Ella Thompson

A guide to research partnerships for pragmatic clinical trials

#### Summary points Pragmatic clinical trials are comparative effectiveness studies conducted in real-world settings to answer questions relevant to patients, clinicians, and healthcare decision makers. In contrast, explanatory clinical trials study how treatments or interventions work in carefully controlled settings and study populations, often to investigate a biological hypothesis or test a drug or device to meet regulatory requirements. The pragmatic approach requires unique methods to achieve the goal of identifying sustainable, generalizable, evidence based ways to improve healthcare.1 2 3 4 5 While previous authors addressed statistical considerations,6 little guidance is available on the methods for establishing partnerships between researchers and the people and processes in usual care settings that are necessary to conduct a pragmatic clinical trial. Based on insights from an initiative to accelerate pragmatic research,7 this article summarizes best practices for researchers and partners in healthcare systems as they establish collaborative relationships, develop research questions, and implement sustainable pragmatic clinical trials. A recent example …

Sustaining Research Networks: the Twenty-Year Experience of the HMO Research Network

Purpose: As multi-institutional research networks assume a central role in clinical research, they must address the challenge of sustainability. Despite its importance, the concept of network sustainability has received little attention in the literature, and the sustainability strategies of durable scientific networks have not been described. Innovation: The Health Maintenance Organization Research Network (HMORN) is a consortium of 18 research departments in integrated health care delivery systems with over 15 million members in the United States and Israel. The HMORN has coordinated federally funded scientific networks and studies since 1994. This case study describes the HMORN approach to sustainability, proposes an operational definition of network sustainability, and identifies 10 essential elements that can enhance sustainability. Credibility: The sustainability framework proposed here is drawn from prior publications on organizational issues by HMORN investigators and from the experience of recent HMORN leaders and senior staff. Conclusion and Discussion: Network sustainability can be defined as (1) the development and enhancement of shared research assets to facilitate a sequence of research studies in a specific content area or multiple areas, and (2) a community of researchers and other stakeholders who reuse and develop those assets. Essential elements needed to develop the shared assets of a network include: network governance; trustworthy data and processes for sharing data; shared knowledge about research tools; administrative efficiency; physical infrastructure; and infrastructure funding. The community of researchers within a network is enhanced by: a clearly defined mission, vision and values; protection of human subjects; a culture of collaboration; and strong relationships with host organizations. While the importance of these elements varies based on the membership and goals of a network, this framework for sustainability can enhance strategic planning within the network and can guide relationships with external stakeholders.

Partnership-Driven Resources to Improve and Enhance Research (PRIMER): A Survey of Community-Engaged Researchers and Creation of an Online Toolkit

Objective: This project aimed to develop an open‐access website providing adaptable resources to facilitate best practices for multisite research from initiation to closeout.

Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems.

Pragmatic clinical trials are increasingly common because they have the potential to yield findings that are directly translatable to real-world healthcare settings. Pragmatic clinical trials need to integrate research into clinical workflow without placing an undue burden on the delivery system. This requires a research partnership between investigators and healthcare system representatives. This paper, organized as a series of case studies drawn from our experience in the NIH Health Care Systems Research Collaboratory, presents guidance from informational interviews of physician-scientists, health services researchers, and delivery system leaders who recently launched pragmatic clinical trials.

Streamlining Research by Using Existing Tools

Over the past two decades, the health research enterprise has matured rapidly, and many recognize an urgent need to translate pertinent research results into practice, to help improve the quality, accessibility, and affordability of US healthcare. Streamlining research operations would speed translation, particularly for multisite collaborations. However, the culture of research discourages reusing or adapting existing resources or study materials. Too often, researchers start studies and multisite collaborations from scratch—reinventing the wheel. Our team developed a compendium of resources to address inefficiencies and researchers’ unmet needs and compiled them in a research toolkit website (http://www.ResearchToolkit.org). Through our work, we identified philosophical and operational issues related to disseminating the tool kit to the research community. We explore these issues here, with implications for the nation’s investment in biomedical research. Clin Trans Sci 2011; Volume 4: 266–267

Embedded research to improve health: the 20th annual HMO Research Network conference, March 31-April 3, 2014, Phoenix, Arizona.

