Critical IllnessAWARENCT02039297
Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE)
A study testing Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation in people with Critical Illness and Sepsis, run by Mayo Clinic at 6 sites in United States.
Trial summary
In this multicenter project, we will introduce AWARE (electronic interface) Using a cloud-based technology . The goal of this project is to improve compliance with best practice through the use of a new acute care interface with built-in tools for error prevention, practice surveillance and reporting (ProCCESs AWARE … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Respiratory Failure
- What is being tested?
- Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,813 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2013to Jun 2017
- Phase
- Interventional
- 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
Who may be able to join
- For the Primary Objective, all critically ill adult patient admitted to an ICU participating in the study will be eligible.
Who cannot join
- For the Primary Objective, all children younger than 18years of age will be excluded.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mayo Clinic
Jacksonville, Florida, 32224
Lawrence Genral Hospital
Lawrence, Massachusetts, 01841
OU Medical center
Oklahoma City, Oklahoma, 73104
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85054
Montefiore Medical Center
The Bronx, New York, 10467
About this study
In this multicenter project, we will introduce AWARE (electronic interface) Using a cloud-based technology . The goal of this project is to improve compliance with best practice through the use of a new acute care interface with built-in tools for error prevention, practice surveillance and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation).The goal of this project is to develop and test a novel acute care interface with built-in tools for error prevention, practice surveillance, decision support and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation). In preliminary studies, these novel informatics supports built on an advanced understanding of cognitive and organizational ergonomics, have significantly decreased the cognitive load of bedside providers and reduced medical errors. Using a cloud-based technology, AWARE will be uniformly available on either mobile or fixed computing devices and applied in a standardized manner in medical and surgical ICUs of five geographically diverse acute care hospitals predominantly serving Medicare and Medicaid patients. The impact of ProCCESs AWARE on processes of care and outcomes in study ICUs; expected to enroll more than 10,000 critically ill patients during the study period.
- Conditions
- Critical Illness, Sepsis, Respiratory Failure, Shock, Coma, Bleeding
- Being tested
- Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation
- Keywords
- AWARE, Checklist, ICU, Outcome, Adults
- Medical subject headings
- Critical Illness, Sepsis, Respiratory Insufficiency, Shock, Coma, Hemorrhage, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Centered Cloud-based Electronic System: Ambient Warning and Response EvaluationOther
Also called ProCCESs AWARE
Computer aided checklist and rounding tool implemented in the Intensive care unit environment
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Baseline arm | Other | Pre and post design (same arm) Receives: Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to process of care
Adherence to best practice for daily intensive care rounds. Appropriate shock resuscitation Appropriate sepsis treatment Appropriate mechanical ventilation Appropriate peptic ulcer, deep vein thrombosis and infectious disease prophylaxis etc.
Measured: Participants will be followed for the duration of ICU stay, an expected average of 3 days
Secondary outcomes (1)
Patient outcomes
We will include, ICU length of stay, Hospital length of stay, ICU free days, standardized mortality ratio in ICU and Hospital, Ventilator free days.
Measured: Hospital length of stay - 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Brian W. Pickering, M.B., B.Ch., Mayo Clinic
- Investigators
- Brian Pickering, MBBCh, Principal investigator, Mayo ClinicOgnjen Gajic, MD, Principal investigator, Mayo ClinicVitaly Herasevich, MD PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039297
- Sponsor's protocol ID
- 12-007918
- Acronym
- AWARE
- Status last verified
- Oct 2017
- First submitted
- 15 Jan 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE)
- ClinicalTrials.gov ID
- NCT02039297
- Acronym / sponsor ID
- AWARE / 12-007918
- Conditions
- Critical Illness, Sepsis, Respiratory Failure, Shock, Coma, Bleeding
- Keywords
- AWARE, Checklist, ICU, Outcome, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,813 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Mar 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Jan 2014 (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.
In this multicenter project, we will introduce AWARE (electronic interface) Using a cloud-based technology . The goal of this project is to improve compliance with best practice through the use of a new acute care interface with built-in tools for error prevention, practice surveillance and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation).The goal of this project is to develop and test a novel acute care interface with built-in tools for error prevention, practice surveillance, decision support and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation). In preliminary studies, these novel informatics supports built on an advanced understanding of cognitive and organizational ergonomics, have significantly decreased the cognitive load of bedside providers and reduced medical errors. Using a cloud-based technology, AWARE will be uniformly available on either mobile or fixed computing devices and applied in a standardized manner in medical and surgical ICUs of five geographically diverse acute care hospitals predominantly serving Medicare and Medicaid patients. The impact of ProCCESs AWARE on processes of care and outcomes in study ICUs; expected to enroll more than 10,000 critically ill patients during the study period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Baseline arm | Other | Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response EvaluationPre and post design (same arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For the Primary Objective, all critically ill adult patient admitted to an ICU participating in the study will be eligible.
Key exclusion criteria (1 listed)
- For the Primary Objective, all children younger than 18years of age will be excluded.
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 |
|---|---|---|
| Patient Centered Cloud-based Electronic System: Ambient Warning and Response EvaluationAlso: ProCCESs AWAREComputer aided checklist and rounding tool implemented in the Intensive care unit environment | Other | No Intervention: Baseline arm |
Primary outcome
Adherence to process of care
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 3 days
Adherence to best practice for daily intensive care rounds. Appropriate shock resuscitation Appropriate sepsis treatment Appropriate mechanical ventilation Appropriate peptic ulcer, deep vein thrombosis and infectious disease prophylaxis etc.
1 secondary outcome
Patient outcomes
Time frame: Hospital length of stay - 2 weeks
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 24 Oct 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.
Brian Pickering, MBBCh principal investigator
Mayo Clinic
Ognjen Gajic, MD principal investigator
Mayo Clinic
Vitaly Herasevich, MD PhD principal investigator
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation in people with Critical Illness and Sepsis, run by Mayo Clinic at 6 sites in United States.
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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Adherence to process of care (time frame: Participants will be followed for the duration of ICU stay, an expected average of 3 days). 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 24 Oct 2017.