Kenneth A LaBresh1, Suzanne Lazorick2, Adolfo J Ariza3, Robert D Furberg4, Lauren Whetstone5, Connie Hobbs4, Janet de Jesus6, Randall H Bender4, Ilse G Salinas7, Helen J Binns8. 1. RTI International, 1440 Main St Waltham, MA, 02451, USA. Electronic address: klabresh@rti.org. 2. Brody School of Medicine, East Carolina University, Departments of Pediatrics and Public Health, 600 Moye Blvd. 174 Life Sciences Bldg., Greenvile, NC 27834. Electronic address: lazoricks@ecu.edu. 3. Pediatric Practice Research Group, Mary Ann & J. Milburn Smith Child Health Research Program, Ann & Robert H. Lurie Children's Hospital of Chicago Research Center, 225 E. Chicago Ave, Box #157, Chicago, IL, 60611, USA. Electronic address: aariza@luriechildrens.org. 4. RTI International, 3040 Cornwallis Rd Cox 319 Research Triangle Park, NC, 27709, USA. 5. Brody School of Medicine, East Carolina University, Departments of Pediatrics and Public Health, 600 Moye Blvd. 174 Life Sciences Bldg., Greenvile, NC 27834. Electronic address: lauren.whetstone@cdph.ca.gov. 6. National Heart, Lung, and Blood Institute, 31 Center Drive, Bethesda, MD, 20892, USA. Electronic address: dejesusjm@mail.nih.gov. 7. Pediatric Practice Research Group, Mary Ann & J. Milburn Smith Child Health Research Program, Ann & Robert H. Lurie Children's Hospital of Chicago Research Center, 225 E. Chicago Ave, Box #157, Chicago, IL, 60611, USA. Electronic address: ilse.salinas@northwestern.edu. 8. Pediatric Practice Research Group, Mary Ann & J. Milburn Smith Child Health Research Program, Ann & Robert H. Lurie Children's Hospital of Chicago Research Center, 225 E. Chicago Ave, Box #157, Chicago, IL, 60611, USA. Electronic address: hbinns@luriechildrens.org.
Abstract
BACKGROUND:Cardiovascular disease (CVD) and the underlying atherosclerosis begin in childhood, and their presence and intensity are related to known cardiovascular disease risk factors. Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD. OBJECTIVE: The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National, Heart, Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. This study compares guideline-based quality measures for body mass index, blood pressure, and tobacco using two strategies: a multifaceted, practice-directed intervention versus standard dissemination. STUDY DESIGN: Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban versus nonurban location, and practice type. The units of observation are individual children because measure adherence is abstracted from individual patient's medical records. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. The intervention practices received toolkits and supported guideline implementation including academic detailing, an ongoing e-learning group. This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction, webinars, and other elements of the trial. SIGNIFICANCE: This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions.
RCT Entities:
BACKGROUND:Cardiovascular disease (CVD) and the underlying atherosclerosis begin in childhood, and their presence and intensity are related to known cardiovascular disease risk factors. Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD. OBJECTIVE: The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National, Heart, Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. This study compares guideline-based quality measures for body mass index, blood pressure, and tobacco using two strategies: a multifaceted, practice-directed intervention versus standard dissemination. STUDY DESIGN: Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban versus nonurban location, and practice type. The units of observation are individual children because measure adherence is abstracted from individual patient's medical records. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. The intervention practices received toolkits and supported guideline implementation including academic detailing, an ongoing e-learning group. This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction, webinars, and other elements of the trial. SIGNIFICANCE: This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions.
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