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

Prematurity Clinical Trial

— PreemieCDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478711
• Other study ID #: 09-007241
• Secondary ID: 1RC1LM010471-01
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: February 25, 2013
• Start date: September 2009
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Premature infants are a vulnerable population with multiple inter-related health problems that put them at risk for poor outcomes. Electronic health records capture large amounts of information that may help guide decisions, but existing alert and reminder-based clinical decision support (CDS) frameworks do not adequately apply multiple overlapping care guidelines to complex patient histories to produce coherent clinical recommendations.

The primary objective of the study is to design and evaluate the usability of a CDS intervention to improve the quality of primary care for low birth weight (LBW) and very low birth weight (VLBW) premature infants from the time of intensive care nursery discharge through 24 months corrected gestational age

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1517
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Weeks to 35 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Prematurity

Intervention

Other:
• Clinical Decision Support Tool
A clinical decision support tool embedded within Epic will appear for children with a history of prematurity at the intervention sites.

Locations

Country	Name	City	State
United States	The Children's Hospital pf Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluate effect on care process	The clinical decision support (CDS) intervention will be tested for correctness and usability prior to implementation. The effect on care processes will examine process outcomes in the following domains: (1) neonatal summary documentation; (2) growth and nutrition; (3) ophthalmology; (4) hearing, speech, and language; (5) development; (6) gastro-esophageal reflux; (7) broncho-pulmonary dysplasia; and (8) apnea of prematurity. The primary evaluation will examine the change in prevalence of these process outcomes between a 12 month pre-intervention phase and a 12 month intervention phase for bo	12 months	Yes