Exploring the Unmeasured Risk and Treating the Untreated Prognostic Factor: Towards Candidate Optimization in Heart and Lung Transplant

PROJECT SUMMARY/ABSTRACT Candidate: Dr. Cassie C. Kennedy is an optimal candidate for this award, possessing a commitment to patient-oriented research, a focused goal for her future research career, a background and attributes that assure success, and a compelling rationale for further training. Dr. Kennedy is a pulmonologist specializing in the care of transplant patients, with a background of outstanding clinical training in Internal Medicine, Pulmonary and Critical Care, and lung transplant at Mayo Clinic. Her prior research experience includes basic science training in infection and immunology (Dr. Limper), Certificate in Clinical and Translational Science, systematic review/meta-analysis (Drs. Cook and Montori), secondary data analysis (Drs. Gajic and Benzo), and retrospective cohort studies. Dr. Kennedy lacks training and experience in qualitative, quantitative, and behavioral intervention methodologies, all essential skills in clinical research. Dr. Kennedy has demonstrated research productivity with 30 published or in press manuscripts (16 first/senior author; 21 original research manuscripts) and success obtaining 10 internal funding awards. She has completed prior research characterizing the risks of obesity, frailty, and psychosocial factors in endstage lung disease and pre-lung transplant patients. Dr. Kennedy is highly committed to her long-term goal to become a leader in the field of pretransplant risk factor identification and optimization, focusing on behavioral intervention. Her short-term goal is to enhance her knowledge and become proficient in qualitative, quantitative, and behavioral intervention research methods. This knowledge and experience will strengthen her skills and competitiveness for an independent clinical research career. During the award period, she will focus on three objectives of advanced learning 1) the fundamentals of qualitative research, 2) the fundamentals of quantitative research, and 3) the fundamentals of behavioral intervention studies. Dr. Kennedy will complete these learning objectives through formal coursework and workshops, mentored skills training, and practical research experience in leading and conducting the proposed research. Environment: Mayo Clinic has a comprehensive research infrastructure, wealth of opportunity for scholarly exchange, and a proven record of dedication to research and the training of junior investigators. Mayo is highly supportive of Dr. Kennedy's development as an investigator and provides the following: ?75% protected research time; >$75,000 in start-up funds; travel, publication, and tuition resources; and adequate protected time for her mentors. Her sponsor, Dr. Roberto Benzo, is a recognized expert in self-management of chronic disease and behavioral intervention research. Dr. Benzo's research is perfectly aligned with the proposed research and career development plan of the candidate. The mentor and co-mentors are well-funded, expert investigators with proven mentoring success. All co-mentors have pre-established mentoring or collaborative relationships with the candidate. An Advisory Committee of mentors and other key multidisciplinary experts will oversee the candidate's progress, meeting on a quarterly basis for the duration of the award. Research: The candidate's proposed research is novel and fulfills a critical need. Currently, transplant providers predict potential transplant candidates' future ability to adhere to complex medical regimens by subjective assessment. These subjective opinions carry substantial weight in practice guidelines as a criterion for both heart and lung transplant. We propose measuring self-management ability as an alternative to subjective assessment, as self-management is known to predict medical adherence. Not only can self- management ability be measured, it can be improved through health coaching intervention. Through our preliminary data and review of the literature we identified patient factors (such as resilience, coping with uncertainty of illness, positive versus negative affect, and lack of frailty) associated with improved self- management. If our hypothesis is correct, these factors are attractive targets for health coaching intervention to improve self-management and thereby adherence. To test these hypotheses we will conduct three lines of research investigation: qualitative assessment of self-management in Aim 1 to identify patient factors that promote self-management in pre-transplant patients from the key stakeholders' perspectives; quantitative assessment of self-management in Aim 2 to determine the association of measurable patient factors in pre- transplant candidates with self-management; and a targeted intervention to improve self-management in Aim 3 to test whether transplant candidates who receive pre-transplant health coaching (informed by triangulation of Aims 1 and 2 results) have greater improvement in self-management abilities. Potential Contribution: This work will make several important contributions. It will improve the understanding of self-management in heart and lung transplant patients. It will assess the importance of patient factors such as frailty, resilience, uncertainty of illness, and positive versus negative affect to self-management in thoracic transplant patients. Finally, it will provide a potential avenue to improve self-management in the pre-transplant period. These contributions may improve transplant candidate selection, risk factors, and ultimately outcomes. Support of the NIH Mission: The proposal supports the NIH mission by striving to improve transplant outcomes in heart and lung disease patients while training a junior investigator in essential skills (quantitative, qualitative, and trial methods) necessary for her to transition to research independence.