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

• ClinicalTrials.gov Identifier: NCT02039297
• Recruitment Status: Completed
• First Posted: January 17, 2014
• Last Update Posted: October 24, 2017
• Sponsor: Mayo Clinic
• Collaborator: Centers for Medicare and Medicaid Services
• Information provided by (Responsible Party): Brian W. Pickering, M.B., B.Ch., Mayo Clinic

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
Critical Illness; Sepsis; Respiratory Failure; Shock; Coma; Bleeding; Trauma	Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: March 2013
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2017

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

• Responsible Party: Brian W. Pickering, M.B., B.Ch., Consultant, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02039297
• Other Study ID Numbers: 12-007918
• First Posted: January 17, 2014
• 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