Skip to main content
OpenTrials
Completed

NCT Number: NCT03898115

Implementation Program to Improve CHG Bathing Compliance

This study will be a 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 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. Primary outcomes and CLABSI rates will be measured at 12 months to assess sustainability.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital, Durham, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CHG Education

Behavioral

The CHG educational intervention will include "educational outreach" and "audit and feedback" implementation strategies

Primary outcomes

  1. CHG Bathing Documentation Compliance

    Time frame: Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020)

    (1) Compliance of daily CHG bathing documentation (measured via documentation audits)

  2. CHG Bathing Process Compliance

    Time frame: Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020)

    (2) Compliance of CHG bathing process (measured via observational audits)

Secondary outcomes

  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: May 2019 - September 2020 (17 months total)

    (5) CLABSI rates (measured via current National Healthcare Safety Network [NHSN] processes)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Effect of a Multifaceted Implementation Program on Compliance of Daily Chlorohexidine Bathing in Critical Care and Bone Marrow Units

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.