Hospital-acquired Pneumonia Prevention: Intervention, Evaluation & Research

NCT04915898 | Completed

• 1 other identifier: 18.074.06
• Study Type: interventional
• Target: 8,709
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthcare-Associated Pneumonia

Keywords

oral hygiene; non-ventilator hospital acquired pneumonia

Outcome Measures

Primary Outcomes (1)

• Reduced non-ventilator hospital acquired pneumonia - NV-HAP

  Percent reduction of hospital acquired pneumonia

  One year - October 1, 2018-September 30, 2019

Secondary Outcomes (1)

• Incidence of NV- HAP

  One year - october 1, 2018-september 30, 2019

Other Outcomes (1)

• Compliance to oral care practices

  One year - October 1, 2018-September 30, 2019

Study Arms (2)

Oral Care Hygiene Intervention Group

ACTIVE COMPARATOR

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

Control group - standard of care oral care on units

NO INTERVENTION

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

Interventions

Oral Hygiene - teeth brushing OTHER

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

Oral Care Hygiene Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Orlando Health, Inc.: lead
• Medline Industries: collaborator

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Penoyer, PhD, RN

  Orlando Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Audits on two control units with no change in oral care practices. Emphasizing that we are supporting patient hygiene
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Nursing Research and Advanced Nursing Practice

Model Details: Cluster randomization of control and intervention groups

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: June 7, 2021
• Study Start: October 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: April 30, 2020
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)