The HMO Research Network (HMORN) is a member-based network of 17 research centers affiliated with not-for-profit health care systems across the US with an eighteenth site in Israel. These health care organizations all provide comprehensive medical services to enrolled members and patients. Though not all HMORN members are Health Maintenance Organizations (HMOs) most are integrated delivery systems, and most of the member research centers reside within the organizational structure of the health system itself. This ‘embeddedness’ of the research center within the health plan creates a natural opportunity for direct interactions between health care leaders, clinicians and staff, patients/members, and research investigators from HMORN member sites. Both organizational and member stakeholders are essential collaborators in the new model of patient and provider engaged research envisioned by the National Institutes of Health (NIH) Health Care Systems Research Collaboratory,1 the Patient Centered Outcomes Research Institute (PCORI),2 as reflected in recent funding opportunities published by NIH, PCORI and the Agency for Healthcare Research and Quality (AHRQ).3,4,5,6,7,8 The theme of the 2014 HMORN annual conference, Embedded Research to Improve Health, was especially timely as the US research environment shifts toward increased stakeholder engagement. The conference included several new features: a poster contest, an award for the best thematic abstract, an investigator development program, project and scientific interest group working meetings, and numerous sessions devoted to sharing methods, best practices, processes, and other information to engage a variety of stakeholders in research and research processes. The 20th annual conference of the HMORN was held in Phoenix, Arizona between March 31 and April 3, 2014. The event was hosted by Kaiser Permanente Colorado with Heather S. Feigelson, PhD, MPH as scientific chair and Sarah Madrid, MA ABD PhD as conference manager. The event marked two decades of sustained and productive collaboration across member sites. The State of the Network Address by the 2013–2014 HMORN Governing Board chair, Dr. John Steiner of Kaiser Permanente Colorado, celebrated this longevity, identified essential elements of network sustainability, and discussed the skills necessary to practice “leadership without control” in decentralized, collaborative research environments such as the HMORN. The keynote address was delivered by Patricia Gabow, MD, the recently retired chief executive officer (CEO) of Denver Health, a nationally prominent, integrated safety-net delivery system. She discussed research-operations partnerships, and presented the Denver Health experience in using Lean9 approaches to improve organizational efficiency and control costs. Senior staff from PCORI offered two luncheon addresses and participated in panel sessions. Four early career investigators awardees shared findings on studies of patient satisfaction, lifetime cancer care costs, breast cancer prevention, and nursing home discharge outcomes. Two poster sessions, numerous sessions for research administrators and IRB officials, and opportunities for informal networking rounded out this year’s event.

PS1-15: What has the HMO Research Network Done for You, Lately? How the Network is Responding to Investigators’ Needs

In late 2007, HMORN leaders surveyed investigators to learn how to better foster and support multi-site projects. This poster recaps survey results, reviews 2008 progress to address findings, and summarizes ongoing efforts. Methods: The 2007 HMORN investigators’ survey was anonymously administered via www.surveymonkey.com. Directors emailed the survey link to their faculty, including one email reminder. A total of 279 surveys were reportedly distributed. 2007 Survey Results: Surveys were completed by 161 investigators (58%) from 14 of 15 Centers. Full/senior Investigators represented 49% of responders, 19% were associate and 24% assistant level researchers. Years of experience averaged 15. The top 5 features investigators identified that would make multi-site research more attractive were: ways to find and connect with colleagues (32%); central or streamlined IRB (12%); more opportunities and better dissemination of them (11%); coordinated budget development and grant administration (10%); boilerplate, website, guides, clear processes (9%). Investigators also shared the top five ways the HMORN could assist investigators. These were: PI directory with bios, virtual scientific interest groups, streamlined grants and contracts administration, web based guides and resources and improved communications. 2008 Progress Made: The Network responded to investigator priorities in 2008 in a number of ways, and there are now many more resources available than when the survey was conducted. A directory of Investigators by site and research interests is now on the HMORN website with links to biographical information on external Center websites. Search features will be added to the PI Directory in 2009. An SOP for streamlined, facilitated IRB review of low-risk, data only studies was adopted across the Network. Templates for coordinating budget and grant development are available as well as a variety of boilerplate, guides, toolkits and best practices. The Network is working to finalize template subcontract and data use agreements and expand functionality of the Network’s website. To support and maintain all of this, every HMORN Center has made a financial commitment to the Network, beginning in 2009. Next Steps: With the funding of the 2009 HMORN Operating Budget, the Network is continuing to implement improvements to the website, administrative resources, VDW, communications and more.

PS1-30: O Say Can You C(ER) – An Inventory of Comparative Effectiveness Research Capacity in the HMO Research Network

Background and Aims: The HMO Research Network (HMORN) is uniquely positioned to conduct Comparative Effectiveness Research (CER). The 2009 health care reform debate; Recovery Act legislation and funding mandates; the Institute of Medicine (IOM) report of Initial National Priorities for Comparative Effectiveness Research and other forces have all worked to focus attention on CER as never before. We present results from a survey of HMORN leadership which explored the Network’s perceived competitiveness in responding to the IOM-generated top 50 priority topics in CER. The survey results are cross-referenced with research interests of HMORN scientific staff. We also review existing methodological and administrative HMORN resources available to assist with proposing, launching and carrying out CER projects. Finally, we briefly summarize initiatives spearheaded by HMORN leadership to build additional CER capacity across the Network. Methods: HMORN Board members were asked to complete an online survey, rating their perceptions of the Network s competitiveness in responding to the top two quartiles of initial national CER priorities outlined by the IOM. Response options were not competitive, a little competitive, somewhat competitive, quite competitive, very competitive and unsure. The initial survey link was sent July 17, 2009. Reminders were sent to non-responders on July 29 and August 14. The survey was completed by 88% of Network leaders (14 of 16). We cross-referenced CER priorities with research interests expressed by Network investigators in the HMORN Researcher Directory, available at www.hmoresearchnetwork.org. Results: Overall, respondents view the HMORN as very well positioned to respond to the top two quartiles of IOM Comparative Effectiveness priorities. While some priorities align well with established Network collaborations (e.g., cardiovascular disease, cancer) the HMORN has not yet fully capitalized on other IOM CER priorities, even though capacity appears to exist (e.g., care coordination, inflammatory diseases, bone health, shared decision making, dissemination techniques). Conclusions: In the CER arena, the HMORN has significant potential, with numerous opportunities to capitalize on its scientific and collaborative expertise. The Network is further improving its ability to respond to emerging CER funding opportunities by proactively inventorying scientific and methodological expertise, enhancing data capabilities, training staff and developing tools.