Kurt Kroenke - US grants

While thousands of clinician-scientists in the U.S. are currently funded by individual or institutional training grants, a comprehensive didactic research curriculum is often not provided since such trainees are often scattered through separate divisions, departments and schools within the university. We propose a 2-year formal program for postdoctoral trainees committed to a career in clinical research, entitled the Clinical Investigator Training Enhancement (CITE) Program. The major aims are to: (1) Develop and implement a 2-year formal clinical research curriculum, including development of 4-new courses, to provide training in clinical research methods, biostatistics, epidemiology, research ethics, clinical trails, translational research, scientific writing, and grant preparation; (2) Create a mentoring effectiveness enhancement program; (3) Develop a new Masters of Clinical Research degree program for CITE enrollees; (4) Produce curricular products (website; audio; video) for both local use and dissemination. Strengths of Indiana University (IU) in achieving these aims include important preliminary work on research curricula done over the past 3 years, a large pool of potential participants drawn from 50 training grants as well as career awards, 72 participating faculty and mentors with a large portfolio of extramural funding, a General Clinical Research Center that has been funded for over 35 years, a large diverse patient population, and partnership in this proposal by IU's Schools of Medicine, Nursing and Dentistry. Participants will take 8 required courses with the option for other elective courses in their area of interest leading to a Masters of Clinical Research Degree. In addition to a primary mentor, each trainee will have a formal Mentor Panel that meets approximately every 4 months and monitors progress according to explicit benchmarks, including two manuscripts and one grant proposal by the end of the 2-year program. Syllabi will be developed for dissemination in both written form as well as a special website. Also selected components of the curriculum will be made available in audiotaped and videotaped formats. Outcomes of the Indiana University CITE Program will be regular output of career clinical researchers, an 8-component curriculum available in various media that is useful beyond our own institution, and innovations in mentoring clinical research that will have broad applicability.

DESCRIPTION (provided by applicant): Pain is a presenting complaint in nearly 20% of all primary care visits in the United States, accounting for more than 100 million clinic visits annually. Pain costs the U.S. over $100 billion each year in health care and lost productivity. Two-thirds of pain-related health care visits are related to musculoskeletal pain with the low back, hip and knee being the most common sites. Studies have consistently shown that at least one-third of patients with pain suffer from concomitant depression, and that comorbid pain and depression have reciprocal adverse effects on both symptom-specific (i.e., pain and depression reduction) as well as health-related quality of life (HRQL) outcomes. What is not established is whether treatment strategies shown to improve outcomes for depression in primary care are effective in patients with comorbid pain and depression. Therefore, we propose to conduct the Stepped Care for Affective disorders and Musculoskeletal Pain (SCAMP) study, designed as a randomized clinical trial nested within a prospective cohort study. SCAMP will enroll 500 patients with musculoskeletal pain of the low back, hip or knee. Of these, half will have clinically significant depression and half will be nondepressed. The 250 depressed patients will be randomized to either stepped care or usual care. The stepped care group will receive 12 weeks of guideline concordant antidepressant treatment (step 1) administered by a Depression Pain Clinical Specialist (DPCS) nurse case manager. Patients not achieving adequate pain or global improvement after 12 weeks will receive a series of 6 manualized, evidence-based pain self-management sessions (step 2) from the DPCS. The 250 depressed patients in the trial will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group, and the 250 nondepressed patients in the cohort will undergo a similar assessment at baseline, 3 and 12 months. Our principal aim is to test whether stepped care is more effective than usual care in improving the co-primary outcomes of depression and pain. Secondarily, we will test the intervention's impact on HRQL, pain beliefs and behaviors, and health care costs. Longitudinal assessment of the nondepressed cohort will establish the frequency and risk factors for incident depression.

