Description of the PBRN Consortium

The Collaborative Ohio Inquiry Network (COIN) is a PBRN learning community that develops the capacity of PBRNs for research, conducts high-impact practice-based research, and translates research into practice. COIN’s PBRNs are affiliated with 4 academic health centers, 3 of which have Clinical and Translational Science Awards that support PBRN development. COIN has 9 PBRNs across the 4 sites: 5 primary care PBRNs affiliated with Case Western Reserve University (CWRU), 2 affiliated with the University of Cincinnati (UC), 2 affiliated with The Ohio State University (OSU), and 1 affiliated with the Northeast Ohio Medical University (NEOMED). COIN’s PBRNs include more than 277 primary care practices and 1,967 clinicians. Together, these PBRNs have conducted 144 externally-funded and 60 internally-funded studies, supported by over $47 million in external funding. The networks have generated 167 peer-reviewed research publications. They have a history of collaboration with each other on specific studies, and of partnership with other PBRNs around the country.

COIN’s mission is to develop the capacity of PBRNs, to do practice-based research by stimulating and fostering research collaborations, and to disseminate research findings by effectively sharing knowledge and translating research into practice. COIN develops research capacity by engaging and recruiting practices, identifying and collaborating with investigators, and by training network-members and academics in PBRN methods. Research is done by transdisciplinary teams that span institutional boundaries and have access to CTSA resources. New knowledge is disseminated through steering committees, at network-wide meetings and convocations, through learning collaboratives that translate research into practice, through Ohio’s unique NetWellness web vehicle, and by innovatively linking practice-based QI and research to maintenance of certification. COIN’s work is undergirded by the research infrastructures of three CTSAs that are invested in COIN’s success.

In the table and in the text below, we summarize the organization and experience of each PBRN, listed according to their sponsoring institution.

Academic Affiliate	Name & Abbreviation	N practices	Practice type*	Other
CWRU	Research Association of Practices (RAP)	41	FM, IM, Ped, NP	7 sub-networks
CWRU	Safety Net Providers’ Strategic Alliance (SNPSA)	20	FM, IM, Ped, NP	CHCs‡, free clinics
CWRU	Cleveland Clinic Ambulatory Research Network (CLAReN)	23	FM, IM	System-affiliated
CRWU	Rainbow Office-Based Clinical Research Network (RRC)	56	Ped, NP	System-affiliated
CWRU	Better Health Greater Cleveland (BHGC)	18	FM, IM, NP	Quality alliance
OSU	Ohio State University Primary Care PBRN (OSU-PCPBRN)	26	FM, IM, Ped, NP	Includes CHCs‡
UC	Cincinnati Area Research Group (CARinG Network)	15	FM, NP	FQHC, teaching
UC	Cincinnati Pediatric Research Group (CPRG)	42	Ped	System-affiliated
NEOMED	Northeast Ohio Network (NEON®)	35	FM	Underserved pop.

*FM=Family Medicine; IM=Internal Medicine; Ped=Pediatric; NP=Nurse Practitioner ‡ CHC= Community Health Center

The figure above shows the distribution and location of the 277 COIN PBRN practices across Ohio.

Case Western Reserve University

The 11 established and 5 developing CWRU-affiliated networks shown in the figure are supported by a CTSA PBRN Shared Resource described in Section b. For the P30 application, we are focusing on the 5 most relevant primary care PBRNs, the Research Association of Practices, the Safety Net Providers’ Strategic Alliance, the Rainbow Research Network, the Cleveland Clinic Ambulatory Research Network, and Better Health Greater Cleveland. The other networks represent a deep resource that can be engaged when it is helpful to the goals of COIN and to the network.

Research Association of Practices Meta-Network

The PBRNs at CWRU began in 1994 with the RAP network. RAP is a member of the Agency for Health Research & Quality (AHRQ) PBRN registry and the Federation of PBRNs. As the health care environment has moved most practices from independent businesses to health care system owned or affiliated entities, RAP has developed sub-networks with their own identities. This allows cross-system studies within the larger coordinating RAP meta-network when that is helpful, and smaller studies within a sub-network when that is relevant to the research question.

Safety Net Providers' Strategic Alliance

The Safety Net Providers' Strategic Alliance (SNPSA) is a safety net practice PBRN started in 2004 that includes MetroHealth (county healthcare system) Community Health Centers, federally qualified community health centers, free-clinics, and health clinics for the homeless. SNPSA is comprised of 20 practices and 120 primary care clinicians. The network’s clinicians and practice administrators comprise a steering committee that meets monthly to conduct research project development, implementation, interpretation, dissemination and application of findings. SNPSA has conducted 16 PBRN studies. Through their participation, SNPSA clinicians obtain training in research design and practice-based research methods, and a subset engage in year-long PBRN training fellowships. SNPSA members seek to use research findings to improve practice and support health policy advocacy to close gaps in the safety net.

Cleveland Clinic Ambulatory Research Network

The Cleveland Clinic Ambulatory Research Network (CLAReN) is made up of 195 primary care physicians operating in 23 Cleveland Clinic Family Health Centers. Established in 2005 with funding from the Health Resources and Services Administration (HRSA), CLAReN holds monthly network meetings where clinician-researchers collaborate with academic investigators to develop research projects for implementation in primary care sites. CLAReN prioritizes the engagement of its clinicians by protecting time for them to participate in the monthly network meetings. CLAReN has engaged in 18 research projects.

