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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02039297
Collaborator
Centers for Medicare and Medicaid Services (U.S. Fed)
7,813
Enrollment
6
Locations
1
Arm
51
Duration (Months)
1302.2
Patients Per Site
25.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7813 participants
Allocation:
N/A
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 :
Mar 1, 2013
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • ProCCESs AWARE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adherence to process of care [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 [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 [Hospital length of stay - 2 weeks]

      Cost of patient care in ICU and Hospital derived from medicare data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85054
    2 Mayo Clinic Jacksonville Florida United States 32224
    3 Lawrence Genral Hospital Lawrence Massachusetts United States 01841
    4 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    5 Montefiore Medical Center The Bronx New York United States 10467
    6 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian W. Pickering, M.B., B.Ch., Consultant, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02039297
    Other Study ID Numbers:
    • 12-007918
    First Posted:
    Jan 17, 2014
    Last Update Posted:
    Oct 24, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Brian W. Pickering, M.B., B.Ch., Consultant, Mayo Clinic
    AWARE, Checklist, ICU, Outcome, Adults
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Critical Illness

    Study Results

    No Results Posted as of Oct 24, 2017