Evidence-Based Tele-Emergency Network Grant Program

NCT02877810 | Completed

• 2 other identifiers: 678668G01RH27872
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Telemedicine

EXPERIMENTAL

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

Telephone

ACTIVE COMPARATOR

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

Interventions

Telemedicine OTHER

Telemedicine is a live, interactive, audiovisual teleconferencing system.

Telemedicine

Telephone OTHER

Consultations will be given over telephone.

Telephone

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (2)

• Marcin JP, Lieng MK, Mouzoon J, Sauers-Ford HS, Tancredi D, Cabri A, Pandya VA, Park AS, Kuppermann N. Telemedicine vs Telephone Consultations and Medication Prescribing Errors Among Referring Physicians: A Cluster Randomized Crossover Trial. JAMA Netw Open. 2024 Feb 5;7(2):e240275. doi: 10.1001/jamanetworkopen.2024.0275.

  PMID: 38421649 DERIVED

• Marcin JP, Sauers-Ford HS, Mouzoon JL, Haynes SC, Dayal P, Sigal I, Tancredi D, Lieng MK, Kuppermann N. Impact of Tele-Emergency Consultations on Pediatric Interfacility Transfers: A Cluster-Randomized Crossover Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255770. doi: 10.1001/jamanetworkopen.2022.55770.

  PMID: 36780158 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• James P Marcin, MD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 24, 2016
• Study Start: November 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

US (1)