Rainbow Office-based Clinical Research Network

The Rainbow Office-based Clinical Research Network (RRN) is a consortium of 265 pediatric primary care physicians in 56 practices affiliated with Rainbow Babies and Children’s Hospital of Cleveland (RB&C). The RRN promotes opportunities for clinicians to participate in research by facilitating collaboration and assisting clinicians in overcoming traditional barriers to conducting clinical research. Launched in 1999 as a PBRN for the Cleveland pediatric community, the RRN builds on the clinical faculty members' strong affiliation with RB&C, and on a history of community-base clinical and translational research. Early studies focused on antibiotic use and resistance. Re-focused with new leadership in 2006, the RRN has since conducted 7 studies, focusing on reducing childhood obesity, diagnosing and treating otitis media, and diagnosing behavioral problems in children.

Better Health Greater Cleveland

Better Health Greater Cleveland (BHGC) is northeast Ohio primary care network of 18 primary care practices with 612 clinicians from 7 health care systems. BHGC was established in 2007 under the Robert Wood Johnson Foundation’s Aligning Forces for Quality initiative. It includes local health care systems, insurers and community organization partners in public reporting of performance on nationally endorsed and locally vetted quality standards, in the generation of new knowledge, and in collaborative practice improvement efforts. BHGC is a leader in the use of electronic medical record technology and data sharing to foster improvements in health care delivery and clinical outcomes in primary care. Health outcomes data across BHGC practices and multiple health care systems are routinely aggregated, analyzed, and publically reported twice yearly. Recent data published in the NEJM¹³ show improvements in the quality and equity of the region’s diabetes care and outcomes in six public reports over three years (www.betterhealthcleveland.org), improvements in blood pressure control over two reports (70% of over 107,000 adult hypertensives with BP<140/90 in 2009-10), and excellent adherence to treatment standards for heart failure (96% of over 5,000 patients treated with ACE inhibitors, ARBs, and/or beta-blockers). The BHGC also effectively uses learning collaboratives for practice improvement. COIN applies BHGC’s learning collaborative model for the dissemination and implementation of research into practice.

Ohio State University

Ohio State University Primary Care Practice-Based Research Network

The 26-practice Ohio State University Primary Care Practice-Based Research Network (OSU-PCPBRN) consists of 7 family medicine clinics of the OSU Primary Care Network, including one shared clinic with general internal medicine, 4 general internal medicine clinics of the OSU Specialty Care Network, 5 Columbus Neighborhood Health Center, Inc. clinics, and 10 Nationwide Children’s Hospital Pediatric Primary Care Centers. These Family Medicine, Internal Medicine, and Pediatric practices include 43 family physicians, 68 pediatricians, 30 general internists, and 12 nurse practitioners and are located throughout Central Ohio and in various Health Professional Shortage Areas.

The OSU-PCPBRN was founded in 2001 through collaborative relationships formed through the OSU Primary Care Research Institute and is a member of the AHRQ PBRN registry. The OSU-PCPBRN’s mission is to foster, facilitate, and report collaborative, interdisciplinary research directed toward optimizing people's health, and the populations targeted include minority and underserved populations. A Steering Committee, including representatives from each of the clinical networks, oversees the research activities in the OSU-PCPBRN and reviews each request to access the OSU-PCPBRN. Collaborating investigators include researchers from each of the clinical networks of the OSU-PCPBRN and from the OSU College of Medicine and College of Public Health.

The OSU-PCPBRN collaborative of clinical networks serves to maximize the diversity, breadth, and depth of the available primary care study populations in Central Ohio and represents the diverse demographics of the region. The OSU-PCPBRN is committed to the performance of high quality practice-based research to add to the primary care knowledge base, enhance delivery of preventive medicine, and positively influence diagnosis and treatment of the health problems of patients, families, and communities.

University of Cincinnati / Cincinnati Childrens Medical Center

Cincinnati Area Research Group

The Cincinnati Area Research Group (CARinG) Network was founded in 2009 and built on strong practice-based research experience in the Department of Family and Community Medicine. Support from the University of Cincinnati’s CTSA program has been instrumental in the network’s development. The CARinG Network is a Family Medicine and general internal medicine primary care PBRN. It is a provider membership organization, where individual physicians, nurse practitioners and physicians assistants join the Network by completing a membership form, modified from the Primary Care Network Survey – 1 (PRINS-1). Beginning with 7 practices in 2009, the CARinG Network currently has 17 member practices, including 2 residency practices and 1 Federally Qualified Health Center. Four practices are NCQA-certified Patient Centered Medical Homes. Many of CARinG’s member practices represent large healthcare organizations in our community, however, one quarter of the network’s practices are small, independent practices. The CARinG Network is led by a Medical Director (Dr. Nancy Elder) and a Research Director (Dr. Saundra Regan). The CARinG Network leadership meets regularly with leadership from the Cincinnati Pediatric Research Group of Cincinnati Children’s Hospital Medical Center, as both PBRNs are active components of the Community Engagement Core of Cincinnati’s CTSA program.

CARinG research leaders are especially skilled in qualitative methods, and interviews, observations and focus groups are often components of their research. Collaborating researchers include a number of family medicine researchers, as well as community physicians. In addition, the CARinG Network collaborates with other community organizations, such as the Health Collaborative of Greater Cincinnati to perform research and primary care project evaluations.

The goal of the CARinG Network is to improve the care of patients and the work experience in primary care through a partnership of clinicians, medical office staff, patients, and researchers. Leaders of the CARinG Network are members of the Cincinnati CTSA’s Community Engagement Steering Committee and serve on subcommittees of the community partner council. The University of Cincinnati Department of Family and Community Medicine also supports the PBRN, and all practices affiliated with the Department are members of the PBRN. The CARinG Network regularly meets with the Cincinnati Pediatric Research Group PBRN of the Cincinnati Children’s Hospital to explore ways to expand research across the lifespan. In addition, Dr. Nancy Elder, CARinG Medical Director has been a co-investigator on several projects with the AAFP-National Research Network and the ACCESS Network in Chicago, giving her experience in working with multiple PBRNs. Dr. Elder will also be spending her sabbatical in 2012 to further develop an infrastructure for Ohio PBRNs to improve the ease with which they continue to work together.

Cincinnati Pediatric Research Group

The Cincinnati Pediatric Research Group (CPRG) is a regional PBRN of over 40 practitioners in 25 pediatric practices. CPRG is financially supported by Cincinnati Children’s Hospital Medical Center and scientifically supported by the University of Cincinnati CTSA’s Community Engagement Core. The goal of the CPRG is to identify problems facing primary care practices and patients, and to design and implement research aimed at addressing these problems and improving care and health outcomes in the community. Fifty-three Greater Cincinnati area pediatric practices have participated in either research or quality improvement projects associated with the network. Since the network’s start in 1996, Cincinnati Children’s Hospital Medical Center has provided financial, technical, and research support to the CPRG.

Dr. Robert Siegel has been the CPRG’s Medical Director since the group's founding in 1996, and he focuses on network leadership, recruitment, and project implementation. Dr. William Brinkman and Dr. Paul Korn are Co-Directors of Research, focusing on scientific rigor. In 2009, the CPRG added the role of Community Director to be a liaison between the group and the community practices. The CPRG’s Steering Committee includes physicians from both community practices and the academic health center, including leaders from the CTSA Community Engagement Core.

Northeast Ohio Medical University

Established in 1993, the Northeastern Ohio Network (NEON®) is the primary care PBRN of the Department of Family & Community Medicine at Northeast Ohio Medical University (NEOMED). Its membership includes 6 family medicine residency sites, their faculty and residents, 40 community-based family physicians, and eight clinics that provide primary care to the medically underserved, and comprises the longest-standing PBRN of residency training practices. Located in urban, suburban, and rural areas, the residency programs provide services in family medicine, obstetrics, pediatrics, and geriatrics, and serve disproportionately large numbers of Medicaid patients. The clinics for the underserved provide acute and chronic care services to a population of vulnerable patients throughout the region. Together the NEON practices provide care to more than 100,000 patients per year.

NEON® is governed by an executive committee that meets monthly at NEOMED to discuss current and future studies. It is composed of a clinical director, six family medicine site research directors, a research coordinator, a community representative, and a representative from a medically underserved site. The administrative support for NEON® is provided by the Department of Family & Community Medicine Office of Research which includes the director, a research coordinator, grants administrator, senior research associate, and department assistant. NEON works as an “opt in” PBRN, where practices are free to join research projects that are of interest to them. It also functions as a “bottom up” organization, where ideas for research studies frequently come from the member practices rather than the executive committee.Research Briefs are issued periodically to update member practices on studies in progress. New studies are featured in Family Ties, our monthly newsletter. Most of our communication is by email distribution lists. NEOMED has videoconferencing capabilities that are available for use by NEON®.

NEON® is recognized as a practice-based research network by AHRQ and is a member of the Federation of PBRNs and the International Federation of Primary Care Research Networks. The NEON® Director sits on the Steering Committee of the Research Association of Practices (RAP at CWRU). NEON® is a member the Federation of Practice Based Research Networks (American Academy of Family Physicians). NEON currently is leading an effort to develop similarly configured PBRNs for the other clinical departments at NEOMED and to link them together to form a large multi-specialty PBRN.

Relationships among the Collaborating CTSAs and Institutions

The PBRNs in COIN have access to abundant resources that support PBRN research, including the Cores and resources of 3 Clinical and Translational Science Awards that are supported by over $100M in NIH research infrastructure through the CTSA program. These institutional resources provide a deep well from which COIN draws to develop networks’ research capacity, foster relationships with a pool of investigators, and streamline the flow of information and participant protection processes. Each Ohio CTSA brings to this collaboration strong clinical and translational research support, including data management, biostatistics, epidemiology and research design, bioethics and regulatory assistance, comparative effectiveness and translational technologies. These resources, which can be ramped up quickly for specific projects, include: core staff devoted to PBRN research and development, regulatory cores that expedite IRB review within and across institutions, pilot study funds, communication vehicles, and PBRN and clinical research training programs. An Ohio Governor’s initiative is fast-tracking ongoing efforts to break down barriers to inter-institutional clinical research collaboration across the state.

In the following sub-section, relevant CTSA resources, regulatory resources, and informatics resources within each COIN partner organization are highlighted. In the subsequent sub-section entitled, “Shared Resources and Initiatives Across the COIN Partner Organizations,” relevant resources that are shared across the collaborating COIN partner organizations are highlighted.

Case Western Reserve University

CTSA Resources and Collaborative Relationships

The Cleveland CTSA’s PBRN Shared Resource serves as the Coordinating Center for COIN. Based on nearly two decades of a local, national and international PBRN leadership,^14-19 the PBRN Shared Resource was initially funded as a Core Facility by the Case Comprehensive Cancer Center in 2006, and in 2007 it became a Core of the Cleveland CTSA program. The Cancer Center and the Cleveland CTSA provide important infrastructure support that continues to enable the development of new PBRNs, the growth and evolution of mature PBRNs, and the conduct of community-based research by greater numbers of investigators. The PBRN Shared Resource provides services to 11 mature and 5 developing PBRNs, and serves as the administrative home for the 16 networks.

