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Completed

NCT Number: NCT02398981

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bao'an Maternity & Child Health Hospital, Shenzhen, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Decision Support Tool

Other

Other names: Checklist

Primary outcomes

  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 outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • University of British Columbia

Registry information

Official study 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

Acronym: CERTAINp

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2015
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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