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Trial registered on ANZCTR


Registration number
ACTRN12621000577819
Ethics application status
Approved
Date submitted
22/02/2021
Date registered
17/05/2021
Date last updated
27/05/2022
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title

Implementing an evidenced based guideline for oxygen use in hospitalised adults.
Scientific title

In hospitalised adults does implementing an evidenced based guideline improve the administration of appropriate oxygen therapy?
Secondary ID [1] 303499 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The IOP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 320829 0
Any patient requiring oxygen therapy 321204 0
Condition category
Condition code
Respiratory 318652 318652 0 0
Other respiratory disorders / diseases
Respiratory 319568 319568 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized time series pilot study. Two clinical wards will be randomized to one of two intervention groups (single intervention or multi-component intervention group). Both wards will receive the intervention in parallel. Medical record audits will allow us to assess the differences between prescribing practices between wards. These outcomes will be compared. Patients will not be enrolled in the study.
Single intervention group (ward)
Time Point 1: Weeks 1-2
Preparation of staff: Staff informed that a study will be commencing regarding the prescription of oxygen therapy. Researchers to demonstrate the prescribing facility in MedChart and provide background. Initial information sessions to raise awareness and to answer staff questions. (Session to be conducted via group in-service sessions 2 x 30 minute training sessions, in week 1 and week 2. In-service sessions will be run by a member of the research team to allow any questions raised to be answered)
Time Point 2: Weeks 3-5
Inform staff of oxygen prescribing: Staff will be informed of the prescribing intervention via ward meetings and inservices during ‘Time Point 2’ (Session to be conducted via group in-service sessions 2 x 30 minute training sessions or more frequently at the request of clinical staff or clinical managers, i.e. nursing unit manager). These sessions will allow clinical staff to ask questions about the oxygen prescription facility in Medchart. This will include informing medical officers, particularly junior medical officers.
Oxygen prescription: The online medication prescription chart (Medchart) will be modified to allow prescription of oxygen therapy. The oxygen prescribing ability will be available to clinicians from ‘Time Point 2.’
Oxygen will be able to be prescribed by medical officers and nurse practitioners as a regular/routine medication. Registered nurses will be able to prescribe oxygen therapy as a nurse initiated medication as per the ‘HNELHD Nurse/Midwife Initiated Medication Protocol’.

Oxygen prescription for all clinicians are categorised for two patient groups. Those ‘at risk’ of hypercapnoea (COPD, obesity, and neuromuscular disorders as per the patient diagnosis or as noted in the patient history) and those ‘not at risk’ of hypercapnoea, as per the evidence based guidelines (Thoracic Society of Australia and New Zealand oxygen guidelines for acute oxygen use in adults) .
Oxygen prescriptions that are available to medical officers and nurse practitioners on Medchart are outlined below:
• Oxygen Gas for those NOT at risk of hypercapnoea
o Dose 0.5 to 4L/min via Nasal Prongs (4 hourly) to be commenced if SpO2 < 92% and titrate to minimum dose to achieve SpO2 92-96%.
o Dose 0.24 to 0.5 FiO2 via Venturi Mask (4 hourly) to be commenced if SpO2 < 92% and titrate to minimum dose to achieve SpO2 92-96%. (Consider clinical review if max dose required)
• Oxygen Gas for those AT RISK of hypercapnoea
o Dose 0.5 to 4L/min via Nasal Prongs (4 hourly) to be commenced if SpO2 < 88% and titrate to minimum dose to achieve SpO2 88-92%. (Consider clinical review if max dose required)
o Dose 0.24 to 0.4 FiO2 via Venturi Mask (4 hourly) to be commenced if SpO2 < 88% and titrate to minimum dose to achieve SpO2 88-92%. (Consider clinical review if max dose required)
Oxygen prescription that are available to registered nurses on Medchart as per the ‘HNELHD Nurse/midwife Initiated Medication Protocol’ and are available for acute deterioration and emergency use only (whilst awaiting urgent clinical review):
• Oxygen Gas for those NOT at risk of hypercapnoea
o Dose 1-15L/min, Stat. To be commenced if SpO2 < 92% and titrated to minimum dose to achieve SpO2 of 92-96%
• Oxygen Gas for those AT RISK of hypercapnoea
o Dose 1-15L/min, Stat. To be commenced if SpO2 < 88% and titrated to minimum dose to achieve SpO2 of 88-92%

Time Point 2 to 5: Weeks 3-16
• Only oxygen prescription to remain insitu until completion of study

