Healthcare-Associated PneumoniaHAPPIER-1NCT04915898
Hospital-acquired Pneumonia Prevention: Intervention, Evaluation & Research
A study testing Oral Hygiene - teeth brushing in people with Healthcare-Associated Pneumonia, run by Orlando Health, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare-Associated Pneumonia
- What is being tested?
- Oral Hygiene - teeth brushing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,709 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients who are on mechanical ventilation, intubated orally, or with tracheostomy
- patients who have contraindications for oral care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthcare-Associated Pneumonia
- Being tested
- Oral Hygiene - teeth brushing
- Keywords
- oral hygiene; non-ventilator hospital acquired pneumonia
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Hygiene - teeth brushingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced non-ventilator hospital acquired pneumonia - NV-HAP
Percent reduction of hospital acquired pneumonia
Measured: One year - October 1, 2018-September 30, 2019
Secondary outcomes (1)
Incidence of NV- HAP
Incidence of NV-HAP per 1000 patient days
Measured: One year - october 1, 2018-september 30, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Oct 2018
- Primary completion30 Nov 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare-Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization of control and intervention groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 8,709 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Medline Industries
- Responsible party
- Principal investigator, Daleen Penoyer, PhD,RN,CCRP,FCNS,FCCM, Orlando Health, Inc.
- Investigators
- Elizabeth Penoyer, PhD, RN, Principal investigator, Orlando Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915898
- Sponsor's protocol ID
- 18.074.06
- Acronym
- HAPPIER-1
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care as Prevention for Non-ventilator Hospital-acquired Pneumonia: A Four-unit Cluster Randomized Study
- ClinicalTrials.gov ID
- NCT04915898
- Acronym / sponsor ID
- HAPPIER-1 / 18.074.06
- Conditions
- Healthcare-Associated Pneumonia
- Keywords
- oral hygiene; non-ventilator hospital acquired pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,709 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Collaborators
- Medline Industries
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Cluster randomization of control and intervention groups
| Arm | Type | Receives |
|---|---|---|
| Oral Care Hygiene Intervention Group | Active comparator | Other: Oral Hygiene - teeth brushingProviding 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- patients who are on mechanical ventilation, intubated orally, or with tracheostomy
- patients who have contraindications for oral care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Hygiene - teeth brushingOral 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 | Other | Oral Care Hygiene Intervention Group |
Primary outcome
Reduced non-ventilator hospital acquired pneumonia - NV-HAP
Time frame: One year - October 1, 2018-September 30, 2019
Percent reduction of hospital acquired pneumonia
1 secondary outcome
Incidence of NV- HAP
Time frame: One year - october 1, 2018-september 30, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Penoyer, PhD, RN principal investigator
Orlando Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Hygiene - teeth brushing in people with Healthcare-Associated Pneumonia, run by Orlando Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced non-ventilator hospital acquired pneumonia - NV-HAP (time frame: One year - October 1, 2018-September 30, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.