Chlorhexidine Gluconate Bathing Education Video Among Hospitalized Patients

Infections Clinical Trial

Official title:

Chlorhexidine Gluconate Bathing Education Video Intervention Among Hospitalized Patients: A Pragmatic Cluster Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112626
• Other study ID #: Pro00112033
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: Staci Reynolds, PhD
• Phone: 317-416-1858
• Email: staci.reynolds[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chlorhexidine gluconate (CHG) bathing is an effective intervention to reduce hospitalized patient's risk of acquiring a central line-associated bloodstream infection (CLABSI). While daily CHG bathing for hospitalized patients is widely supported in the literature, patient adherence with this practice is suboptimal. Written and verbal information is provided to patients by nursing staff regarding the importance of CHG bathing and the correct usage of the CHG cloths; however, these methods can be hindered by literacy and language barriers. Medical videos have become popular avenues to provide necessary education to patients, and have been shown to improve patient-reported outcomes. Whereas the benefits of educational videos has been described in previous studies on advanced care planning and postoperative quality of life, they have not been described for CHG bathing. In this study, we aim to provide education (including the rationale/importance of CHG bathing, and the appropriate process for bathing) through the use of a short video provided to hospitalized patients. The purpose of this study is to evaluate the use of medical videos to educate patients on CHG bathing while hospitalized in the inpatient setting.

Description:

For this study, approximately 16 inpatient units will be included; 8 will be randomized to the intervention (access to patient-facing CHG video) with the remaining units continuing with usual care (providing education via verbal/written information). All patients who require a CHG bath would be eligible to participate.

Intervention Group: In addition to the current educational document available for CHG bathing, patients admitted to the intervention units will be provided access to a CHG bathing video through multiple avenues (QR codes placed in the room/unit, video provided on unit iPads). Nurses will be instructed to provide QR codes to patients to scan and watch the video. Patients can scan the QR code using their own smart device or through unit-based iPads. After viewing the video, patients will be directed to scan a separate QR code to complete a voluntary questionnaire.

Control Group: Patients in the control group would have access to the current education available (patient education document) - usual care

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients admitted to an intervention unit who require a CHG skin treatment

Exclusion Criteria:

• CHG allergy

• Patients on comfort care

Related Conditions & MeSH terms

• Infections

Intervention

Behavioral:
• CHG Skin Treatment Video
Short CHG skin treatment video that reviews the rationale/importance of CHG bathing, and the appropriate process for bathing

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	Indiana University Health University Hospital	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Indiana University Health, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a documented chlorhexidine gluconate bath documentation compliance	Compliance with documenting CHG bath treatment in the electronic health record; measured via a report from the electronic health record	Up to 12 months
Secondary	Rate of central line associated bloodstream infections per 1000 central line days	Central line associated bloodstream infection rate per 1000 patient days, measured by standard National Healthcare Safety Network (NHSN) criteria by the hospital's infection prevention departments	Up to 12 months
Secondary	Patient use of CHG skin treatment video	number of patients who opened the video, percentage of patients who opened the video (# of video views / total # of patients admitted to the unit per month), percentage of the video viewed	4 weeks
Secondary	Patient-centered outcome questionnaire	Patients' perceptions of: how helpful they found the video; if they are likely to participate in CHG skin treatments; how comfortable they were watching the video	4 weeks