Multi-component intervention group (ward)
As per the ‘Single Intervention Ward’ for weeks 1-2 and 3-5 with the addition of the following interventions introduced at various ‘Time Points’ during the study.
Time Point 2: Weeks 3-5
• Inform staff of intervention group (single or multi-intervention group)
• Introduce local leader/champion to act as a resource person/oxygen leader and be available to answer questions regarding oxygen therapy.
Time Point 3: Weeks 6-8
• Introduce targeted education (to be delivered by a member of the research team). Targeted education as informed by expert reference group and will include
o Week 6: Oxygen package stickers – oxygen stickers will be placed on outer oxygen packaging. Packaging will be checked once per week by a member of the research team to ensure outer packaging has a sticker in place. Oxygen stickers will read "has this oxygen been prescribed"
o Week 6: Informational posters placed in patients’ rooms/bedside near the oxygen flow meter. Poster colour will be changed at ‘Time Point 4’ – week 9. There will be 2 posters at each bedside reading: POSTER 1."Titrate oxygen 'up arrow' and 'down arrow' to maintain an SpO2 88-92% as per prescription, for all patients which COPD or those at risk of hypercapnoea. Patients at risk include: COPD/Obese/neuromuscular disorders" POSTER 2. "Titrate oxygen 'up arrow' and 'down arrow' to maintain an SpO2 92-96% as per prescription, for all patients without risk factors for hypercapnoea."
o Week 6: Informational posters placed in prominent locations. (Staff room, staff bathrooms, above handwash basins, around computer terminals) Poster will contain the following information in different sections: "Oxygen therapy. Has your patient's oxygen been prescribed? Aim for SpO2 88-92%. Those at risk of hypercapnoea including COPD/Obese/Neuromuscular disorders. Actively titrate oxygen therapy to achieve a saturation between 88-92%. Aim for SpO2 92-96%. Most medical patients ONLY require an oxygen saturation between 92-96%. Actively titrate oxygen therapy to achieve a saturation between 92%-96%. Prescribe oxygen based on patient assessment and to achieve a specified saturation range. Alter call criteria to match the prescription chart."
o Week 7: Fast facts at safety huddle to be delivered about oxygen therapy. To be delivered by the nursing unit manager or nurse in charge, one day each week.
o Week 8: Pre-existing online eLearning package. ‘My Health Learning’ education module regarding acute oxygen use in adults. 3 hour pre-existing spaced eLearning module to be completed at any time during week 8-12. The eLearning package delivers 2 questions to participants every 2 days with participants allowed up to 3 attempts to complete all questions. Time taken to answer each question will vary depending on the participant completing the question, it is not envisaged that it would take more than 15 minutes to complete each question. Completion of the module may qualify the participants for up to 1.0 hr of Continuous Professional Development (CPD).
The module explores decision-making processes and is based on the TSANZ oxygen guideline and complements the NSW Health policy directive ‘PD2020_018 Recognition and management of patient who are deteriorating.’ The module is designed for NSW Health Clinicians in non-critical care areas caring for patients requiring oxygen therapy.
• REDcap software will be used to email clinical staff the details of the online ‘My Health Learning’ education module and encouraged to enroll, to improve their knowledge around the administration of oxygen therapy.
Time Point 4: Weeks 9-11
• Introduce weekly email communication (via REDcap software) to ward clinical staff outlining the progress of the study to date. Highlighting areas where adherence is high and areas for improvement)
Withdrawal: Weeks 12 – 14 inclusive
• Email invitations to participate in qualitative interview to be sent by nursing unit managers, pharmacy manager and allied health manager.
• Qualitative interview invitation posters to be placed in the staff room.
• Oxygen prescription facility in Medchart to remain insitu
• Researcher presence and activity will be withdrawn. This includes withdrawal/removal of:
o Oxygen stickers on oxygen packages
o Informational posters in patient rooms and at all previously placed staff locations
o Cessation of oxygen fast facts during safety huddle
o Cessation of weekly progress emails
NB: as the ‘My Health Learning’ education module can be accessed by any NSW clinical staff at any time, with a valid log in, access will still be possible for clinical staff if they should wish to continue or repeat this education module.

Time Point 5: Week 15-16
• Qualitative interviews will occur face to face or via telephone/internet as requested by the participants.
Intervention code [1] 319787 0
Behaviour
Intervention code [2] 320060 0
Treatment: Other
Comparator / control treatment
The single intervention group (ward) will act as the comaparator group
Control group
Active

Outcomes
Primary outcome [1] 326596 0
Proportion of patients with a valid oxygen prescription increased from baseline measurements (Collected in week 1-2)
Outcome is assessed by auditing the medical record of patients for evidence of an oxygen prescription.
Timepoint [1] 326596 0
Baseline, week 15 - 16 post active intervention completion
Secondary outcome [1] 392044 0
Proportion of patients receiving oxygen therapy in line with TSANZ guidance
Outcome is assessed by auditing the medical record of patients for evidence of patient receiving oxygen therapy as per TSANZ guideline.
Timepoint [1] 392044 0
Baseline, week 15 - 16 post active intervention completion
Secondary outcome [2] 392045 0
Proportion of patients whose ‘calling criteria’ are altered on the Standard Adult General Observation chart in line with the oxygen prescription
Outcome is assessed by auditing the medical record of patients for evidence of altered 'call criteria'
Timepoint [2] 392045 0
Baseline, week 15 - 16 post active intervention completion

