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

NCT ID: NCT01478711

Last Updated: 2013-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1517 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

A clinical decision support tool for the care and management of premature infants will be embedded into the electronic health record.

Group Type ACTIVE_COMPARATOR

Clinical Decision Support Tool

Intervention Type OTHER

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 clinical decision support tool will be used for non-intervention sites.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Library of Medicine (NLM)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Grundmeier, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Children's Hospital pf Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1RC1LM010471-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-007241

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.