The PBRN Shared Resource has a 3-person leadership team: Director, Dr. James Werner, Research and Development Mentor, Dr. Kurt Stange, and Administrative Director, Amanda Ross. The Shared Resource includes 3.5 FTE research support staff members and 3 faculty members supported by the Cleveland CTSA and the Case Comprehensive Cancer Center. This staffing supports PBRN research initiated by network practices and academic investigators, and links PBRNs and investigators to additional resources at the Cleveland CTSA and Cancer Center. Located in the CWRU Department of Family Medicine, the PBRN Shared Resource supports network communication, research consultation, network development, project implementation, analysis, and dissemination. It also offers PBRN training initiatives, including year-long PBRN fellowships and a 3-credit MPH course in PBRN research methods.

Other Cleveland CTSA resources providing services to the PBRNs at Case are the Community Partnership Core, the Regulatory Support Core, the Pilot Studies Core, the Biostatistics Core, KL2 post-doc training program and the Biomedical Research Informatics Management Core (BRIM). The Community Partnership Core and the PBRN Core collaborate extensively and serve on one another’s Advisory Committees to engage more readily with surrounding communities. Collaborations have led to research partnerships between the PBRNs, community groups, community organizations, and academic investigators. The Cleveland CTSA principal investigator, Dean Pamela Davis, also is PI of the $8M Regional Extension Center (REC) grant that is assisting regional primary care practices with developing their electronic medical record infrastructure. The REC is working to help independent PBRN practices develop the research and data-sharing capabilities of their electronic medical records.

Regulatory and IRB Resources

The Cleveland CTSA’s Regulatory Core, led by Philip Cola, advises the PBRNs in preparing IRB applications, provides expertise in HIPAA regulations and data security, and in collaboration with PBRN Shared Resource has developed and published an innovative IRB process specifically for PBRN card studies.²⁰ PBRN pilot studies are frequently funded by the Cleveland CTSA Pilot Studies Core, which provides essential funding to generate preliminary data to support proposals for large-scale PBRN studies. The Cleveland CTSA Biostatistics Core provides data analysis consultations. The Cleveland CTSA’s Biomedical Research Informatics Management (BRIM) Core is a resource for COIN’s utilization of the Redcap database tool for data collection and data management. The BRIM Core is described in the “Informatics Resources” sub-section below.

IRBs across the Cleveland CTSA and PBRN clinical partners (University Hospitals, Cleveland Clinic, and MetroHealth Systems) have developed a Facilitated Review agreement, whereby a single application is written and submitted to one of the IRBs. The 3-way Facilitated Review agreement streamlines the IRB process and creates efficiency for PBRN investigators in Cleveland. A recent innovation resulting from a collaboration between the PBRN Shared Resource and the Cleveland CTSA Regulatory Core has enabled further streamlining of card study protocols, which now are covered by a single IRB protocol under which new card study proposals are submitted as addenda.²⁰

Informatics Resources

The Cleveland CTSA’s PBRN Shared Resource has access to Explorys, a powerful electronic tool to enable rapid search and retrieval of information from vast numbers of electronic health records (EHRs) from many different EHR systems. The majority of the Cleveland CTSC’s PBRN practices and NEOMED’s NEON PBRN practices are members of the four major healthcare systems in northeast Ohio that contribute system-wide EHR data to Explorys: the Cleveland Clinic, University Hospitals, MetroHealth, and Summa Health System. Explorys has curated more than 24 billion clinical and operational data points over 10 million unique cared for lives. The PBRN Shared Resource of the Cleveland CTSA uses Explorys to aggregate and create complex queries of EHRs for hypothesis generation and testing within a privacy protected and HIPAA compliant framework. For hypothesis generation, Explorys enables de-identified data sets to be quickly aggregated from millions of current EHRs, from which trends can be ascertained. Through such rapid analyses, Explorys will provide information about the prevalence of patients or health conditions and associated covariates that will be needed to make feasibility decisions about FOAs. For Task Order work requiring in-depth analysis, Explorys data will be analyzed using statistical software applications, and Explorys data may be merged with large administrative data bases. Explorys is also capable of re-identifying health records for aggregation by healthcare system, by practice, and for individual case finding. Additionally, in Ohio, negotiations are under way with several health systems throughout the Columbus and Cincinnati regions.

Anil Jain, MD, FACP, Senior VP & Chief Medical Information Officer at Explorys, actively collaborates with COIN and has provided a letter of support for this P30 application. On the P30 project, Dr. Jain will provide IT support and will use de-identified healthcare data to rapidly assess feasibility of FOAs, and will use large electronic data acquisition for specific studies. He will be invited to COIN research calls or contacted separately for study feasibility determinations, and will serve as a contractor as needed.

The PBRN Shared Resource of the Cleveland CTSA is supported by the CTSA’s Biomedical Research Informatics (BRIM) Core. The BRIM Core manages shared IT and informatics resources, tools, systems, underlying connectivity and security, and provides a cooperative academic environment for research IT, informatics and computer systems. G.Q. Zhang, PhD is Division Chief for Medical Informatics for the Case Center for Clinical Investigation, and is Co-Director of Informatics for the Cleveland CTSA and the BRIM Core. Dr. Zhang and his staff provide access to the IT and communication tools needed for efficient and effective program operations within the Cleveland CTSA’s PBRN Shared Resource.

Ohio State University

CTSA Resources and Collaborative Relationships

The OSU-PCPBRN was founded in 2001 through collaborative relationships formed through the OSU Primary Care Research Institute. OSU-PCPBRN is component of the Ohio State University Center Clinical and Translational Science Award (OSU CTSA) program, which is a collaboration among the University, The Ohio State University Medical Center and Nationwide Children's Hospital. Within the OSU CTSA, the Ohio OSU-PCBPRN is a member of the Participant & Clinical Interactions Resources group, where it collaborates to serve investigators in partnership with the Community Engagement Core, the Clinical Research Services Core, and the Regulatory Core. The OSU-PCPBRN receives services from other Cores of the OSU CTSA, including Biomedical Informatics; Design, Biostatistics & Ethics; Regulatory Support; and Community Engagement.

