Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants

NCT01478711 | Completed

• 2 other identifiers: 09-0072411RC1LM010471-01
• Study Type: interventional
• Target: 1,517
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use a rules-based expert system embedded in an electronic health record (EHR) to extract, interpret, and present salient facts and recommendations related to the healthcare of premature infants.

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

• Evaluate usability of the intervention

  Design and evaluation of the pre-implementation data-mining and expert system will employ usability methods from the human-computer interaction (HCI) field. The methods are based on the collection of quantitative and qualitative data where each method has specific metric-based goals that are to be achieved before the next phase. 10-20 clinicians, including attending physicians, nurse practitioners and nurses, from a single practice will be recruited to participate in the Usability Study.

  12 months

Secondary Outcomes (1)

• Evaluate effect on care process

  12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

A clinical decision support tool for the care and management of premature infants will be embedded into the electronic health record.

Other: Clinical Decision Support Tool

No Intervention

NO INTERVENTION

No intervention, No clinical decision support tool will be used for non-intervention sites.

Interventions

Clinical Decision Support Tool OTHER

A clinical decision support tool embedded within Epic will appear for children with a history of prematurity at the intervention sites.

Intervention

Eligibility Criteria

• Age: 20 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All clinicians from participating practices.
• Premature Infants: Receive preventive healthcare from a participating practice at least twice during the study period; (2) age less than 24 months; and (3) birth weight less than 2000 g or gestational age at birth less than 35 weeks.

You may not qualify if:

• Residents will not eligible to participate in this study due to the fact that they receive significant ongoing education related to the inpatient and outpatient management of premature infants as part of their day-to-day training.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Library of Medicine (NLM): collaborator

Study Sites (1)

The Children's Hospital pf Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Robert Grundmeier, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

US (1)