Scale and significance of the problem:  Presently it takes approximately 17 years on average for a physician to adopt a level 1 standard of care.  Part of this delay in adopting standards of care is the absence of a standardized method to disseminate tools for implementation.  The adoption of best practices may require tools, checklists, protocols, procedures, medical center memorandum, and computerized order sets. Currently, each hospital and clinic separately designs their own procedures (evidence and systems-based), protocols, tools and guidelines, which are rarely tested, validated, or optimized. Hundreds of man hours of clinicians’ time go into development of these tools. Often committees working on protocols run out of time, or energy, and the tool is lost. When tools are implemented at one facility, they are rarely validated, tested, optimized, maintained, or distributed to others.  While evidence-based and systems-based medicine may be optimal for patient care from the standpoint of safety and efficacy, the absence of a standardized method to implement, optimize, validate, maintain, and disseminate tools that are developed within a single hospital, renders use of such tools, best practice in concept only, wastes staff resources, and fails to provide the best care possible.

Current approaches (nationally) The VA System has 171 medical centers and more than 1000 clinical sites, with little sharing of protocols, checklists, and systems based medicine tools. VA Central Office will provide regulations on what must be accomplished  but the actual tools, checklists, and approaches are left to individual medical centers to develop.  Kaiser Permanente (KP) has 37 medical centers with a system to share systems based medicine tools. KP has a centralized library of validated order sets, checklists, and tools for systems based medicine.

Proposed approach and why it is innovative:  Establish a centralized systems based medicine resource group to optimize, validate, maintain, communicate, promote, distribute, and disseminate tools developed through systems-based and evidence-based medicine in the VA, KP,  and UCSF facilities, utilizing a central repository system. These tools would assist in the implementation of systems-based medicine.  These implementation tools may include protocols, checklists, Apps, memoranda, computerized order sets, and patient care practices. The medical protocols could be checked using epidemiologic analysis of computerized medical records for safety and efficacy. The cost to produce systems based medicine resources would be dramatically reduced by validating already available tools and then distributing them, rather than have each hospital in a system develop tools individually. In the VA, the work to produce a systems based medicine tool would be cut by a factor of more than 100 (1 protocol used in 171 hospitals, rather than each hospital developing their own independently).

Potential Partners:  The systems based medicine resource group could collaborate with Kaiser Permanente, the VA, and UCSF to share systems based medicine tools. KP has borrowed protocols from the SF VAMC. KP has an extensive library of these tools which could provide a basis for the library.

Projected impact, if possible, use back of the envelop calculation to provide quantitative support: A central repository system that effectively disseminates validated tools for implementing best practices would improve availability of evidence and system-based resources to clinicians,  reduce the time and cost for adoption of best practices thereby improving patient care.The result would be improvements in patient outcomes, reduction of mortality rates, reduction of operating costs, improved efficiency, and wider use of evidence and systems-based medicine. Use of individual protocols has reduced mortality rates by 35-50%. Cost savings in the VA are estimated to be a minimum of $1 billion dollars per year.

Drug development is a complex and resource-intensive process, with few academic institutions able to provide its translational researchers with the all the necessary infrastructure and resources to advance promising targets or early-stage molecules to validation. We propose to create an Exchange Marketplace – a framework in which a university can offer its unique capabilities and core resources in drug development in exchange for those that are not readily available on that particular campus.  We propose to utilize the UC BRAID (Biomedical Research Acceleration, Integration & Development) network and the Drug and Device Discovery and Development (D4) workgroup within BRAID to engage the five participating UC campuses of BRAID into the Marketplace.

A recent summit of the BRAID D4 workgroup in April 2013 made it clear that no single campus has all the necessary core resources to do drug development in-house. The summit also helped identify some of unique drug development infrastructure and core resources on each of the D4 campuses which can be shared via the Marketplace.  For example, UCSF leads the group with a state-of-the-art small molecule screening facility and medicinal chemistry capability (SMDC), while UCSD can contribute access to its unique marine natural products library.  UCD can contribute its GMP manufacturing facility and UCLA its GLP Toxicology facility – such facilities are not available at any other D4 campus.  These aforementioned facilities are meant to be representative examples of unique resources on each campus, but they demonstrate the increased breadth of capabilities that immediately opens up to the research community once the campuses agree to the exchange.

