Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE) (AWARE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02039297 |
|
Recruitment Status :
Completed
First Posted : January 17, 2014
Last Update Posted : October 24, 2017
|
Sponsor:
Mayo Clinic
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Brian W. Pickering, M.B., B.Ch., Mayo Clinic
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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 - 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Illness Sepsis Respiratory Failure Shock Coma Bleeding Trauma | Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 7813 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE) |
| Study Start Date : | March 2013 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | June 2017 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Baseline arm
Pre and post design (same arm)
|
Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation
Computer aided checklist and rounding tool implemented in the Intensive care unit environment
Other Name: ProCCESs AWARE |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Patient outcomes [ Time Frame: Hospital length of stay - 2 weeks ]We will include, ICU length of stay, Hospital length of stay, ICU free days, standardized mortality ratio in ICU and Hospital, Ventilator free days.
Other Outcome Measures:
- Cost of patient care in ICU and Hospital [ Time Frame: Hospital length of stay - 2 weeks ]Cost of patient care in ICU and Hospital derived from medicare data
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
For the Primary Objective, all critically ill adult patient admitted to an ICU participating in the study will be eligible.
Exclusion Criteria:
For the Primary Objective, all children younger than 18years of age will be excluded.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039297
Locations
| United States, Arizona | |
| Mayo Clinic Arizona | |
| Scottsdale, Arizona, United States, 85054 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Massachusetts | |
| Lawrence Genral Hospital | |
| Lawrence, Massachusetts, United States, 01841 | |
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Montefiore Medical Center | |
| The Bronx, New York, United States, 10467 | |
| United States, Oklahoma | |
| OU Medical center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
Sponsors and Collaborators
Mayo Clinic
Centers for Medicare and Medicaid Services
Investigators
| Principal Investigator: | Brian Pickering, MBBCh | Mayo Clinic | |
| Principal Investigator: | Ognjen Gajic, MD | Mayo Clinic | |
| Principal Investigator: | Vitaly Herasevich, MD PhD | Mayo Clinic |
| Responsible Party: | Brian W. Pickering, M.B., B.Ch., Consultant, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT02039297 History of Changes |
| Other Study ID Numbers: |
12-007918 |
| First Posted: | January 17, 2014 Key Record Dates |
| Last Update Posted: | October 24, 2017 |
| Last Verified: | October 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Brian W. Pickering, M.B., B.Ch., Mayo Clinic:
|
AWARE, Checklist, ICU, Outcome, Adults |
Additional relevant MeSH terms:
|
Respiratory Insufficiency Critical Illness Respiration Disorders |
Respiratory Tract Diseases Disease Attributes Pathologic Processes |