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Trial record 21 of 30 for:    Diseases | ( Map: Congo )

Implementation of a Web Based Real Time Clinical Decision Support Tool. (CERTAINp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02398981
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : February 6, 2019
University of British Columbia
Information provided by (Responsible Party):
Grace M. Arteaga, M.D., Mayo Clinic

Brief Summary:
In the developed world critical illness is routinely treated in an intensive care unit (ICU) by highly specialized physicians, nurses and support staff. This model of intensive care is spreading rapidly to low and middle income countries and as it spreads, challenges and limitations to this model arise. In resource-poor settings, inadequate human resources, training, and equipment all present barriers to safe and effective use of life-saving procedures. The advances in medical informatics and human factors engineering have provided tremendous opportunity for novel and user-friendly clinical decision support (CDS) tools that can be applied in a complex and busy hospital setting. Real-time data feeds and standardized patient care tasks in a simulated acute care environment have been proven to have a significant advantage of a novel interface (compared to a conventional) in reducing provider cognitive load and errors. Currently researchers within the investigator's research group have developed and are pilot testing a simple electronic decision support tool: CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness). This tool has been successfully tested and validated in simulated settings and is being implemented as pilot study in 18 countries. Worldwide infant and early childhood mortality continues to be very high partly due to the inability to recognize and respond aggressively to critical illnesses. Investigators expect that adaptation of the algorithms from CERTAIN has potential to be a powerful tool to improve on the medical care of children in developing countries. Investigators aim in this project is 1) to develop a pediatric adaptation of CERTAIN (CERTAINp) and 2) to implement it into clinical practice in resource-poor settings and evaluate the impact of the tool on the processes and patient outcomes.

Condition or disease Intervention/treatment Phase
Critical Illness Sepsis Respiratory Failure Shock Bleeding Other: Clinical decision support tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 962 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Design and Pilot Implementation of a Web Based Real Time Clinical Decision Support Tool. (Checklist for Early Recognition and Treatment of Acute Illness in Pediatrics. CERTAINp
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
No Intervention: Baseline
Baseline data collection ( 20 patients per ICU)
Experimental: Checklist
This study is about training and implementation of best critical care practices in the international ICUs with variable resources facilitated by access to a specifically designed electronic checklist 40 patients per ICU
Other: Clinical decision support tool
Other Name: Checklist

Primary Outcome Measures :
  1. ICU and hospital lengths of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks ]
    Patient will be followed till they get discharged from hospital for whatever length they stay

Secondary Outcome Measures :
  1. Adherence to best critical care practices as measured by composite measures of best practice guidelines. [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks ]
    Adherence to best practice in initial evaluation and treatment of critically ill medical and surgical patients Appropriate shock resuscitation Appropriate sepsis treatment Appropriate mechanical ventilation Appropriate peptic ulcer, deep vein thrombosis and infectious disease prophylaxis. For example Number of patients managed with 100% compliance with sepsis guidelines ( included in the standard operating procedures)/ Number of eligible patients admitted in the time period .

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All pediatric patients (< 18 years) admitted for the first time to the participating PICUs will be included.

Exclusion Criteria:

  • Not critically ill, admitted for low risk monitoring, planned PICU admission for routine post operative surveillance for less than 24 hours after uncomplicated surgery, readmission and transfer from outside PICU.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02398981

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China, Guangdong
Bao'an Maternity & Child Health Hospital
Shenzhen, Guangdong, China
China, Sichuan
Chengdu 2nd Hospital
Chengdu, Sichuan, China
Chengdu Women & Children's Central Hospital
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China
Shanghai Childrens' Medical Center
Shanghai, China
Centre Medical Evangelique-Nyankunde
Nyankunde, Eastern Province, Congo
University Hospital of Split
Split, Croatia
Fiji National University
Samabula, Fiji
JSS hospital
Mysore, Karnataka, India
Instituto Nacional de Salud del Niño
Lima, Peru
Sponsors and Collaborators
Mayo Clinic
University of British Columbia

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Responsible Party: Grace M. Arteaga, M.D., PI, Mayo Clinic Identifier: NCT02398981     History of Changes
Other Study ID Numbers: 14-004429
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes