Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants (PreemieCDS)
Primary Purpose
Prematurity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support Tool
Sponsored by

About this trial
This is an interventional health services research trial for Prematurity
Eligibility 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.
Sites / Locations
- The Children's Hospital pf Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
No Intervention
Arm Description
A clinical decision support tool for the care and management of premature infants will be embedded into the electronic health record.
No intervention, No clinical decision support tool will be used for non-intervention sites.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01478711
First Posted
November 21, 2011
Last Updated
February 25, 2013
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Library of Medicine (NLM)
1. Study Identification
Unique Protocol Identification Number
NCT01478711
Brief Title
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
Acronym
PreemieCDS
Official Title
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Library of Medicine (NLM)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1517 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
A clinical decision support tool for the care and management of premature infants will be embedded into the electronic health record.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No intervention, No clinical decision support tool will be used for non-intervention sites.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support Tool
Intervention Description
A clinical decision support tool embedded within Epic will appear for children with a history of prematurity at the intervention sites.
Primary Outcome Measure Information:
Title
Evaluate usability of the intervention
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluate effect on care process
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Grundmeier, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital pf Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
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