We propose that each campus contributes a chosen $ amount of services, linked to specific cores, to be offered to other campuses.  In return, each campus will be eligible to receive the amount of services on the marketplace equal to its contribution.  A process will be set up to issue the awards (in the form of services) to the investigators of the participating campuses.  The awards can be issued through a multi-campus RFP process, with a review team comprised of representatives from each campus.  Alternatively, each campus can conduct its own evaluation of proposals and recommend projects to receive the awards. 

Exchange Marketplace for drug development resources brings together and leverages the strengths and capabilities of each of the participating institutions.  It provides the research community with the knowledge of the types of services available on sister campuses.  It can seed collaborations between researchers across campuses.  Exchange Marketplace can offer pre-negotiated rates on a fee-for-service model, removing the IP roadblocks to collaborations.  A planning grant through the Big Tent Open Proposal mechanism could allow us to evaluate the feasibility of establishing such marketplace, gathering campus-level support from the participants, and refining the list of cores and facilities interested in participating in the program.

The recent Institute of Medicine review of CTSA programs strongly emphasizes a need to engage in substantive and productive collaborations as well as develop and disseminate research resources while focusing and leveraging on individual CTSA institution’s strengths.   The Exchange Marketplace does precisely that by linking the resources of the 5 BRAID participants (UCSF, UCD, UCLA, UCI, UCSD) and making them available to the research community.  Once the program is established and successful, this platform can be extended to other areas of research and development (e.g. Device development) and/or to other institutions.  Initially, however, we believe that the network comprising the BRAID D4 provides a powerful foundation for establishment of the program. 

The IOM has called for the CTSAs to expand research on children. The CTSI and the California Department of Public Health have a common vision of improving the health of children through newborn screening programs for genetic disorders. California has been a pioneer in developing new approaches to diagnosis, education, and treatment of disorders detected in the newborn period. Currently, several million newborns in California are screened for 21 genetic disorders each year. 

Overall, screening disorders are identified in 1 of every 500 births.  The data indicate hereditary disease expression is strongly affected by ethnicity/race. In California, there are 16 separate racial/ethnic groups at disproportional risk for specific genetic disorders.  For instance, 1 in every 80 Southeast Asians has a screening disorder.  Asian East Indians have the highest prevalence of endocrine disorders, Native Americans have a disproportional prevalence of cystic fibrosis, and metabolic disorders are highest in the Middle Eastern population.

Systematic problems, magnified by the diverse cultural and economic factors affecting the target population, impair the ability of the California State Newborn Screening Program to optimally reach its public health goals.  These goals include appropriate evaluation, performance monitoring, and access from birth through young adulthood to specialized treatment for all persons affected by screening disorders. Furthermore, significant numbers of families with affected newborns currently lack an informed provider in a medical home, do not have access to the latest therapy, and/or are not able to obtain counseling.

The goal of this proposal is to form an innovative partnership between the California Department of Public Health’s Genetic Disease Screening Program (CDPH BDSP) and the CTSI. The decision makers at the CDPH BDSP are “on board” and eager to have an opportunity to develop these ideas in a planning period.  Likely CTSI partners include the Comparative Effectiveness Large Dataset Analysis Core (CELDAC), the CTSI Community Engagement Program, CTSI Clinical Research Services, and the Children’s Hospital & Research Center Oakland, which runs the state screening program for hemoglobinpathies and has worked with the state screening program for many years. Other UCs are also potential partners.

This partnership will have several objectives:

(1)    Improve medical homes through provider education— The initiative will foster an active network of medical home physicians, and will develop provider education programs focusing on standard of care practice guidelines for each disorder, leading to better quality of care and improved guideline compliance. 

(2)    Develop a patient registry-- In collaboration with the medical homes, the initiative will develop an active registry of patients identified in the newborn screening program. These patients will receive educational services through multimedia approaches and have access to clinical trials.

(3)    Improve the infrastructure to conduct translational research-- The provider network and patient registry will provide a platform for conducting longitudinal studies for rare diseases, development of biomarkers, and a biologic bank for research, and will greatly facilitate access to patients and data for the development of new therapies.

Strategically combining resources of the CTSI and the CDPH BDSP will open up new and unprecedented research avenues from T1-T4.  California is uniquely positioned to utilize its screening registry for translational research purposes. We believe that a small planning grant will allow us to develop these ideas into a compelling project that would greatly strengthen the CTSI renewal and would ultimately serve as a model for other states. 

