Clinical trial NCT02398981: Implementation of a Web Based Real Time Clinical Decision Support Tool.
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
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Sepsis
Respiratory Failure
Shock
Bleeding
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2015-03-26
Enrollment: 962
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: ICU and hospital lengths of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary outcomes:
measure: Adherence to best critical care practices as measured by composite measures of best practice guidelines.
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Bao'an Maternity & Child Health Hospital
state: Guangdong
city: Chengdu
country: China
facility: Chengdu 2nd Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Women & Children's Central Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Shanghai
country: China
facility: Shanghai Childrens' Medical Center
city: Nyankunde
country: Congo
facility: Centre Medical Evangelique-Nyankunde
state: Eastern Province
city: Split
country: Croatia
facility: University Hospital of Split
city: Samabula
country: Fiji
facility: Fiji National University
city: Mysore
country: India
facility: JSS hospital
state: Karnataka
city: Lima
country: Peru
facility: Instituto Nacional de Salud del NiÃ±o
Study officials:
References: