Evidence-Based Tele-Emergency Network Grant Program

Critical Illness Clinical Trial

Official title:

Evidence-Based Tele-Emergency Network Grant Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877810
• Other study ID #: 678668
• Secondary ID: G01RH27872
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 2019

Study information

• Verified date: October 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 696
• Est. completion date: August 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Emergencies

Intervention

Other:
• Telemedicine
Telemedicine is a live, interactive, audiovisual teleconferencing system.
• Telephone
Consultations will be given over telephone.

Locations

Country	Name	City	State
United States	University of California, Davis, Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Care Implicit Review Instrument	The investigators hypothesize that children receiving care in EDs during periods of telemedicine use will receive higher quality of care than similar children who receive care during periods of telephone use. A previously validated 5-item implicit review instrument that measures 4 aspects of process of care in the ED, along with a fifth item assessing the overall quality of care provided to the patient will be used. The sum of the 5 item-specific scores will be aggregated from each reviewer to obtain a summary quality score for each medical record.	Year 3
Primary	Pediatric Risk of Admission (PRISA II)	The investigators hypothesize that children receiving care in EDs during randomized periods of telemedicine use will be admitted more appropriately than similar children who receive care during periods randomized to telephone use. To compare the cohort of seriously ill children treated during the telephone and telemedicine time blocks, observed to expected (O/E) ratios will be calculated using an intention-to-treat framework.	Year 3
Primary	Pediatric Emergency Assessment Tool (Re-PEAT)	The investigators hypothesize that children receiving care in EDs during randomized periods of telemedicine use will be transferred more appropriately than similar children who receive care during periods randomized to telephone use. The investigators will compare O/E ratios.	Year 3
Primary	Medication Error Rate Instrument	The investigators hypothesize that children receiving care in EDs during periods of telemedicine use will experience fewer physician-related medication errors than similar children who receive care during periods of telephone use. A previously published instrument developed specifically to evaluate medication errors among children receiving care in the ED will be used.	Year 3
Primary	Economic Efficiency Cost-Analysis	The investigators hypothesized that care provided to children in EDs during randomized periods of telemedicine use will be economically more efficient than care provided during randomized periods of telephone. Cost analysis will estimate return-on-investment indicating the cost saving amount per $1 investment in telemedicine compared to care without telemedicine.	Year 3