DESCRIPTION (provided by applicant): In October 2000, Indiana University was awarded a K-30 grant which helped fund the development and implementation of a university-wide Clinical Investigator Training Enhancement (CITE) Program. In just 3 years, the CITE Program has been remarkably successful, leading to: a new 30-credit Master of Science in Clinical Research degree; three new graduate courses; a structured mentoring program with a formal Advisory Committee for each trainee and explicit benchmarks; recruitment of 40 research fellows and junior faculty from over 20 disciplines who devote 50-70% of their time to the CITE program for an average of 2-3 years; a diverse program with 48% women and 10% underrepresented minority trainees; a 77% increase in the number of clinical researchers appointed as faculty in the university Graduate School; 27 faculty scientists serving as primary mentors for our CITE trainees and 38 serving on CITE Advisory Committees; submission of 24 new patient-oriented research career award applications (18 K-23, 6 other), of which 12 are already funded; and substantial productivity by CITE trainees as measured by papers, grants, and honors. Renewed funding is important not only to sustain the momentum of the young and still-evolving CITE program but also to support a number of important new initiatives that include: 1. Developing a Certificate in Clinical Research as a companion to the M.S. degree; 2. Enhancing recruitment of postdoctoral trainees from 7 disciplines (surgery, psychology, pharmacy, nutrition, dentistry, nursing, physical therapy); 3. Facilitating interdisciplinary training through a new Multidisciplinary Research Training Task Force; 4. Creating, implementing and evaluating at least 3 new specialty electives for the MS degree; 5. Recruiting and training additional faculty mentors (especially from new disciplines); 6. Supporting career development through a K-23 support group and assistance in K-24 applications; 7. Partnering with faculty at Purdue and Indiana University campuses at Lafayette and Bloomington. These 7 new initiatives coupled with furthering the maturation of programs still in development will continue the acceleration in clinical research training and funding that has been fueled by our K-30 award.

DESCRIPTION (provided by applicant): Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20-30% of oncology patients. Both symptoms, however, frequently go either unrecognized and/or under-treated. Four common harriers include underdetection, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Nurse-delivered care management models proven effective for depression in primary care have considerable potential for optimizing both depression and pain care in cancer patients. Therefore, we propose to conduct the Indiana Cancer Pain and Depression (INCPAD) study, a randomized clinical trial conducted in a statewide network of community-based cancer clinics located in both rural and urban oncology practices. INCPAD will enroll 480 patients with cancer-related pain (n = 240) or clinical depression (n = 240), randomizing them to either the intervention or usual care control group. The intervention will be based upon the empirically-validated Three-Component Model (TCM) which for INCPAD will involve collaboration between the oncology practice, a centralized nurse care manager, and a supervising pain-psychiatrist. In this trial, TCM will involve an innovative telemedicine approach involving automated home-based symptom monitoring coupled with telephone-based nurse care management. All subjects will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. Our principal aim is to test whether TCM is more effective than usual care in improving the co-primary outcomes of depression and pain. Secondarily, we will test the intervention's impact on health-related quality of life, cost-effectiveness of care, and treatment satisfaction. This intervention has the potential for improving symptom management in cancer patients across a wide range of oncology practices that may be geographically dispersed and varying in location (rural or urban), health plan, payer, or other characteristics. Furthermore, if proven effective for depression and pain, TCM could readily be expanded to reducing barriers and improving care of other cancer-related symptoms.

This application proposes the Indiana Emergency Care Research training program (Indiana EMCARE) at the Indiana University School of Medicine (IUSM), currently the nation's largest allopathic medical school. As a unique identifier, Indiana EMCARE will offer specific expertise in training scholars to conduct clinical trials. For the scholars, the clinical trials focus will provide skill to address a critical gap in knowledge translation, but will accommodate and facilitate virtually any intrinsic clinical interest held by scholars. Clinical trials can include a wide range of topics from early phase, translational trials with emphasis in technology transfer, to single center studies of device diagnostic accuracy, to multicenter randomized controlled treatment trials. This focus will be driven by the manifest clinical trial expertise of both co-principle investigators, one from emergency medicine (Jeffrey Kline MD) and the other from internal medicine (Kurt Kroenke MD). Dr. Kline brings decades of experience training 12 research fellows in emergency medicine, and continuous NIH or AHRQ funding as PI since 2003. Dr. Kroenke brings decades of experience as PI on multiple training grants, including a T32, KL2, R25 and K30 awards. Dr. Kroenke will direct the coursework portion of Indiana EMCARE, known as the Career development, Education, and Research Training, or CERT program, which grants a Master of Science in Clinical Research. To be responsive to the published request for applications, Indiana EMCARE leadership that includes a program director from emergency medicine (Kline) and psychiatry (Alexander Niculescu, MD PhD) with mentorship and tangible commitment from the School of Nursing. Scholars can choose from 15 clinician-researchers who represent 10 disciplines, including emergency medicine, cardiology, pulmonology, psychiatry, rehabilitative medicine, and nursing. The program will seek and recruit the true rising stars in the field, with a plan to enhance diversity, evidenced already by the list of potential scholars in waiting. Oversight is provided by an internal committee comprising five senior leaders, all of whom have at minimum, directed a T32 program and three external advisors with R01 funding and collective expertise in emergency medicine and psychiatry. The program will incorporate bidirectional evaluation of the scholars, their mentors and the PDs, as well as evaluation of the program by the advisory committees.  Each scholar must produce a manuscript submitted for peer review and write a first draft of a K23 application (or, depending upon the particular trainee, another relevant NIH application such as an R21).

I. INSTITUTIONAL CAREER DEVELOPMENT CORE (KL2) SUMMARY/ABSTRACT The Indiana Clinical and Translational Sciences Institute (CTSI) has a sustained record of accomplishment of training KL2 Scholars through its Career development, Education and Research Training (CERT) Program. Notably, CERT has trained 47 KL2 Scholars, with most retained in academic positions (92%), spending a median of 75% of their time in research, being promoted to Associate Professor (43%), and obtaining external funding as principal investigators (95%) including 14 R01s, 7 other R-level awards and 15 K or equivalent career awards. These 47 Scholars have come from 29 different disciplines, have been diverse in terms of gender (46% women) and race/ethnicity (15% underrepresented minorities), and are nicely distributed across the spectrum of T1 through T4 research. An additional strength is the fact that our Scholars are recruited from the 3 major research universities in the state: Indiana University, Purdue University, and the University of Notre Dame. This expands the pool or Scholars, faculty mentors, and breadth of translational research. In this application, we propose a number of new and innovative training initiatives that build upon our foundational programs. We designed the four specific aims of the KL2 Career Development Core Program to maximize its impact on the training and career development of clinical and translational scientists at an institutional, regional, and national level. 1) Increase the flexibility and reach of our foundational programs for personalize research training and accelerate mentored-to-independent investigator (K to R) status. 2) Add training in areas where our CERT program has unique strengths as well as gaps. Key domains include implementation, community-engagement, regulatory affairs, and population health. 3) Develop research training in 3 new areas: team science, entrepreneurship, and experiential learning. 4) Test innovative training approaches through research and national collaborations. We employ the continuous innovation cycle of ?4Ds? in all of our CTSI activities: Design, Demonstrate, Duplicate, and Disseminate. We also plan innovative initiatives that can serve as model programs for dissemination more broadly. These include a) peer and community mentoring programs to complement our already robust faculty-mentoring program: b) an inter-CTSA KL2 Scholar exchange program; c) an I-Corps training course that serve regional CTSA programs; d) national coordination of an on-line CTSA-industry training program in drug development conducted in collaboration with Lilly, our founding industry partner. We are optimizing program evaluation utilizing NCATS common metrics augmented with novel metrics. We are enhancing recruitment and retention of underrepresent minority scientists, and offering a new course in translational research ethics.