RFA-DP-16-004 amendment 2 1.11.16.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Childhood Obesity Research Demonstration 2.0

RFA-DP-16-004

Application Due Date: 01/29/2016

Childhood Obesity Research Demonstration 2.0

RFA-DP-16-004

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Childhood Obesity Research Demonstration 2.0 Activity Code AMENDMENT I made December 9, 2015

Added Figure 1: CORD 2.0 Logic Model to "Evaluation/Performance Measurement" under 2.

Approach in Section 1.

AMENDMENT II made January 7, 2016

Appendix A "Questions from Potential Applicants and CDC Responses" added to Section VIII.

Other Information.

U18

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-16-004

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.535 Category of Funding Activity:

Health FOA Purpose The purpose of this Funding Opportunity Announcement (FOA) is to test a model of quality clinical care addressing childhood obesity for U.S. low-income children, especially those enrolled in or eligible for health care coverage under the Children’s Health Insurance Program (CHIP) or Medicaid. Specifically, the purpose of this FOA is to implement and test the ability of a model of clinical childhood obesity management along with a Electronic Health Record (EHR)-referral-based, family centered pediatric weight management program, to reduce body mass index (BMI) in children with obesity, or overweight with risks (including, e.g., medical and behavioral risks, and family history). Health outcomes of interest include measurable changes in BMI, nutrition and physical activity behaviors, health care satisfaction and service delivery, and quality of life. This will be accomplished through pediatric care and an intensive family centered weight management program in the clinic or community.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-16-004, return to the

Publication Date: To receive notification of any changes to RFA-DP-16-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 12/30/2015 Letter of intent is voluntary.

Application Due Date: 01/29/2016

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 03/22/2016 3/22/2016-3/23/2016

Secondary Review: 04/18/2016

Estimated Start Date: 06/01/2016

Expiration Date: 01/30/2016 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

Executive Summary

The purpose of this FOA is to test a model of quality clinical care addressing childhood obesity for U.S.

low-income children, especially those enrolled in or eligible for health care coverage under the Children’s Health Insurance Program (CHIP) or Medicaid. Specifically, the purpose of this FOA is to implement and test the ability of a model of clinical childhood obesity management along with a EHR-referral-based, family centered pediatric weight management program, to reduce body mass index (BMI) in children with obesity, or overweight with risks (including, e.g., medical and behavioral risks, and family history). Health outcomes of interest include measurable changes in body mass index (BMI), nutrition and physical activity behaviors, health care satisfaction and service delivery, and quality of life. This will be accomplished through pediatric care including:

Implementing and evaluating a model addressing childhood obesity that includes clinical screening and counseling and a EHR-referral-based, structured, intensive family centered pediatric weight management http://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf program located in the clinic or community;

Collaboration with state CHIP and/or Medicaid offices to advise a state-wide or regional level project and to be part of a stakeholder group that can help generate suitable recommendations for sustainability and program components to be further replicated or scaled.

Mechanism of Support: Applications in response to this FOA will be funded using the U18 cooperative agreement mechanism.

Funds Available and Anticipated Number of Awards: It is anticipated that up to 2 awards of approximately $4.25M to each recipient will be made For each awardee, approximately $1,750,000 will be available for Budget Year 1 and $2,500,000 available for Budget Year 2. Budget Year 2 will extend from June 1, 2017-September 29, 2018. These estimates include direct and indirect costs. Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Budget and Project Period. The estimated total funding (direct and indirect) for the first year will be $3,500,000The estimated total funding (direct and indirect) for the entire project period will be $8,500,000.

