COACH - Combating Obesity in Community Health Centers: Network Dissemination of a Group Program for Weight Management

Specific Aims: We know how to treat obesity and prevent complications such as diabetes through implementing healthy lifestyle behavior change programs.1 To date there has been limited implementation of such interventions to address obesity and its complications through clinical settings2-5 or with community organizations.6-9 We can incorporate behavioral interventions into standard clinical care,10 but growing evidence suggests group visits effectively complement individual care to promote behavior change for obesity and related conditions.11-13 Implementation science teaches us how to disseminate, implement and assess sustainability of health interventions in real-world settings with diverse patient populations.14-19 Community health centers (HCs) serve a large “safety-net” population of vulnerable patients at high risk for obesity and its complications.20 To date there has not been a significant network approach to collaboratively implement a group weight management program in community HCs. Successful implementation of an obesity lifestyle intervention through a network of HCs would have significant potential to reduce obesity, its complications and related societal costs.

The MidWest Clinicians’ Network (MWCN) is a large network of HCs caring for medically underserved populations which is primed to implement a group program for weight management. MWCN comprises 120 community HCs with over 300 primary care practice sites in 10 MidWestern states, serving diverse patient populations in both urban and rural settings. MWCN has a long track record of partnering successfully with quality improvement (QI) leaders from the University of Chicago (UC) to implement and study QI collaboratives for patients with obesity, diabetes and related conditions.21-34 Recently, MWCN piloted a successful QI collaborative for weight management programs in 5 HCs, the COACH (Combating Obesity in Community Health Centers) collaborative.34 The COACH pilot demonstrated feasibility of the collaborative network approach across geographic distance, involving HCs serving diverse minority and immigrant populations. The COACH pilot supported collaborative QI activities for existing weight loss programs in HCs, but did not disseminate a common curriculum. COACH leaders expressed a strong desire for a common core weight management program which they could tailor and implement at their own HCs, and a current survey of MWCN HCs indicates broad interest in implementing a group weight management program for obese adult patients.

This proposal builds on the productive history of collaboration between MWCN and UC, the extensive existing infrastructure of the MWCN network, and the expressed readiness of HCs to implement a group program for weight management. The COACH healthy lifestyle program is a 14 week group curriculum for adults with obesity, drawn from the Diabetes Prevention Program35 and related resources, and developed, tested and refined previously as the REACH-OUT8 healthy lifestyle program for families. We propose to disseminate and implement the COACH program for adult patients with obesity at 10-15 MidWestern HCs (representing 30-50 primary care practice sites) using the Consolidated Framework for Implementation Research (CIFR)17 to address key constructs, with subsequent dissemination throughout 120 MWCN HCs through state-based Primary Care Associations (PCAs) and MWCN network infrastructure. If successful, the COACH collaborative will demonstrate an effective dissemination and implementation approach for safety-net clinics in dispersed urban and rural settings, with potential for application to other health problems facing vulnerable populations.

Specific Aims: 1. Disseminate and implement the COACH group weight management program at 10-15 HCs (representing 30-50 practice sites) using existing MWCN network infrastructure, with subsequent dissemination to other MWCN HCs through presentations and training at state PCAs and through MWCN network channels. -Convene 2-3 key leaders from each HC for an in-person Learning Session, followed by monthly webinars and conference calls to disseminate the COACH curriculum and related resources. -Assist HC leaders as they tailor and implement COACH for obese patients at each participating HC. -Train staff from 100+ other HCs in COACH program at state PCAs and through MWCN networking.2. Assess implementation and sustainability of the COACH group weight management program by HCs through qualitative assessment of stakeholders (clinicians, administrators, PCA leaders, and patients) using the CIFR framework, and quantitative assessment of patient outcomes (weight change). For example, -PROCESS: Can webinar technology successfully disseminate COACH across geographic distance? -INTERVENTION: Can COACH be tailored to meet the needs of culturally diverse patient populations? -INNER SETTING: What HC barriers/facilitators affect clinician and patient engagement in COACH? -OUTER SETTING: What external policies/incentives affect HCs’ ability to implement and sustain COACH?

3. Assess costs to HCs of implementing the COACH group weight management program, including staff effort, training and materials, space and local resources, and financial outcomes.

1. Background1.a. Need and rationale To date there has been limited implementation of healthy lifestyle interventions to address obesity and its complications – diabetes, hypertension, arthritis, cancer, and others, through clinical settings.2-5 Obesity complications are very costly to society in terms of disability, lost time from work, and higher healthcare costs. A recent study found we spend $190 billion per year on obesity-related healthcare costs, over 20% of overall healthcare expenditures.36 The Veterans Administration used its extensive network infrastructure to implement the MOVE! program37, 38 to address obesity among veterans, but to date there has not been a significant network approach to collaboratively implementing weight management in community health centers. We can incorporate behavioral approaches to decrease obesity in the clinical setting,10 but growing evidence argues for the use of group visits to encourage behavior change.11-13 Community health centers (HCs) serve a large “safety-net” population of vulnerable patients at high risk for diabetes and its complications.20 Successful implementation of a lifestyle intervention to decrease obesity and related complications through a network of HCs would therefore have potential for significant reduction of obesity, its societal costs and complications.

The MidWest Clinicians’ Network (MWCN) is a well-established not-for-profit professional development organization comprising 120 community HCs throughout 10 MidWestern states, serving very diverse, medically underserved patient populations in both urban and rural settings. Most HCs encompass multiple practice sites; MWCN represents over 300 primary care practices serving ~2 million patients, 25% African American and 22% Latino.39 In 2008, MWCN identified obesity as a priority area based on survey responses from clinician members. MWCN partnered with the University of Chicago to conduct the ‘Combating Obesity in Community Health Centers’ (COACH) QI pilot collaborative described below. Recent MWCN member survey shows even greater interest in using MWCN network and infrastructure to collaboratively disseminate and implement a group weight management program for obese adults.

Healthcare Reform: As we move away from fee-for-service payments toward population management and global payments under the Affordable Care Act, HCs will need to implement effective programs to improve the health of populations they manage. As a major risk factor for HTN, diabetes, osteoarthritis, cancer, and depression, obesity is a key driver of costs.36 Few HCs have the training and resources needed to develop population management approaches to addressing obesity. The COACH program will guide HCs through developing the QI infrastructure and population management approaches they will need to address obesity.