Regulatory and IRB Resources

Supported by the OSU CTSA, OSU sites of the OSU-PCPBRN are covered by the OSU Office of Responsible Research Practices Institutional Review Board, and the pediatric sites of the PBRN are covered by the Nationwide Children's IRB. The OSU and Nationwide Children's Hospital IRBs share a reciprocity agreement to facilitate cross-site collaboration and decrease investigator burden.

Informatics Resources

Each clinical network of the OSU-PCPBRN uses an electronic medical record, and the clinical networks of Nationwide Children’s Hospital and the OSU Medical Center each use Epic. Nationwide Children’s Hospital and the OSU Medical Center have various tools for electronic data capture, including REDCap, REDCap Survey, TeleForm, and StudyTrax, and utilize SharePoint to facilitate communication and collaboration. Nationwide Children’s Hospital and the OSU Medical Center also have data warehouses, which are tools for clinicians, researchers, administrators, and decision support services to examine and analyze integrated data sets in order to address strategic goals and research objectives. These data warehouses bring data from billing and clinical systems into a centralized data repository to provide a single-point access to a large volume of detailed and aggregated healthcare-related patient and research data to allow multilevel use across all teaching, research, and patient care missions at each institution. These services facilitate clinical research and personalized medicine and ensure data security and HIPAA compliance.

University of Cincinnati

CTSA Resources and Collaborative Relationships

The CARinG Network and the Cincinnati Pediatric Research Group (CPRG) are closely affiliated with the Cincinnati CTSA. Development of the CARinG Network and growth of the CPRG are key aims of the Community Engagement Core of the Cincinnati CTSA, which provides financial support, research expertise, and collaborative research faculty at the University of Cincinnati, Cincinnati Children’s Hospital, Veterans Affairs Medical Center, and University of Cincinnati Health, the Hamilton County and Cincinnati Health Departments, HealthCareAccess Now, and over 100 local providers served through Cincinnati Children’s Hospital Physician’s Health Organization, as well as our PBRN networks. The Cincinnati CTSA also has a well-established KL2 career development program, its nationally-acclaimed Community Leadership Institute grants programs, and other funding programs to support research faculty and programs. The Community Leaders Institute is a 6-week leadership development training program that is designed to enhance community research and capacity building competencies in community leaders, including PBRN members and associates.

Through the Cincinnati Community-Academic Partnership for Primary Care Quality and Research, UC and the CARinG Network actively partner with several community organizations involved in enhancing primary care in our region. One of these community partners is the Health Collaborative of Greater Cincinnati, which leads Cincinnati’s RWJ Aligning Forces for Quality initiative. With workgroups on health information technology, health measures, quality improvement, consumer engagement and the Patient Centered Medical Home (PCMH), the Health Collaborative is an important partner in primary care in our region. Already 20 primary care practices have achieved NCQA PCMH certification through participation in Health Collaborative transformation projects, including four CARinG Network practices; an additional four CARinG Network practices are in the project now. Future initiatives through COIN will likely focus on PCMH initiatives, transformation and outcomes – our partnership with the Health Collaborative-led RWJ Aligning Forces for Quality program positions us to be prepared to respond to these initiatives.

Regulatory and IRB Resources

The primary IRB for CARinG is the University of Cincinnati Institutional Review Board. A number of network practices are affiliated with the Christ Hospital IRB, which has reviewed protocols from the network. The primary IRB for Cincinnati Pediatric Research Group is the Cincinnati Children's Hospital Medical Center Institutional Review Board. The Cincinnati CTSA works to streamline inter-institutional IRB review.

Informatics Resources

The Cincinnati CTSA’s Informatics Center serves as the hub of research informatics activity for the Academic Health Center. Directed by Dr. Mark Wess, the Cincinnati CTSA’s Informatics Center supports research, including practice based research data management services for investigators, improved protocol design, analysis, and trial management, assistance with complex research data warehouse queries and advanced dissemination of knowledge at point-of-care. Dr. Wess is a key member of the CTSA and also serves on the Beacon research team for the Greater Cincinnati Beacon Collaborative, awarded in 2010, Dr. Wess and the CTSA Informatics Center are working to enhance research capabilities as the Beacon Collaborative rolls out enhanced health information exchange infrastructure and coordinates regional health information technology extension center services. As electronic records advance in our region, this partnership and ability to communicate across health systems and vendors will be pivotal in enhancing primary care and researching outcomes.

Cincinnati is home to HealthBridge, a not-for-profit corporation that supports health information technology adoption, health information exchange, and innovative use of information for improved health care outcomes. For well over a decade, HealthBridge has been recognized as one of the nation’s largest, most advanced, and most financially sustainable health information exchanges. HealthBridge’s information network now encompasses more than 50 hospitals, 800 physician practices and 7,500 physicians in five different communities in three states. HealthBridge’s secure electronic network sends roughly 3.2 million electronic messages per month, including lab tests, radiology reports, discharge summaries and other information vital to better care for more than 2.75 million patients.Through the Greater Cincinnati Beacon Collaboration, HealthBridge is developing and implementing innovative solutions to improve the health care quality, cost-effectiveness and population health of the communities it serves. University of Cincinnati and Cincinnati Children's Hospital are active partners in HealthBridge and the Beacon collaborative.