The entire 28 month project period will run from 6/1/2016 to 09/29/2018.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Secti on IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1 are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Application Type. New (type 1). Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Medicare Access and CHIP Reauthorization Act of 2015, Section 304, extends and amends Section 1139A (e)(8) of the Social Security Act (42 U.S.C. 1320b-9a(e)(8)

1. Background and Purpose Obesity: A Public Health Problem http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV https://www.congress.gov/114/plaws/publ10/PLAW-114publ10.pdf

Obesity: A Public Health Problem

Childhood obesity prevalence remains high (Ogden 2014). Overall, obesity among our nation’s young people, aged 2 to 19 years, has not changed significantly since 2003-2004 and remains at about 17 percent (or 12.7 million children). Among low-income preschoolers 2-4 years of age in 2011, approximately 14% have obesity (Vital Signs 2013; DNPAO website: Nutrition, Physical Activity and Obesity: Data, Trends and Maps ).

Socioeconomic, racial/ethnic and age disparities in obesity prevalence also exist among children and adolescents.

Childhood obesity puts children at greater risk for numerous health consequences, including cardiovascular disease, type-2 diabetes and asthma (Cotes 2013; Freedman 2007; Visness 2010). Childhood obesity is also associated with increased school absenteeism, poorer school performance, and depression (Geier 2007, Taras 2005, Lim 2015). The health care costs associated with childhood obesity may also be significant. Analyses using the Medical Expenditure Panel Survey (MEPS) indicate that obese children and adolescents with overweight or obesity have higher annual medical care and utilization costs compared to children of normal weight (Trasande 2009, Wright 2014). A randomized trial of children with overweight or obesity in a pediatric weight management program with allied professionals identified provider-incurred costs in the intervention group as a major driver of significantly greater costs compared to a usual care group (Wright 2014). Recently, several experts provided a recommendation that all projects addressing childhood obesity should assess and report on cost data such that improvements in health care delivery could be structured in sustainable ways (BPC 2015).

Evidence Base Addressing Clinical Management of Childhood Obesity

The Expert Committee Recommendations of 2007 state that “all physicians and health care providers address weight management and lifestyle issues with all patients, regardless of presenting weight, at least each year” (Barlow 2007) (see Table). According to the Expert Committee, providers should assess medical, behavioral and family history-based risk for obesity for all children and provide behavior counseling on key obesity-related behaviors. Furthermore, providers should initiate a staged multidisciplinary team intervention for treatment for those children with a body mass index (BMI) in the 85 th-94th percentile and risks (i.e., overweight with risks), or > 95th percentile (having obesity). Children who are overweight with risks aged 2-18 years of age should receive prevention counseling addressing key obesity-related behaviors. For children with obesity, a staged comprehensive multidisciplinary intervention that increases the intensity of behavior counseling, the frequency of visits, and incorporates specialists, maximizes support for behavior changes.

Included in this comprehensive approach is a multidisciplinary team with experience in childhood obesity and delivering motivational counseling that engages families and incorporates healthy eating and activity goals.

The multidisciplinary team may include a behavioral counselor (such as a social worker, nurse practitioner or mental health care provider), registered dietitian, a team member with knowledge of community resources, and a primary care provider. The Recommendations note that the capacity to support a multidisciplinary team with staged management of obesity risk and counseling is likely beyond the capacity of most pediatric primary care practices and that referrals to family centered structured weight management programs might be necessary.

Table: Assessment and Management of Obesity Risk (adapted from Barlow 2007)

Child BMI Percentile Risk Assessment Prevention

5th-84th Obesity-related behaviors Child’s growth, history and physical exam Parental and family history of obesity Child and family readiness

Preventive behavioral counseling Engage family to support healthy behaviors http://nccd.cdc.gov/NPAO_DTM/

85th-94th Obesity-related behaviors Child’s growth, history and physical exam Parental and family history of obesity Child and family readiness Laboratory testing as indicated

No risk identified: As above Risks identified: Begin staged multidisciplinary approach based on age and BMI

>=95th Obesity-related behaviors Child’s growth, history and physical exam Parental and family history of obesity Child and family readiness Laboratory testing

Begin staged multidisciplinary intervention approach for treatment based on age and

