Clinical trial NCT01537510: Study of Technology to Accelerate Research
Official title: Accelerating Adoption of Childhood Obesity Comparative Effectiveness Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Cambridge Health Alliance
name: Harvard Vanguard Medical Associates
First posted: 2012-02-23
Enrollment: 549
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Childhood obesity is highly prevalent and is associated with both short- and long-term adverse outcomes.

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.


Eligibility criteria: Inclusion Criteria:

* child is age 6.0 through 12.9 years at baseline
* 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:

* children who do not have at least one parent who is able to follow study procedures for 1 year
* 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

Primary outcomes:
measure: Change in 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
timeFrame: Baseline and 1 Year
Secondary outcomes:
measure: Change in Body Mass Index
timeFrame: Baseline and 1 year
measure: Change in Health Behaviors
timeFrame: Baseline and 1 year
measure: Costs (including clinician and family time) and cost-effectiveness in terms of children's change in BMI and weight-related behaviors
timeFrame: For the duration of the intervention, from planning through completion of the intervention, up to 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
Study officials:
affiliation: Harvard Pilgrim Health Care Institute/Harvard Medical School
name: Elsie M Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.