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Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections

Primary Purpose

Healthcare-associated Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Positive Deviance
Standard-of-Care Infection Control approach
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthcare-associated Infections focused on measuring Positive Deviance, Infection Control, Healthcare-Associated Infections, Staff Engagement, Cluster Randomized Controlled Trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

The intervention was performed on the staff members providing care in the three wards belonging to the intervention arm of the study. These staff members were invited to participate in the positive deviance intervention on a voluntary and anonymous basis.

The primary outcome was measured in all the patients who received care in the three intervention wards and the three control wards.

Inclusion Criteria:

  • For Intervention: All staff members employed in the study wards assigned to the intervention arm.
  • For Primary Outcome Assessment:

    • All patients admitted to any of the six study wards included in the study over the 24-month study period.

Exclusion Criteria:

-None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Positive Deviance Intervention Arm

    Control Arm

    Arm Description

    Three hospital wards received Positive Deviance intervention.

    Three hospital wards randomized to control arm received the Standard-of-Care Infection Control approach.

    Outcomes

    Primary Outcome Measures

    Number of HAI per 1000 patient-days per month.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2014
    Last Updated
    March 16, 2020
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02244905
    Brief Title
    Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections
    Official Title
    Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthcare-associated Infections
    Keywords
    Positive Deviance, Infection Control, Healthcare-Associated Infections, Staff Engagement, Cluster Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    16876 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Positive Deviance Intervention Arm
    Arm Type
    Experimental
    Arm Description
    Three hospital wards received Positive Deviance intervention.
    Arm Title
    Control Arm
    Arm Type
    Other
    Arm Description
    Three hospital wards randomized to control arm received the Standard-of-Care Infection Control approach.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Positive Deviance
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Standard-of-Care Infection Control approach
    Intervention Description
    Standard-of-Care Infection Control approach
    Primary Outcome Measure Information:
    Title
    Number of HAI per 1000 patient-days per month.
    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.
    Time Frame
    24 Months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    The intervention was performed on the staff members providing care in the three wards belonging to the intervention arm of the study. These staff members were invited to participate in the positive deviance intervention on a voluntary and anonymous basis. The primary outcome was measured in all the patients who received care in the three intervention wards and the three control wards. Inclusion Criteria: For Intervention: All staff members employed in the study wards assigned to the intervention arm. For Primary Outcome Assessment: All patients admitted to any of the six study wards included in the study over the 24-month study period. Exclusion Criteria: -None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pranavi Sreeramoju, MD
    Organizational Affiliation
    UT Southwestern Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections

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