BMI

The Expert Committee endorsed the use of multi-disciplinary teams of health care providers and allied health professionals such as nurses, registered dietitians to share the responsibility of delivering interventions (Barlow 2007). Allied health professionals can assist children and families by using reminder and access strategies for referrals and motivational interviewing to develop self-monitoring, self-reward and goal-setting techniques. Community health workers (CHWs) and care managers can integrate with and provide outreach to community resources. CHWs have effectively worked within communities in a patient-centered medical home approach (Findley 2013, Raphael 2013) to reduce health disparities and improve health outcomes associated with chronic diseases such as diabetes (Shah 2013). CHWs may also help families to promote healthful behaviors relating to obesity (Ayala 2010). Social workers, CHWs and care managers have the training and skills to address upstream determinants of health while improving outcomes and lowering costs;

the evidence is growing for the utility and effectiveness of these team members (Manchanda 2015, Tulloch 2006, Allen 2015).

In 2010, the U.S. Preventive Services Task Force (USPSTF) recommended (Grade B) that clinicians screen all children aged 6-18 years for obesity by measuring body mass index (BMI) and offering or referring obese children for intensive counseling and behavioral interventions to promote improvements in weight status (Whitlock/USPSTF 2010). There was sufficient evidence to recommend that moderate to high intensity comprehensive programs (defined as >25 hours to <75 hours of child and/or family contact in a six month period) that incorporate counseling targeting diet and physical activity, and that include behavioral management techniques, lead to modest improvements in weight status within 12 months.

Population Health Focus on Health Care Systems

Experts have also noted that health care systems can be important stakeholders in integrated community frameworks (Hester 2015). New emerging healthcare delivery models are increasing their focus on population health and thereby moving to the inclusion of an integrator. Integrators are macro system level agents that function to address upstream determinants of health across a population to achieve the 'triple aim'-- improve quality of care, and population health and reduce health care costs. In some instances, health care systems might drive the main integrator functions: by convening stakeholders, assessing community resources through existing community coalitions and facilitating stakeholder agreement, gathering and analyzing data to improve health indicators, and working at policy, systems and environment levels to sustain change, integrators can systematically support cross-sector engagement to improve population health (IOM Cross Sector Responses to Obesity, 2015).

Barriers to the Clinical Management of Childhood Obesity

Barriers to the Clinical Management of Childhood Obesity

However, there remain barriers to the assessment, counseling and effective management of children with overweight or obesity. National surveys of pediatricians have shown that only half assess BMI (Huang 2009, Klein 2010). The majority of pediatricians also report that they do not have the tools or time to counsel, do not know proper billing and coding procedures, or that families do not want to receive counseling around weight (Klein 2010). In a national survey of parents of children with overweight or obesity, only 22% of parents reported receiving counseling from their child’s primary care provider around weight status (Perrin 2012). An analysis using 2005-2009 data from both the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) showed that of children who are identified with obesity, as few as 7% receive appropriate referrals, regardless of comorbidity status (Walsh 2013).Another analysis of nationally representative surveys showed that of children who are identified with obesity, as few as 7% receive appropriate referrals, regardless of comorbidity status (Walsh 2013). Another analysis of nationally representative data found that children on Medicaid were less likely to receive appropriate clinical obesity prevention counseling than children on private insurance (Branner 2008). Finally, a 2013 survey conducted by the Children’s Hospital Association found a number of barriers for families related to referral and participation in weight management programs. More specifically it found that the majority of structured weight management programs were of varying intensity and duration, and had long waiting times, operating costs in excess of revenues and sub-optimal recognition and reimbursement of services rendered by non-physician providers (CHA 2013). Several experts have noted that to make goals relating to weight management and child and family involvement feasible, a number of actions including training and workflow optimization, securing adequate reimbursement for services provided, and familiarity with addressing the upstream determinants of health, such as food security and socioeconomic dynamics, (Daniels 2015, MHCU 2015).

Approaches to Enhance Effective Implementation

The chronic care model, as described by Wagner et al, organizes approaches to support chronic disease management. The obesity chronic care model (Dietz 2007; Barlow 2007 – Figure 2) draws from the Wagner model and includes information systems, decision supports, delivery system design and self-management support that centers on patient self-management. This framework focuses on interventions to improve obesity-related behaviors as taking place in three overlapping arenas: (1) the community and its resources and policies; (2) the health care system and payment structures; and (3) the health care provider.

