De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle (CHORAL)

Mortality Clinical Trial

— CHORAL  

Official title:

A Multi-centered Stepped Wedge Cluster Randomized Controlled Trial of the De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle for Ventilated Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382730
• Other study ID #: 0913
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2022
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the CHORAL study is to evaluate the de-adoption of oral chlorhexidine and the introduction of a bundle of oral care practices on selected outcomes in critically ill mechanically ventilated adults.

Description:

Infrequent or ineffective oral care can lead to mouth discomfort and lung infection for patients treated with ventilators (breathing machines) in intensive care units (ICUs). A commonly used mouthwash called chlorhexidine can reduce lung infection but most recent evidence shows it may increase the risk of death. In this study 6 participating intensive care units (ICUs) will de-adopt oral chlorhexidine and introduce a bundle of oral care practices using a multi-faceted educational tool kit. The investigators will measure changes in patient-oriented outcomes including mortality, ventilator-associated complications (VACs) and oral health status. A concurrent process evaluation will study how the intervention is delivered and received by patients and clinicians..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3260
• Est. completion date: January 1, 2020
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients who receive mechanical ventilation in the participating ICUs.

Exclusion Criteria:

• Does not meet inclusion criteria.

Related Conditions & MeSH terms

• Dryness, Mouth
• Facial Pain
• Mortality
• Oral Health
• Pain, Orofacial
• Xerostomia

Intervention

Other:
• Chlorhexidine Mouth Rinse
Oral chlorhexidine gluconate oral rinse
• Chlorhexidine Mouth Rinse De-Adoption
Multifaceted education and audit/feedback.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
University of Toronto	MOUNT SINAI HOSPITAL, Sunnybrook Health Sciences Centre, Toronto General Hospital, Unity Health Toronto, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Dale CM, Rose L, Carbone S, Pinto R, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Scales DC, Cuthbertson BH. Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the — View Citation

Dale CM, Rose L, Carbone S, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Pinto R, Quiñonez CR, Sutherland S, Scales DC, Cuthbertson BH. Protocol for a multi-centered, stepped wedge, cluster randomized controlled trial of the de-adoption of oral chlorhexidine prophylaxis and implementation of an oral care bundle for mechanically ventilated critically ill patients: the CHORAL study. Trials. 2019 Oct 24;20(1):603. doi: 10.1186/s13063-019-3673-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Care Unit (ICU) Mortality	All-cause mortality at time of ICU discharge	14 months
Secondary	Infection-related ventilator-associated complications (IVACs)	Changes in IVACs rates between groups	14 months
Secondary	Beck Oral Assessment Score (BOAS), Modified	Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).	14 months
Secondary	Critical Care Pain Observational Tool (CPOT)	Changes in oropharyngeal pain between groups. CPOT scores range from 0-8 with a score >2 indicating presence of pain.	14 months
Secondary	Oral Dryness - Numeric Rating Intensity Scale (NRS)	Changes in oral dryness scores between groups. NRS scores range from 0 (no dryness) to 10 (severe dryness).	14 months