Implementation Program to Improve CHG Bathing Compliance

Central Line-associated Bloodstream Infection (CLABSI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898115
• Other study ID #: Pro00101819
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 30, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Central Line-associated Bloodstream Infection (CLABSI)
• Sepsis

Intervention

Behavioral:
• CHG Education
The CHG educational intervention will include "educational outreach" and "audit and feedback" implementation strategies

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina
United States	Wake Med	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Reynolds SS, Granger BB, Hatch D. Self-Reported versus observed audit: Measuring CHG bathing compliance. Am J Infect Control. 2021 Dec;49(12):1575-1577. doi: 10.1016/j.ajic.2021.08.019. Epub 2021 Aug 22. — View Citation

Reynolds SS, Woltz P, Keating E, Neff J, Elliott J, Granger BB. Program Evaluation of Implementation Science Outcomes From an Intervention to Improve Compliance With Chlorhexidine Gluconate Bathing: A Qualitative Study. Dimens Crit Care Nurs. 2022 Jul-Aug — View Citation

Reynolds SS, Woltz P, Keating E, Neff J, Elliott J, Hatch D, Yang Q, Granger BB. Results of the CHlorhexidine Gluconate Bathing implementation intervention to improve evidence-based nursing practices for prevention of central line associated bloodstream i — View Citation

Reynolds SS, Woltz P, Neff J, Elliott J, Granger BB. Impact of an Implementation Science Study on Nursing Leader Competencies: A Qualitative Study. Nurse Leader. 2022; 20(1): 70-74.

Woltz PC, Granger BB, Reynolds SS. Measuring and Evaluating Clinical Context in Implementation Science Research. AACN Adv Crit Care. 2022 Mar 15;33(1):103-110. doi: 10.4037/aacnacc2022664. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Unit Culture	(3) Unit culture (measured via the Context Assessment Index)	Pre (month 0); will be open for 2 weeks
Secondary	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)
Secondary	CLABSIs	(5) CLABSI rates (measured via current National Healthcare Safety Network [NHSN] processes)	May 2019 - September 2020 (17 months total)