NCT00457600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
Last Updated

April 6, 2007

Status Verified

January 1, 2007

First QC Date

April 4, 2007

Last Update Submit

April 5, 2007

Conditions

Keywords

information technologyemergency departmentmedication errorquality of carepatient-centered care

Interventions

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • year - 12 years with asthma history and respiratory chief complaint
  • months - 2 years with fever
  • Parent speaks English or Spanish
  • Triage status is non-emergent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

MeSH Terms

Conditions

Otitis MediaUrinary Tract InfectionsAsthmaCraniocerebral TraumaEmergencies

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic DiseasesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen C Porter, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 6, 2007

Study Start

June 1, 2005

Study Completion

July 1, 2006

Last Updated

April 6, 2007

Record last verified: 2007-01

Locations