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

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398981
• Other study ID #: 14-004429
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 962
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis
• Shock

Intervention

Other:
• Clinical decision support tool

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of British Columbia

Countries where clinical trial is conducted

China,  Congo,  Croatia,  Fiji,  India,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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