1. Scale and significance: Creative and groundbreaking T-2-T-3 Innovations in health care and community delivery have been developed and tested within many UCSF settings. While some successes have been achieved, the campus has not been able to leverage the full power of these innovations; limitations in the scalability of even the strongest and best-tested innovations occur. Many of the innovations are disseminated and potentially exported externally to UCSF, but few systematic approaches exist to internally marshal innovation for internal consumption in potential “next circle” of settings for replications and further testing, adaptation, and cultural refinements. Few systematic approaches for collecting information on these “home-grown” initiatives exist, precluding “mindful” and meaningful expansion into other “neighborhoods”.

2. Current Approaches (nationally). Our “distributive” nature lends to lost opportunities for cross-fertilization, delays as new initiatives are tested, lack of recognition of previous institutional history that could help avoid common, but time- and expense-intense errors. National innovation “explosion” being tested nationally could have great utility for UCSF/UC-wide, in an effort to make information more readily available.

3. Potential Approach: Establish a campus-wide Innovation Bank. Readily available and consistent information on the innovations, including how they were established, funded, who was involved, how did the model evolve, outcomes, evidence of effectiveness (i.e., cost-savings, increased patient satisfaction, improved use of existing resources) has not been centralized as we aim to develop additional quality and cost-reduction improvements. Additional strategies are needed for sharing the results of the innovations: short videos, podcasts, retreat briefings, panels. A “concierge” element, matching individuals ready to implement new initiatives with those who might have had relevant experience. Evaluation of the process of matching, as well as utility of the repository, is needed. The clearinghouse could also help in the diffusion of practice for those interested in identifying “works in progress”, wherein the innovation is still in the initial process of implementation. “Crowd-sourcing” could be tapped, contributing to ideas, in real time.

4. Partners: An Advisory Board comprised of Clinical Chairs would guide the development and implementation of the repository; proposed activities would also coordinate with the Implementation Science endeavor, Center for Healthcare Value, etc. Other CTSA/UCOP could participate once the initial resource is launched at UCSF.

5. Projected Impact: A collective fund, supported in part by the Clinical Departments, Schools, and Medical Center, would help create an “incentive” matching fund to implement innovations (UCSF and elsewhere) that have been shown to have success in improving quality, safety, outcomes, cost containment, and patient satisfaction. A process for applying for funds (building on campus efforts in Implementation Sciences) will be established and a review panel will select prioritized innovations, continuing to monitor and provide oversight as the replications are implemented. Leveraging innovations that work could help reduce substantial medical costs.

Advancements in technology, greater acceptance of remote communication by patients and insurance providers, and a trend toward an  increasing demand for providers and cost effective approaches will ensure telemedicine will play a much large role in the future of healthcare delivery than it does currently.   T4 research on outcomes, efficacy, cost, quality of care, and patient satisfaction related to the various applications and potential applications of telemedicine has grown significantly over the past decade, and there are now two journals dedicated to telemedicine.   However, little research to date has been with the pediatric or diverse rural or urban underserved populations.  The Institute of Medicine recently published its report on advancing translational research among the CTSA programs and recommended a greater focus on both children and ethnic minorities.

Largely with federal funding, the California Telehealth Network has built an infrastructure of high-speed broadband throughout California.  With expertise in numerous pediatric specialties and diverse population populations and a progressive spirit, CTSI could be the hub of research at the forefront of telehealth research.

Studies on outcomes, patient satisfaction, cost effectiveness and ROI, and comparative effectiveness may be applied to timely topics such as but not limited to:

•             Tele-care coordination, home health 

•             Remote monitoring of persons nursing homes

•             Tele-care for persons in correctional facilities and other institutions

•             Telepsychiatry and behavioral medicine

•             Oversight of non-MDs if scope of practice bills pass (SB 491,SB 492, and SB 493)  

•             Access to specialty care in rural areas of California

•             Provider training

In addition to research on telemedicine, the utility of these new technologies within the research enterprise has barely been tapped. There are numerous applications and opportunities to both study and utilize new communication technologies within translational research to facilitate participant interaction and involvement and oversight more non-academic community research locations. 

