Cardiovascular Risk ReductionPhase 4NCT01893593
Young Hearts, Strong Starts
A Phase 4 study testing Intervention in people with Cardiovascular Risk Reduction, run by RTI International at 2 sites in United States.
Trial summary
This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Cardiovascular Risk Reduction
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients seen for well child visits
Who cannot join
- Terminally ill patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lurie Children's Hospital
Chicago, Illinois, 60611
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: A Cluster Randomized Trial of the Implementation of the NHLBI Expert Panel Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents
This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices
Read the detailed 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.
- Conditions
- Cardiovascular Risk Reduction
- Being tested
- Intervention, Control
- Keywords
- Cardiovascular risk, lifestyle change, blood pressure, body mass index, tobacco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems
ControlOther
Guideline summary and data feedback from a baseline medical record review
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Usual care Receives: Other: Control |
| Intervention | Active comparator | Multifaceted intervention to improve clinical systems Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary composite measure of practice performance and exposure
Summary measures of the number of guideline recommended actions in each area divided by the number of eligible patients. Process measures of adherence to guidelines in the measurement, interpretation, and recommendations for blood pressue and BMI, and measures of assessment and advice for tobacco exposure and use.
Measured: One year
Secondary outcomes (1)
Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure
Process measures of adherence to guidelines in the measurement, interpretation, and recommendations for blood pressue and BMI, and measures of assessment and advice for tobacco exposure and use.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University, Pediatric Practice Research Group, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Sponsor
- Investigators
- Ken LaBresh, MD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893593
- Sponsor's protocol ID
- Young Hearts, Strong Starts
- Status last verified
- Aug 2014
- First submitted
- 27 Jun 2013
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
LaBresh KA, Ariza AJ, Lazorick S, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Salinas IG, Bender RH, Binns HJ. Adoption of cardiovascular risk reduction guidelines: a cluster-randomized trial. Pediatrics. 2014 Sep;134(3):e732-8. doi: 10.1542/peds.2014-0876.
PubMed 25157013LaBresh KA, Lazorick S, Ariza AJ, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Bender RH, Salinas IG, Binns HJ. Implementation of the NHLBI integrated guidelines for cardiovascular health and risk reduction in children and adolescents: rationale and study design for young hearts, strong starts, a cluster-randomized trial targeting body mass index, blood pressure, and tobacco. Contemp Clin Trials. 2014 Jan;37(1):98-105. doi: 10.1016/j.cct.2013.11.011. Epub 2013 Dec 1.
PubMed 24295879
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial of the Implementation of the NHLBI Expert Panel Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01893593
- Acronym / sponsor ID
- Young Hearts, Strong Starts
- Conditions
- Cardiovascular Risk Reduction
- Keywords
- Cardiovascular risk, lifestyle change, blood pressure, body mass index, tobacco
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- East Carolina University, Pediatric Practice Research Group, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlUsual care |
| Intervention | Active comparator | Other: InterventionMultifaceted intervention to improve clinical systems |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients seen for well child visits
Key exclusion criteria (1 listed)
- Terminally ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionGuideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems | Other | Intervention |
| ControlGuideline summary and data feedback from a baseline medical record review | Other | Control |
Primary outcome
Summary composite measure of practice performance and exposure
Time frame: One year
Summary measures of the number of guideline recommended actions in each area divided by the number of eligible patients. Process measures of adherence to guidelines in the measurement, interpretation, and recommendations for blood pressue and BMI, and measures of assessment and advice for tobacco exposure and use.
1 secondary outcome
Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Derived from this study: PubMed 25157013LaBresh KA, Ariza AJ, Lazorick S, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Salinas IG, Bender RH, Binns HJ. Adoption of cardiovascular risk reduction guidelines: a cluster-randomized trial. Pediatrics. 2014 Sep;134(3):e732-8. doi: 10.1542/peds.2014-0876.
- Derived from this study: PubMed 24295879LaBresh KA, Lazorick S, Ariza AJ, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Bender RH, Salinas IG, Binns HJ. Implementation of the NHLBI integrated guidelines for cardiovascular health and risk reduction in children and adolescents: rationale and study design for young hearts, strong starts, a cluster-randomized trial targeting body mass index, blood pressure, and tobacco. Contemp Clin Trials. 2014 Jan;37(1):98-105. doi: 10.1016/j.cct.2013.11.011. Epub 2013 Dec 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken LaBresh, MD principal investigator
RTI International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention in people with Cardiovascular Risk Reduction, run by RTI International at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary composite measure of practice performance and exposure (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893593, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.