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Implementation Program to Improve CHG Bathing Compliance

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ClinicalTrials.gov Identifier: NCT03898115
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:

This study will be multicenter, cluster randomized, step-wedged design. The unit of randomization will be the inpatient units admitted critically ill patients, with the interventions being carried out over 4 months. The study plans to enroll approximately 14 units at 2 sites. Four sequences will be enrolled into the intervention each month; each sequence will have 3-4 units (see figure 1).

Units eligible for the study will have patients that are critically ill admitted and have had at least 1 CLABSI events over the past 12 months (fiscal year). Given the pragmatic nature of the study design, there will be limited additional inclusion and exclusion criteria. Prior to the beginning the study, all nursing staff (RNs and nursing assistants [NAs]) will receive a survey link (RedCAP) to understand their perceptions of CHG bathing. After all units have been enrolled (approximately 4 months), nursing staff will be sent a post-survey to see if their perceptions have improved after the program. Further, the Context Assessment Index (used with permission; via RedCAP) will also be used to assess the context (i.e., culture) in which clinicians works and the effect this has on using evidence in practice. This will be provided to infection prevention champions on each unit one time, at the beginning of enrollment.

All hospitals in the trial will receive access to site-level quality reports on CLABSI data. The interventions will include a "direct engagement" at the site level; this strategy will build upon current quality improvement interventions developed from the Agency for Healthcare Research & Quality for optimization of care for critically ill patients at risk for CLABSIs. The multidisciplinary teams will include national key opinion leaders in quality improvement working with local infection prevention specialists and support staff to help healthcare systems and hospitals design or revise quality improvement plans. Units will receive feedback on quality improvement efforts, including audit and feedback reviewing their CHG bathing compliance and CLABSI rates. Duke will serve as the primary statistical center and analysis will be generated by Duke. The only risk in this study is the possibility of breach of confidentiality.

The primary objective of this study is to assess the effect of a customized, multifaceted quality improvement [QI] program on compliance with daily chlorhexidine gluconate (CHG) bathing per the AHRQ protocol in inpatient units that admit critically ill patients. Further, we will assess the effect of this program on nursing staffs' perception of the importance of CHG bathing. The Context Assessment Index (used with permission) will also be used to assess the context (i.e., culture) in which clinicians works and the effect this has on using evidence in practice. The secondary objective of this study is to examine the effect of the QI program on central line associated bloodstream infection (CLABSI) rates.


Condition or disease Intervention/treatment Phase
Central Line-associated Bloodstream Infection (CLABSI) Behavioral: CHG Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This study will be multicenter, cluster randomized, step-wedged design. The unit of randomization will be the inpatient units admitted critically ill patients, with the interventions being carried out over 4 months. The study plans to enroll approximately 14 units at 2 sites. Four sequences will be enrolled into the intervention each month; each sequence will have 3-4 units
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of a Multifaceted Implementation Program on Compliance of Daily Chlorohexidine Bathing in Critical Care and Bone Marrow Units
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: CHG Bathing Implementation
In a step-wedged design, ICUs and BMT units will be enrolled into a educational program to improve knowledge/compliance with daily CHG bathing
Behavioral: CHG Education
The CHG educational intervention will include "educational outreach" and "audit and feedback" implementation strategies

No Intervention: Control
In a step-wedged design, ICUs and BMT units will be enrolled over a rolling 4 month time frame; when not enrolled, this data will serve as control data



Primary Outcome Measures :
  1. CHG Bathing Documentation Compliance [ Time Frame: 6 months ]
    (1) Compliance of daily CHG bathing documentation (measured via documentation audits)

  2. CHG Bathing Process Compliance [ Time Frame: 6 months ]
    (2) Compliance of CHG bathing process (measured via observational audits)


Secondary Outcome Measures :
  1. Unit Culture [ Time Frame: Pre (month 0); will be open for 2 weeks ]
    (3) Unit culture (measured via the Context Assessment Index)

  2. Staff perceptions/knowledge of CHG bathing [ Time Frame: Pre (month 0) and post (170 weeks later) ]
    (4) Nursing staffs' perceptions of CHG bathing (measured via a Qualtrics pre- and post-survey of 24 total questions; 12 demographic and 12 related to CHG bathing)

  3. CLABSIs [ Time Frame: 12 months ]
    (5) CLABSI rates (measured via current National Healthcare Safety Network [NHSN] processes)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Units eligible for the study will have patients that are critically ill admitted and have had at least 1 CLABSI events over the past 12 months (fiscal year).

Exclusion Criteria:

  • Units with 0 CLABSIs over the past 12 months (fiscal year).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898115


Contacts
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Contact: Staci Reynolds, PhD 9196843865 staci.reynolds@duke.edu
Contact: Bradi Granger, PhD 9193084982 bradi.granger@duke.edu

Locations
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United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27110
Contact: Staci Reynolds, PhD    919-684-3865    staci.reynolds@duke.edu   
Contact: Bradi Granger, PhD       bradi.granger@duke.edu   
Wake Med Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Pat Woltz    919-350-1700    pwoltz@wakemed.org   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Staci Reynolds, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03898115     History of Changes
Other Study ID Numbers: Pro00101819
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
implementation science
chlorhexidine gluconate bathing