A CTSI planning grant will allow a select group of researchers across partnering institutions to secure partners, define its goals, and narrow its focus.  Potential partners include the UCSF Telemed Dept., the CTSI Community Engagement Program, Children’s Hospital & Research Center Oakland, and the UC Davis Pediatric Telemedicine Project. Other potential partners include SF Bay CRN, UC Davis, UC Berkeley, and various organizations around the state.

A coordinated effort among and between UCs in California and community partners could serve as a national model and source of expertise for the study of telehealth clinical applications and the utility of telehealth applications within translational science. 

Adverse social circumstances like community violence, unstable housing, food deserts and poverty can have dramatic, negative impacts on the health of vulnerable children. In safety-net settings, the prevalence of these adverse social circumstances is alarmingly high. A 2007 study in a pediatric emergency department demonstrated that over 97% of presenting families had at least one unmet basic social need; over 48% of families reported that within the last 12 months they had either been threatened with or experienced utility shut-offs; and over 30% of families said that they had either reduced the size of their meals or skipped meals because they did not have enough money for food. [1] These collective social needs, often referred to as social determinants of health, are well-documented to cause psychological stress in families.[2] [3]

There is an increasing body of literature that shows an association between aggregate psychological stress over the life course[4] and the risk for the development and severity of numerous chronic diseases[5]. The combined physiological response to environmental, social, and personal stressors is referred to as allostatic load[6]. Allostasis refers to the body’s ability to adapt to stress (physical, psychological, and social) through activation of the sympathetic nervous system, hypothalamus-pituitary-adrenal axis and metabolic system. As the allostatic load increases, this system breaks down and leads to the dysregulation of stress hormones, which causes disease or worsens disease states, and leads to behavioral/developmental and potentially lifelong psychiatric problems.

Correlating disease processes with adverse childhood experiences, and incorporating indicators of social stress and allostatic load into the medical model represents a new frontier in disease management.  There is a need for research to more firmly define the link between social stressors, disease, and the healing process, and to understand the impact of epigenetics on brain development and its relationship to the toxic stressors of poverty.

Incorporating a “Social Determinants of Health” framework into a mechanistic model of disease represents a new direction in disease prevention and management. It would necessitate building a new system of identifying patients’ needs, and would mandate including social determinants of health in disease prevention strategy. It would allow for new areas of drug development,  transform health care delivery systems, health care utilization and training of health care providers. The “Social Determinants of Health” approach has broad implications for both bench research and clinical trials at UCSF and throughout the country.  Moreover, allostatic load is a concept that is exceptionally well suited for T1-T4 research. A CTSI initiative investigating allostatic load would establish CTSI as a leader in this innovative approach to disease and help encourage a paradigm shift in translational research and medicine.

A primary partner on this project would be the UCSF Center for Genes, Environments & Health, which is already doing social and biologic research on allostatic load. In addition to the translational sciences research team, partners include Children’s Hospital & Research Center Oakland (CHRCO), which has a high volume of children significantly affected by social stressors. The Institute of Medicine (IOM) recently published its report on advancing translational research among the CTSA programs and recommended a greater focus on both children and ethnic minorities, with CHRCO this recommendation will be met. The proposed project will appeal to a diverse team from multidisciplinary backgrounds and we foresee the CTSI Community Engagement Program, other UC health care providers, epidemiologists, sociologists, anthropologists, public health experts, and national groups already addressing issues of poverty and health as potential partners.  Lastly, partnerships with community agencies will be essential in building a foundation for community-based participatory research. 

Challenge: Many UCSF researchers are interested in questions about human health and the delivery of health care services that could be studied using large administrative datasets, such as those generated by the Centers for Medicare and Medicaid Services (CMS), the California Office of Statewide Health Planning and Development (OSHPD), and agencies that collect vital statistics data (e.g., birth certificates, death certificates). While some UCSF researchers have conducted important research with these datasets, expanding the pool of researchers who work with them is challenging for several reasons. Organizations that produce these datasets often have difficulty responding to requests promptly due to limited resources and competing priorities. In addition, extensive programming is often required to transform the raw data into usable information. For some research questions, researchers also need to link vital statistics records with administrative data on the delivery of health care services. Because many of the publicly available versions of data sets are de-identified, linking such datasets typically relies upon probabilistic matching algorithms. The complexities and error-prone nature of probabilistic matching represents a barrier to the full exploitation of administrative and vital statistics data by researchers who are not experts in these techniques.