Advancement in the clinical management of childhood obesity reflect emerging areas that need further research on best practices and on effective and reimbursable models of care delivery (Daniels 2015). Effective childhood obesity weight management programs should include family-tailored, culturally relevant and developmentally appropriate approaches and a dynamic relationship with children and families (Daniels 2015). In some communities providers can refer children to healthy weight clinics based in either a tertiary care center or a free-standing setting. Children and families may also be referred to non-clinical, community based structured weight management programs where nutritional and physical activity counseling are provided. The use of a healthy weight team (including physicians, allied health professionals (e.g., nurses, nurse practitioners, social workers, physician assistants), and CHWs or care managers who collaborate to provide evidence-based quality care is also critical(Barlow 2007). Healthy weight teams can delineate roles and meet multiple family needs such as serving as the patient centered medical home wherein: (a) the child and family’s cultural and linguistic needs are met; and, (b) social determinants of health and barriers to care such as transportation and follow-ups are addressed (Ader 2015).

On-site counseling in the primary care setting has been shown in a few studies to increase consumption of fruits and vegetables, increase physical activity and reduce sedentary time (Kubik 2008, Ford 2002, Taveras 2011). Experts have also noted that effective primary care-based counseling requires that all providers, allied professionals, CHWs and care managers, who are engaging children and families, should be trained in motivational interviewing and effective means of supporting families (Daniels 2015). A study of the effectiveness of motivational interviewing for obesity delivered by intensively trained providers and http://www.medicalhomeinfo.org/ registered dietitians showed reductions in BMI compared to a usual care group not utilizing motivational interviewing (Resnicow 2015). This study also demonstrated a dose-response relationship between the number of motivational interviewing sessions attended and BMI reduction, thus interventions improved the quality of care and outcomes for childhood obesity.

Electronic Health Records (EHRs) aid screening of children for growth and healthy weight status through their ability to calculate BMI and chart and display growth trajectories (Barlow 2007). EHRs can also assist providers by providing clinical decision supports (CDS) and counseling recommendations on obesity-specific content to guide the care and management of children’s healthy growth, children who are overweight with risks and children with obesity. EHRs can be further augmented by including diagnostic codes, links to further resources, and referrals. An optimized EHR can plot BMI on appropriate growth charts, include evidence-based guidelines for screening, assessment and management of childhood obesity, utilize alerts aligned with these guidelines, and provide obesity-specific note templates (Taveras 2015). EHRs can furthermore provide support for proper billing procedures for overweight and obesity and related diagnostic codes, including comorbidities, and procedural, evaluation and management codes (Davis 2007).

One study described a childhood obesity treatment intervention based on the use of an enhanced EHR that included two optimized health care information technology components: computerized CDS using enhanced EHR for pediatric clinicians and support for self-guided behavior change for families for children aged 6 to 12 years compared to usual care (Arsenault 2015, Taveras 2015). Supportive strategies, including on-site counseling, educational materials, text messages and follow-up telephone calls by a health coach, increased parental confidence to change behaviors and provided children and families with the information and knowledge needed to improve self-efficacy and change behaviors. At the 12-month follow-up, the intervention resulted in improved childhood BMI compared to usual care practices without the two components and substantially greater rates of BMI assessment and counseling, as measured by the childhood obesity Healthcare Effectiveness Data and Information Set (HEDIS) measures, in the CDS arm.

With national population health and healthcare transformation efforts gaining momentum, the U.S. Office of the National Coordinator for Health Information Technology issued Meaningful Use (MU) standards, for childhood obesity specify that in order to qualify for maximal incentive payments, providers must demonstrate that their EHR systems calculate and display BMI for all patients, and plot and display growth charts, including BMI, for all children (CMS 2012). However, a survey of physicians describing EHRs used in their daily practice found that 83% of EHRs could calculate BMI, however only 52% could calculate an age- and gender-specific BMI percentile for children (Bronder 2015). Only 32% of EHRs flagged patients with abnormal BMIs and 36% were reported to provide obesity-related CDSs such as prompts for best practices, counseling or diagnostic codes. Furthermore, only 17% of EHRs suggested additional resources such as referrals to other clinic-based personnel (e.g., dieticians), support staff for case management or community-based resources. Because weight assessment and counseling for nutrition and physical activity are common clinical quality measures linked to payor reimbursement (e.g. Quality of Child Care Core Set HEDIS), enhanced EHRs with CDS have the potential to increase the frequency of these important activities, as well as increase payor reimbursement to healthcare providers. Further, BMI and obesity-related data collected in EHRs, if transferred to health information exchanges, have broad potential for providing feedback to clinicians and public health practitioners regarding efficacy of interventions, obesity disparities, as well as informing decision makers including Medicaid directors regarding the weight status of children in their community.

Current Opportunity

This funding opportunity will emphasize the primary care sector’s role in childhood obesity prevention and treatment, specifically the implementation of quality clinical pediatric primary care and use of weight management programs based in either the clinic or community. There are 31 million children covered by either CHIP or Medicaid (Medicaid.gov), and Medicaid bears a significant portion of the cost burden associated with obesity (Trasande 2010). Thus, developing quality clinical strategies and weight management programs that are acceptable to payors is critical and timely.

http://www.icd10data.com/ICD10CM/Codes/E00-E89/E65-E68/E66-http://www.wpsmedicare.com/j8macparta/policy/active/national/_files/gsurg044-icd10.pdf http://www2.aap.org/pubserv/codingforpeds/obesitycodingfactsheet0208.pdf http://www.ncqa.org/ReportCards/HealthPlans/StateofHealthCareQuality/2014TableofContents/WeightAssessment.aspx http://www.medicaid.gov/medicaid-chip-program-information/by-topics/quality-of-care/downloads/2015-child-core-set.pdf

Healthy People 2020 and other National Strategic Priorities The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) of CDC, within the Department of Health and Human Services (HHS) is committed to achieving the objectives of “Healthy People 2020.” This funding opportunity addresses the following Healthy People 2020 priorities: Focus Area 19: Nutrition and Overweight and Focus Area 22: Physical Activity and Fitness.

This FOA is also in alignment with performance Goal 6, Performance Measure 1(HHS FY 2008 Congressional Justification). For more information go to http://www.healthypeople.gov/ and https://www .whitehouse.gov/omb/mgmt-gpra/index-gpra. The FOA evaluation measures align with the 2015 Medicaid child core set of quality measures, and the Healthcare Effectiveness Data and Information Set (HEDIS) measures for BMI assessment and counseling.

This FOA is also aligned with the following activities under NCCDPHP’s Domains 3 and 4:

Domain 3

Health system interventions to improve the effective delivery and use of clinical and other preventive services in order to prevent disease, detect diseases early, and reduce or eliminate risk factors and mitigate or manage complications.

1.

Increase EHR adoption and the use of health IT to improve performance2.

Increase use of team-based care in health systems-Increase engagement of patient navigators in the health care system-Increase use of self-management plans monitoring tied with clinical support

3.

Domain 4: Strategies to improve community-clinical linkages ensuring that communities support and clinics refer patients to programs that improve management of chronic conditions. Such interventions ensure those with or at high risk for chronic diseases have access to quality community resources to best manage their conditions or disease risk.

Increase the use of effective community interventions such as chronic disease self-management programs by making them widely available, ensuring that doctors refer their patients to them, and helping to insure that they are covered by health insurance

1.

Link existing public health services to health care systems2.

Encourage a broader spectrum of health care workers-including pharmacists, patient navigators, and community health workers-to help people manage their own health.

3.

