Hospital-acquired Pneumonia Prevention: Intervention, Evaluation & Research (HAPPIER-1)

Oral Care as Prevention for Non-ventilator Hospital-acquired Pneumonia: A Four-unit Cluster Randomized Study

The purpose of this study is to determine the effectiveness of a universal, standardized oral care protocol on prevention of non-ventilated hospital-acquired pneumonia (NV-HAP) in the acute care setting. In the course of the year-long study, the research team will provide educational and materials support for oral hygiene on two interventional units (one medical; one surgical) and two control units (one matched medical; one surgical). At the end of the study, the research team will evaluate existing hospital data to determine the number of NV-HAPs in the interventional and control groups.

Study Overview

• Status: Completed
• Conditions: Healthcare-Associated Pneumonia
• Intervention / Treatment: Other: Oral Hygiene - teeth brushing

Detailed Description

Prior to the study, the research team will have a lead-in period where education will be provided to the interventional groups and demonstration of desired oral care practices for patients (September 1-30, 2018) Design Previous research on the effectiveness of oral care for NV-HAP prevention has primarily relied on pre/post intervention study designs. In order to enhance compliance and avoid contamination of both the treatment and intervention groups, the research proposed the use of cluster randomization.

ICD-10 codes and a standardized CDC definition of non-ventilator hospital-acquired pneumonia will be used to determine the baseline incidence on NV-HAP for the 12 months prior to study implementation. The incidence will be expressed as both an overall incidence based on total patient days, as well as a rate per 1000 patient days.

The research team will follow the consolidated standards of reporting trials (CONSORT) research methods and reporting for pragmatic trials (2010). The research team will implement the HAPPI protocol using Stetler's model of implementation science. Overall the implementation process will be guided by Influencer Model ™ .

Methods There are no experimental procedures or medications use proposed in this study. The study consists of implementing a standardized oral care protocol (Attachment A) which are components of basic nursing care. Previous research has found that opportunities for oral care were often missed as part of daily care. The research team proposed to set specific standards and protocols for delivery of oral care on the intervention unit and to monitor the amount of oral care provided on both the control and intervention units.

The evidence-based oral care protocol consists of:

• oral care assessment by a RN to determine type and frequency oral care
• brushing the teeth with a soft-bristled toothbrush and plaque removing toothpaste
• rinsing with a non-alcohol based mouth wash
• application of lip and mouth moisturizer
• use of 24-hour suction toothbrush kits for high aspiration-risk patients who meet criteria, per oral care protocol

The study coordinator will provide educational information and support on the study units for use of the oral care kit and implementation of oral care after meals and before bedtime on the interventional units. As part of validation of oral care, the coordinator will make rounds on patients on the study units and validate and audit oral care activities with the patient/family and encourage their participation in oral care and with documentation checks. On the control units, the coordinator will also make rounds and evaluate oral care frequency in a non-conspicuous manner and through documentation.

• Study Type: Interventional
• Enrollment (Actual): 8709
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• in-patient adults (18 and older) in control (one medical/one surgical) and interventional (one medical/one surgical) study units in whom oral care is not contraindicated

Exclusion Criteria:

• patients who are on mechanical ventilation, intubated orally, or with tracheostomy
• patients who have contraindications for oral care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Care Hygiene Intervention Group; Providing oral care kits designed to facilitate adherence to brushing teeth after meals and before sleep. Providing continuous education and feedback on performance to team members on the interventional units. Encouraging patients to brush their teeth and use the kits or own materials if desired.	Other: Oral Hygiene - teeth brushing; Oral hygiene using a special kit with recommended materials and instructions: Use of an ADA approved toothbrush, toothpaste with dentifrice, antiseptic mouthwash and non-drying lip moisturizer encouraged after meals and at bedtime
No Intervention: Control group - standard of care oral care on units; These units will perform their 'usual' or standard of care for oral hygiene practices without use of the oral care kits, no encouragement to perform outside of usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced non-ventilator hospital acquired pneumonia - NV-HAP	Percent reduction of hospital acquired pneumonia	One year - October 1, 2018-September 30, 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of NV- HAP	Incidence of NV-HAP per 1000 patient days	One year - october 1, 2018-september 30, 2019

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to oral care practices	The number of oral care practices per patient per day	One year - October 1, 2018-September 30, 2019

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Collaborators: Medline Industries
• Investigators: Principal Investigator: Elizabeth Penoyer, PhD, RN, Orlando Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: oral hygiene; non-ventilator hospital acquired pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia
• Other Study ID Numbers: 18.074.06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No