Solution - Data Concierge Service: Building upon resources for analysis of large, public datasets that are already available to UCSF researchers through the Comparative Effectiveness Large Dataset Analysis Core (CELDAC), this project would establish a concierge service that would assist UCSF researchers in accessing large administrative datasets. A ‘special access’ data manager who would simultaneously be employed by UCSF and agencies that collect administrative data (OSHPD, CA Department of Public Health, CMS) would link records across datasets. The data manager would have expertise in the use of deterministic and probabilistic matching algorithms to merge datasets using unique identifiers (where available) and other variables such as date, age, gender, and zip code. The data manager would generate customized datasets that are tailored to researchers’ specifications, create de-identified versions of them, and deliver them to requestors (probably through MyResearch). The data manager and CELDAC’s principal investigator would work with investigators to ensure they secure the approvals needed to analyze and report upon the data and serve as a liaison with data-providing agencies. This service could be funded in a manner similar to CTSI’s existing consultation services (CTSI subsidy for initial hour of consultation, recharge for subsequent hours of service). It could also be made available to researchers at other CTSAs to broaden the potential user base.

Potential Partners: Members of Stanford’s CTSA have expressed interest in collaborating with UCSF CTSI to enhance capacity to conduct research using secondary datasets. CTSAs at other UC campuses may be interested as may faculty and trainees in the School of Public Health at UC-Berkeley. The UC Research Exchange would be a valuable partner in this effort due to its experience in bringing UC campuses together to improve access to administrative data for health research. In addition, CELDAC’s principal investigator has good contacts with staff of OSHPD’s Healthcare Information Division who are interested in enhancing their ability to serve researchers and other customers.

Innovation: This proposal builds upon UCSF CTSI’s existing resources for conducting research with large administrative datasets by creating a data concierge service that would help UCSF researchers to more quickly obtain secondary datasets tailored to their specific research interests. If successful, CELDAC could be transformed from a conduit of information about datasets that other organizations generate to a concierge that works proactively with these organizations to help researchers at UCSF and potentially other CTSAs obtain the data they need for their research. Making requisite public data more accessible is expected to significantly expand the use of secondary data to address important hypotheses in public health and comparative effectiveness research. This innovation may be particularly valuable during the current contraction in national research funding.

Projected Impact: This project could enhance UCSF researchers’ ability to conduct timely research using large administrative datasets that would enhance our understanding of factors that affect human health. If successful, the project could serve as a model for other CTSAs.

We recommend that the UCSF CTSI initiate a grants program to support collaborative, multidisciplinary, translational research (CMTR) at UCSF and, in future years, across the entire UC system.

      1. Scale and significance of the problem. Successful translational research requires the collaborative effort of individuals with expertise in a broad range of disciplines, including (among many) bench science, structural biology, chemistry, clinical medicine, and statistics. At UCSF, as at almost all academic research centers, collaboration among faculty and trainees is made difficult by the mechanisms of funding, which reward individual success, and by the measures of academic success, which do not sufficiently reward collaboration. Despite this, there is a strong tradition of collegiality at UCSF and we believe that support for collaborative translational research here will be rewarded with success. This effort can then be scaled to include the other UC campuses, to broaden expertise and access to patients. This would be facilitated by current initiatives to foster collaborations across UC medical centers (e.g., BRAID and UC ReX).

      2. Current approaches (nationally). The NIH has stressed the importance of translational research and academic centers have moved to meet this need in a variety of ways. Often, these approaches are “top-down,” including, for example, the creation of new departments or facilities to create lead compounds or to develop screening procedures for drugs. UCSF has in addition utilized “bottom-up” approaches, supporting investigators with concepts that may lead to new therapies, e.g., the T1 Catalyst program and the UCSF/Pfizer Center for Therapeutic Innovation. The CTSI has in particular supported the development of clinical researchers, with notable success. These efforts, however, have not yet succeeded in developing strong partnerships between clinical and basic sciences. Instead, at UCSF, as at most academic medical centers across the nation, basic scientists and clinical scientists work in different worlds, with little overlap. We believe that the CTSI has the power to help change this.

