ParentLink: Better and Safer Emergency Care for Children

Asthma Clinical Trial

Official title:

ParentLink: Better and Safer Emergency Care for Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457600
• Other study ID #: CHB-R01HS014947
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 4, 2007
• Last updated: April 5, 2007
• Start date: June 2005
• Est. completion date: July 2006

Study information

• Verified date: January 2007
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Asthma
• Emergencies
• Head Injury
• Otitis Media
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Procedure:
• patient-driven health IT product

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	South Shore Hospital

Country where clinical trial is conducted

United States,