<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/NCT02223455</url>
  </required_header>
  <id_info>
    <org_study_id>CRE 12-289</org_study_id>
    <nct_id>NCT02223455</nct_id>
  </id_info>
  <brief_title>Building an Optimal Hand Hygiene Bundle</brief_title>
  <official_title>Building an Optimal Hand Hygiene Bundle: A Mixed Methods Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hand hygiene is the single most effective practice in preventing the spread of&#xD;
      hospital-acquired infections. Despite the strength of the evidence, hospital staff continue&#xD;
      to sanitize their hands less than half of the time required by guidelines. Effective&#xD;
      interventions are needed to improve hand hygiene compliance rates among hospital staff, but&#xD;
      most are of poor quality and do not examine the specific effects of individual interventions.&#xD;
      This study will build a &quot;bundle&quot; of three hand hygiene interventions using a research design&#xD;
      that allows for the effectiveness of each intervention to be measured individually and&#xD;
      combined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The two specific aims and associated hypotheses of CREATE Project 2 include:&#xD;
&#xD;
        1. Identify combinations of hand-hygiene intervention strategies that optimize hand-hygiene&#xD;
           compliance and that could form an evidence-based hand-hygiene bundle for Veterans Health&#xD;
           Administration (VHA) implementation.&#xD;
&#xD;
           Hypothesis 1: Combinations of interventions will increase compliance rates more than&#xD;
           single interventions.&#xD;
&#xD;
           Aim 1 will entail a 30-month cluster-randomized controlled trial that will sequentially&#xD;
           test three individual hand-hygiene interventions - hand-hygiene point-of-use reminder&#xD;
           signs to serve as an environmental cue to action, individual hand sanitizers, and health&#xD;
           care worker hand cultures - to identify an optimal combination of interventions to&#xD;
           increase hand-hygiene compliance. The trial will be conducted in 59 hospital units in 10&#xD;
           VA hospitals in order to test the efficacy of individual and then sequentially added&#xD;
           interventions to determine their incremental impact on hand-hygiene compliance.&#xD;
&#xD;
           The focus for this clinical trial will be on Aim 1--Single Hand Hygiene Sign changes.&#xD;
&#xD;
        2. Identify institutional, organizational, ward/ICU, and individual level facilitators and&#xD;
           barriers to implementing hand-hygiene interventions.&#xD;
&#xD;
      Hypothesis 2: Facilitators and barriers will pattern around contextual factors such as level&#xD;
      of leadership support and organization of infection control programs.&#xD;
&#xD;
      Aim 2 will entail a qualitative process evaluation that includes site visits to purposefully&#xD;
      selected sites, semi-structured interviews, and observations to examine barriers and&#xD;
      facilitators to the interventions and develop contextual insight for implementing and&#xD;
      scaling-up the intervention at additional sites as a national initiative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2016</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hand Hygiene Compliance</measure>
    <time_frame>phase 1 (7-12 months) thru phase 3 (19-21 months)</time_frame>
    <description>Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research &amp; Development (HSR&amp;D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Hand Hygiene</condition>
  <condition>Health Care Associated Infection</condition>
  <condition>Compliance</condition>
  <arm_group>
    <arm_group_label>Single Hand Hygiene Sign</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand Hygiene Signs Changed Monthly</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand Hygiene Signs Changed Weekly</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hand Hygiene Signs</intervention_name>
    <description>Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
    <arm_group_label>Hand Hygiene Signs Changed Monthly</arm_group_label>
    <arm_group_label>Hand Hygiene Signs Changed Weekly</arm_group_label>
    <arm_group_label>Single Hand Hygiene Sign</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on&#xD;
             these wards/units&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather S Reisinger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iowa City VA Health Care System, Iowa City, IA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami VA Healthcare System, Miami, FL</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa City VA Health Care System, Iowa City, IA</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246-2208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System, Ann Arbor, MI</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105-1873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Portland Health Care System, Portland, OR</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Health Care System, San Antonio, TX</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Salt Lake City Health Care System, Salt Lake City, UT</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>July 19, 2019</results_first_submitted>
  <results_first_submitted_qc>September 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 4, 2019</results_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Methicillin-resistant Staphylococcus aureus (MRSA)</keyword>
  <keyword>Infection Control (IC)</keyword>
  <keyword>Hospital-associated infections (HAI)</keyword>
  <keyword>Hand Hygiene (HH)</keyword>
  <keyword>Compliance</keyword>
  <keyword>Health Care Workers (HCWs)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>As requested</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>August 2020 for 7 years</ipd_time_frame>
    <ipd_access_criteria>IRB and VA Research and Development approval of protocol for sharing</ipd_access_criteria>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Hand Hygiene Sign</title>
          <description>Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
        <group group_id="P2">
          <title>Hand Hygiene Signs Changed Monthly</title>
          <description>Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
        <group group_id="P3">
          <title>Hand Hygiene Signs Changed Weekly</title>
          <description>Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="NA">Participant level data not collected.</participants>
                <participants group_id="P2" count="NA">Participant level data not collected.</participants>
                <participants group_id="P3" count="NA">Participant level data not collected.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="NA">Participant level data not collected.</participants>
                <participants group_id="P2" count="NA">Participant level data not collected.</participants>
                <participants group_id="P3" count="NA">Participant level data not collected.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="NA"/>
                <participants group_id="P2" count="NA"/>
                <participants group_id="P3" count="NA"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This study is a cluster randomized control trial. Outcomes are measured by unit/ward not individual participant.</population>
      <group_list>
        <group group_id="B1">
          <title>Single Hand Hygiene Sign</title>
          <description>Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
        <group group_id="B2">
          <title>Hand Hygiene Signs Changed Monthly</title>
          <description>Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
        <group group_id="B3">
          <title>Hand Hygiene Signs Changed Weekly</title>
          <description>Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
        <group group_id="B4">
          <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="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>We did not collect age at a participant level. Data are aggregated at the unit level.</description>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>We did not collect sex at a participant level. Data are aggregated at the unit level</description>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>ward/unit</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hand Hygiene Compliance</title>
        <description>Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research &amp; Development (HSR&amp;D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.</description>
        <time_frame>phase 1 (7-12 months) thru phase 3 (19-21 months)</time_frame>
        <population>Entry and exit HH compliance were calculated for units in each treatment group. Crude (unadjusted) change in HH compliance from baseline to follow-up was assessed for each intervention group using Fisher's exact test.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Hand Hygiene Sign</title>
            <description>Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.&#xD;
Hand Hygiene Compliance Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
          </group>
          <group group_id="O2">
            <title>Hand Hygiene Signs Changed Monthly</title>
            <description>Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Compliance Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
          </group>
          <group group_id="O3">
            <title>Hand Hygiene Signs Changed Weekly</title>
            <description>Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Compliance Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Hygiene Compliance</title>
          <description>Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research &amp; Development (HSR&amp;D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.</description>
          <population>Entry and exit HH compliance were calculated for units in each treatment group. Crude (unadjusted) change in HH compliance from baseline to follow-up was assessed for each intervention group using Fisher's exact test.</population>
          <units>percentage of change in HH compliance</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>inpatient wards/units</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="NA"/>
                <count group_id="O2" value="NA"/>
                <count group_id="O3" value="NA"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>inpatient wards/units</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Room Entry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-20.5" upper_limit="23.0"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-21.5" upper_limit="29.7"/>
                    <measurement group_id="O3" value="-1.3" lower_limit="-17.9" upper_limit="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Room Exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" lower_limit="-16.4" upper_limit="10.2"/>
                    <measurement group_id="O2" value="-5.2" lower_limit="-16.2" upper_limit="6.7"/>
                    <measurement group_id="O3" value="1.8" lower_limit="-11.1" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse Events were not collected because of the nature of the trial - no individual level data collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Single Hand Hygiene Sign</title>
          <description>Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
        <group group_id="E2">
          <title>Hand Hygiene Signs Changed Monthly</title>
          <description>Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</description>
        </group>
        <group group_id="E3">
          <title>Hand Hygiene Signs Changed Weekly</title>
          <description>Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.&#xD;
Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </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>Heather Reisinger</name_or_title>
      <organization>CADRE - Iowa City VAHCS</organization>
      <phone>319-338-0581 ext 7715</phone>
      <email>heather.reisinger@va.gov</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/NCT02223455
org study id: CRE 12-289
nct id: NCT02223455
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Hand hygiene is the single most effective practice in preventing the spread of
      hospital-acquired infections. Despite the strength of the evidence, hospital staff continue
      to sanitize their hands less than half of the time required by guidelines. Effective
      interventions are needed to improve hand hygiene compliance rates among hospital staff, but
      most are of poor quality and do not examine the specific effects of individual interventions.
      This study will build a "bundle" of three hand hygiene interventions using a research design
      that allows for the effectiveness of each intervention to be measured individually and
      combined.
The two specific aims and associated hypotheses of CREATE Project 2 include:

        1. Identify combinations of hand-hygiene intervention strategies that optimize hand-hygiene
           compliance and that could form an evidence-based hand-hygiene bundle for Veterans Health
           Administration (VHA) implementation.

           Hypothesis 1: Combinations of interventions will increase compliance rates more than
           single interventions.

           Aim 1 will entail a 30-month cluster-randomized controlled trial that will sequentially
           test three individual hand-hygiene interventions - hand-hygiene point-of-use reminder
           signs to serve as an environmental cue to action, individual hand sanitizers, and health
           care worker hand cultures - to identify an optimal combination of interventions to
           increase hand-hygiene compliance. The trial will be conducted in 59 hospital units in 10
           VA hospitals in order to test the efficacy of individual and then sequentially added
           interventions to determine their incremental impact on hand-hygiene compliance.

           The focus for this clinical trial will be on Aim 1--Single Hand Hygiene Sign changes.

        2. Identify institutional, organizational, ward/ICU, and individual level facilitators and
           barriers to implementing hand-hygiene interventions.

      Hypothesis 2: Facilitators and barriers will pattern around contextual factors such as level
      of leadership support and organization of infection control programs.

      Aim 2 will entail a qualitative process evaluation that includes site visits to purposefully
      selected sites, semi-structured interviews, and observations to examine barriers and
      facilitators to the interventions and develop contextual insight for implementing and
      scaling-up the intervention at additional sites as a national initiative.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Hand Hygiene Compliance
time frame: phase 1 (7-12 months) thru phase 3 (19-21 months)
description: Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research & Development (HSR&D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.
arm group label: Single Hand Hygiene Sign
arm group type: Placebo Comparator
description: Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.
arm group label: Hand Hygiene Signs Changed Monthly
arm group type: Active Comparator
description: Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.
arm group label: Hand Hygiene Signs Changed Weekly
arm group type: Active Comparator
description: Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.
intervention type: Other
intervention name: Hand Hygiene Signs
description: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.
arm group label: Hand Hygiene Signs Changed Monthly
arm group label: Hand Hygiene Signs Changed Weekly
arm group label: Single Hand Hygiene Sign
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Heather S Reisinger, PhD
role: Principal Investigator
affiliation: Iowa City VA Health Care System, Iowa City, IA
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Cross Infection
sharing ipd: Yes
ipd description: As requested
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: August 2020 for 7 years
ipd access criteria: IRB and VA Research and Development approval of protocol for sharing
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 