SepsisScoreIntNCT02755025
Clinical Score Usefulness and EHR Integration
An observational study of Sepsis, run by Mayo Clinic.
Trial summary
The SOFA score is a severity of illness and prognostic score used in the ICU. It has also recently been adopted as part of the definition of sepsis. This study will prospectively evaluate the usability of automated SOFA scoring for ICU patients within an electronic patient monitoring dashboard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Automated SOFA scoring calculator
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 31 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the medical intensive care unit during the 2 month time period after the automated SOFA scoring module is activated within the electronic dashboard.
Who may be able to join
- Patients admitted to the medical intensive care unit within 2 months of automated SOFA scoring module activation.
Who cannot join
- Refusal to allow medical records to be used for clinical research.
About this study
Official title: Evaluation of Clinical Score Usefulness and Feasibility of Integration Into Electronic Health Record Interfaces
The SOFA score is a severity of illness and prognostic score used in the ICU. It has also recently been adopted as part of the definition of sepsis. This study will prospectively evaluate the usability of automated SOFA scoring for ICU patients within an electronic patient monitoring dashboard. It will also assess for changes in physician ordering (volume and types of orders) after automatic scoring is implemented.
- Conditions
- Sepsis
- Being tested
- Automated SOFA scoring calculator
- Keywords
- Sepsis, SOFA score, Automated calculation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated SOFA scoring calculatorOther
Automated SOFA scoring will be activated within an existing electronic patient care dashboard for ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | This group will include ICU patients for the two month period after the automated SOFA score has been activated within the electronic patient care dashboard. Receives: Other: Automated SOFA scoring calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA related laboratory order volume
The total number of SOFA related laboratory orders on all patients in the ICU during the intervention period
Measured: 2 months
Secondary outcomes (1)
Module usability
Providers will be surveyed on the usability of the automated scoring module
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start1 Jul 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Aakre, Mayo Clinic
- Investigators
- Christopher A Aakre, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755025
- Sponsor's protocol ID
- 15-009228
- Acronym
- ScoreInt
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Score Usefulness and Feasibility of Integration Into Electronic Health Record Interfaces
- ClinicalTrials.gov ID
- NCT02755025
- Acronym / sponsor ID
- ScoreInt / 15-009228
- Conditions
- Sepsis
- Keywords
- Sepsis, SOFA score, Automated calculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SOFA score is a severity of illness and prognostic score used in the ICU. It has also recently been adopted as part of the definition of sepsis. This study will prospectively evaluate the usability of automated SOFA scoring for ICU patients within an electronic patient monitoring dashboard. It will also assess for changes in physician ordering (volume and types of orders) after automatic scoring is implemented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Other: Automated SOFA scoring calculatorThis group will include ICU patients for the two month period after the automated SOFA score has been activated within the electronic patient care dashboard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the medical intensive care unit during the 2 month time period after the automated SOFA scoring module is activated within the electronic dashboard.
Key inclusion criteria (1 listed)
- Patients admitted to the medical intensive care unit within 2 months of automated SOFA scoring module activation.
Key exclusion criteria (1 listed)
- Refusal to allow medical records to be used for clinical research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated SOFA scoring calculatorAutomated SOFA scoring will be activated within an existing electronic patient care dashboard for ICU patients. | Other | Prospective cohort |
Primary outcome
SOFA related laboratory order volume
Time frame: 2 months
The total number of SOFA related laboratory orders on all patients in the ICU during the intervention period
1 secondary outcome
Module usability
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher A Aakre, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA related laboratory order volume (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.