Public Health Impact This research opportunity has the potential to demonstrate effective models in addressing child obesity through the delivery of quality clinical services and family centered pediatric weight management programs for millions of at-risk children, especially for CHIP and Medicaid eligible children. This work will expand on a limited research base on how to implement and evaluate a model for operationalizing the US Preventive Services child obesity recommendations among low income children, including a pediatric weight management program. Strategies and recommendations derived from this research can be offered to state and federal agencies and adapted and scaled to local circumstances and a variety of payors.

Relevant Work The Division of Nutrition, Physical Activity and Obesity (DNPAO) at the Centers for Disease Control and Prevention (CDC) aims to:

Increase health-related physical activity through population-based approaches;1.

Improve those aspects of dietary quality most related to population burden of chronic disease and unhealthy child development;

2.

http://www.healthypeople.gov/ https://www.whitehouse.gov/omb/mgmt-gpra/index-gpra https://www.whitehouse.gov/omb/mgmt-gpra/index-gpra http://www.medicaid.gov/medicaid-chip-program-information/by-topics/quality-of-care/downloads/2015-child-core-set.pdf http://www.medicaid.gov/medicaid-chip-program-information/by-topics/quality-of-care/downloads/2015-child-core-set.pdf http://www.ncqa.org/ReportCards/HealthPlans/StateofHealthCareQuality/2014TableofContents/WeightAssessment.aspx

Decrease prevalence of obesity through prevention of excess weight gain and maintenance of healthy weight loss;

3.

Reduce health disparities.4.

DNPAO is currently overseeing the 4-year CORD project. CORD is testing whether a coordinated approach to address childhood obesity between primary care and public health strategies including efforts in early care and education, schools and communities can improve health behaviors and weight status for lower-income children 2-12 years of age eligible for, or on CHIP. A comprehensive evaluation report of this project will be made available to grantees by Fall 2016. DNPAO is also currently supporting work to standardize how obesity data collected for clinical purposes in electronic health records can be transmitted to local public health agencies, provider groups or other communities of clinical/public health practice for the purpose of child obesity surveillance to improve primary care and community-level public health child obesity interventions ( HL7 International 2013; Integrating the Healthcare Enterprise 2013). Standards, implementation tools, lessons and experience from this work will be shared with grantees to inform their work in this area.

2. Approach The project goal is to implement and evaluate a model addressing childhood obesity among low-income children that includes pediatric clinical care (on-site assessment, counseling) and an affordable, EHR-referral-based, family centered intensive weight management program. To meet this goal, grantees will answer the following quantitative research question: Does an affordable referral-based family centered intensive weight management program reduce BMI in low-income children who are overweight with risks or who have obesity versus usual clinical care?

Objectives/Outcomes Implementation and Evaluation

1. Readiness of Existing Intervention:Applicants must identify an existing family-centered pediatric weight management program intervention that is implementation ready (or that can be readily adapted), and has process data including number of children/families enrolled and retained in the program, program staff trained, and evidence of program effectiveness, but that has not been rigorously evaluated in low-income children. Applications must include a summary of the intervention, a logic model, and target population selected for recruitment and program delivery.

2.Intervention Design:As part of the proposed applicant work, the pediatric primary care center and proposed family centered pediatric weight management program are to follow expert recommendations to screen, assess and manage overweight and obesity. The applicant should use an EHR with clinical decision supports, a multi-disciplinary team, and a program that delivers a minimum of moderate intensity nutrition and physical activity education and behavior modification (i.e. at least 25 hours of contact time over 6 months) for children and families. The proposed intervention program should be tested in low-income children aged 6 to 12 years of age, with the option of also including low-income children 2-5 years. If a control group consisting of usual care is planned, it must be clearly described.

The family-centered pediatric weight management program can be delivered in either the primary care or community setting and may include a combination of group and individual/family sessions, and in-person or virtual (telephone or web-based) health coaches. The delivery of the program, including a description of the theoretical base, the content (nutrition and physical activity and other behavior goals), and intensity and frequency of counseling and educational engagement of children and families should be provided. The program should be able to be delivered at a cost not to exceed $1000 per family. Applicants should demonstrate capacity and experience accessing and working with the proposed target age range and program setting, including evidence of successful enrollment in programs, intervention studies or trials, and the http://www.cdc.gov/nccdphp/dnpao/division-information/programs/researchproject.html http://www.hl7.org/implement/standards/product_brief.cfm?product_id=315 http://www.ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_HW_Rev1-0_PC_2013-06-03.pdf expertise to implement the intervention with fidelity.

