Clinical trial NCT03382730: De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mortality
Oral Health
Dryness, Mouth
Pain, Orofacial
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Toronto General Hospital
name: University Health Network, Toronto
name: Unity Health Toronto
name: MOUNT SINAI HOSPITAL
First posted: 2017-12-26
Enrollment: 3260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centered stepped wedge cluster randomized controlled trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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..

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Does not meet inclusion criteria.

Primary outcomes:
measure: Intensive Care Unit (ICU) Mortality
timeFrame: 14 months
Secondary outcomes:
measure: Infection-related ventilator-associated complications (IVACs)
timeFrame: 14 months
measure: Beck Oral Assessment Score (BOAS), Modified
timeFrame: 14 months
measure: Critical Care Pain Observational Tool (CPOT)
timeFrame: 14 months
measure: Oral Dryness - Numeric Rating Intensity Scale (NRS)
timeFrame: 14 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Brian Cuthbertson, MD FRCA
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre; University of Toronto
name: Craig Dale, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dale CM, Rose L, Carbone S, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Pinto R, Quinonez 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.
citation: 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 intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial. Intensive Care Med. 2021 Nov;47(11):1295-1302. doi: 10.1007/s00134-021-06475-2. Epub 2021 Oct 5.