Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01537510
Status:
COMPLETED
Last Update Posted:
2013-09-27
First Post:
2012-02-07
Brief Title:
Study of Technology to Accelerate Research
Sponsor:
Harvard Pilgrim Health Care
Organization:
Harvard Pilgrim Health Care
Study Overview
Official Title:
Accelerating Adoption of Childhood Obesity Comparative Effectiveness Research
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
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 childs 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 interventions costs including clinician and family time and cost-effectiveness in terms of childrens 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
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 childs 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 interventions costs including clinician and family time and cost-effectiveness in terms of childrens 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None