Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000187549
Ethics application status
Approved
Date submitted
21/01/2024
Date registered
27/02/2024
Date last updated
27/02/2024
Date data sharing statement initially provided
27/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Hospital Acquired Pneumonia PrEveNtion (The HAPPEN study): exploring the effectiveness of oral care on the incidence of pneumonia in hospitalised patients.
Scientific title
Hospital Acquired Pneumonia PrEveNtion (The HAPPEN study): A multi-centre randomised control trial exploring the effectiveness of improving the frequency and quality of oral care, in reducing the incidence of pneumonia in hospitals.
Secondary ID [1] 311364 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HAPPEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital-acquired pneumonia 332632 0
Condition category
Condition code
Infection 329337 329337 0 0
Other infectious diseases
Respiratory 329508 329508 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will develop a multi-modal intervention that aims to improve the frequency and quality of oral care for patients in hospitals. This intervention will be developed in consultation with healthcare professionals and consumers. Clinical evidence from the literature will be used to help design the intervention strategy. The three pillars of the intervention include oral care, education, and audit/feedback.

1. Oral care
During the intervention, every patient on the ward will be assisted with oral care by a nurse. Oral care includes cleaning of the teeth/dentures, tongue, moisturising the lips, using toothbrushes suitable for elderly populations, and toothpaste containing sodium bicarbonate.
The goal is for oral care to be performed twice a day, increasing to 4-hourly in participants who are nil by mouth or require assistance with oral care (dependent participants).
An oral care pack (containing a toothbrush and sodium bicarbonate toothpaste) will be offered to all hospitals, improving the ease of use. It is not mandatory for patients to use the provided pack, it is provided as an optional resource to aid the intervention.
The patient will be encouraged and reminded to undertake oral care by the study and nursing team; for dependent participants, a suction toothbrush may be used, with oral care provided by nursing staff, supported by the study team (research nurse).

2. Education
For Staff
Face-to-face education and educational resources (developed in our foundation work) for nursing staff will be provided immediately before the intervention phase and reinforced during the intervention. A nurse on the study team will assist in disseminating educational resources to staff on the participating wards. The initial training session will be run by a nurse on the research team, and consist of a 30-min face-to-face session with nursing staff on the wards, to describe the project and how to use the oral care pack. The nurse employed by the study will be available for training and/or to answer questions weekdays during the intervention, thus there is no limit to the frequency/duration of education provided. Additional training sessions will be run as needed, depending on the need (example: a face-to-face 10 min training session to refresh training on the technique of providing oral care).
For patients
The face-to-face education for patients will be delivered by a nurse on the research team with the appropriate qualifications and experience. The education topics covered include: why improving oral care may reduce the incidence of pneumonia, the correct technique of oral care, where to find information and resources (for example, the study website). This nurse will be available on the ward weekdays during the intervention, thus there is no limit to the frequency/duration of education provided.
Resources
Additional online resources will be made available to participating wards that cover the topics covered in the face-to-face education sessions. Examples of these include: a video explaining why improving oral care may reduce the incidence of pneumonia, a video of a nurse providing oral care to a patient, a link to the study website and a flyer that describes the relationship between oral care and pneumonia. The use of resources will be available for all patients and staff, but will not be monitored. The online resources will be designed specifically for this study, in co-design with consumers and clinicians.

3. Audit/feedback
Adherence to the intervention will be monitored electronically by reviewing hospital notes and recording when patients/nurses performed oral care. The nurse employed by the study team will have the ability to record when patients performed, or were assisted with oral care. Nurses can also record when the supplied oral care pack is given to patients, to help monitor stock levels. Audit results will be used to inform further informal face to face education and training. Additional reports will be provided for internal committees, such as the Infection Prevention and Control committee, as required. Ongoing education will be based on a behaviour change model – based on information obtained during the trial regarding how many times a day patients perform oral care. The nurses employed by the research team will provide monthly feedback on the number of cases of HAP and compliance with the intervention to nursing staff. This will be face-to-face or via email, depending on the preference of the nursing staff. Adherence to the education, for example following correct technique of oral care, will not be audited.
Intervention code [1] 327806 0
Prevention
Comparator / control treatment
The usual practice of oral care will continue during the control phase. The usual practice of oral care is determined by local practice and policy. These will be described in any future reporting. Generally, standard oral care would include supporting the brushing someone’s teeth at least once per day, using a toothbrush and toothpaste. 
No education will be provided and no feedback on the cases of HAP will be provided during the control phase.
Control group
Active

Outcomes
Primary outcome [1] 337154 0
Incidence of HAP, measured as the number of cases per 100 admissions.
Timepoint [1] 337154 0
All patients discharged from participating wards during the study period will be included for analysis. For example, once a patient has been discharged from the participating ward their medical records will be used to determine if they acquired a respiratory infection during their most recent hospital stay.
Secondary outcome [1] 430874 0
Incidence of lower and upper respiratory tract infection, per 100 admissions (composite outcome).
Timepoint [1] 430874 0
All patients discharged from participating wards during the study period will be included for analysis. For example, once a patient has been discharged from the participating ward their medical records will be used to determine if they acquired a respiratory infection during their most recent hospital stay.
Secondary outcome [2] 430875 0
Estimate excess attributable length of stay in hospital associated with HAP
Timepoint [2] 430875 0
Participants will be assessed for their length of stay once they have been discharged from hospital. For example, once a patient has been discharged from the participating ward their medical records will be used to determine the length of their hospital stay. The secondary outcome [2] will be assessed at the conclusion of the study for control and intervention periods.
Secondary outcome [3] 430876 0
Description of the patient experience of having HAP
Timepoint [3] 430876 0
Once a patient has recovered from HAP, they will be invited to participate in an interview. Interviews will occur within 3 months of discharge from our study hospitals at a time convenient for the patient.
Secondary outcome [4] 430877 0
Understanding clinician barriers, enablers and the experience of implementing the intervention and educational approaches used (composite outcome).
Timepoint [4] 430877 0
An invitation to participate will be shared electronically and in flyers to nurses on the participating wards at the conclusion of the intervention period. Interviews will occur within 1 month of the conclusion of the intervention period.
Secondary outcome [5] 430878 0
Evaluating the cost-effectiveness of adopting the intervention
Timepoint [5] 430878 0
This secondary outcome will be assessed at the conclusion of the trial, when all hospitals have finished the intervention period.

Eligibility
Key inclusion criteria
The eligible hospital will meet the following criteria:
• classified as a “Public acute group A hospital” by the Australian Institute of Health and Welfare and
• have an intensive care unit and
• have on average, over 50,000 admissions each year and

Three Australian hospitals categorised by the Australian Institute of Health and Welfare as either a principal referral hospital, public hospital (Group A) or private hospital (Group A) will participate in the study. We will randomly select three eligible wards, within each hospital. Wards will qualify for inclusion if they have one or more of the following characteristics enabling the recruitment of participants at greater risk of HAP: medical ward, stroke ward, patients with an average age greater than 70 years. Eligible wards must have a turnover of approximately 150 patients per month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions include: any unit that cares for ventilated patients, paediatric, neonatal, adolescent, mental health, medical admission units and wards managing specific respiratory conditions e.g., COVID-19.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A research assistant will collect data from patients’ records (electronic medical record and pathology). The research assistant will be blinded from knowing whether the ward they are collecting data on is a control or intervention ward. Thus, allocation was concealed as the person who determined if a subject was eligible for inclusion in the trial (the data collector) was unaware, when this decision was made, whether the patient was in the control or intervention period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation for the study will be performed through the allocation of cluster identifiers prior to commencement of the intervention roll-out. There will be sequential roll-out of the intervention. All wards receive the intervention, with the timing randomised. An independent statistician will be responsible for computer generation of the allocation times and the allocation of hospital identifiers. Wards will be informed of their intervention start date four weeks prior.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2024
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
15000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 315624 0
Government body
Name [1] 315624 0
Medical Research Future Fund, administered by the National Health and Medical Research Council
Country [1] 315624 0
Australia
Primary sponsor type
University
Name
Avondale University
Address
582 Freemans Drive, Cooranbong NSW 2265 Australia
Country
Australia
Secondary sponsor category [1] 317718 0
None
Name [1] 317718 0
Address [1] 317718 0
Country [1] 317718 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314507 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 314507 0
Locked Bag 1 New Lambton NSW 2305
Ethics committee country [1] 314507 0
Australia
Date submitted for ethics approval [1] 314507 0
16/11/2023
Approval date [1] 314507 0
19/12/2023
Ethics approval number [1] 314507 0
2023/ETH02447

Summary
Brief summary
Why this study is important?
Healthcare-associated infections (HAIs) are acquired as a direct or indirect result of healthcare. Infections associated with healthcare are not inevitable, and prevention programmes have been successful at reducing the incidence of some HAIs. In Australia, we have estimated 160,000 patients contract a HAI annually. Furthermore, one in ten patients today have an infection acquired in hospital. Non-ventilator hospital-associated pneumonia (HAP) is the most common type of HAI, accounting for approximately one third of these infections, with an estimated 50,000 patients affected each year in Australian public hospitals alone. HAP is associated with increased length of stay in hospital, increased morbidity, mortality, and healthcare costs.Approximately 19% of patients with HAP require transfer into an intensive care unit (ICU), with mortality reported at 18%. Patients with HAP are eight times more likely

Our study will:
Evaluate the effectiveness and cost-effectiveness of the intervention
Develop educational and digital resources and evaluate these as part of the trial
Estimate excess length of stay in hospital associated with HAP
Describe the patient’s experience of a having a HAP
Understand the clinician’s experience of implementing the intervention
Assess the impact of HAP on quality of life
Trial website
happenstudy.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131830 0
Prof Brett Mitchell
Address 131830 0
Avondale University, 582 Freemans Drive, Cooranbong NSW 2265 Australia
Country 131830 0
Australia
Phone 131830 0
+61 24980 2213
Fax 131830 0
Email 131830 0
brett.mitchell@avondale.edu.au
Contact person for public queries
Name 131831 0
Prof Brett Mitchell
Address 131831 0
Avondale University, 582 Freemans Drive, Cooranbong NSW 2265 Australia
Country 131831 0
Australia
Phone 131831 0
+61 24980 2213
Fax 131831 0
Email 131831 0
brett.mitchell@avondale.edu.au
Contact person for scientific queries
Name 131832 0
Prof Brett Mitchell
Address 131832 0
Avondale University, 582 Freemans Drive, Cooranbong NSW 2265 Australia
Country 131832 0
Australia
Phone 131832 0
+61 24980 2213
Fax 131832 0
Email 131832 0
brett.mitchell@avondale.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No; IPD will not be available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.