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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478711
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : February 26, 2013
National Library of Medicine (NLM)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Prematurity Other: Clinical Decision Support Tool Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1517 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
Study Start Date : September 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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.

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

Primary Outcome Measures :
  1. Evaluate usability of the intervention [ Time Frame: 12 months ]
    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 :
  1. Evaluate effect on care process [ Time Frame: 12 months ]
    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

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Ages Eligible for Study:   20 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478711

United States, Pennsylvania
The Children's Hospital pf Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Library of Medicine (NLM)
Principal Investigator: Robert Grundmeier, MD Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia Identifier: NCT01478711     History of Changes
Other Study ID Numbers: 09-007241
1RC1LM010471-01 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013