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

Study Overview
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Brief Summary
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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
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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..

Official Title
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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

Conditions
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Mortality, Oral Health, Dryness, Mouth, Pain, Orofacial

Intervention / Treatment
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* Other: Chlorhexidine Mouth Rinse
* Other: Chlorhexidine Mouth Rinse De-Adoption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who receive mechanical ventilation in the participating ICUs. Exclusion Criteria: Does not meet inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-centered stepped wedge cluster randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oral Chlorhexidine Mouth Rinse<br>Application of chlorhexidine gluconate mouth rinse per unit protocol. | Other: Chlorhexidine Mouth Rinse<br>* Oral chlorhexidine gluconate oral rinse<br>* Other names: Chlorhexidine;|
| Experimental: De-Adoption of Oral Chlorhexidine Mouth Rinse<br>No application of chlorhexidine gluconate mouth rinse. Oral care bundle. | Other: Chlorhexidine Mouth Rinse De-Adoption<br>* Multifaceted education and audit/feedback.<br>* Other names: De-adopt chlorhexidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit (ICU) Mortality | All-cause mortality at time of ICU discharge | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection-related ventilator-associated complications (IVACs) | Changes in IVACs rates between groups | 14 months | 
| Beck Oral Assessment Score (BOAS), Modified | Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction). | 14 months | 
| 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 | 
| 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 |