Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04915898 |
| Other study ID # |
18.074.06 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
April 30, 2020 |
Study information
| Verified date |
February 2024 |
| Source |
Orlando Health, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
