Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants (PreemieCDS)
|ClinicalTrials.gov Identifier: NCT01478711|
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : February 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prematurity||Other: Clinical Decision Support Tool||Not Applicable|
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|
|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|
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478711
|United States, Pennsylvania|
|The Children's Hospital pf Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Robert Grundmeier, MD||Children's Hospital of Philadelphia|