Implementation Program to Improve CHG Bathing Compliance

NCT03898115 | Completed

• 1 other identifier: Pro00101819
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Central Line-associated Bloodstream Infection (CLABSI)

Keywords

implementation science; chlorhexidine gluconate bathing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Unit Culture

  Pre (month 0); will be open for 2 weeks

• Staff perceptions/knowledge of CHG bathing

  Pre (month 0) and post (170 weeks later)

• CLABSIs

  May 2019 - September 2020 (17 months total)

Study Arms (2)

CHG Bathing Implementation

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

CHG Education BEHAVIORAL

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

CHG Bathing Implementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke University Hospital

Durham, North Carolina, 27110, United States

Location

Wake Med

Raleigh, North Carolina, 27610, United States

Location

Related 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.

  PMID: 34433015 BACKGROUND

• 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. No abstract available.

  PMID: 35259215 BACKGROUND

• 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.

  BACKGROUND

• 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 infections Study (CHanGing BathS): a stepped wedge cluster randomized trial. Implement Sci. 2021 Apr 26;16(1):45. doi: 10.1186/s13012-021-01112-4.

  PMID: 33902653 RESULT

• 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 01;41(4):200-208. doi: 10.1097/DCC.0000000000000530.

  PMID: 35617584 RESULT

Study Officials

• Staci Reynolds, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: May 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: September 30, 2020
• Last Updated: July 20, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)