ParentLink: Better and Safer Emergency Care for Children - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 4, 2007

Last Updated Date

April 5, 2007

Start Date ^†

June 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00457600 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

ParentLink: Better and Safer Emergency Care for Children

Official Title ^†

ParentLink: Better and Safer Emergency Care for Children

Brief Summary

The emergency department (ED) constitutes a high-risk environment for errors and poor quality of care. Pediatric patients are at increased risk of medical errors. We postulate that implementation of a patient-centered health information technology - ParentLink - can address system-level deficiencies and the unique “just-in-time” information needs of ED physicians and the parents of ill children. The proposed work delivers an innovative product – an electronic interface linked to a pediatric knowledge base that integrates parent-derived data with best practices for safe and effective emergency care across common pediatric disease conditions: otitis media, urinary tract infections, asthma, and head trauma. The study has two aims, the first of which addresses critical gaps in data capture: to evaluate the completeness and accuracy of information on symptoms, disease condition, medications and allergies generated by parents using ParentLink versus information documented by ED physicians and nurses, using structured telephone interviews as a gold standard. The second aim measures the ParentLink’s impact on ED patient safety and quality, specifically: a) the error rate for ordering and prescribing of medications during ED care, and b) the percent of ED visits that adhere to national evidence-based guidelines. Parentlink will be rigorously evaluated in a clinical trial at two diverse ED sites and will use a sequential, non-randomized observational design with two intervention and two control periods to measure the effects of ParentLink on data capture and safety and quality of patient care.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Observational

Study Design ^†

Longitudinal, Defined Population, Prospective Study

Condition ^†

Otitis Media
Urinary Tract Infection
Asthma
Head Injury

Intervention ^†

Procedure: patient-driven health IT product

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

3000

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Age less than 12 years with head trauma
Age less than 12 years with ear pain
Ages less than 12 years with concern for UTI
1 year - 12 years with asthma history and respiratory chief complaint
3 months - 2 years with fever
Parent speaks English or Spanish
Triage status is non-emergent

Gender

Both

Ages

up to 12 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00457600

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Children's Hospital Boston

Collaborators ^††

South Shore Hospital

Investigators ^†

Principal Investigator:

Stephen C Porter, MD

Children's Hospital Boston

Information Provided By

Children's Hospital Boston

Verification Date

January 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.