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Implementation Program to Improve CHG Bathing Compliance

Primary Purpose

Central Line-associated Bloodstream Infection (CLABSI)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHG Education
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Central Line-associated Bloodstream Infection (CLABSI) focused on measuring implementation science, chlorhexidine gluconate bathing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Duke University Hospital
  • Wake Med

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CHG Bathing Implementation

Control

Arm Description

In a step-wedged design, ICUs and BMT units will be enrolled into a educational program to improve knowledge/compliance with daily CHG bathing

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

Outcomes

Primary Outcome Measures

CHG Bathing Documentation Compliance
(1) Compliance of daily CHG bathing documentation (measured via documentation audits)
CHG Bathing Process Compliance
(2) Compliance of CHG bathing process (measured via observational audits)

Secondary Outcome Measures

Unit Culture
(3) Unit culture (measured via the Context Assessment Index)
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)
CLABSIs
(5) CLABSI rates (measured via current National Healthcare Safety Network [NHSN] processes)

Full Information

First Posted
March 28, 2019
Last Updated
July 18, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03898115
Brief Title
Implementation Program to Improve CHG Bathing Compliance
Official Title
Effect of a Multifaceted Implementation Program on Compliance of Daily Chlorohexidine Bathing in Critical Care and Bone Marrow Units
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Line-associated Bloodstream Infection (CLABSI)
Keywords
implementation science, chlorhexidine gluconate bathing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHG Bathing Implementation
Arm Type
Experimental
Arm Description
In a step-wedged design, ICUs and BMT units will be enrolled into a educational program to improve knowledge/compliance with daily CHG bathing
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CHG Education
Intervention Description
The CHG educational intervention will include "educational outreach" and "audit and feedback" implementation strategies
Primary Outcome Measure Information:
Title
CHG Bathing Documentation Compliance
Description
(1) Compliance of daily CHG bathing documentation (measured via documentation audits)
Time Frame
Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020)
Title
CHG Bathing Process Compliance
Description
(2) Compliance of CHG bathing process (measured via observational audits)
Time Frame
Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020)
Secondary Outcome Measure Information:
Title
Unit Culture
Description
(3) Unit culture (measured via the Context Assessment Index)
Time Frame
Pre (month 0); will be open for 2 weeks
Title
Staff perceptions/knowledge of CHG bathing
Description
(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)
Time Frame
Pre (month 0) and post (170 weeks later)
Title
CLABSIs
Description
(5) CLABSI rates (measured via current National Healthcare Safety Network [NHSN] processes)
Time Frame
May 2019 - September 2020 (17 months total)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Staci Reynolds, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27110
Country
United States
Facility Name
Wake Med
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be available to other researchers.
Citations:
PubMed Identifier
34433015
Citation
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.
Results Reference
background
PubMed Identifier
35259215
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
33902653
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 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.
Results Reference
result
PubMed Identifier
35617584
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 01;41(4):200-208. doi: 10.1097/DCC.0000000000000530.
Results Reference
result

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Implementation Program to Improve CHG Bathing Compliance

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