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

NCT02398981 | Completed DMC

• 1 other identifier: 14-004429
• Study Type: interventional
• Target: 962
• Locations: 6 countries
• Sites: 10

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.

Conditions

Critical Illness; Sepsis; Respiratory Failure; Shock; Bleeding

Outcome Measures

Primary Outcomes (1)

• ICU and hospital lengths of stay

  Patient will be followed till they get discharged from hospital for whatever length they stay

  Participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Secondary Outcomes (1)

• Adherence to best critical care practices as measured by composite measures of best practice guidelines.

  Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

Study Arms (2)

Baseline

NO INTERVENTION

Baseline data collection ( 20 patients per ICU)

Checklist

EXPERIMENTAL

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

Interventions

Clinical decision support tool OTHER

Also known as: Checklist

Checklist

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• University of British Columbia: collaborator

Study Sites (10)

Bao'an Maternity & Child Health Hospital

Shenzhen, Guangdong, China

Location

Chengdu 2nd Hospital

Chengdu, Sichuan, China

Location

Chengdu Women & Children's Central Hospital

Chengdu, Sichuan, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

Shanghai Childrens' Medical Center

Shanghai, China

Location

University Hospital of Split

Split, Croatia

Location

Fiji National University

Samabula, Fiji

Location

JSS hospital

Mysore, Karnataka, India

Location

Instituto Nacional de Salud del Niño

Lima, Peru

Location

Centre Medical Evangelique-Nyankunde

Nyankunde, Eastern Province, Republic of the Congo

Location

MeSH Terms

Conditions

Critical Illness; Sepsis; Respiratory Insufficiency; Shock; Hemorrhage

Interventions

Checklist

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 26, 2015
• Study Start: February 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

IN (1); FI (1); CN (5); CR (1); PE (1); RE (1)