Study Results
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.
COMPLETED
NA
549 participants
INTERVENTIONAL
2010-12-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Despite availability of guidelines for nearly a decade and more recent comparative effectiveness research (CER) evidence, the health care system has been slow to adopt recommended practices. Although pediatric health care providers often cite barriers such as limited time, skill, and resources, a frequently overlooked barrier is the lack of data systems to efficiently and accurately assess guideline implementation and to improve quality of care for childhood obesity. Health information technology (HIT) offers potential for accelerating the adoption of CER evidence regarding childhood obesity screening and management, for establishing treatment benchmarks, and for supporting patients and their clinical teams in care improvement. Incorporation of HIT may be especially effective if augmented by outreach to parents and children.
The goal of this study is to develop and test system-level interventions to accelerate the adoption of CER evidence on childhood obesity screening and management, and ultimately improve obesity-related health care quality and outcomes. To achieve this goal, the investigators will work with two health care systems in Massachusetts with strong track records of research collaboration: Cambridge Health Alliance (CHA), an integrated academic public health system, and Harvard Vanguard Medical Associates (HVMA), a large multi-site group practice. Both systems use an electronic medical record for all aspects of ambulatory care, including point of care services such as electronic order entry and centralized functions such as patient scheduling.
In these settings of innovation and commitment to improving quality of care, the investigators will develop and test two systematic strategies for adoption of CER evidence. The first incorporates computerized point of care decision alerts to pediatric primary care providers during routine office visits, linked to CER-based algorithms of care. The second augments this HIT approach with direct-to-parent communication of child's body mass index (BMI) along with recommended evaluation and management. The specific aims of this study are:
1. In 18 community health centers of CHA, to identify barriers to and facilitators of adoption of an existing set of computerized point of care decision alerts for childhood obesity screening and management. The investigators will achieve this aim through in-depth interviews and surveys with primary care clinicians, which will inform the design of the investigators proposed intervention.
2. In 14 practices of HVMA, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of CER evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile. The investigators will determine the extent to which each of the 2 intervention conditions, compared with the usual care control condition and with each other, results in:
1. Increased screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling,
2. A smaller age-associated increase in BMI over a 1-year period, and,
3. Improved specific dietary, physical activity, and sedentary behaviors over a 1-year period.
3. To evaluate each intervention's costs (including clinician and family time) and cost-effectiveness in terms of children's change in BMI and weight-related behaviors.
4. To develop a detailed dissemination guide to further accelerate adoption of CER evidence on childhood obesity in practices and communities interested in implementing similar interventions.
To achieve the investigators aims, the investigators have assembled a research team with extensive experience in obesity prevention, clinician and child behavior change, clinical informatics, statistical methodology in cluster randomized controlled trials, cost-effectiveness analyses, and dissemination science. If successful, this project will provide new and sustainable approaches for accelerating adoption of CER evidence for childhood obesity screening and management and for improving quality of care for childhood obesity in pediatric primary care.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Usual Care
STAR - Study of Technology to Accelerate Research
In 14 pediatric practices, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of comparative effectiveness research evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile.
Clinician intervention only
This arm will entail the development and deployment of alerts and access to a SmartSet at the time of a well child visit with a child between the ages of 6-12 years with a BMI ≥ 95th percentile.
STAR - Study of Technology to Accelerate Research
In 14 pediatric practices, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of comparative effectiveness research evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile.
Clinician intervention plus Direct-to-parent communication
Parents of children enrolled in this intervention arm will receive mailings, text messages and a series of 4 calls with a health coach to encourage behavior change in addition to the intervention received by the clinicians.
STAR - Study of Technology to Accelerate Research
In 14 pediatric practices, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of comparative effectiveness research evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
STAR - Study of Technology to Accelerate Research
In 14 pediatric practices, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of comparative effectiveness research evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* child's BMI exceeds the 95th percentile for age and sex (CDC criteria
* parent can respond to interviews and questionnaires in English
* child has obtained well-child care from HVMA for at least the previous 15 months.
Exclusion Criteria
* families who plan to leave HVMA within the study time frame
* families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or mental difficulties
* children with chronic conditions that substantially interfere with growth
6 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Cambridge Health Alliance
OTHER
Harvard Vanguard Medical Associates
OTHER
Harvard Pilgrim Health Care
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elsie Taveras
Associate Professor of Population Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elsie M Taveras, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Harvard Pilgrim Health Care Institute/Harvard Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fiechtner L, Fonte ML, Castro I, Gerber M, Horan C, Sharifi M, Cena H, Taveras EM. Determinants of Binge Eating Symptoms in Children with Overweight/Obesity. Child Obes. 2018 Nov/Dec;14(8):510-517. doi: 10.1089/chi.2017.0311. Epub 2018 Aug 28.
Taveras EM, Marshall R, Kleinman KP, Gillman MW, Hacker K, Horan CM, Smith RL, Price S, Sharifi M, Rifas-Shiman SL, Simon SR. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial. JAMA Pediatr. 2015 Jun;169(6):535-42. doi: 10.1001/jamapediatrics.2015.0182.
Taveras EM, Marshall R, Horan CM, Gillman MW, Hacker K, Kleinman KP, Koziol R, Price S, Simon SR. Rationale and design of the STAR randomized controlled trial to accelerate adoption of childhood obesity comparative effectiveness research. Contemp Clin Trials. 2013 Jan;34(1):101-8. doi: 10.1016/j.cct.2012.10.005. Epub 2012 Oct 22.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.