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

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 Overview

• Status: Completed
• Conditions: Sepsis; Shock; Critical Illness; Respiratory Failure; Bleeding; Trauma; Coma
• Intervention / Treatment: Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation

• Study Type: Interventional
• Enrollment (Actual): 7813
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85054
      • Mayo Clinic Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Massachusetts
    • Lawrence, Massachusetts, United States, 01841
      • Lawrence Genral Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • New York
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will be followed for the duration of ICU stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Hospital length of stay - 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of patient care in ICU and Hospital	Cost of patient care in ICU and Hospital derived from medicare data	Hospital length of stay - 2 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Centers for Medicare and Medicaid Services
• Investigators: Principal Investigator: Ognjen Gajic, MD, Mayo Clinic; Principal Investigator: Brian Pickering, MBBCh, Mayo Clinic; Principal Investigator: Vitaly Herasevich, MD PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: AWARE, Checklist, ICU, Outcome, Adults
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: 12-007918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO