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

NCT ID: NCT02398981

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

962 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness Sepsis Respiratory Failure Shock Bleeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Baseline

Baseline data collection ( 20 patients per ICU)

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Clinical decision support tool

Intervention Type OTHER

Interventions

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Clinical decision support tool

Intervention Type OTHER

Other Intervention Names

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Checklist

Eligibility Criteria

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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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Grace M. Arteaga, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bao'an Maternity & Child Health Hospital

Shenzhen, Guangdong, China

Site Status

Chengdu 2nd Hospital

Chengdu, Sichuan, China

Site Status

Chengdu Women & Children's Central Hospital

Chengdu, Sichuan, China

Site Status

West China Hospital

Chengdu, Sichuan, China

Site Status

Shanghai Childrens' Medical Center

Shanghai, , China

Site Status

University Hospital of Split

Split, , Croatia

Site Status

Fiji National University

Samabula, , Fiji

Site Status

JSS hospital

Mysore, Karnataka, India

Site Status

Instituto Nacional de Salud del Niño

Lima, , Peru

Site Status

Centre Medical Evangelique-Nyankunde

Nyankunde, Eastern Province, Republic of the Congo

Site Status

Countries

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China Croatia Fiji India Peru Republic of the Congo

Other Identifiers

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14-004429

Identifier Type: -

Identifier Source: org_study_id

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