Young Hearts, Strong Starts

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RTI International

Status and phase

Completed
Phase 4

Conditions

Cardiovascular Risk Reduction

Treatments

Other: Control
Other: Intervention

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT01893593
Young Hearts, Strong Starts

Details and patient eligibility

About

This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices

Full description

Objective: The Young Hearts Strong Starts Study was designed to test strategies to facilitate adoption of the Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents among pediatric and family medicine providers. The study compares quality measures based on the guidelines for two dissemination strategies: a multi-faceted, practice-directed intervention or standard dissemination. Methods: Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to either the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban vs. nonurban location, and practice type. In this design, the units of observation are individual children because outcomes are abstracted from medical records for individual patients. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. Implementation The intervention practices receive toolkits, including guideline summaries and slides, a patient and family behavior change workbook, and a clinical decision support tool. Guideline implementation was promoted through an introductory academic detailing session and the use of an ongoing e-learning group. The intervention strategy was further enhanced by aligning this project with the American Board of Pediatrics quality improvement Maintenance of Certification (MOC) requirements and offers voluntary MOC participation to participants. MOC participation includes the creation of a practice aims statement, monthly physician self-abstraction to track progress throughout the intervention, and participation in webinar presentations and sharing of best practices.

Enrollment

32 patients

Sex

All

Ages

3 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients seen for well child visits

Exclusion criteria

Terminally ill patients

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Control
Other group
Description:
Usual care
Treatment:
Other: Control
Intervention
Active Comparator group
Description:
Multifaceted intervention to improve clinical systems
Treatment:
Other: Intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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