Northeast Ohio Medical University (NEOMED)

CTSA Resources and Collaborative Relationships

The NEON PBRN at NEOMED has a longstanding collaborative relationship with the CTSA-funded PBRN Shared Resource in at Case Western Reserve University. Examples of past collaborative studies have been the National Ambulatory Medical Care Survey (NAMCS) study and the Direct Observation of Primary Care (DOPC) study. We are currently working with CWRU faculty on a project entitled, “A Study of Physician-Patient Interactions in Primary Care.” NEOMED faculty also serve as key members of the planning committee of the Cleveland CTSA PBRN Shared Resource-sponsored Ohio PBRN Festival, and NEOMED faculty and NEON investigators lead workshops at the conference. In addition, Dr. Werner is currently engaged in community-based research initiatives at NEOMED.

Regulatory and IRB Resources

The NEOMED IRB reviews NEON’s research protocols and serves as a resource for investigators when questions arise. In addition, the NEOMED office of research and sponsored programs serves as a resource for any of our grant-funded studies. A number of additional IRBs become involved in reviewing PBRN protocols if members of their faculty are involved in the study in question, and IRB expedited reviews are provided at NEOMED’s partner institutions including Summa Health System, Barberton Hospital, Akron General Medical Center, Aultman Hospital, St. Elizabeth Health Center, Northside Medical Center, Children’s Hospital Medical Center of Akron, the University of Akron, and Kent State University.

Informatics Resources

NEOMED’s NEON PBRN practices contribute data to Explorys and they have access IT resources through the CWRU PBRN Shared Resource. In addition, NEON practices are being brought together through a Regional Health Information Organization (RHIO) which is enabling the development of a Health Information Exchange to improve the safety, quality, and efficiency of healthcare through the efficient application of health information technology.

Shared Resources and Initiatives Across the COIN Partner Organizations

The Ohio CTSA Consortium comprised of CWRU, OSU and UC provides a robust infrastructure for PBRN research. The initiation of the CTSA program by the NIH has provided a previously unattainable degree of PBRN and community-based participatory research support. Ohio is blessed to have 3 CTSAs that are working with support from the highest levels to foster a highly collaborative research environment. This work involves ongoing efforts to streamline IRB protocol review across the institutions, data sharing agreements, and IT support for sharing clinical data for research purposes.

With local enthusiasm and considerable encouragement from the NIH office that directs the CTSA program, the Ohio Consortium is working aggressively to expand inter-CTSA collaboration, PBRN and community engagement, and pilot study funding. Current CTSA site collaborations that exist between the CTSC and the CTSA sites at Ohio State University and University of Cincinnati include development of a streamlined inter-institutional IRB approval process, development of robust IT infrastructure for sharing clinical research data, and a program to share resources important for drug development including high throughput screening at UC, medicinal chemistry at OSU, and protein structure determination at CWRU, as well as the NetWellness public website described below.

The Ohio Practice-Based Research Festival held in Cleveland on December 2, 2011 involved PBRNs affiliated with the four collaborating sites. The 56 posters and 12 research support workshops showcased the collaborative PBRN research possibilities that the proposed P30 grant will further enable.

Ohio Governor’s Biomedical Corridor Initiative

An important step for cross-CTSA collaborative research was taken when Ohio Governor Kasich convened a committee of the 3 Ohio CTSAs and associated hospitals in August 2011 to begin the Governor’s Biomedical Corridor Initiative. The purpose of the Biomedical Corridor Initiative is to capitalize on the strengths of the health research in the State in order to catalyze clinical research and create jobs. Committee members are medical school Deans from the 3 CTSA institutions and senior representatives from University Hospitals Case Medical Center, Cleveland Clinic, University of Cincinnati Hospitals, Cincinnati Children’s Hospital, and Nationwide Children’s Hospital. The Deans and Hospital Administrators support the Governor’s Biomedical Corridor Initiative. They are led by Pamela Davis, MD, PhD, Dean of the Case Western Reserve University School of Medicine and PI of the Cleveland CTSA.

Inter-Institutional Expedited Regulatory Review and IRB Processes

As part of the Governor’s Biomedical Corridor Initiative, Ohio’s 3 CTSAs are developing a State-wide facilitated/reliant review of IRB protocols through inter-CTSA agreements. A statewide regulatory infrastructure is being modeled on agreements are already in place at the Cleveland CTSA institutions and those within the Ohio State University CTSA. These inter-institutional agreements reduce the regulatory burden on each site for IRB review and expedite the process for investigators. This process is managed by a CTSC-supported electronic IRB hub that routes protocols approved by one of the IRBs to any other IRB.

The Governor’s Biomedical Corridor Initiative has brought together the regulatory parties at the State CTSA-funded institutions. The leader of this group is Philip Cola, MA, Director, Regulatory Core of the Cleveland CTSA and Director of Regulatory and Human Subjects protection function of COIN’s Administrative and Regulatory Core. Mr. Cola is leading an IRB Facilitation team from the 3 Ohio CTSAs that is working to enhance inter-CTSA collaboration. The IRB Facilitation team’s primary focus is to ensure efficiency and reduce regulatory burdens for investigators, and it is piloting the electronic facilitated/reliant review hub. Through frequent team meetings, the Ohio CTSAs have reached agreement in principle to the legal language underlying electronic facilitated/reliant review. Documents are presently under review by the Ohio CTSAs and the associated IRBs, with formalization expected by February, 2012. For Task Order FOAs pursued by COIN partners across Ohio, the inter-CTSA facilitated/reliant review process will expedite IRB review for rapid-cycle projects, enabling COIN projects to efficiently obtain regulatory approval.

