Evidence-Based Tele-Emergency Network Grant Program
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Telephone
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness
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.
Sites / Locations
- University of California, Davis, Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telemedicine
Telephone
Arm Description
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.
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..
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02877810
First Posted
August 3, 2016
Last Updated
October 29, 2019
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02877810
Brief Title
Evidence-Based Tele-Emergency Network Grant Program
Official Title
Evidence-Based Tele-Emergency Network Grant Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
696 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
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.
Arm Title
Telephone
Arm Type
Active Comparator
Arm Description
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..
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Telemedicine is a live, interactive, audiovisual teleconferencing system.
Intervention Type
Other
Intervention Name(s)
Telephone
Intervention Description
Consultations will be given over telephone.
Primary Outcome Measure Information:
Title
Quality of Care Implicit Review Instrument
Description
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.
Time Frame
Year 3
Title
Pediatric Risk of Admission (PRISA II)
Description
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.
Time Frame
Year 3
Title
Pediatric Emergency Assessment Tool (Re-PEAT)
Description
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.
Time Frame
Year 3
Title
Medication Error Rate Instrument
Description
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.
Time Frame
Year 3
Title
Economic Efficiency Cost-Analysis
Description
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.
Time Frame
Year 3
10. Eligibility
Sex
All
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P Marcin, MD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis, Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evidence-Based Tele-Emergency Network Grant Program
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