Implementation Science teaches us how to disseminate, implement and assess sustainability of health interventions in real-world settings.14-19 Key features of such projects include identifying questions of importance to stakeholders (e.g. clinicians, healthcare systems, and patients), using existing networks to implement interventions in heterogeneous, real-world settings, and employing few exclusion criteria.16

Justification and Significance of the Project: Building on the successful COACH pilot, the extensive existing infrastructure of the MWCN network, and the history of highly productive collaboration between MWCN and UC, we propose to disseminate and implement the COACH group visit lifestyle program for patients with obesity at 10-15 core HCs, with subsequent dissemination to 100+ HCs representing over 300 primary care practices in the network. COACH combines an existing evidence-based intervention with a large network primed for dissemination and implementation across geographic distance. The COACH collaborative, if successful, will demonstrate an effective dissemination and implementation network approach for safety-net clinics in widely dispersed, urban and rural settings, and will potentially serve as a model for dissemination and implementation of programs to address other significant health problems facing vulnerable populations in similar settings.

1.b. Evidence base / Prior studies, preliminary work, and history of MWCN-UC collaborationThe primary evidence base is the Diabetes Prevention Program1 and various adaptations growing out of this experience.6 The DPP showed that weight loss and reduction in related health risks can be achieved successfully through a 14-week intensive lifestyle intervention program. Our group has significant relevant experience adding powerfully to this evidence base, much of which has been done in collaboration with MWCN.

PATHWAYS (M Quinn, et al): Designed specifically for African-American (AA) women with or at risk for type 2 diabetes, the PATHWAYS program40-41 comprises 14 weekly followed by eight monthly sessions, and includes a comprehensive program manual, instructor’s guide, and all participant materials. One hundred twenty seven (86%) of the 147 who participated in the program completed all 14 weeks; those completing the program had

an average weight loss of 6 lb (p = 0.00) from a mean baseline of 196 lb, with 27% showing a clinically significant weight loss of 10 lb or more.

REACH-OUT Chicago Children’s Diabetes Prevention Project (D Burnet, M Quinn, M Chin, et al): REACH-OUT 8 was a randomized study of 130 families in a community-based nutrition and exercise program to reduce overweight and diabetes risk among obese AA youth ages 9-12 on Chicago’s South Side. Lay leaders effectively engaged families resulting in behavior change; however, children’s mean BMI (33.7) did not change significantly over time, suggesting children with this high degree of obesity need a more intensive intervention, more closely linked to the clinical setting.

POWER-UP After-School Obesity Prevention Program (D Burnet, M Quinn, M Chin, et al): POWER-UP 9

engaged 40 elementary school children and their families in an after-school healthy nutrition and exercise program, with text-messaging to extend healthy behavior change into the family setting. Half the children were overweight or obese at baseline. Post-intervention, mean BMI z-scores decreased from 1.05 to 0.81 (p<0.0001); changes were most pronounced for overweight and normal weight children. The after-school venue proved feasible. Use of CBPR principles helped successfully integrate the POWER-UP program into many school activities, contributing to its sustainability.

Health Disparities Collaboratives (M Chin, L Heuer, C Schaefer, M Quinn, et al): The Health Disparities Collaboratives (HDC), a QI collaborative approach incorporating the Plan-Do-Study-Act (PDSA)42 rapid cycle model, the Chronic Care Model,43 and learning sessions, has been implemented in over 1000 HC sites across the country. The HDC have successfully improved quality of care in HCs and are societally cost-effective, but policy reforms are necessary to create a sustainable business case. Our team analyzed the clinical, organizational, and economic outcomes of the HDC, and also implemented a high-intensity HDC model for improving diabetes care throughout Midwestern HCs in collaboration with MWCN, and in West Central US.21-32

Addressing Needs of Latino Patients with Diabetes (A Baig, A Campbell, L Heuer, C Schaefer, M Quinn, D Burnet, M Chin, et al): In collaboration with MWCN, Arshiya Baig surveyed MidWestern HCs to document their services and resources available to Latino patients with diabetes.33 Dr. Baig partners with churches in Chicago’s Latino community to implement real-world (church-based) interventions for Latino patients with diabetes and their families.44,45

Group Visits for Diabetes Care (A Baig, A Campbell, C Schaeffer, L Heuer, D Burnet, M Quinn, M Chin, et al.): Dr. Baig is leading a study with MWCN assessing the perceived benefits of diabetes group visits and the barriers and facilitators to implementing and sustaining them in 5 MidWestern HCs. The study involves site visits HCs and interviews with 26 HC leaders, providers, and staff. Preliminary findings indicate that HC leaders, providers, and staff believe group visits are an effective way to promote patient behavior change, educate patients on diabetes, and provide patients with routine, guideline-driven diabetes care. Essential components of successful group visits include having institutional support, a champion to organize and promote group visits, a multidisciplinary team to run the visits, and a mechanism for reimbursement.

COACH Combating Obesity in Community Health Centers34 (D Burnet, M Quinn, A Campbell, L Heuer, C Schaeffer, L Vinci, M Chin, et al): The COACH pilot comprised 5 MidWestern HCs, with HC staff as primary participants. Participants attended three in-person Learning Sessions to build skills in QI planning and implementation, share best practices, and plan for improvement and sustainability of their heterogeneous existing weight management programs. Tailored coaching and co-development of Learning Session curricula addressed local needs. Monthly conference calls facilitated updates and enabled HCs to share experiences. Topics rated most valuable were patient recruitment and retention strategies, QI techniques, evidence-based weight management practices and motivational interviewing. Most highly valued components were face-to-face Learning Sessions, monthly conference calls and resource sharing. Challenges included difficulty engaging providers, staff turnover and data tracking. HC leaders expressed a strong desire for a common core curriculum that could be tailored as needed for HC settings. The COACH pilot demonstrated feasibility of a collaborative network approach for improving weight management programs at HCs and yielded practical lessons in implementing such programs.

2. Project Plan 2.a. Theory and Conceptual ModelIn designing the COACH collaborative we draw from the key domains in the Consolidated Framework for Implementation Research (CIFR)17 to make this dissemination and implementation project as effective, relevant

and transparent as possible for future dissemination efforts in safety-net settings. CIFR is a pragmatic, theory grounded model for identifying and documenting key components necessary for successful implementation of health care programs in diverse, real-world settings.

