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

Sepsis Clinical Trial

— AWARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039297
• Other study ID #: 12-007918
• Status: Completed
• Phase: N/A
• First received: January 15, 2014
• Last updated: October 20, 2017
• Start date: March 2013
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7813
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Coma
• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis
• Shock
• Trauma

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Lawrence Genral Hospital	Lawrence	Massachusetts
United States	OU Medical center	Oklahoma City	Oklahoma
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Montefiore Medical Center	The Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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