is completed by providing an infection management in Advanced Dementia booklet to proxies of patients with AD upon resident enrollment in study.
arm group label: TRAIN-AD
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Susan L Mitchell, MD. MPH
role: Principal Investigator
affiliation: Hebrew SeniorLife
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Hebrew SeniorLife
investigator full name: Susan Mitchell, MD
investigator title: Senior Scientist
mesh term: Bacterial Infections
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: 