Figure 1 – Conceptual Model: MidWest Clinicians’ Network – University of Chicago COACH Partnership

DISSEMINATION

Network dissemination, training & support via in-person Learning Session and monthly webinar-conference calls with 10-15 core COACH HCs, varying in size, geographic location, and urban / rural setting: HC1 HC2 HC3 HC4 HC5 HC6 HC7 HC8 HC9 HC10…(10-15 core HCs

IMPLEMENTATION representing 30-50 primary care practices)

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PHASE 2 DISSEMINATION Presentations by core HC leaders at 10 Midwestern State PCAs

PCA1 PCA2 PCA3 PCA4 PCA5 PCA6 PCA7 PCA8 PCA9 PCA10 Training and support for COACH

IMPLEMENTATION at all MWCN HCs <---------------------------120 MWCN HCs representing 300+ primary care practices----------------------------- Additional dissemination & support through MWCN newsletter, website, webinars & publications,

and peer coaching of new HC staff from Champions at core COACH HCs HC = Health Center, PCA = Primary Care Association

The MWCN network itself is part of the OUTER SETTING for HCs, providing training and resources as HCs seek to address obesity for their patients. State-based Primary Care Associations (PCAs) exemplify another key part of the OUTER SETTING, supporting HCs to implement behavior-change programs for patients and providing venues for further dissemination and shared learning among all 120 MWCN HCs with 300+ practices.

The INNER SETTING encompasses the characteristics (size, location, etc.), culture, communications and other key aspects of each individual HC. While characteristics differ, collaborative interactions at the in-person Learning Session and in conference calls support and enable COACH HC leaders to learn from each other and implement ‘best practices’ to influence their HC’s INNER SETTING as they implement the COACH program.

The COACH lifestyle INTERVENTION is built upon a strong evidence base, drawn from the DPP and related resources, and developed, tested and refined previously as the REACH-OUT8 healthy lifestyle program for families. At the in-person Learning Session (LS) and in webinar-conference calls, HC leaders will be trained and supported as they tailor COACH to meet the needs of diverse patient populations at each HC.

IMPLEMENTATION PROCESS occurs on three levels: 1) Planning and executing the DISSEMINATION of COACH program to HC leaders through MWCN network via in-person LS and webinar-conference calls, and 2) Planning and executing the IMPLEMENTATION of the COACH program with obese patients at each of 10-15 participating HCs, and 3) DISSEMINATION of COACH program, experience and training at PCAs and through MWCN network to all 120 HCs. Each level requires thoughtful planning, successful engagement of stakeholders (HC leaders, management, patients, and PCA leaders), committed and supported champions, and opportunities to reflect, assess and learn collaboratively from shared experience.

Likewise, INDIVIDUALS’ CHARACTERISTICS and readiness for change are important on two levels: 1) Knowledge, beliefs and self-efficacy of HC leaders as they learn and implement the COACH program, and 2)

Knowledge, beliefs and self-efficacy of individual patients as they learn and implement healthy behavior change as participants in the COACH program at each HC.

CIFR17 Domain Selected CIFR Constructs applied to MWCN context / COACH Strategy INTERVENTION CHARACTERISTICS

Evidence Strength / Quality

Do HC stakeholders believe the COACH weight management program will have desired outcomes? / Will review evidence base at in-person Learning Session

Relative Advantage

Do stakeholders perceive advantage of implementing COACH vs. continuing with status quo weight management at their HC? / MWCN HCs have already expressed strong interest in new weight management strategies

Adaptability Degree to which COACH can be tailored to address needs of particular patient population at each HC / Will teach tailoring strategies at LS and in webinars

Complexity Perceived difficulty of implementing COACH program at each HC / Will address complexity through planning at LS, & in iterative fashion in webinars & conf. calls

Cost Costs of implementing COACH, including staff effort, training and materials, and financial outcomes / Will assess COACH costs qualitatively and quantitatively

OUTER SETTING

Patient Needs & Resources

Do stakeholders know & prioritize needs of patients with obesity? / Will explore patient perspectives at LS & revisit periodically in webinar-conference calls

External Policy & Incentives

Policies, mandates, guidelines, pay-for-performance, professional organizations and public reporting / State PCAs encourage HCs to implement behavioral interventions & offer venue for dissemination & shared learning

INDIVIDUALS’ CHARACTERISTICS

Knowledge & Beliefs

Individuals’ knowledge & attitudes toward implementing COACH / LS will share evidence behind COACH & empower HC leaders to in-service HC colleagues

Self-Efficacy Individuals’ belief in their own capability to implement COACH / LS will assess participants’ self-efficacy and teach strategies for leading and motivating change

Stages of Change

Stage on continuum toward skilled & sustained COACH implementation / LS will teach Stages of Change & how to empower staff and patients on this continuum

INNER SETTING

Structural Characteristics

Social architecture, size, age, location (urban/rural) of each HC / We will select HCs which differ in key characteristics and analyze effects on implementation

Networks & Communications

Quality of HC’s social networks and communications / Communications strategies will be addressed in LS and webinars, and queried in stakeholder interviews

Implementation Culture

Capacity for change; receptivity of staff to COACH implementation. Contains 5 sub-constructs:

1. Tension for Change

Is current obesity practice in need of change? / Explore tension for change at LS, & how this can help COACH leaders engage providers, management and patients

2. Relative Priority

Stakeholders’ perception of importance of implementing COACH vs. competing priorities / Elicit discussion at LS and assist COACH leaders in aligning priorities

3. Organizational Incentives

Awards, promotions, salary raises, increased stature for implementing COACH / We will encourage leaders & HC management to recognize and value efforts

4. Goals & Feedback

Are COACH implementation goals and progress feedback clearly communicated? / LS and webinars will address communicating goals and giving feedback

5. Learning Climate

Does HC climate encourage teamwork? Do leaders feel safe to try implementing COACH? Is time built in for reflective thinking and evaluation? / LS and webinars will offer strategies for building a safe & reflective learning environment

Readiness for Implementation

Tangible indicators of each HC’s commitment to implement COACH / Contains 3 sub-constructs:

1. Leadership Engagement

Commitment of HC management to implementing COACH / Documented prior to each HC’s participation and bolstered through strategies shared in webinar-calls

2. Available Resources

HC resources dedicated to implementing COACH, including training, space, staff time, and materials / Commitment documented in advance; reimbursements defray costs

3. Access to Information

Easy access to useful information about COACH program & weight management / Curriculum based on prior studies; collaborative sharing of practical materials

