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

Primary Purpose

Critical Illness, Sepsis, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clinical decision support tool
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bao'an Maternity & Child Health Hospital
  • Chengdu 2nd Hospital
  • Chengdu Women & Children's Central Hospital
  • West China Hospital
  • Shanghai Childrens' Medical Center
  • Centre Medical Evangelique-Nyankunde
  • University Hospital of Split
  • Fiji National University
  • JSS hospital
  • Instituto Nacional de Salud del Niño

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline

Checklist

Arm Description

Baseline data collection ( 20 patients per ICU)

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

Outcomes

Primary Outcome Measures

ICU and hospital lengths of stay
Patient will be followed till they get discharged from hospital for whatever length they stay

Secondary Outcome Measures

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 .

Full Information

First Posted
February 13, 2015
Last Updated
February 4, 2019
Sponsor
Mayo Clinic
Collaborators
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02398981
Brief Title
Implementation of a Web Based Real Time Clinical Decision Support Tool.
Acronym
CERTAINp
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of British Columbia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Sepsis, Respiratory Failure, Shock, Bleeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
962 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Baseline data collection ( 20 patients per ICU)
Arm Title
Checklist
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Clinical decision support tool
Other Intervention Name(s)
Checklist
Primary Outcome Measure Information:
Title
ICU and hospital lengths of stay
Description
Patient will be followed till they get discharged from hospital for whatever length they stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary Outcome Measure Information:
Title
Adherence to best critical care practices as measured by composite measures of best practice guidelines.
Description
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 .
Time Frame
Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bao'an Maternity & Child Health Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Chengdu 2nd Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Chengdu Women & Children's Central Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Shanghai Childrens' Medical Center
City
Shanghai
Country
China
Facility Name
Centre Medical Evangelique-Nyankunde
City
Nyankunde
State/Province
Eastern Province
Country
Congo
Facility Name
University Hospital of Split
City
Split
Country
Croatia
Facility Name
Fiji National University
City
Samabula
Country
Fiji
Facility Name
JSS hospital
City
Mysore
State/Province
Karnataka
Country
India
Facility Name
Instituto Nacional de Salud del Niño
City
Lima
Country
Peru

12. IPD Sharing Statement

Learn more about this trial

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

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