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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Shock; Critical Illness; Respiratory Failure; Bleeding
• Intervention / Treatment: Other: Clinical decision support tool

• Study Type: Interventional
• Enrollment (Actual): 962
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Checklist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to best critical care practices as measured by composite measures of best practice guidelines.	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 .	Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: 14-004429