IMPLEMENTATION PROCESS

Planning How well planned was the COACH implementation process? / We will draw from prior experience, and query needs of COACH participants prior to in-person LS

Engagement Are providers and patients engaged in COACH? / LS will address strategies for engaging providers to refer patients (e.g. training, social marketing, role modeling); participants share ‘best practices’ in webinars and conference calls

Champions Leaders committed to supporting and completing COACH implementation / LS & webinars will help leaders align COACH with personal and professional goals to enhance likelihood of success

Executing Is COACH implemented according to plan? / Timeline and checklists will be reviewed in calls, with trouble-shooting & support for individual HCs as needed

Reflecting & Evaluating

Feedback about progress and quality of COACH implementation; team debriefing / COACH collaborative will share feedback regularly among participants, encourage reflections within HC teams and shared learning across collaborative

2.b. Logistics of Training and ImplementationA survey by MWCN leadership in August, 2013 documented a high degree of interest among MWCN members in implementing a group weight management program at their HCs. Thirty-two HCs responded to the survey, with most indicating a high degree of interest in this topic. Interest in participation is further documented in accompanying Letters of Support from 15 MidWestern HCs encompassing 48 primary care practices, and 8 state Primary Care Associations. During Grant Year 1, COACH project leaders (MWCN leadership in collaboration with University of Chicago QI leaders) will finalize selection of the 10-15 core HCs which will participate in the COACH collaborative from among the interested applicants, using the following criteria: 1. Documented interest, capacity (staff, space, patients appropriate for COACH program) and readiness to implement the COACH group weight management program for obese adults. 2. Identified Champion and 2-3 HC staff interested and available to participate in COACH training and implementation (attend in-person Learning Session in Yr 1 and participate in monthly COACH webinars thereafter). We anticipate these could include physicians, nurses, PAs, dietitians, health educators. 3. Documented support of HC leadership (CEO or Medical Director).4. Capacity to collect and share implementation process measurements and basic clinical data on HC patients participating in COACH weight management program (as measures of implementation and program impact).5. Commitment to share COACH experience at state PCA meetings and serve as peer coaches for other HCs implementing COACH in Phase 2 Dissemination (Years 3 & 4).

Learning Session: Leaders from the 10-15 core COACH HCs will participate in a two-day in-person Learning Session (LS) in Chicago near the end of Grant Year 1. Topics covered will include QI approaches to boost recruitment and retention of patients participating in weight management programs, PDSA approach identify and optimize challenging areas of weight management implementation, introduction to motivational interviewing skills to help COACH program leaders engage patients in healthy behavior change, core nutrition and physical activity topics in the COACH curriculum (see Appendix), common challenges and best practices for implementing group weight management programs at HCs, strategies for cultural tailoring of COACH curriculum for diverse patient populations, and documentation of process and patient-level outcome measures.

For example, with regard to patient identification and recruitment, we will help HC staff learn to approach this activity from a population management strategy, by identifying obese patients using their electronic health record (EHR) to search by BMI. Search functionality meets a Medicare “Meaningful Use Requirement” and is a milestone for Patient Centered Medical Home accreditation. Over 80% of HCs already use EHR 39 and many

are working to develop this search capacity (aligning with external incentives and addressing CIFR OUTER SETTING). LS will help COACH leaders develop identification and recruitment approaches to engage patients beyond the highly motivated group which may self-refer, a key difference between a population management approach versus selective implementation.

Monthly Webinars and Conference Calls: MWCN will utilize their existing “Go to Webinar” (GTW) format for webinars, group meetings and instructional sessions throughout the COACH project.  This technology enables screen and voice presentation by presenter, and also enables conference call discussion by participants. We plan to use both functionalities in the COACH monthly webinar-conference calls. MWCN has extensive experience coordinating webinars with GTW for numerous activities in recent years, with participation ranging from 10 – 200 attendees per event.  MWCN is able to schedule webinars in advance, allow for online registration, recording of participants and web-based archival of webinars for later access by additional MWCN members.  We plan to advertise and archive COACH webinars on the MWCN website so these didactic sessions will be available to MWCN HCs who are not among the core 10-15 HCs in the COACH collaborative, to disseminate program content and resources beyond this core group (Phase 2 DISSEMINATION, described below, will further enhance this process).

COACH webinar-conference calls will cover in more depth topics introduced at the LS and topics relevant for leading COACH group classes with patients. Webinar-conference calls will last one hour, comprising a 30-minute didactic webinar followed by 30 minutes of Q/A and discussion by HC leaders on how this topic will help them implement the COACH program at their HCs. Following in-person LS we will conduct bi-weekly webinar-calls the first 2 months as HCs engage in planning to implement COACH at their HCs. Initial topics will focus on setting up group classes, provider engagement and patient recruitment and enrollment, with enrollment goal of 10-15 adult participants in the initial COACH weight management group at each HC (see Inclusion Criteria below). COACH group weight management sessions for patients will be implemented in HCs approximately 2 months after in-person LS, with webinar-calls monthly thereafter to support HCs as they implement COACH group classes for patients. Webinars 5-8 will be concurrent with the first 14-week series of group classes and will preview upcoming weekly COACH curricula, emphasizing skills relevant for each class session. After HCs conduct their first 14-week series of COACH group classes for patients, webinar-calls will not need to focus as much on individual curricular sessions; subsequent webinar topics will expand on specific nutrition and physical activity topics as well as patient motivation, retention, documentation of clinical outcomes, and implementation issues of concern and interest which arise from participating core HC staff.

COACH Curriculum: The COACH curriculum includes a Leaders Guide and Participant Booklets (see Appendix) for the 14-week COACH healthy lifestyle program. The curriculum is drawn from the DPP35 and related resources, and was developed, tested and refined previously as the REACH-OUT healthy lifestyle program for families.8 Adult REACH-OUT participants found the curriculum practical and easy to use, and effective at helping them make changes in their diet and physical activities. Fourteen sessions cover topics such as the MyPlate model,46 food groups, portion sizes and tracking, menu planning, food labels and shopping, eating out, incorporating physical activity into daily and weekly routines, and aerobic, strength and flexibility activities.

Cultural Tailoring and Spanish Version of COACH Curriculum: As was done for the DPP curriculum35 our collaborative group has extensive experience assisting HC staff in tailoring behavioral interventions for various cultural settings. We will assist COACH leaders at the in-person LS and in webinar-calls as they tailor COACH for their own patient populations. In addition, we are currently engaging in the professional translation of the COACH curriculum into Spanish, as many MWCN HCs serve significant Spanish speaking populations (including some submitting Letters of Support). Dr. Baig has studied needs of Spanish-speaking populations in MWCN HCs, and will oversee this effort. The Spanish version of COACH curriculum will be refined through focus groups in Chicago and will be ready for use during Grant Year 1.

