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

NCT02039297 | Completed DMC

• 1 other identifier: 12-007918
• Study Type: interventional
• Target: 7,813
• Locations: 1 country
• Sites: 6

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.

Conditions

Critical Illness; Sepsis; Respiratory Failure; Shock; Coma; Bleeding; Trauma

Keywords

AWARE, Checklist, ICU, Outcome, Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient outcomes

  Hospital length of stay - 2 weeks

Other Outcomes (1)

• Cost of patient care in ICU and Hospital

  Hospital length of stay - 2 weeks

Study Arms (1)

No Intervention: Baseline arm

OTHER

Pre and post design (same arm)

Other: Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation

Interventions

Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation OTHER

Computer aided checklist and rounding tool implemented in the Intensive care unit environment

Also known as: ProCCESs AWARE

No Intervention: Baseline arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the Primary Objective, all critically ill adult patient admitted to an ICU participating in the study will be eligible.

You may not qualify if:

• For the Primary Objective, all children younger than 18years of age will be excluded.

Sponsors & Collaborators

• Mayo Clinic: lead
• Centers for Medicare and Medicaid Services: collaborator

Study Sites (6)

Mayo Clinic Arizona

Scottsdale, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Lawrence Genral Hospital

Lawrence, Massachusetts, 01841, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

OU Medical center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Critical Illness; Sepsis; Respiratory Insufficiency; Shock; Coma; Hemorrhage; Wounds and Injuries

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiration Disorders; Respiratory Tract Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Brian Pickering, MBBCh

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Ognjen Gajic, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Vitaly Herasevich, MD PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)