Clinical trial NCT02877810: Evidence-Based Tele-Emergency Network Grant Program
Official title: Evidence-Based Tele-Emergency Network Grant Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 696
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the impact of an existing tele-emergency care network on quality of care, appropriateness of care utilization, patient safety (medication errors), and cost effectiveness compared to telephone consultations from a healthcare system prospective.

Detailed description: The investigators will use a novel cluster randomized unbalanced crossover trial design. When a new site is enrolled, the first approximately 6 months of the project will be a "ramp-up" period during which the protocol will be re-reviewed during a site visit to the participating EDs and random block assignments will be generated and delivered. The last 6 months will be reserved for data analysis, study closeout, and manuscript preparation. An intervening 2-year period will be divided into 4 six-month calendar time periods for carrying out the protocol and data collection. For each 6-month period, each ED will have a randomized treatment assignment for pediatric emergency and critical care consultations ("M" for telemedicine and "P" for telephone.) Participating EDs (the unit of randomization) will be stratified into two strata by size of ED and geographical location. EDs will then be randomized within-strata to one of the four unbalanced (3:1) crossover treatment assignment sequences, each consisting of a 6-month period: PMMM, MPMM, MMPM, or MMMP. During these assigned periods, the type of consultation being assigned will be strongly encouraged, but deviating from protocol (i.e., using telephone consultation when randomized to telemedicine, or the vice-versa) will be allowed as needed by the physicians. Data will be collected and abstracted through retrospective chart review.

Eligibility criteria: Inclusion Criteria:

* Children younger than or equal to 14 years of age at the time of their ED visit.

Exclusion Criteria:

* Children evaluated at the ED for non-medical reasons such as elective surgeries and social reasons (i.e., cases of possible endangerment) and other non-medical reasons.
* Children evaluated at the ED preoperatively, for elective surgical procedures.
* Children transferred to the ED from another hospital ED.
* Children transiently "held" in the ED in the process of a direct admission to the ward.

Primary outcomes:
measure: Quality of Care Implicit Review Instrument
timeFrame: Year 3
measure: Pediatric Risk of Admission (PRISA II)
timeFrame: Year 3
measure: Pediatric Emergency Assessment Tool (Re-PEAT)
timeFrame: Year 3
measure: Medication Error Rate Instrument
timeFrame: Year 3
measure: Economic Efficiency Cost-Analysis
timeFrame: Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: James P Marcin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: