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Trial record 5 of 5 for:    FCNS

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

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ClinicalTrials.gov Identifier: NCT04915898
Recruitment Status : Completed
First Posted : June 7, 2021
Last Update Posted : June 7, 2021
Sponsor:
Collaborator:
Medline Industries
Information provided by (Responsible Party):
Daleen Penoyer, PhD,RN,CCRP,FCNS,FCCM, Orlando Health, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthcare-Associated Pneumonia Other: Oral Hygiene - teeth brushing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8709 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomization of control and intervention groups
Masking: Single (Care Provider)
Masking Description: Audits on two control units with no change in oral care practices. Emphasizing that we are supporting patient hygiene
Primary Purpose: Prevention
Official Title: Oral Care as Prevention for Non-ventilator Hospital-acquired Pneumonia: A Four-unit Cluster Randomized Study
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : April 30, 2020


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



Primary Outcome Measures :
  1. Reduced non-ventilator hospital acquired pneumonia - NV-HAP [ Time Frame: One year - October 1, 2018-September 30, 2019 ]
    Percent reduction of hospital acquired pneumonia


Secondary Outcome Measures :
  1. Incidence of NV- HAP [ Time Frame: One year - october 1, 2018-september 30, 2019 ]
    Incidence of NV-HAP per 1000 patient days


Other Outcome Measures:
  1. Compliance to oral care practices [ Time Frame: One year - October 1, 2018-September 30, 2019 ]
    The number of oral care practices per patient per day



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04915898


Locations
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United States, Florida
Orlando Health
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Orlando Health, Inc.
Medline Industries
Investigators
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Principal Investigator: Elizabeth Penoyer, PhD, RN Orlando Health, Inc.
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Responsible Party: Daleen Penoyer, PhD,RN,CCRP,FCNS,FCCM, Director, Center for Nursing Research and Advanced Nursing Practice, Orlando Health, Inc.
ClinicalTrials.gov Identifier: NCT04915898    
Other Study ID Numbers: 18.074.06
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daleen Penoyer, PhD,RN,CCRP,FCNS,FCCM, Orlando Health, Inc.:
oral hygiene; non-ventilator hospital acquired pneumonia
Additional relevant MeSH terms:
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Pneumonia
Healthcare-Associated Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes