<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/NCT02244905</url>
  </required_header>
  <id_info>
    <org_study_id>STU 072011-079</org_study_id>
    <secondary_id>Grant # 137911</secondary_id>
    <nct_id>NCT02244905</nct_id>
  </id_info>
  <brief_title>Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections</brief_title>
  <official_title>Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthcare-associated infections (HAI) are a significant public health burden. Even with&#xD;
      existence of recommendations on technical strategies to prevent these infections, there is a&#xD;
      need for strategies to increase staff engagement within the local organizational and cultural&#xD;
      context. Positive deviance is one such approach that engages people in improvement efforts.&#xD;
      Positive Deviance is based on the observation that in every community there are certain&#xD;
      individuals or groups whose uncommon behaviors and strategies enable them to find better&#xD;
      solutions to problems than their peers, while having access to the same resources and facing&#xD;
      similar or worse challenges. In the proposed study, the investigators plan to test the&#xD;
      effectiveness of using positive deviance based horizontal infection prevention approach to&#xD;
      achieve overall reduction of HAIs among hospital inpatients. The investigators hypothesized&#xD;
      that a broad and horizontal approach to reduce opportunities for acquisition of nosocomial&#xD;
      pathogens using PD will lead to greater reduction of HAI among hospital inpatients compared&#xD;
      to standard-of-care infection control approach. The investigators objective was to test the&#xD;
      investigators hypothesis and evaluate whether there is greater decline in rate of HAI in the&#xD;
      experimental group of wards compared to the control group of wards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate whether positive deviance (PD) based horizontal infection prevention&#xD;
      approach will result in a higher rate of decline in incidence density of patients with HAI&#xD;
      (central line-associated bloodstream infection, healthcare-associated pneumonia,&#xD;
      catheter-associated urinary tract infection, or Clostridium difficile infection) per 1000&#xD;
      patient days per month in the intervention wards compared to control wards.&#xD;
&#xD;
      Design: A cluster randomized controlled trial was conducted over a period of 24 months. Six&#xD;
      medical wards were randomized and positive deviance intervention was randomly allocated to&#xD;
      one of the two groups of three wards each. The baseline, intervention and follow-up periods&#xD;
      were 6, 9 and 9 months respectively.&#xD;
&#xD;
      Setting: A public safety-net major teaching hospital in United States.&#xD;
&#xD;
      Participants: The ward staffs participated in the intervention.&#xD;
&#xD;
      Intervention: Key components of the intervention were invitation to participate voluntarily,&#xD;
      open-ended dialogues with staff members to discover barriers and seek solutions to prevent&#xD;
      HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions&#xD;
      generated. Staffs of all six wards were asked to voluntarily participate in a modified&#xD;
      hospital survey of patient safety climate (HSOPSC) and a social network survey at 6, 15, and&#xD;
      24 months.&#xD;
&#xD;
      Statistical analysis: Statistical methods used were time series modeling, summary of&#xD;
      frequencies, Chi-square or Fisher's exact for testing difference in proportions and t-test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of HAI per 1000 patient-days per month.</measure>
    <time_frame>24 Months</time_frame>
    <description>The primary study outcome is the incidence density of HAI [a composite of central line associated bloodstream infection (CLABSI), hospital-acquired pneumonia (HAP), catheter-associated urinary tract infection (CAUTI) and C.difficile infection (CDI)] per 1000 patient-days per month.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16876</enrollment>
  <condition>Healthcare-associated Infections</condition>
  <arm_group>
    <arm_group_label>Positive Deviance Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three hospital wards received Positive Deviance intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Three hospital wards randomized to control arm received the Standard-of-Care Infection Control approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Deviance</intervention_name>
    <description>The recipients of the Positive Deviance intervention are the staff members of the three wards in the intervention arm, while the outcomes are measured among the patients receiving care in the three wards in the intervention arm. Key components of the intervention were invitation to participate voluntarily, open-ended dialogues with staff members to discover barriers and seek solutions to prevent HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions generated.</description>
    <arm_group_label>Positive Deviance Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard-of-Care Infection Control approach</intervention_name>
    <description>Standard-of-Care Infection Control approach</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Positive Deviance Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The intervention was performed on the staff members providing care in the three wards&#xD;
        belonging to the intervention arm of the study. These staff members were invited to&#xD;
        participate in the positive deviance intervention on a voluntary and anonymous basis.&#xD;
&#xD;
        The primary outcome was measured in all the patients who received care in the three&#xD;
        intervention wards and the three control wards.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  For Intervention: All staff members employed in the study wards assigned to the&#xD;
             intervention arm.&#xD;
&#xD;
          -  For Primary Outcome Assessment:&#xD;
&#xD;
               -  All patients admitted to any of the six study wards included in the study over&#xD;
                  the 24-month study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pranavi Sreeramoju, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Positive Deviance</keyword>
  <keyword>Infection Control</keyword>
  <keyword>Healthcare-Associated Infections</keyword>
  <keyword>Staff Engagement</keyword>
  <keyword>Cluster Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02244905
org study id: STU 072011-079
secondary id: Grant # 137911
nct id: NCT02244905
lead sponsor: 
has dmc: No
Healthcare-associated infections (HAI) are a significant public health burden. Even with
      existence of recommendations on technical strategies to prevent these infections, there is a
      need for strategies to increase staff engagement within the local organizational and cultural
      context. Positive deviance is one such approach that engages people in improvement efforts.
      Positive Deviance is based on the observation that in every community there are certain
      individuals or groups whose uncommon behaviors and strategies enable them to find better
      solutions to problems than their peers, while having access to the same resources and facing
      similar or worse challenges. In the proposed study, the investigators plan to test the
      effectiveness of using positive deviance based horizontal infection prevention approach to
      achieve overall reduction of HAIs among hospital inpatients. The investigators hypothesized
      that a broad and horizontal approach to reduce opportunities for acquisition of nosocomial
      pathogens using PD will lead to greater reduction of HAI among hospital inpatients compared
      to standard-of-care infection control approach. The investigators objective was to test the
      investigators hypothesis and evaluate whether there is greater decline in rate of HAI in the
      experimental group of wards compared to the control group of wards.
Objective: To evaluate whether positive deviance (PD) based horizontal infection prevention
      approach will result in a higher rate of decline in incidence density of patients with HAI
      (central line-associated bloodstream infection, healthcare-associated pneumonia,
      catheter-associated urinary tract infection, or Clostridium difficile infection) per 1000
      patient days per month in the intervention wards compared to control wards.

