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Completed Not applicable Interventional Accepts healthy volunteers

Implementation Program to Improve CHG Bathing Compliance

ClinicalTrials.gov ID: NCT03898115

Public ClinicalTrials.gov record NCT03898115. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 12:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03898115
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Duke University
Other
Enrollment
14 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2019
Primary completion
Oct 30, 2019
Completion
Sep 29, 2020
Last update posted
Jul 19, 2022

2019 – 2020

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Duke University Hospital Durham North Carolina 27110
Wake Med Raleigh North Carolina 27610

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03898115, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 19, 2022 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03898115 live on ClinicalTrials.gov.

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