ANZCTR - Registration

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]

None

Universal Trial Number (UTN)

Trial acronym

INFORMED

Linked study record

Health condition

Health condition(s) or problem(s) studied:

sepsis

Condition category

Condition code

Emergency medicine

Other emergency care

Infection

Studies of infection and infectious agents

Public Health

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]

Treatment: Other

Intervention code [2]

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]

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]

30 days post enrolment

Secondary outcome [1]

Participants consent experience using the study-specific questionnaire

Timepoint [1]

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

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]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Perth Hospital Nursing Research Foundation

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Royal Perth Hospital Research Foundation

Country [2]

Australia

Primary sponsor type

Hospital

Name

Royal Perth Hospital

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital HREC

Ethics committee address [1]

Victoria Square
Perth WA 6000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/10/2021

Approval date [1]

14/10/2021

Ethics approval number [1]

RGS0000004668

Summary

Brief summary

Sepsis is a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs. Globally, sepsis kills more people each year than any other condition except cardiovascular disease, yet few Australian’s know what it is. This study asks, 'what is the baseline awareness of sepsis in Emergency Department patients and what is the best way to educate them about it?' To answer that question participants will undergo a short test to measure their knowledge of sepsis. Then they will be split evenly into two groups at random (like tossing a coin), one group will receive a one-page paper handout that tells them what they need to know about sepsis while the other group will watch a video that presents the same information. One month after receiving the sepsis education the participant will receive a follow-up phone call and be asked to take the short sepsis test again to measure how much they have learned and retained about sepsis. By comparing the difference between the average test scores in each group we will learn which education method (paper handout or video) is most effective at teaching participants about sepsis.

Embedded within the process of signing up to this study will be another study component focused on different ways to present consent information for research. People who are interested in participating will be split evenly into two groups. One group will receive information about the study in paper form, the other electronically. Those who consent to participate will be followed up one month later and asked what they recall of the consent process. Recall of study and consent details will be compared between the group receiving the paper study information and the group receiving the electronic version.  This is how we will show which method of presenting information results in better understanding and recollection.

We hypothesise that electronic consenting and educational materials will allow patients to better comprehend the information and recall this at 30 days post-enrolment.

Trial website

Public notes

Contacts

Principal investigator

Name

Mr Jonathon Burcham

Address

Royal Perth Hospital
Victoria Square
Perth WA 6000

Country

Australia

Phone

+61433886068

Email

[email protected]

Contact person for public queries

Name

Jonathon Burcham

Address

Royal Perth Hospital
Victoria Square
Perth WA 6000

Country

Australia

Phone

+61433886068

Email

[email protected]

Contact person for scientific queries

Name

Jonathon Burcham

Address

Royal Perth Hospital
Victoria Square
Perth WA 6000

Country

Australia

Phone

+61433886068

Email

[email protected]

Doc. No.	Type	Email	Attachment
16653	Study protocol		384393-(Uploaded-15-07-2022-15-33-13)-Study-related document.doc
16654	Informed consent form	[email protected]
16655	Clinical study report	[email protected]
16656	Ethical approval	[email protected]

Trial Review

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