Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001056785
Ethics application status
Approved
Date submitted
15/07/2022
Date registered
29/07/2022
Date last updated
29/07/2022
Date data sharing statement initially provided
29/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The INFORMED Sepsis study: Targeting Information Comprehension and Recall Metrics in the Emergency Department
Scientific title
The INFORMED Sepsis study: Efficacy of Digital Sepsis Education on Information Comprehension and Recall Metrics in Adult Patients in the Emergency Department
Secondary ID [1] 307594 0
None
Universal Trial Number (UTN)
Trial acronym
INFORMED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 327039 0
Condition category
Condition code
Emergency medicine 324210 324210 0 0
Other emergency care
Infection 324228 324228 0 0
Studies of infection and infectious agents
Public Health 324229 324229 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two randomisation steps in this study that will determine the interventions the participant will receive. The first is when a potential participant is interested in finding out more, the researcher will randomise them to either the eConsent or paper consent process. Another likely outcome at this stage is that the potential participant may be ineligible to participate or decline to participate. The second randomisation step is after a participant does consent to participate and they will be allocated to receive either the sepsis video or sepsis information sheet in paper format. This means that there will be 8 possible groups of patients:
1) eConsent - declines to participate
2) eConsent - ineligible
3) Paper Consent - declines to participate
4) Paper Consent - ineligible
5) eConsent completed, electronic sepsis education
6) eConsent completed, paper sepsis education
7) Paper consent - electronic sepsis education
8) Paper consent - paper sepsis education

Patients who decline to participate or are ineligible will not be included in the assessment of study outcomes.

The eConsent group will receive the Patient Information Sheet electronically and then an electronic eConsent form, signed digitally. The eConsent forms are designed specifically for this study utilising the TRANSFORM templates for eConsent on the REDCap platform hosted by the Western Australian Department of Health. The potential participant can opt to use their own personal device (eg mobile phone) to complete the consent process or a research iPad available to research staff.

The consent process will take approximately 10 minutes to complete in both eConsent and Paper Consent formats. Clinical Research Nurses will be available at the bedside to answer any questions the potential participant may have. Clinical Research Nurses will complete this process after receiving study specific training and adherence will be audited at 10% and 50% of the total anticipated enrolments by the investigator and a research assistant.

The electronic format sepsis education group will receive sepsis information digitally by way of a link to a video called What is Sepsis? Sepsis explained in 3 minutes (In English – 2020 version) that can be viewed here: https://youtu.be/NsPDjOX8QHA
This video was created for and made available publicly by World Sepsis Day (Global Sepsis Alliance). The video includes basic information such as the definitions, epidemiology, signs and symptoms of sepsis. The participant can opt to use their own personal device (eg mobile phone) to access the video or a research iPad available to research staff. Clinical Research Nurses will be available at the bedside to answer questions that the participant may have. Clinical Research Nurses will complete this process after receiving study specific training and adherence will be audited at 10% and 50% of the total anticipated enrolments by the investigator and a research assistant using a study-specific checklist.
Intervention code [1] 324041 0
Treatment: Other
Intervention code [2] 324115 0
Treatment: Devices
Comparator / control treatment
There are two randomisation steps in this study that will determine the interventions the participant will receive. The first is when a potential participant is interested in finding out more, the researcher will randomise them to either the eConsent or paper consent process. Another likely outcome at this stage is that the potential participant may be ineligible to participate or decline to participate. The second randomisation step is after a participant does consent to participate and they will be allocated to receive either the sepsis video or sepsis information sheet in paper format. This means that there will be 8 possible groups of patients:
1) eConsent - declines to participate
2) eConsent - ineligible
3) Paper Consent - declines to participate
4) Paper Consent - ineligible
5) eConsent completed, electronic sepsis education
6) eConsent completed, paper sepsis education
7) Paper consent - electronic sepsis education
8) Paper consent - paper sepsis education

Patients who decline to participate or are ineligible will not be included in the assessment of study outcomes.

The consent control group will receive the Patient Information Sheet in hardcopy paper format and a paper consent form, signed in wet ink.

