Implementation Program to Improve CHG Bathing Compliance

Study Overview
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Brief Summary
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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.

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

Conditions
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Central Line-associated Bloodstream Infection (CLABSI)

Intervention / Treatment
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* Behavioral: CHG Education


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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 initial intervention 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHG Bathing Implementation<br>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<br>* The CHG educational intervention will include educational outreach and audit and feedback implementation strategies<br>|
| No Intervention: Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHG Bathing Documentation Compliance | (1) Compliance of daily CHG bathing documentation (measured via documentation audits) | Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020) | 
| CHG Bathing Process Compliance | (2) Compliance of CHG bathing process (measured via observational audits) | Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unit Culture | (3) Unit culture (measured via the Context Assessment Index) | Pre (month 0); will be open for 2 weeks | 
| Staff perceptions/knowledge of CHG bathing | (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) | Pre (month 0) and post (170 weeks later) | 
| CLABSIs | (5) CLABSI rates (measured via current National Healthcare Safety Network [NHSN] processes) | May 2019 - September 2020 (17 months total) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation science, chlorhexidine gluconate bathing