      3. Proposed approach and why it is innovative. We propose that the CTSI directly counter the barriers to collaborative translational research by supporting research that promotes synergy among investigators across highly disparate areas of research. Collaboration between clinical and basic science investigators would be especially encouraged. Awards would be for up to $100,000, spent over a period of up to two years. Criteria would include:  A. Goals that will advance the possibility of new therapies or diagnostics that will benefit humans with disease. Translation of discoveries made in UCSF laboratories would be given high priority; B. An operational plan that demonstrates how support will promote interactions and collaboration among investigators; C. A path to clinical implementation, even if this is not a goal of the grant. D. Explanation of how the studies will add value to the work such that it is more likely to generate support from other sources.

Applicants would be encouraged to make use of the CTSI resources, e.g., in statistics, study design, patient recruitment, etc. Applications would begin with a one-page pre-application. Selected pre-applicants would be invited to submit a 4-page application for review by a standing committee. Full applications would be accepted at least twice yearly.

During the first two years of the CMTR program it would be limited to UCSF, in order to test approaches and maximize success. In the third year, the program would be expanded to include all UC campuses, thereby enhancing the breadth of expertise as well as the number patients studied. Other UC campuses would be asked to contribute to the costs of the collaborative programs.

Even as we provide support for collaborative, multidisciplinary research, we would initiate programs to facilitate this. Possible approaches include:  (1) a research “exchange”, where investigators can post ideas, problems, and requests and where they can ‘recruit’ collaborators – like a Craig’s list for research, (2) work with the sponsors of the proposed “speed dating” approach to linking investigators, (3) leverage Profiles to identify researchers working on areas of possible common interest, (4) create a small leadership team with broad knowledge of programs and individuals at UCSF to serve as “matchmakers” for collaborative research, (5) strive to enhance the culture of collaborative research at UCSF by altering promotion criteria to favor it, and by educating faculty in opportunities for collaborative research, (6) as suggested by the review panel, planning for the CMTR program would benefit from input by non-health care partners regarding methods for fostering cross-disciplinary research, e.g., Technology (Google, Microsoft) or Energy (Schlumberger, Chevron), etc.

By supporting collaboration rather than individual effort, the CMTR program will tap into the great expertise in both clinical and bench science at UCSF. The innovation in this approach is its direct support of a bridge between these domains. Support for team research has long been the approach in industry, but it is little tested in academia.

      4. Potential Partners. The proposed program will benefit from several CTSI programs that already exist, including especially the Catalyst Award and the Annual Pilot Awards.  Indeed these have overlapping aims with the CMTR program.  The CMTR differs substantially in its emphasis on cross-disciplinary research, but there may be opportunity to wed the Catalyst program and/or other CTSI programs to the proposed CMTR program.  The CTSI will also be of direct scientific benefit because of its relevant programs for consultation in statistics, patient recruitment, data management, etc. 

Within UCSF, we will be assisted by recent efforts to standardize and centralize biobanking and to access information in the biorepositories.  We plan to partner with other UC campuses beginning in year 3, and we expect that this will increase funding. For the review of applications, we will use not only UC faculty but also representatives from Pharma, as well as from non-health care partners on methods for fostering cross-disciplinary research as noted above. Pharma is also an expected future partner for successful awardees, and is even a potential partner for the CMTR program itself. Although we do not plan to use patients or disease advocates in reviewing grants, we do plan to use them in reviewing the success and failures of the program.

      5. Projected Impact. Translational research inherently carries high risk, with a concomitant high payoff if successful. Because of this, it is our expectation that many of the projects will fail. If they do not, we are probably not assuming enough risk. But the payoff can be very large, as shown by the UCSF Program for Breakthrough Biomedical Research (PIBBR), which supports risky research but has brought in support that is many times greater than the investment.

This proposal is endorsed by:  Joe DeRisi (Biochemistry and Biophysics), John Fahy (Medicine), Kathy Giacomini (BioEngineering and Therapeutic Sciences), Steve Hauser (Neurology), Tippi MacKenzie (Surgery), Mike McCune (Medicine), William Seaman (Medicine), Kevin Shannon (Pediatrics), Kevan Shokat (Cellular and Molecular Pharmacology), Eric Small (Medicine) and Zena Werb (Anatomy).

