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Evidence-Based Tele-Emergency Network Grant Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877810
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Critical Illness Other: Telemedicine Other: Telephone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 696 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evidence-Based Tele-Emergency Network Grant Program
Actual Study Start Date : November 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2019

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.




Primary Outcome Measures :
  1. Quality of Care Implicit Review Instrument [ Time Frame: Year 3 ]
    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.

  2. Pediatric Risk of Admission (PRISA II) [ Time Frame: Year 3 ]
    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.

  3. Pediatric Emergency Assessment Tool (Re-PEAT) [ Time Frame: Year 3 ]
    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.

  4. Medication Error Rate Instrument [ Time Frame: Year 3 ]
    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.

  5. Economic Efficiency Cost-Analysis [ Time Frame: Year 3 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877810


Locations
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United States, California
University of California, Davis, Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: James P Marcin, MD, MPH University of California, Davis

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Any study documents may be requested directly from Jamie Kissee at jkissee@ucdavis.edu

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02877810    
Other Study ID Numbers: 678668
G01RH27872 ( Other Grant/Funding Number: HRSA )
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Emergencies
Critical Illness
Disease Attributes
Pathologic Processes