In addition to the proposed program intervention component:

The intervention pediatric primary care office that offers or refers children and families to the program needs to have the following capacities and resources in place:

Utilization of an EHR system that calculates BMI and flags at-risk children and, with minimal improvements, provides decision supports and referrals to a weight-management program for children who are overweight with risks or who have obesity. This enhanced EHR will assist the clinician in implementing expert recommendations and improve achievement of measurable relevant clinical quality measures including:

Documenting and coding for BMI percentile, Placing referrals for ongoing weight management activities (either onsite at the clinic or to a separate community program).

A primary care site that utilizes counseling and/or motivational interviewing in order to assist children and families with education, remove barriers to access to programs and referrals, support enrollment and retention in the family-centered pediatric weight management program, and aid with identification of other community resources.

3. Stakeholders Recipients are also expected to engage key stakeholders that support preventive care for low-income children including the state CHIP or Medicaid offices to advise on a state-wide or regional level project, as well as local or state health departments. These stakeholders are encouraged to partner with the grantee including but not limited to:

Regularly take part in advisory meetings in order to aid the grantee in development of appropriate information and data collection in order to help develop sustainable delivery strategies that align with clinical quality measures, flexible delivery approaches, and/or value-based care.

Provide recommendations on study design that increase the chance for widespread, sustainable coverage for the program if it is found to be effective.

Objectives

Objective 1: Develop the proposed intervention for a rigorous evaluation. Below are some of the activities anticipated for Objective 1.

Identify and convene a Study Team.1.

Identify and convene a consultative advisory group that includes the State CHIP office, Medicaid off and other relevant healthcare stakeholders.

2.

Refine and enhance the electronic health record system.3.

Provider refresher training to the existing usual care primary care staff regarding referral to the family centered pediatric weight management program and appropriate follow-up.

4.

Refine and finalize program intervention materials (as applicable) to prepare for the implementation and evaluation, including but not limited to a logic model, data collection instruments and processes, training materials, educational and behavioral modification curricula and materials.

5.

Determine approach for rapidly identifying a pool of children eligible for the study. This could include a review of EHR information or a data registry.

6.

Objective 2. Implement the Intervention Below are some of the activities anticipated for Objective 2, as previously described.

The pediatric primary care center is to follow expert recommendations to screen, assess and manage overweight and obesity.

1.

The applicant should use an EHR with clinical decision supports and ability for referral.2.

Deliver the program, including a minimum of moderate intensity nutrition and physical activity education and behavior modification (i.e. at least 25 hours of contact time over 6 months) for children and families. The family centered pediatric weight management program can be delivered in either the primary care or community setting and may include a combination of group and individual/family sessions, and in-person or virtual (telephone or web-based) health coaches.

3.

Objective 3: Evaluate the intervention. There will be two evaluation elements: a quantitative efficacy evaluation and a qualitative evaluation. Below are the parameters for the evaluation design and some of the anticipated activities for Objective 2.

Develop and implement a quantitative efficacy evaluation of the intervention.1.

The proposed evaluation plan should be accompanied by a logic model and address key activities and outcomes. Evaluations implementing randomized controlled trials (RCTs) including cluster RCTs are preferred, though rigorous evaluations with non-randomized designs are also acceptable with justification. The comparison usual care group needs to be described and justified.

2.

3. Applicants should provide a power analysis that demonstrates the proposed sample size after anticipated attrition is sufficient to detect an intervention effect.

Evaluation outcomes: The primary outcomes to be assessed are BMI/weight status, nutrition and physical activity behaviors, quality of life, satisfaction with care, and cost to carry out the components of the FOA as well as other costs such as parent/caregiver time-costs.

