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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01478711
First received: November 21, 2011
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Prematurity
Other: Clinical Decision Support Tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Evaluate usability of the intervention [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Evaluate effect on care process [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 1517
Study Start Date: September 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
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
A clinical decision support tool embedded within Epic will appear for children with a history of prematurity at the intervention sites.
Other Name: clinical decision support tool
No Intervention: No Intervention
No intervention, No clinical decision support tool will be used for non-intervention sites.

Detailed 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

  Eligibility

Ages Eligible for Study:   20 Weeks to 35 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478711

Locations
United States, Pennsylvania
The Children's Hospital pf Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Robert Grundmeier, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01478711     History of Changes
Other Study ID Numbers: 09-007241, 1RC1LM010471-01
Study First Received: November 21, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014