Principal Investigator: Catarina I. Kiefe, PhD, MD Dept of Quantitative Health Sciences (QHS)

1. Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE) Principal Investigator: Catarina I. Kiefe, PhD, MD Dept of Quantitative Health Sciences (QHS) Funded by the National Heart, Lung, and Blood Institute, Grant # U01HL105268

2. Action Transitions of Care Scores Project Project ESI Development and Training Longitudinal Cohort TRACE )

3. Macon site • PI, David Parish, MD, MPH • Local Faculty Investigators • Randolph Devereaux, PhD, MSPH • Hamza Awad, MD, PhD • Ahmed Shah, MD • Staff • Suzie Lamarca, MPH • ChiChiNwankwo, MD, MPH • MPH students and Summer Scholars

4. HAS 4 AIMS: Recruit and follow 2,500 patients hospitalized for ACS in 6 hospitals inMA and GA Cohort Transitions Project Examine transitions from hospital to community testing hypotheses relating transition quality, HRQOL, cognition, and racial disparities Action Scores Project Develop and validate scores that predict cardiac events and HRQOL and emphasize actionable risk factors Early Stage Investigators Develop careers in CVD outcomes research for 4 ESIs

5. The Transitions Project uses data from baseline, 1, and 3 month follow-ups, medical records, claims, and GIS to test hypotheses.

6. CVD risk scores abound but are limited in patient-centeredness and in disentangling modifiable from immutable predictors of CVD health.

7. The Action Scores Project will test hypotheses AND produce a usable tool (dashboard) to prompt beneficial actions by the patient-provider dyad.

8. TRACE Cohort includes a diverse group of patients hospitalized with ACS (N= 1,928).

9. Recruitment goals at 6 hospitals in 2 states are being met through hard work and creative adaptation; 1/3 to 3/4 of eligible patients are consenting.

10. Patient-Reported Data + Chart and Other Data 24 Months Follow-up Baseline CAPI Interview (~ 60 minutes) • Follow-up CATI Interviews • 1 month • 3 months • 6 months • 12 months • 30 - 45 minutes each Medical Record Reviews TRACE-CORE Data • Claims data • GIS data Blood Samples (1 site)

11. 1, 3, 6, and 12 month telephone follow-ups are underway. Overall 86% of all eligible patients have completed at least one follow-up interview

12. We created two site-specific protocols for follow-up at each site • Standard follow-up as currently followed by Office of Survey Research • Intensive follow-up protocol directly by central TRACE-CORE office or at the site-level in Macon, including staff with higher educational levels, access to medical records, access to clinics, and more intensive follow-up contact.

13. We use different data-driven cut-offs to triage to high-intensity protocol. UMass Site: Macon Site: At the UMass site, we used a cut-off so that 25% would fall into the more intensive follow-up; in Macon, we wanted 33% to have more intensive follow-up.

14. Is it working? – UMass Site Additionally, we have “recaptured” 23 individuals at the UMass site that we considered to be lost to follow-up (non-completion of two or more consecutive follow-ups)

15. Is it working? – Macon site • Too early to tell – process started on October 8, 2012 but was slow to start. • Early data suggest success: 1-mo completion rates are currently 67% at the site-level compared to a previous overall rate at that site of 58%.

16. As of 11/20/12, TRACE-CORE has • 8 poster/oral presentations: AHA Epi Council, ISOQOL, HMO Research Network, QCOR, Gerontological Society of America (2 oral) (Parish, 2) • Design paper published in Circ: Outcomes (Devereaux) • 28 acknowledgments in published papers (including 1 NEJM and 2 JAMA); 6 paper proposals approved and in progress (Awad) • 2 ESIs funded: NHLBI R21 ancillary to TRACE-CORE, and CTSA KL2; Other 2 ESIs applied for NIH funding (R01 and K01) • 2 doctoral theses proposed using TRACE-CORE data • TRACE-CORE data and phenotype part of NIH UH2/UH3 proposal submitted 11/12 • Role of extracellular microRNAs as biomarkers for CVD

17. Our plans for the next year are to: Complete enrollment/baseline interview 4/13 Continue efforts to increase follow-up rates PCORI application based on TRACE-CORE 4/13(Devereaux, Parish, Awad) R01 based on TRACE-CORE 10/13 Submit to journals 5 – 10 papers based on baseline & 1 month follow-up by 12/13 Submit high-profile transitions paper(s) 10/13 Continue ESI development

18. Examples of early TRACE-CORE findings on ACS: • Cognitive Impairment • Quality of transition and QOL • Physicians recommend lifestyle changes to only a fraction of those who would benefit • Depression but not anxiety or perceived stress are related to angina frequency, physical functioning and QOL at 1 month • Modest agreement between self-report and medical record on health care proxies (k=0.42)

19. About 1/3 of patients hospitalized with ACS have Cognitive Impairment, i.e. TICS≤ 30 (N=1,730). Correlates are:

20. TRACE-CORE is well positioned to study cognitive trajectories and their determinants • Of the 284 patients who were impaired at baseline, 224 (79%) were no longer impaired 1-month after hospital discharge • Of the 831 not impaired at baseline, 47 (6%) were impaired 1 month later

21. MUSM site challenges and adaptation • No team existed when we submitted the grant • Study elements all developed specifically for the study, difficulties with chart reviews, recruitment and retention • Macon site contributed to solving problems in each area • New team members as students graduate

22. Building research capacity at MUSM • Establishing ourselves through collaboration with well-respected researchers and institution • Contributing conceptually and operationally • Identifying strengths/weaknesses, key personnel, policies, sources of data at MCCG and other MUSM departments • Identifying and overcoming issues with Grants and Contracts and developing collaboration between the staff at the two institutions • Establishing a good source of research assistants • Engaging other basic science and clinical faculty as collaborators and consultants • Developing close relationship with IRBs at MU and MCCG • Developing a database that can be used by other MUSM faculty and students

23. QUESTIONS ?????

24. p-value = 0.001

25. Care transition quality is directly associated with mental component score of SF-36 (N=748).

27. Lack of behavioral intentions and low confidence to make lifestyle changes may be important targets for intervention post-ACS (N=605).