Key intermediate outcomes based on the logic model should be assessed including electronic health record use including CDS audits, documentation of staff training and competencies, metrics that capture that referrals were appropriate, and clinical quality measures.

Implementation of the evaluation should include process monitoring and quality assurance activities; protection of human subjects; baseline and follow-up data collection for intervention and comparison groups; and data security, cleaning and analysis activities.

4. Develop and implement qualitative evaluation of the intervention

The purpose of the qualitative evaluation element is to provide context to the quantitative results and enhance understanding of the intervention, such as components that resonate with participants and mediate behavior change, barriers to behavior change and intervention program attendance. This evaluation element should also assess facilitators and barriers to program implementation and provide information for replication of the intervention package.

Objective 4: Develop and implement a plan to summarize efficacious interventions and disseminate study results and products for stakeholders. Below are some of the activities anticipated for Objective 3.

Prepare a manuscript(s) that report results from the quantitative and qualitative including effects on BMI, cost and other key outcomes.

1.

Use lessons learned from the quantitative and qualitative evaluations, including but not limited to, information on the intervention’s logistics, team member roles, training, referral flow, and cost. Report this information as part of the evaluation.

2.

Provide sustainability plans based on these findings and their discussions with their stakeholders, including state CHIP or Medicaid offices. These plans may include aspects of replication of optimal pediatric care and weight management program implementation, staff certification and reimbursable components.

3.

Target Population Target population

Target population

The target population is low-income children aged 6-12 years for this FOA. The applicant should document their ability to reach this population through appropriate data sources, such as:

Documenting eligibility for services under titles XIX (Medicaid) or XXI (CHIP) of the Social Security Act; income eligibility levels for Medicaid and CHIP are available at: http://www.medic aid.gov/medicaid-chip-program-information/program-information/downloads/medicaid-and-chip -eligibility-levels-table.pdf

OR

Establishing catchment areas where 50% of students are in schools eligible for free or reduced meals in the National School Lunch Program, and come from families at or below 185% of the federal poverty level. See Census Bureau’s American Fact Finder page: http://factfinder.census .gov

OR,

1.

Providing documentation of the proportion of children (using chart audits, EHR data pulls or administrative data), seen in the clinic office who are covered by CHIP, Medicaid, or Medicaid managed care plans

Collaboration/Partnerships Grantees are expected to develop a Study Team to fulfill the capacity needs for successfully completing the project (e.g. team member(s) within a primary care center collaborating with intervention program staff).

Grantees should work to ensure that the intervention tested is feasible and sustainable. Grantees are also expected to collaborate with the CHIP or Medicaid office in the state. In addition to the CHIP or Medicaid office, grantees should collaborate when appropriate with community organizations that can provide resources for children and families , and state and local health departments. Grantees will be expected to collaborate closely with the other investigators funded under this announcement and CDC.

Evaluation/Performance Measurement All funded grantees are expected to complete a rigorous evaluation designed to address the elements in the logic model. Applicants should include a preliminary evaluation plan that includes the following evaluation components: outcome evaluation, process evaluation and cost evaluation. The outcome evaluation will include a plan for measurement and evaluation of the primary FOA outcomes, see Objective 3.

Figure 1: CORD 2.0 Logic Model http://www.medicaid.gov/medicaid-chip-program-information/program-information/downloads/medicaid-and-chip-eligibility-levels-table.pdf http://www.medicaid.gov/medicaid-chip-program-information/program-information/downloads/medicaid-and-chip-eligibility-levels-table.pdf http://www.medicaid.gov/medicaid-chip-program-information/program-information/downloads/medicaid-and-chip-eligibility-levels-table.pdf http://factfinder.census.gov http://factfinder.census.gov

Translation Plan All funded grantees are expected to prepare an intervention outcome-related manuscript. Applicants are expected to create additional written and verbal products as part of the project including costs. These include but are not limited to presentations, toolkits, meetings with CDC and key partners and stakeholders.

OMB/PRA not expected to be required

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