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Central Line-associated Bloodstream Infection (CLABSI)NCT03898115

Implementation Program to Improve CHG Bathing Compliance

A study testing CHG Education in people with Central Line-associated Bloodstream Infection (CLABSI), run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
CHG Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesUnited States
Study dates
1 May 2019to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University Hospital

    Durham, North Carolina, 27110

  • Wake Med

    Raleigh, North Carolina, 27610

Other trials in United States

About this study

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

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.

Read more

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.

Being tested
CHG Education
Keywords
implementation science, chlorhexidine gluconate bathing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHG EducationBehavioural

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

Study groups in NCT03898115
Study groupRoleWhat they receive
CHG Bathing ImplementationExperimentalIn a step-wedged design, ICUs and BMT units will be enrolled into a educational program to improve knowledge/compliance with daily CHG bathing
Receives: Behavioral: CHG Education
ControlNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. CHG Bathing Documentation Compliance

    (1) Compliance of daily CHG bathing documentation (measured via documentation audits)

    Measured: Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020)

  2. CHG Bathing Process Compliance

    (2) Compliance of CHG bathing process (measured via observational audits)

    Measured: Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020)

Secondary outcomes (3)

  1. Unit Culture

    (3) Unit culture (measured via the Context Assessment Index)

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

  2. 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)

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

  3. CLABSIs

    (5) CLABSI rates (measured via current National Healthcare Safety Network [NHSN] processes)

    Measured: May 2019 - September 2020 (17 months total)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start1 May 2019
  3. Primary completion31 Oct 2019
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
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)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03898115
Sponsor's protocol ID
Pro00101819
Status last verified
Feb 2020
First submitted
28 Mar 2019
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be available to other researchers.

Publications

  • 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.

    PubMed 34433015

  • 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.

    PubMed 35259215

  • 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.

  • 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.

    PubMed 33902653

  • 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.

    PubMed 35617584

Questions about this trial

What is this clinical trial studying?

A study testing CHG Education in people with Central Line-associated Bloodstream Infection (CLABSI), run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHG Bathing Documentation Compliance (time frame: Span of 17 months total (initial intervention May - Oct. 2019; sustainability Sept. 2020)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03898115, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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