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The INFORMED Sepsis study: Targeting Information Comprehension and Recall Metrics in the Emergency Department

The INFORMED Sepsis study: Efficacy of Digital Sepsis Education on Information Comprehension and Recall Metrics in Adult Patients in the Emergency Department

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001056785
Acronym
INFORMED
Enrollment
600
Registered
2022-07-29
Start date
2022-08-01
Completion date
2022-12-30
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 wi

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.

Sponsors

Royal Perth Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients attending the Royal Perth Hospital Emergency Department (for any condition) Competent to prospectively consent (as assessed by their treating doctor)

Exclusion criteria

Clinical acuity precludes participation Unable to be reliably followed up in 4 weeks

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026