Inter-Institutional Research Information Technology

The Governor’s Biomedical Corridor Initiative is accelerating CTSA efforts to create common IT platforms. This builds on the work that has been done across the CTSA in using a common database REDCap (Research Electronic Data Capture) to store and share research data. REDCap is a secure, web-based application designed to support data capture for research studies that provides: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.²¹ REDCap is in use at the 3 CTSA sites and is made available to the NEOMED site to create a common platform across all COIN sites. RedCap resources across the COIN consortium are coordinated by G.Q. Zheng, PhD, Director of the Cleveland CTSA’s Biomedical Research Informatics (BRIM) Core and Co-Director of Informatics for the Cleveland CTSA. For AHRQ task orders, the BRIM Core will coordinate the deployment and implementation of REDCap across COIN for data capture, data management, information integration, report generation, and evaluation.

The Cleveland CTSA’s BRIM Core manages COIN’s shared IT and informatics resources, data capture tools, communications tools, and data security needs. Utilizing BRIM’s resources, the COIN Coordinating Center harnesses cutting-edge informatics resources readily available or easily adaptable from existing CTSA infrastructure. Tools for communication, training, project management, data capture, and reporting are made available, creating and providing both public and password-protected web-site for local and statewide COIN activities (exclusive of protected health information). A Content-Management-System framework in a wiki environment such as Semantic Mediawiki is used to allow for delegating control of different content areas to designated individuals across the network. Other communication venues include online blogs, an events calendar, and news updates. For task orders, the BRIM Core will deploy and implement REDCap for data capture, information integration, report generation and evaluation.

The Governor’s Health Corridor initiative also builds on ongoing work to develop interoperable platforms for sharing de-identified clinical data for research purposes. This includes the work of each CTSA’s BRIM Core and the Regional Extension Centers to develop data sharing platforms, and the work of Explorys to share data across a rapidly expanding web of collaborating clinical site. Explorys is an electronic tool that enables rapid search and retrieval of information from electronic health records from different systems, and is described in the following section. The development of interoperable informatics platforms is an area of considerable investment and growth across the institutions, and the Governor’s initiative and a strong collaborative spirit among the CTSA leaders will make this an area of rapidly increasing capacity for Ohio PBRNs. Under the Governor’s Health Corridor Initiative, shared data agreements are being aggressively negotiated among the partnering institutions. Below we describe existing informatics resources that are available to COIN. Each CTSA has an Informatics Shared Resource that is engaged in advancing shared data use agreements.

To support communication across the COIN consortium the Coordinating Center is working with NetWellness to expand its ability to serve as a portal for COIN, providing information and resources for PBRN directors and members alike in support of the development, implementation and dissemination goals of the COIN consortium and its members.

To respond to AHRQ FOAs, we will use COIN’s inter-institutional information technology resources in two ways. First, to quickly determine feasibility of studies (e.g. to determine if there are enough diabetics of a certain age and number of co-morbidities) we will provide a rapid turn-around query to Explorys and to the relevant healthcare system IT organizations described below. Using de-identified data, these often can be turned around within several working days. In order to conduct specific projects, IT experts who can access and manage inter-institutional data available through Explorys and healthcare system data available through the CTSAs’ Biomedical Research Informatics Management (BRIM) Core will be engaged as co-investigators in FOA proposals. For more minor data needs, these Cores will be paid on a contract basis for data retrieval services.

Inter-Institutional Dissemination & Implementation Resources

Each partner has strong working relationships with a number of community organizations involved in enhancing health care and health in their region of Ohio. For the three of the sites, these are supported by the community engagement arm of their CTSAs. In addition, the Cleveland and Cincinnati are sites for the Robert Wood Johnson Foundation Aligning Forces for Quality (AF4Q) initiative (described above under each site). These initiatives bring together diverse health care partners to share health care quality data across the region, and to work together in learning collaboratives and with multi-stakeholder groups to improve the quality of health care. These initiatives provide a powerful platform for dissemination and implementation of PBRN findings at the level of the local primary care practice, multiple healthcare systems, and the community.

A unique dissemination, implementation and research support engine is provided by NetWellness (www.netwellness.org). Launched in 1995, NetWellness was one of the first consumer health sites on the internet. A partnership of CWRU, OSU and UC, NetWellness offers understandable health information for a general audience. The partnership uniquely provides an internet environment and program support for faculty members to participate, sharing up-to-date information from their field of specialty. Tapping into the intrinsic mission of universities to educate, NetWellness has succeeded as a valued non-profit resource, serving a national and international audience, receiving over 13 million visitors per year. More than 66,000 questions have been answered to date through its Ask-an-Expert Service. The inclusion of PBRN members and leaders, and CTSC faculty make this a unique and vital mechanism to foster implementation and dissemination of PBRN Research.

NetWellness provides a communications platform for PBRNs and their academic partners. CTSA and NetWellness partners are developing an in-depth, web-based research center. The content is being designed to demystify and illuminate research is in a way that a general audience can understand. Descriptions and examples will demonstrate the guiding research objective of improved health, and describe how people can participate at all levels of the research process. Content will illustrate how medical science evolves from basic science to clinical studies and the safeguards in place throughout that process. Content on translational research will be featured, highlighting how this approach makes a difference in taking results to the community. Accessible, person-centered content provided by faculty experts will help build trust in the research itself. The site will serve as a resource for research education materials that can be reproduced for community-based outreach activities and as ongoing, comprehensive information available online at any time. Because the information is web-based and interactive through e.g. an “ask-an-expert” service, the site can be an asset for long-term relationship-building for CTSA universities, PBRN members and researchers.