COACH Group Weight Management Classes: Starting early in Year 2, 10-15 adult patients at each HC will participate in 90-minute weekly COACH weight management classes, in English or in Spanish, over the course of the 14-week COACH curriculum. Sessions will take place on-site at each participating HC (or at an appropriate location selected by HC staff), with occasional educational outings as feasible at each HC. HC staff (physicians, nurses, PAs, dietitians, or health educators) at each HC will conduct the COACH classes using the COACH curriculum, in which these leaders receive training at the in-person LS and in monthly COACH webinars. HCs serving significant Spanish-speaking populations have Spanish-speaking staff qualified to lead COACH sessions.33 After completing the 14-week COACH program, patients will be invited back to monthly COACH booster support group sessions to sustain healthy lifestyles. Each core HC will enroll patients and

conduct a new round of COACH classes twice a year throughout the duration of this project. Twice yearly programs of 14-week duration will allow time for HC staff to help graduates transition to monthly support groups and facilitate time for reflection, learning and improvement among COACH leaders. HCs with multiple sites will be encouraged to implement and spread COACH classes throughout their practice sites by Year 3.

QI Coaching: In addition to monthly webinar-conference calls, individual monthly coaching phone calls will take place between the COACH Project Coordinator and HC staff at each core HC to assist as needed with challenging areas of COACH implementation. Other QI leaders from UC will participate in coaching calls to address issues as needed. Challenges identified as relevant to several HCs and best practices identified through coaching calls will be incorporated into subsequent monthly webinars for spread to other HCs.

Recording and Posting of Webinars for Other MWCN HCs: Real-time participation in COACH webinar-calls will be limited to the 10-15 core HCs in order to best address issues of interest to these HCs; however, COACH curriculum and recorded webinars will be posted on the MWCN website where other MWCN members can access these materials for their own learning and implementation to further disseminate weight management skills and materials throughout this network.

Phase 2 DISSEMINATION to the rest of MWCN’s 120 member HCs with over 300 practice sites will take place in Years 3-4 as COACH leaders from core HCs present experience and share materials at state PCA meetings. MWCN will disseminate COACH curriculum and webinars via their newsletter, website and other networking channels. Leaders from core COACH HCs will serve as peer mentors and coaches to staff at other HCs interested in implementing COACH, and MWCN-UC COACH team will provide additional support to MWCN HCs as they implement COACH.

2.c. Roles and Responsibilities of Participating Institutions, and Project TeamBuilding on the successful COACH pilot experience, MWCN and University of Chicago QI leaders will partner to disseminate and implement the COACH group weight management program at 10-15 core HCs, with further dissemination throughout 120 HCs in Years 3-4. Fifteen HCs representing 48 practice sites have already demonstrated significant interest in participating as core HCs, as documented in Letters of Support.

As shown in Figure 1, MWCN serves as the hub to convene the collaborating HCs to work collaboratively to implement the COACH group weight management program. HCs have strong ties to MWCN, and MWCN leadership has significant credibility with member HCs due to lasting relationships over time and a history of successful collaborative work in the past. Amanda Campbell, MWCN Director, has been key to success of the COACH pilot project and to assessing interest in a larger COACH collaborative going forward. MWCN has existing webinar technology which members are already accustomed to using for training and professional development. Ms. Campbell will work closely with University of Chicago QI leaders to finalize selection of the 10-15 participating HCs, bring participating staff together for the Year 1 in-person COACH Learning Session in Chicago, implement monthly COACH webinars in conjunction with UC QI leaders, and further disseminate to 100+ MWCN HCs through state PCAs in Phase 2. Other senior leaders from the MWCN Research Committee, Loretta Heuer, RN, PhD and Cynthia Schaeffer, RN, MS, will serve in advisory roles for this project.

University of Chicago personnel include: Deborah Burnet, MD, MA, Professor of Medicine & Pediatrics. Dr. Burnet is a senior leader in QI and in community-based and collaborative projects addressing obesity among underserved adults and children. Dr. Burnet served as a social worker on Chicago’s South Side before coming to medicine, and she has extensive experience with cultural tailoring of behavioral interventions addressing nutrition and weight management. As PI, Dr. Burnet will oversee all aspects of the COACH project, assuring scientific integrity as well as compliance with AHRQ expectations, IRB protocols and other regulations.

Michael Quinn, PhD. Dr. Quinn is a senior behavioral scientist with significant experience implementing community-based and collaborative weight management programs. Dr. Quinn has extensive experience training lay health leaders to lead group sessions on healthy nutrition and exercise topics, and on teaching relevant skills such as patient engagement and motivational interviewing. He will co-direct the two-day COACH Learning Session in Chicago with Dr. Burnet and Ms. Campbell, and he will work closely with Dr. Burnet and Ms. Campbell to conduct the monthly webinars as HCs implement the COACH curriculum.

Marshall Chin, MD, MPH, Richard Parrillo Family Professor of Healthcare Ethics in the Department of Medicine. Dr. Chin is a senior investigator with extensive experience implementing QI programs to improve diabetes care and outcomes at community HCs. He has a long track record of successful collaborative projects with MWCN and the national HC community, and he currently leads Improving Diabetes Care and Outcomes

on the South Side of Chicago, a complex QI intervention involving 4 HCs and 2 academic clinics. Dr. Chin will serve in an advisory role regarding collaborative engagement of HC staff, training and implementation of the COACH collaborative group weight management program, and assessment of process and outcome measures.

Lisa Vinci, MD, MS, Associate Professor of Medicine. Dr. Vinci directs the Primary Care Group, the large, on-site general medicine clinic at the University of Chicago. She is an experienced leader and teacher of QAIC, the Quality Assessment and Improvement Curriculum at UC,47 for which she and the Primary Care Group won the national Innovations in Clinical Practice Award from the Society of General Internal Medicine in 2009. Dr. Vinci is co-investigator with Drs. Chin, Burnet and Quinn on the Improving Diabetes Care and Outcomes on Chicago’s South Side project involving 4 HCs and 2 academic clinics. Dr. Vinci will serve as a trainer in the COACH Learning Session, will contribute periodically to the bi-weekly webinar series, and will serve in an advisory capacity regarding practical aspects of implementing group classes for patients in a clinical setting.