The sepsis education control group will receive sepsis information in hardcopy paper format. The hardcopy sepsis information sheet used can be found here and has been developed and made public by the Australian Commission on Safety and Quality in Health Care https://www.safetyandquality.gov.au/about-us/latest-news/our-campaigns/sepsis-campaign

A Clinical Research Nurse will be available at the bedside to answer questions as they arise for participants in all groups.
Control group
Active

Outcomes
Primary outcome [1] 332026 0
The difference between the mean scores on the recall quiz for each group (electronic vs paper). The quiz has been designed specifically for this study.
Timepoint [1] 332026 0
30 days post enrolment
Secondary outcome [1] 411935 0
Participants consent experience using the study-specific questionnaire
Timepoint [1] 411935 0
30 days post-enrolment

Eligibility
Key inclusion criteria
Patients attending the Royal Perth Hospital Emergency Department (for any condition)
Competent to prospectively consent (as assessed by their treating doctor)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical acuity precludes participation
Unable to be reliably followed up in 4 weeks

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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 randomisation using a randomisation table created by computer software (i.e. computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
There are two randomisation steps in this study that will determine the interventions the participant will receive. The first is when a potential participant is interested in finding out more, the researcher will randomise them to either the eConsent or paper consent process. Another likely outcome at this stage is that the potential participant may be ineligible to participate or decline to participate. The second randomisation step is after a participant does consent to participate and they will be allocated to receive either the sepsis video or sepsis information sheet in paper format. This means that there will be 8 possible groups of patients:
1) eConsent - declines to participate
2) eConsent - ineligible
3) Paper Consent - declines to participate
4) Paper Consent - ineligible
5) eConsent completed, electronic sepsis education
6) eConsent completed, paper sepsis education
7) Paper consent - electronic sepsis education
8) Paper consent - paper sepsis education
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will not begin prior to completing data collection, checking the data through an audit and closing the database. Once the data is available this will be read into a software package.

The primary outcome will be measured by calculating the difference of two means (paper vs electronic).

The baseline knowledge of all participants will be presented descriptively.

A description of test results between groups for each question in the quiz will be displayed and if there is sufficient power the significance of the difference of proportions (of correct answers) will be analysed utilising a chi squared test.

A qualitative and descriptive analysis of responses to questions regarding consent experience will be presented in narrative.

We aim to enrol 600 participants. This accounts for 250 in each arm of the study with full data allowing for 20% loss to follow up in each arm. The sample size has been chosen to be able to detect a difference (p=0.05) between means of at least 0.5021 with 80% power. The standard deviation between baseline and one month follow up for both groups is estimated to be 2 in these calculations. The standard deviation is not known because the sepsis knowledge assessment tool has not been used in previous studies but is likely to be low given that this is a repeated measure on the same participant. These estimates have been informed by consultation with a biostatistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/01/2023
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22841 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 38139 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 311862 0
Charities/Societies/Foundations
Name [1] 311862 0
Royal Perth Hospital Nursing Research Foundation
Country [1] 311862 0
Australia
Funding source category [2] 311864 0
Charities/Societies/Foundations
Name [2] 311864 0
Royal Perth Hospital Research Foundation
Country [2] 311864 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Victoria Square
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 313337 0
None
Name [1] 313337 0
Address [1] 313337 0
Country [1] 313337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311301 0
Royal Perth Hospital HREC
Ethics committee address [1] 311301 0
Ethics committee country [1] 311301 0
Australia
Date submitted for ethics approval [1] 311301 0
12/10/2021
Approval date [1] 311301 0
14/10/2021
Ethics approval number [1] 311301 0
RGS0000004668

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

Contacts
Principal investigator
Name 120630 0
Mr Jonathon Burcham
Address 120630 0
Royal Perth Hospital
Victoria Square
Perth WA 6000
Country 120630 0
Australia
Phone 120630 0
+61433886068
Fax 120630 0
Email 120630 0
jonathon.burcham@health.wa.gov.au
Contact person for public queries
Name 120631 0
Jonathon Burcham
Address 120631 0
Royal Perth Hospital
Victoria Square
Perth WA 6000
Country 120631 0
Australia
Phone 120631 0
+61433886068
Fax 120631 0
Email 120631 0
jonathon.burcham@health.wa.gov.au
Contact person for scientific queries
Name 120632 0
Jonathon Burcham
Address 120632 0
Royal Perth Hospital
Victoria Square
Perth WA 6000
Country 120632 0
Australia
Phone 120632 0
+61433886068
Fax 120632 0
Email 120632 0
jonathon.burcham@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD has been considered however the proposed analysis and reporting plan will provide sufficient granularity to describe participant responses.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16653Study protocol    384393-(Uploaded-15-07-2022-15-33-13)-Study-related document.doc
16654Informed consent form  jonathon.burcham@health.wa.gov.au
16655Clinical study report  jonathon.burcham@health.wa.gov.au
16656Ethical approval  jonathon.burcham@health.wa.gov.au



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.