Experience in Conducting Research

In addition to inter-CTSA collaborations, the COIN institutions have a strong history of collaboration on PBRN research projects. This began in the early 1990s when PBRNs affiliated with Ohio medical schools began meeting as part of the activity of the Ohio Academy of Family Physicians Research Planning Committee. In 1994, the NEON and RAP networks (affiliated with NEOMED & CWRU, respectively) collaborated on the landmark Direct Observation of Primary Care Study, which resulted in 70 peer-reviewed research publications. This collaboration led to several other NIH-funded studies and to two collaborative AHRQ PBRN research infrastructure grants that developed novel methods for observational and patient-reported PBRN data collection. Later in the 1990s, the (CWRU) Rainbow and Cincinnati Pediatric networks began collaborating on studies of child behavior and childhood obesity. Formal and informal consultations and shared teaching of fellows, practice members and faculty members have been pursued among the 4 collaborating institutions for the past two decades.

Below we summarize PBRN research conducted by the collaborating institutions. Appendix B lists PBRN studies and funding amounts, and Appendix C lists PBRN publications.

Case Western Reserve University

The experience of the CWRU-affiliated PBRNs began in 1994 with the Direct Observation of Primary Care Study, conducted in the Research Association of Practices (RAP) and the NEON network affiliated with NEOMED. This NIH- and Robert Wood Johnson Foundation- funded study of 4454 patient visits to 138 primary care clinicians in 84 RAP practices resulted in 70 peer-reviewed publications and led to more than a dozen subsequent clinician-initiated studies and to a group randomized clinical trial.^{15, 17, 22, 23} This trial, the Study to Enhance Prevention by Understanding Practice (STEP-UP) used a practice-individualized intervention²⁴ that resulted in improvement in USPSTF-recommended clinical preventive service delivery²⁵ that was sustained over 2 years of follow up.²⁶ Additional multimethod research developed a model of the practice change process,²⁷ and a clinical trial of the use of Appreciative Inquiry for practice improvement.

Since 2007, 118 PBRN research studies have been completed or are in progress within the 16 PBRNs supported by the PBRN Shared Resource. Sixty-one studies were academic health center (AHC) investigator-initiated studies and 57 were led by PBRN clinicians and facilitated by PBRN Shared Resource staff and AHC investigators. Each study investigator has been provided services by one or more staff members of the PBRN Shared Resource. PBRN studies have been supported by NCI, ACS, and other NIH and HHS agencies. Funders also include the Robert Wood Johnson Foundation, the NIH-funded Clinical and Translational Science Collaborative, and other peer-reviewed funders.

Ohio State University

The OSU-PCBRN serves as a community-based translational research laboratory for research faculty with members from 9 colleges and 22 departments. To date the OSU-PCPBRN has conducted 57 research studies including industry trials, 25 of which were internally funded and 32 of which were externally funded. Fifteen of the externally funded studies were supported by federal grants. Presently, there are 12 active studies being conducted in the OSU-PCPBRN. This network allows investigators to examine health issues at the community level, test and validate various screening and therapeutic approaches, evaluate reasons for variation in practice performance, determine how changes in practice patterns can be translated into Medicare/Medicaid cost savings, and evaluate the management of clinical care in diverse populations. Research foci include chronic disease management, cancer prevention, and interventions for hypertension.

University of Cincinnati

The Cincinnati Pediatrics Research Group (CPRG) PBRN has pursued projects in a variety of areas in response to the interests of community-based physicians. Obesity and attention deficit hyperactivity disorder are prioritized conditions with active projects. The CPRG has received grant funding from the AHRQ, NIH, AAP, Cincinnati Health Department, and Atkins Foundation. The seventeen projects completed by the CPRG have led to 19 publications and 33 national abstract presentations.

Care for children with obesity is a focus of much CPRG activity. In 2009, the CPRG began a collaborative effort with Dr. Carole Lannon of the Cincinnati Children’s Hospital Medical Center James M. Anderson Center for Health Systems Excellence called Healthy Kids Ohio. Healthy Kids Ohio was initially funded by the Ohio Department of Health and is a one-year primary care practice learning collaborative to address obesity prevention and treatment. The program is now called “We Thrive” and is funded by a grant from the CDC. The CPRG was successful in recruiting 22 practices for this learning collaborative and supplying faculty for the project.

Initial research in the CARinG Network built on previous work on patient safety risks in primary care, identification of domestic violence, and primary care management of common problems such as headache and diabetes to develop strengths in health services and implementation research. Care for children with attention-deficit hyperactivity disorder (ADHD) has also been a recent focus of activity. Research examining factors that contribute to ADHD medication continuity among children cared for in primary care practices has enrolled over 170 children newly diagnosed with ADHD cared for by 58 pediatricians in 18 practices.

The CARinG Network has implemented 3 research projects, two with external funding (from AHRQ and the American Academy of Family Physicians Foundation), and has plans for 2 more projects to begin in 2012 (with funding from the Health Collaborative of Greater Cincinnati and the Reynolds Foundation). The research focus has been on improving systems of primary care practice, rather than a specific disease entity. An initial evaluation of the quality of chronic pain assessment and management is leading to learning collaboratives for improved chronic pain care; a study of Medical Assistant roles in practice teams is leading to a model for communication and training; and a study of infectious disease practices by physicians and staff is leading to system changes for behavior change. CARinG Network research uses mixed methods, including observations, interviews, chart abstraction/patient level data, and surveys.

Northeast Ohio Medical University

The NEON® PBRN has conducted a number of studies since 1993, mostly involving clinical questions posed by member practices. NEON collaborated with RAP on the landmark direct-observation of primary care study (DOPC) study¹⁵ and a study to replicate the National Ambulatory Medical Care Survey (NAMCS) in northeast Ohio.²⁸ In addition, we have conducted 20 studies focusing on educational outcomes, 13 on health literacy, and 8 on care to the underserved. Network leadership has decided on four focus areas for future studies – chronic pain management, health disparities, health literacy, and the use of technology in health care delivery – and expects to spend about 75% of our efforts in these areas.