Arshiya Baig, MD, MPH, Assistant Professor of Medicine. Dr. Baig conducts diabetes self-management classes for Latino patients with diabetes in Chicago through outreach in Latino Catholic churches.44,45 She also studies quality of care for Latino patients with diabetes at HCs33 and group visits for HC patients with diabetes, through collaborative projects with MWCN. Dr. Baig will contribute her expertise in cultural tailoring of behavioral interventions with special focus on Latino populations, and implementation of group visits in HCs.

Chia Hung “Ed” Chou, PhD, Research Associate (Assistant Professor). Dr. Chou is an expert in health policy/intervention evaluation, with a special focus on costs.  His primary interest is evaluating the cost and impact of health interventions and policies on healthcare access and use among vulnerable populations. His prior work includes evaluating impact of state-level policies on pharmacists’ participation in patient care, clinical and economic outcomes for patients with sickle cell anemia, and the extent to which tax-exempt hospitals provide community benefits such as charity care and health promotion programs. 48 Dr. Chou’s current work includes evaluating the effectiveness and costs of diabetes prevention programs for state-wide dissemination in New York.  Dr. Chou’s extensive experience in program evaluation, economic outcomes, behavioral science and chronic conditions make him highly qualified to conduct the cost assessment for the COACH project.

Sang Mee Lee, PhD. Dr. Lee is a biostatistician with extensive expertise in analyzing interventions to address obesity and related conditions. She will assist with data management and analysis in the assessment of COACH process and outcome measures.

Lead Project Coordinator, TBN. We will recruit a fulltime Project Coordinator for the COACH collaborative project, with masters-level training and relevant expertise in QI, behavioral interventions, and project management. Project Coordinator will work closely with Ms. Campbell, Dr. Burnet and the COACH team to engage staff from core HCs, organize and implement the in-person LS, and conduct monthly webinar-calls. The Project Coordinator will also be responsible for individual monthly coaching calls to core COACH HCs, which will complement the group calls and allow for tailoring, trouble-shooting and support at each site.

2.d. Coordination, Challenges, Timeline Coordination: This collaborative project is a complex undertaking across geographic distance and involving both urban and rural HCs of varying sizes and demographics. MWCN Director Amanda Campbell will play a key coordinating role, working closely with the fulltime COACH Project Coordinator to maintain clear communications with the 10-15 core HCs. MWCN already has well established lines of communication with HCs including e-mail list serve, monthly newsletter, and regular webinars. The COACH project will add to these communications channels monthly webinars for participating COACH staff and monthly calls with the Project Coordinator to assess implementation progress, trouble-shoot challenges, and identify best practices.

Potential Challenges: Recruitment of core HCs is a potential challenge; however, we already have Letters of Support from 15 HCs representing 48 primary care practice sites, with many other HCs documenting significant interest in a recent MWCN survey. Participation by HC staff in COACH training and implementation: HCs will be selected for criteria including support of HC management and availability of staff to participate. Webinar-conference calls could be challenging to implement; however, webinars are already a central part of MWCN culture and practice. Collaborating across distance presents significant challenge. In-person LS develops a cohesive learning community. Webinar-calls offer convenient outreach; state PCAs reinforce skills for behavioral interventions and offer regional venues for support and shared learning. Culturally diverse populations present a significant challenge. We have extensive experience from the COACH pilot, in which participating HCs successfully engaged urban and rural AA, white and Latino patients, Somali refugees and

others. Our team has extensive experience tailoring obesity and diabetes programs for AA and Latino populations, including access to professional translators and opportunities for focus group optimization of tailored curricula. Collection and sharing of process and outcome measures can present challenges for busy HC staff. We have limited clinical data collection to height and weight for maximum utility, and provide annual reimbursements for core HCs to offset staff time and related expenses. Interviews of HC staff and patients will be conducted at times convenient for respondents and limited to 45-60 minutes, with incentives of $50 per respondent. Wider dissemination throughout 120 MWCN HCs presents a challenge, which will be addressed through support of PCA networks where COACH leaders will present and share the COACH program with peers from other HCs, and throughout MWCN’s extensive other network opportunities.

Figure 2. TimelineYr1: 4/14-3/15 Yr2: 4/15-3/16 Yr3: 4/16-3/17 Yr4: 4/17-3/18

Recruit and train staff Final selection of 10-15 HCs Prep for Learning Session /-----------------------------------In person Learning Session [X] Implement monthly webinar-calls & monthly coaching calls with individual HCs

/--------------------------------------------------------------------------------------- Core HCs implement COACH group classes, & follow up booster sessions

/ ---------------------------------------------------------------------------------------Collection of patient-level data /------------------------------------------------------------------------------Assessment and analysis of costs /-------------------------------------------------------------------Qualitative assessments for sustainability and spread /-----------------------------------------------------Phase 2 Dissemination: Presentations at state PCAs, MWCN network spread and peer coaching:

/--------------------------------------------------------Analysis, Preparation of manuscripts /-----------------------------------------

3. Capacities of Participating Organizations and Personnel The MidWest Clinicians’ Network (MWCN) is a regional network of 120 community HCs representing over 300 primary care practices in 10 MidWestern states. For over 15 years, MWCN has had a productive collaborative Research Committee that includes HC members and health services researchers from the University of Chicago. The Research Committee utilizes the principles of CBPR and community-engaged research to improve care and outcomes of HC patients. Most research topics emanate from the priorities of MWCN membership as assessed through surveys and in-person meetings. The Research Committee is chaired by Loretta Heuer, RN, PhD, and Cynthia Schaefer, RN, CS. Amanda Campbell, Executive Director of the MWCN, provides direct support and connection to the regional network. Additional infrastructural support for the MWCN Research Committee is funded with a subcontract from the NIDDK P30 Chicago Center for Diabetes Translation Research (PI: M. Chin). Supported by AHRQ, the MWCN-University of Chicago collaboration performed the comprehensive evaluation of HRSA’s Health Disparities Collaboratives. Other projects have examined health literacy, care of Latino patients with diabetes, group diabetes visits, and care coordination in HCs. The Research Committee disseminates study results throughout the HC, academic, and policy communities. In addition to the extensive networking of HCs within its network, MWCN has the support of each of the 10 state Primary Care Associations (PCAs) in the region.  PCAs are funded by HRSA’s Bureau of Primary Health Care to provide resources and assistance to HCs to increase access and meet the needs of underserved populations, with special emphasis on behavioral health interventions. PCAs assist with dissemination of information from MWCN to HCs in their states at their annual meetings and through their clinical networks (see PCA Letters of Support).

The University of Chicago is a private, non-sectarian, co-educational institution ranked 5th nationally by US News and World Report. The University consists of four graduate divisions (Biological Sciences, Physical Sciences, Social Sciences, and Humanities), six professional schools (Medicine, Law, Divinity, Social Sciences Administration, Public Policy Studies, and Business) and an undergraduate college. The student population is nearly 12,000, with two-thirds of students engaged in graduate and professional study. There are approximately 1,200 faculty; over 70 Nobel Prize Laureates are current or prior UC faculty. The Biological Sciences Division (BSD) includes 19 academic departments, 12 interdisciplinary graduate committees, 11 extramurally-funded research centers, and 3 major institutes. The BSD includes more than 820 faculty in the clinical sciences, 420 research associates and fellows, and nearly 190 practitioners from affiliated hospitals. The BSD has a broad training mission: the Pritzker School of Medicine has an entering class of approximately 88 medical students (ranked 10th by USNWR), 19 graduate degree programs, and the Collegiate Division.

Health Outcomes Research Group, Section of General Internal Medicine, and Dept. of Health Studies: The Section of General Internal Medicine, led by Dr. Deborah Burnet, has an active program in health services research and QI directed by Dr. Marshall Chin. Research and teaching in health services and QI are significant, with a strong record of publication, external funding, and an AHRQ-funded National Research Service T32 Award in Health Services Research. For more than 10 years the Health Outcomes Research Group hosted the Robert Wood Johnson Clinical Scholars Program. The development and growth of the Health Studies Department (Dr. Lee) in direct proximity to the Section adds resources in epidemiology, biostatistics, health services research and QI. The close proximity of premier social science departments and long history of interdisciplinary collaboration provide an unusually rich environment for health services research and QI at UC.

Chicago Center for Diabetes Translation Research: Marshall Chin, MD, MPH, directs this NIDDK P30 center with mission to improve lives of people with diabetes or at risk for diabetes through innovative, high-impact research and programs. The Center seeks to prevent diabetes, improve the quality and value of diabetes care, and empower patients and communities. The Center collaborates with researchers, policymakers, healthcare providers and community partners; shares findings to improve practices and policies; improves the health of vulnerable populations and reduces racial, ethnic and socioeconomic disparities in health and health care. The Center has cores in Outcomes Improvement, Quantitative Analysis, and Health Disparities and Community-Based Participatory Research.

The Combined Strengths of MWCN and UC will be utilized in this COACH dissemination and implementation project. Director Amanda Campbell will use her position, communications infrastructure, and her detailed knowledge of MidWestern HCs to convene staff from interested HCs to participate in the COACH collaborative. Together, the COACH leadership team will finalize selection of core HCs to participate in COACH, using criteria outlined above. The Project Coordinator, working closely with Ms. Campbell and Dr. Burnet, will coordinate the in-person LS in Chicago toward the end of Grant Yr 1, with instructors including COACH leadership team and selected others to cover key topics noted above. With advisory input from other team members, Ms. Campbell, Dr. Burnet and Dr. Quinn will plan and implement monthly webinar-calls, using prior experience, COACH curriculum and issues of interest raised by HC leaders at LS. Webinar presenters will include COACH leadership team as well as core HC staff as they gain expertise and share learning across the collaborative. Phase 2 DISSEMINATION will involve presentation of COACH experience and resources at state PCA meetings and through MWCN channels, to reach the rest of the 120 MWCN HCs, representing over 300 primary care practice sites.

4. Metrics for Documenting Implementation and Spread Our strategy for assessing implementation and spread of COACH will also use the CIFR framework as follows:

CIFR Domain Selected metrics for assessment / Strategies for further dissemination INTERVENTION CHARACTERISTICS

Adaptability Assess COACH tailoring for various patient populations in interviews / Share best practices in Phase 2 Dissemination

Cost Assesses COACH program costs from HC perspective qualitatively and quantitatively (Aim 3 – cost analysis described below)

OUTER SETTING

External Policy & Incentives

Assess effects of external incentives on implementing and sustaining COACH in qualitative interviews / Incorporate updates on relevant policy issues at state PCA meetings to empower staff from 120 HCs

INNER SETTING

Structural Characteristics

Assess effects of HC size, location and other characteristics on COACH implementation through qualitative interviews and process measures

Networks & Communications

Communications strategies relevant for implementing COACH will be queried in depth in stakeholder interviews / Share best practices through PCAs and MWCN

Implementation Culture

Constructs including relative priority, organizational incentives, goals and feedback, and learning climate will be queried in depth in stakeholder interviews

Readiness for Leadership engagement, available resources, and access to information will be

Implementation queried in depth in stakeholder interviews

IMPLEMENTATION PROCESS

Planning Quality of implementation planning will be assessed through evaluation at in-person Learning Session and in interviews

Engagement Interviews will query engagement / Conference calls will identify ‘best practices’ for engaging providers and patients which will be shared in webinars and PCAs

Champions Coaching calls will assess and support champions; interviews assess champion roles / In Phase 2, Champions coach peer staff at other HCs

Executing Implementation timeline and checklists will be reviewed in conference calls; interviews review execution

Reflecting & Evaluating

Conference calls assess reflection at HCs; interviews query reflection process / Webinars and PCA presentations will teach QI, reflection and evaluation activities

Assessment of COACH implementation: HC staff will document dates, times and attendance at each COACH group weight management session. Checklists will be used for HC staff to document adherence to COACH curriculum, areas of challenge, observations, questions and problems, which will be discussed during monthly coaching calls with the Project Coordinator. Challenges identified as relevant to several HCs and best practices identified through these coaching calls will be incorporated into subsequent monthly webinars for sharing with other HCs.

In Years 3-4, we will conduct semi-structured interviews with key stakeholders, including participating HC staff and HC leadership (CEOs/CFOs), PCA leaders, and representative patients from COACH programs at participating HCs. We will interview approximately 5 staff / administrative leaders and 5 patients from each core HC and 1-2 leaders from each state PCA totaling approximately 135 interviews overall. Interviews will be conducted in English or Spanish as respondents prefer. Interviews will be conducted by phone, scripted with open-ended questions and more specific probes to elicit respondents’ perceptions of INTERVENTION CHARACTERISTICS including the COACH curriculum and its adaptability for various populations; INNER SETTING (HC) barriers and facilitators to program implementation, cultural attributes which help successfully integrate COACH into existing HC workflow and routines, aspects which enhance clinicians’ investment in referring patients into COACH and how this could be enhanced, COACH leaders’ experience and effects of INDIVIDUAL CHARACTERISTICS while working to motivate patients toward healthy lifestyle changes. Additional INTERNAL SETTING factors to be queried for each HC include openness to change, local champions, HC and community culture, support and advocacy for healthy lifestyle activities, dedicated time and resources, among others. IMPLEMENTATION PROCESS aspects queried will include planning and communication with COACH leaders from each HC, quality and content of in-person Learning Session, effectiveness and ease of use of COACH webinar-conference calls, among others. OUTER SETTING constructs will be queried as HC leaders and staff perceive COACH implementation is enhanced or hampered by health care reform and factors in the local environment. For administrators and team leaders, interviews will also include perceptions of costs, as described below. Respondents will each receive $50 incentive for completing an interview, which is expected to last approximately 45-60 minutes. Experienced facilitators (Drs. Burnet and Quinn) will conduct interviews with assistance form the Project Coordinate and Graduate Student Assistant. Interviews will be audio-taped, transcribed, and analyzed for content by our multidisciplinary team, using CIFR constructs to identify key elements necessary for HC’s to successfully implement and sustain the COACH program over time and elicit considerations relevant for further spread.

Patient-level data: Inclusion criteria and recruitment: Adults ages 18 years and over with obesity (BMI>30) or with overweight (BMI 25-29) and related co-morbidities (e.g. hypertension, diabetes) will be eligible to participate in the COACH group weight management program at participating HCs. We have intentionally kept inclusion criteria broad in order to make this a ‘real-world’ implementation study. As described above, we will encourage systematic identification of obese patients through EMR, to implement a population management orientation. Primary Care Providers (PCPs) at HCs will also refer patients into the COACH program as part of their routine care of patients, and PCPs will be responsible for any needed clinical assessment prior to patients’ participation (most patients will not require additional testing or assessment prior to participation). Finally, patients may self-refer based on outreach and social marketing materials which will be shared through LS and webinars prior to implementation of COACH group classes. Baseline data: Height and weight measured according to routine HC practice. Patient’s gender, race/ethnicity, and age will also be recorded.

Measurement of weight will be repeated after the 14 week COACH program and again at the end of 6 months and one year during monthly COACH booster sessions. For patients not attending booster sessions, COACH staff will retrieve 6 and 12 month follow up recorded weights from routine HC visits documented in patient charts, as part of this QI effort within their HC.

Cost assessment (Aim 3): We will assess costs of implementing the COACH group weight management program from the HCs’ perspective,29,29,49 as they bear the majority of costs for the implementation. Costs to the HCs of implementing the COACH group weight management program will include costs of staff time to participate in training (LC and webinars) and costs of implementing the COACH program. These include: 1) Startup costs - training, educational materials; 2) Personnel costs (provider and staff time devoted to COACH program); 3) Supplies, space costs (if incremental to routine care), and local resources needed to run the COACH group program on an on-going basis. We will not include costs of caring for patients (clinic visits and related lab tests, patient time) in our analysis because participation in the COACH weight management program will be considered part of the routine clinical care of patients with obesity. We will use data from multiple sources:

Cost Metric 1: COACH Administrative Costs. We will use a self-administered survey to estimate annual intervention administrative costs. Staff will assess the number of hours spent on administrative costs such as training sessions, regular COACH activities (for example, preparing and conducting group sessions, data tracking, and team meetings), and dollars spent on COACH-related purchases. All costs will be estimates of the opportunity costs of individual items. To calculate the costs of non-provider staff time, we will determine an hourly wage on the basis of annual salaries and a 40-hour work week. To calculate the costs of provider time devoted to administering the intervention, we will use a missed-revenue approach. We first estimate the average revenue for a patient visit by year from billing data, then calculate the total potential visits missed by multiplying the yearly hours clinicians spend on administration by an estimated rate of 4 visits per hour and an 8 hour work day.

Cost Metric 2: Indirect Costs and Benefits. In addition to the direct cost assessment described above, we will seek out reports of indirect costs and benefits through qualitative interviews conducted by telephone with HC leaders (CEO, CFO, and COACH team leader) at each core HC. Using open-ended questions, we will ask HC leaders to identify costs and benefits related to COACH implementation that might not appear in financial ledgers. Other questions will focus on the experience of the HC in implementing COACH, effects of local economic trends, major changes in the HC’s organization such as expansion or layoffs, hidden costs and benefits of COACH implementation such as in-kind services exchanged with local grocery stores or fitness centers, and any additional grants or donated supplies attributable to COACH. Interviews will be taped, transcribed, and analyzed for content by at least two project personnel.

Power analysis and statistical plan for patient data: We plan to recruit 500-750 patients with obesity (50 on average, in each of 10-15 participating HCs) over the study period. With this targeted number, power of the study is calculated on the basis of differences for percent change in body weight before and after intervention. In a related study,6 Ackermann found that body weight decreased by 6.0% (95% CI=4.7, 7.3) at the 4-6 month follow-up visit in the intervention group. A predefined target of 500 participants will provide 100% power with a significance level of 0.05. Further evidence of sufficient power with the planned sample size can be obtained from the percent change in BMI within the same study. We will analyze changes in patient-level outcome measures compared to baseline to evaluate the intervention effect. Paired t-tests will be used to compare weights as a continuous variable. Generalized linear modeling will be used to account for clustering of patients within HCs. For each model, assessment time point will be included as a fixed effect to capture any time trend. We will fit unadjusted models first, then control for patient characteristics followed by backward elimination to identify the best-fitting, most parsimonious model.

Summary: COACH combines an existing evidence-based intervention with a large network primed for dissemination and implementation across geographic distance. MWCN encompasses 120 HCs representing over 300 primary care practices serving a very diverse patient population at high risk for obesity and its complications. The COACH collaborative, if successful, will demonstrate an effective dissemination and implementation network approach for safety-net clinics in widely dispersed urban and rural settings, and will potentially serve as a model for dissemination and implementation of programs to address other significant health problems facing vulnerable populations in similar settings around the country.

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