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Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE) (AWARE)

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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

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 :
  1. 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 :
  1. 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:
  1. 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



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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