Evidence-Based Tele-Emergency Network Grant Program

NCT ID: NCT02877810

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

696 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Telemedicine

Intervention Type OTHER

Telemedicine is a live, interactive, audiovisual teleconferencing system.

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..

Group Type ACTIVE_COMPARATOR

Telephone

Intervention Type OTHER

Consultations will be given over telephone.

Interventions

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Telemedicine

Telemedicine is a live, interactive, audiovisual teleconferencing system.

Intervention Type OTHER

Telephone

Consultations will be given over telephone.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James P Marcin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis, Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38421649 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36780158 (View on PubMed)

Other Identifiers

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G01RH27872

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

678668

Identifier Type: -

Identifier Source: org_study_id

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