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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:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Brian W. Pickering, M.B., B.Ch., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 15, 2014
First Posted Date  ICMJE January 17, 2014
Last Update Posted Date October 24, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 15, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE)
Official Title  ICMJE Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Critical Illness
  • Sepsis
  • Respiratory Failure
  • Shock
  • Coma
  • Bleeding
  • Trauma
Intervention  ICMJE 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
Study Arms  ICMJE No Intervention: Baseline arm
Pre and post design (same arm)
Intervention: Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2017)
7813
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2014)
12000
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02039297
Other Study ID Numbers  ICMJE 12-007918
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Brian W. Pickering, M.B., B.Ch., Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Centers for Medicare and Medicaid Services
Investigators  ICMJE
Principal Investigator: Brian Pickering, MBBCh Mayo Clinic
Principal Investigator: Ognjen Gajic, MD Mayo Clinic
Principal Investigator: Vitaly Herasevich, MD PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP