Evidence-Based Tele-Emergency Network Grant Program

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Telemedicine; Other: Telephone

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.

• Study Type: Interventional
• Enrollment (Actual): 696
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis, Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine; A consultation will be given for the care of a critically ill pediatric patient to a remote hospital emergency department physician by telemedicine, a live, interactive, audiovisual teleconferencing system, from a pediatric critical care physician.	Other: Telemedicine; Telemedicine is a live, interactive, audiovisual teleconferencing system.
Active Comparator: Telephone; A consultation will be given for the care of a critically ill pediatric patient to a remote hospital emergency department physician by telephone, from a pediatric critical care physician..	Other: Telephone; Consultations will be given over telephone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: James P Marcin, MD, MPH, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Critical Illness
• Other Study ID Numbers: 678668; G01RH27872 (Other Grant/Funding Number: HRSA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED