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

Primary Purpose

Healthcare-Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Hygiene - teeth brushing
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthcare-Associated Pneumonia focused on measuring oral hygiene; non-ventilator hospital acquired pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orlando Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Oral Care Hygiene Intervention Group

Control group - standard of care oral care on units

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Reduced non-ventilator hospital acquired pneumonia - NV-HAP
Percent reduction of hospital acquired pneumonia

Secondary Outcome Measures

Incidence of NV- HAP
Incidence of NV-HAP per 1000 patient days

Full Information

First Posted
February 25, 2021
Last Updated
May 31, 2021
Sponsor
Orlando Health, Inc.
Collaborators
Medline Industries
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1. Study Identification

Unique Protocol Identification Number
NCT04915898
Brief Title
Hospital-acquired Pneumonia Prevention: Intervention, Evaluation & Research
Acronym
HAPPIER-1
Official Title
Oral Care as Prevention for Non-ventilator Hospital-acquired Pneumonia: A Four-unit Cluster Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando Health, Inc.
Collaborators
Medline Industries

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare-Associated Pneumonia
Keywords
oral hygiene; non-ventilator hospital acquired pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomization of control and intervention groups
Masking
Care Provider
Masking Description
Audits on two control units with no change in oral care practices. Emphasizing that we are supporting patient hygiene
Allocation
Non-Randomized
Enrollment
8709 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Care Hygiene Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group - standard of care oral care on units
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Oral Hygiene - teeth brushing
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduced non-ventilator hospital acquired pneumonia - NV-HAP
Description
Percent reduction of hospital acquired pneumonia
Time Frame
One year - October 1, 2018-September 30, 2019
Secondary Outcome Measure Information:
Title
Incidence of NV- HAP
Description
Incidence of NV-HAP per 1000 patient days
Time Frame
One year - october 1, 2018-september 30, 2019
Other Pre-specified Outcome Measures:
Title
Compliance to oral care practices
Description
The number of oral care practices per patient per day
Time Frame
One year - October 1, 2018-September 30, 2019

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Penoyer, PhD, RN
Organizational Affiliation
Orlando Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hospital-acquired Pneumonia Prevention: Intervention, Evaluation & Research

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