      Design: A cluster randomized controlled trial was conducted over a period of 24 months. Six
      medical wards were randomized and positive deviance intervention was randomly allocated to
      one of the two groups of three wards each. The baseline, intervention and follow-up periods
      were 6, 9 and 9 months respectively.

      Setting: A public safety-net major teaching hospital in United States.

      Participants: The ward staffs participated in the intervention.

      Intervention: Key components of the intervention were invitation to participate voluntarily,
      open-ended dialogues with staff members to discover barriers and seek solutions to prevent
      HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions
      generated. Staffs of all six wards were asked to voluntarily participate in a modified
      hospital survey of patient safety climate (HSOPSC) and a social network survey at 6, 15, and
      24 months.

      Statistical analysis: Statistical methods used were time series modeling, summary of
      frequencies, Chi-square or Fisher's exact for testing difference in proportions and t-test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of HAI per 1000 patient-days per month.
time frame: 24 Months
description: The primary study outcome is the incidence density of HAI [a composite of central line associated bloodstream infection (CLABSI), hospital-acquired pneumonia (HAP), catheter-associated urinary tract infection (CAUTI) and C.difficile infection (CDI)] per 1000 patient-days per month.
arm group label: Positive Deviance Intervention Arm
arm group type: Experimental
description: Three hospital wards received Positive Deviance intervention.
arm group label: Control Arm
arm group type: Other
description: Three hospital wards randomized to control arm received the Standard-of-Care Infection Control approach.
intervention type: Behavioral
intervention name: Positive Deviance
description: The recipients of the Positive Deviance intervention are the staff members of the three wards in the intervention arm, while the outcomes are measured among the patients receiving care in the three wards in the intervention arm. Key components of the intervention were invitation to participate voluntarily, open-ended dialogues with staff members to discover barriers and seek solutions to prevent HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions generated.
arm group label: Positive Deviance Intervention Arm
intervention type: Other
intervention name: Standard-of-Care Infection Control approach
description: Standard-of-Care Infection Control approach
arm group label: Control Arm
arm group label: Positive Deviance Intervention Arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pranavi Sreeramoju, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Cross Infection