 The Problem

               We live in a highly stressful world that has resulted in an unprecedented incidence of stress-related mental and physical illnesses. Research in the neurosciences has made significant progress in identifying the role of environmental stressors (e.g. violence, abuse, disasters, neglect, harassment, discrimination) in the development of illness. There is particularly striking evidence that one’s interpersonal environment can shape and modify neurobiological factors that subsequently result in health problems. There is also growing evidence to indicate the role of psychosocial and behavioral interventions in modifying these neurobiological factors. Yet little research has focused on translating this exciting knowledge into evidence-based interventions to prevent and treat adverse effects of stress on health.  Although highly relevant to adults, psychosocial/behavioral interventions for stress-related illness have particular importance for children whose brains and other organ systems are more vulnerable to adverse effects of biological treatments. In addition, early interventions with children have the potential to address emerging problems before they develop into more severe disease.  

Current Approaches

               The importance of stress reduction is widely recognized.  However, there is a significant gap between advances in the neurosciences regarding allostatic load, psychoneuroimmunology, or epigenetics and their application to the development and testing of psychosocial/behavioral interventions that can attenuate or modify the neurobiological effects of stress on the nervous system. Studies are needed to assess the impact of these interventions on neuroplasticity and to examine how neurobiological outcomes of these therapies relate to psychological and physical symptoms across stress-related disorders.

Proposed Approach

               The UCSF CTSI can create a targeted program that encourages the translation of basic neuroscientific knowledge into the development and testing of psychotherapeutic and behavioral interventions for stress-related illnesses. This would involve 2 key components: 1) develop a centralized infrastructure that will bring together investigators in the field to share their expertise and facilitate collaboration of researchers across stress-related health problems. This infrastructure could also include innovative subject recruitment programs, a sample repository specific to stress-related biomarkers, and a repertoire of interventions that show promise in enhancing therapeutic neuroplasticity and reducing stress-related neurobiological deficits or injury; and 2) provide funding for pilot studies to test psychosocial/behavioral interventions that build on neuroscientific findings and measure the impact of these interventions on biomarkers specific to these findings.

Potential Partners

               There are many opportunities for collaboration. One of our strong community partners - Children’s Hospital and Research Center in Oakland – is submitting this idea in collaboration with UCSF. There would also be interest from our partners at SF General Hospital, SF Child and Behavioral Health Services, and CHILD at UCB. On a national level, there could be collaboration with the National Network of Depression Centers (of which our UCSF Depression Center is a member) and their CTSIs/CTSAs. This initiative would have important links to many of our CTSI’s programs, including Recruitment and Study Management Services, Strategic Opportunities Support, Community Engagement and Health Policy, and Early Translational Research.

Projected Impact and Innovation

               The initiative will foster collaboration among different disciplines at UCSF, with our community partners, and with colleagues nationally to achieve a much greater impact than would the efforts of individual investigative teams. It could provide a model infrastructure for an innovative field of research that other CTSIs and research institutions could use to advance the prevention and treatment of stress-related illnesses. It will also provide support to interdisciplinary, investigative teams in conducting important pilot work that will serve as the basis for applications to acquire extramural funding.  The initiative is highly congruent with NIH interests in fostering multi-disciplinary and biobehavioral research.   

Academic institutions, civic agencies at all levels, and NGOs of all kinds have joined what’s being called a “data revolution” by making the information they collect and use publicly available. How can this “open data” movement advance and accelerate clinical and translational research to improve health and eliminate health inequities? The CTSI Open Data Initiative will bring together under one umbrella projects currently underway at UCSF and other UC campuses along with their government and community partners to explore fruitful routes and best practices for maximizing the applicability and interoperability of publicly available (and potentially available) datasets, including clinical and population health data; economic and demographic data; transportation and planning data; and research datasets that could influence and improve the health care and health status of individuals and populations. 

Activities at UCSF that fall under the rubric of this initiative include SFHIP (including HUMS), CELDAC, and DataShare. Partners in San Francisco include the Hospital Council of Northern and Central California, SF Department of Public Health, DataSF/Mayor’s Office of Civic Innovation, SF Police Department, SF MTA, SF Rec and Park Department, District Attorney’s Office, and other city offices and agencies. Community partners include the San Francisco health disparities and health parity coalitions, healthy retail coalitions, alcohol prevention coalition, and nonprofits such as the YMCA. Resources would support the application and use of open data to meet the aims and activities of those health improvement and disparities-focused partnerships. Resources would also support the development of evidence-based health and healthcare apps and other technology tools (registries, health information exchanges, new and improved mobile devices). Activities would include Translational Science Hackathons and intensive workshops to identify mutually-held incentives, establish cost-savings goals, and activate assets and resources to maximize the impact of collaborative efforts.