NCT02244905

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,876

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

September 15, 2014

Last Update Submit

March 16, 2020

Conditions

Keywords

Positive DevianceInfection ControlHealthcare-Associated InfectionsStaff EngagementCluster Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 Months

Study Arms (2)

Positive Deviance Intervention Arm

EXPERIMENTAL

Three hospital wards received Positive Deviance intervention.

Behavioral: Positive DevianceOther: Standard-of-Care Infection Control approach

Control Arm

OTHER

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

Other: Standard-of-Care Infection Control approach

Interventions

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.

Positive Deviance Intervention Arm

Standard-of-Care Infection Control approach

Control ArmPositive Deviance Intervention Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pranavi Sreeramoju, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 19, 2014

Study Start

August 1, 2011

Primary Completion

March 1, 2013

Study Completion

August 1, 2014

Last Updated

March 17, 2020

Record last verified: 2020-03