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

Primary Purpose

Critical Illness, Sepsis, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring AWARE, Checklist, ICU, Outcome, Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Arizona
  • Mayo Clinic
  • Lawrence Genral Hospital
  • Mayo Clinic in Rochester
  • Montefiore Medical Center
  • OU Medical center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

No Intervention: Baseline arm

Arm Description

Pre and post design (same arm)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 15, 2014
Last Updated
October 20, 2017
Sponsor
Mayo Clinic
Collaborators
Centers for Medicare and Medicaid Services
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1. Study Identification

Unique Protocol Identification Number
NCT02039297
Brief Title
Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE)
Acronym
AWARE
Official Title
Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Centers for Medicare and Medicaid Services

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Sepsis, Respiratory Failure, Shock, Coma, Bleeding, Trauma
Keywords
AWARE, Checklist, ICU, Outcome, Adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7813 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: Baseline arm
Arm Type
Other
Arm Description
Pre and post design (same arm)
Intervention Type
Other
Intervention Name(s)
Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation
Other Intervention Name(s)
ProCCESs AWARE
Intervention Description
Computer aided checklist and rounding tool implemented in the Intensive care unit environment
Primary Outcome Measure Information:
Title
Adherence to process of care
Description
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.
Time Frame
Participants will be followed for the duration of ICU stay, an expected average of 3 days
Secondary Outcome Measure Information:
Title
Patient outcomes
Description
We will include, ICU length of stay, Hospital length of stay, ICU free days, standardized mortality ratio in ICU and Hospital, Ventilator free days.
Time Frame
Hospital length of stay - 2 weeks
Other Pre-specified Outcome Measures:
Title
Cost of patient care in ICU and Hospital
Description
Cost of patient care in ICU and Hospital derived from medicare data
Time Frame
Hospital length of stay - 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Pickering, MBBCh
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ognjen Gajic, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vitaly Herasevich, MD PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Lawrence Genral Hospital
City
Lawrence
State/Province
Massachusetts
ZIP/Postal Code
01841
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefiore Medical Center
City
The Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
OU Medical center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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