Integrating Evidence Based Pediatric Pre-Hospital Protocols into Practice

Study ID
STU 082010-307

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Amanda Lee
214-456-0195
amanda.lee@utsouthwestern.edu

Principal Investigator
Halim Hennes

Summary

The overall study design is a prospective cohort study with a historical control. The objective for this project is to develop a model statewide infrastructure for the development, implementation, and measurement of outcomes of evidence-based pediatric prehospital protocols in independently functioning emergency Medical Services (eMS) systems and to compare the effectiveness of a currently used protocol with the evidence based protocol developed by this study in pediatric patients with Respiratory Distress. This multicenter study will be led and coordinated by Dr. Manish Shah at Baylor College of Medicine (BCM) in conjunction with the Texas Children's Hospital evidence-Based outcomes Center (TCH eBoC) in Houston, Texas. The university of Texas Southwestern Medical Center (uTSW) in conjunction with Children's Medical Center Dallas (CMCD) and Dell Children's Medical Center in austin, Texas will be the two other study sites.

This study consists of three phases: 1. establishment of a protocol development committee and the evaluation of the process in which this committee uses to develop an evidence-based prehospital protocol on a selected medical condition; 2. implementation of the developed prehospital protocol for pediatric patients transported with the clinical condition of Respiratory Distress within each of the targeted eMS systems in Houston, Dallas and austin through the training of prehospital personnel in the indications and use of the newly developed protocol; 3. evaluation of the impact of the developed prehospital protocol by tracking structural, process and outcomes measures after its implementation into multiple systems.

There will be several study populations involved in this study. For the Dallas study site, however, there will only be two study populations: patients utilizing BioTel eMS system with respiratory distress that arrive to Children's emergency Department for care (phase 3) and eMS providers/educators that are involved in the implementation phase of the study (phase 2).

This study will be implementing an approved evidence-based pediatric prehospital protocol and evaluating the impact of the protocol. There is no treatment involved in this study and there will be no randomization.

Data to be collected on patient subjects will include information about the care they receive in the prehospital and emergency department settings and the final outcomes of the patient. This information will be collected on one year of patients prior to and one year of patients after the implementation of the study protocol. all eligible patients will be enrolled. Patient subjects will not be approached about participation in this study.

Data to be collected on eMS providers will include information on their retention of the protocol information obtained from the study developed training module utilizing pre and post test scores from a knowledge application test and information about their satisfaction with the module and time logs. all eligible eMS providers will be given the option to participate at the time they are completing the training module during the implementation phase of the study. eMS educators will also be given a satisfaction survey and time log inquiry.

Participant Eligibility

Pediatric Population:
-Patients ages 0-18 years
-Has the clinical condition of Respiratory Distress
-Patients who received pre-hospital care from BioTel EMS (for Dallas site)
-Patients who receive subsequent care at Children[Single Quote]s Medical Center (for Dallas site)

Emergency Medical Technician Educators:
-An Emergency Medical Technician (EMT) or physician
-Has the designated responsibility of educating other EMT-Basic (EMT-B), EMT-Intermediate (EMT-I), or EMT-Paramedic (EMT-P) level providers in the BioTel EMS system
-18 years and older

Emergency Medical Technician Patient Care Providers:
-A First Responder (FR), EMT-Basic (EMT-B), EMT-Intermediate (EMT-I) or EMT-Paramedic (EMT-P) level provider
-Provides care to patient in the pre-hospital setting for the BioTel EMS system
-18 years and older