Eligibility
Key inclusion criteria
Intervention wards
Two wards at an acute care hospital whose admitted patient cohort includes a broad range of adult medical admission and whose nursing unit managers have agreed to participate in the intervention.
Qualitative Interviews
Multi-component intervention group (ward)
aged 18 years or older
employed as staff at the acute care hospital and worked in the multi-component intervention ward including registered nurse, enrolled nurse, medical officer, physiotherapist, pharmacist or any other clinicians who administers oxygen during routine clinical work
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Qualitative interviews
Clinician staff who have not worked on the multi-component intervention ward
Clinician staff who do not administer/use oxygen during routine clinical work

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a coin toss to allocate the wards.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The only randomisation that will occur is randomising which ward will receive the single component intervention and the multi-component intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Study Size Calculations
Intervention wards:
Data collected from the wards depends on several factors: (1) the number of patients admitted to each ward, (2) the number of patients who require oxygen therapy. It is not possible to predict the exact number of patients who may require oxygen therapy during their hospital admission. However, Eastwood et al, (2011) identified that 24% of hospital admissions in their study received oxygen therapy.
Assuming both wards maintain occupancy at 100% this would equate to approx. 7.6 patients (each ward) on each data collection day (twice per week) who would require oxygen therapy. Based on data collection twice per week over a 16 week period (13 weeks of data collection) we estimate that we would record data on approx. 390 patient admissions.
Ward A & B: 30 (approx. no. patients on each ward, each week) x 13 (weeks) = 390

Qualitative interviews with multiple component ward clinicians:
Sample size is based on several factors: (1) data saturation being reached when no new information being gathered, (2) the study population (3) the nature and number of questions being asking in the interview guide.
We estimate that a sample size n= 10 from the multiple component site will achieve data saturation. If data saturation has not been achieved we will seek a variation to increase the sample.

Statistical methods/analysis
Intervention ward data
Stata I5 (Stata Corporation, College Station, Texas, USA) software will be used for this analysis. Normally distributed continuous variables will be described as mean (SD), skewed continuous variables as median (IQR) and categorical variables as percentage. Outcomes will be analysed in 2 (group: multi-component intervention vs. single component intervention) x 5 (time; pre-intervention [Time Point 1], during intervention [Time Points 2,3,4] and post intervention [Time Point 5]) logistic regression for binary outcomes. Planned comparisons will be undertaken to examine change over time in the intervention and control group separately. Results will be considered statistically significant when p<0.05.

Qualitative interviews
Recordings will be transcribed verbatim and transcripts will be anonymised and entered into NVivo to assist data management and coding. Initial descriptive coding will be performed, which will progress to inductive pattern coding and synthesis of data into themes and subthemes. To ensure accurate representation of the interview content, themes will be repeatedly checked. As each interview is conducted, analysis will be carried out iteratively. Comparison, charting and mapping will occur for cross-case examination that will assist in interpretation. Dependability and confirmability to ensure the trustworthy of this research will be undertaken via audit trail with records of the research path being kept during the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/05/2021
Actual
24/05/2021
Date of last participant enrolment
Anticipated
10/09/2021
Actual
10/09/2021
Date of last data collection
Anticipated
13/09/2021
Actual
14/04/2022
Sample size
Target
390
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18759 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 33203 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 307917 0
Government body
Name [1] 307917 0
Australian Government Research Training Program
Country [1] 307917 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 308634 0
None
Name [1] 308634 0
None
Address [1] 308634 0
None
Country [1] 308634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307915 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 307915 0
Ethics committee country [1] 307915 0
Australia
Date submitted for ethics approval [1] 307915 0
30/11/2020
Approval date [1] 307915 0
19/03/2021
Ethics approval number [1] 307915 0
2020/ETH02841

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108914 0
Prof Vanessa McDonald
Address 108914 0
Hunter Medical Research Institute
Lot 1, Kookaburra Cct,
New Lambton Heights NSW 2305
Country 108914 0
Australia
Phone 108914 0
+61 02 40420146
Fax 108914 0
Email 108914 0
vanessa.mcdonald@newcastle.edu.au
Contact person for public queries
Name 108915 0
Vanessa McDonald
Address 108915 0
Hunter Medical Research Institute
Lot 1, Kookaburra Cct,
New Lambton Heights NSW 2305
Country 108915 0
Australia
Phone 108915 0
+61 02 40420146
Fax 108915 0
Email 108915 0
vanessa.mcdonald@newcastle.edu.au
Contact person for scientific queries
Name 108916 0
Vanessa McDonald
Address 108916 0
Hunter Medical Research Institute
Lot 1, Kookaburra Cct,
New Lambton Heights NSW 2305
Country 108916 0
Australia
Phone 108916 0
+61 02 40420146
Fax 108916 0
Email 108916 0
vanessa.mcdonald@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
non-identifiable data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
On a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Access subject to approval by Principal Investigator
vanessa.mcdonald@newcastle.edu.au


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.