Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE)

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

Funded by the National Heart, Lung, and Blood Institute, Grant # U01HL105268

)Transitions of CareProject

ActionScores Project

Longitudinal TRACE Cohort

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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– ChiChi Nwankwo, MD, MPH– MPH students and Summer Scholars

4

Recruit and follow 2,500 patients hospitalized for ACS in 6 hospitals in MA and GA

HAS 4 AIMS:

Develop and validate scores that predict cardiac events and HRQOL and emphasize actionable risk factors

Develop careers in CVD outcomes research for 4 ESIs

Examine transitions from hospital to community testing hypotheses relating transition quality, HRQOL, cognition, and racial disparities

Transitions Project

Cohort

Action Scores Project

Early Stage Investigators

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

H1: Better transition quality is associated with improved post-discharge health-related quality of life.

H2: Better transition quality is associated with longer time to first Emergency Department visit or readmission.

H3: Patients who are potentially vulnerable due to (a) race/ethnicity, (b) socioeconomic status, (c) total morbidity burden, or (d) cognitive status will have worse transition quality.

H4: Transition quality partially mediates observed disparities in outcomes for vulnerable patients.

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

Action scores have diverse outcomes• Recurrent ACS and mortality • Health-related quality of life

Action scores emphasize modifiable predictors• Medication adherence• Physician medication intensification• BP and lipid control, depression, diet, exercise, smoking, weight

Action scores include socioeconomic predictors • Income, education, health insurance, access to care • Social support• Neighborhood characteristics

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

H5: Observed health disparities for vulnerable populations would be reduced if actions identified by the Action Scores were taken by patients and providers.

Dashboard (control panel) for CVD Action• Uses only modifiable predictors from risk scores • Blueprint of a future tailored measurement system• Summarizes complex data to improve care

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

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33%

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Age < 62 yrs Women Non-Whites Latino

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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.

Site Goal Start date

Accrual Through

11/17/2012Worcester, MA (3 hospitals) 1,342 4/2011 1,083

Macon, GA (1 hospital) 875 4/2011 714

Atlanta, GA (2 hospitals) 286 9/2011 118

Total 2,503 1,928

Patient-Reported Data + Chart and Other Data 24 Months Follow-up

TRACE-CORE Data

Baseline CAPI Interview (~ 60 minutes)

Follow-up CATI Interviews• 1 month• 3 months• 6 months• 12 months30 - 45 minutes each

Medical Record Reviews

• Claims data• GIS data

Blood Samples(1 site)

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

Follow-up interview completed as of 11/17/12: N(% of eligible)

Site 1 month 3 months 6 months 12 months

Worcester, MA 781(78%) 611(69%) 494(69%) 292(66%)

Macon, GA 373(58%) 289(52%) 221(52%) 98(47%)

Atlanta, GA 50(58%) 40(53%) 34(59%) 10(71%)

Total 1,210(70%) 949(62 %) 757(63%) 400(60%)

We created two site-specific protocols for follow-up at each site

1. Standard follow-up as currently followed by Office of Survey Research

2. 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.

We use different data-driven cut-offs to triage to high-intensity protocol.

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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.

Is it working? – UMass Site

Before New Process 8/27-11/15N=97

Completion Rates (1-month)

Completion Rates (1-month)

Overall rate 77.7% 82.5%

Above threshold (new intensive protocol)

67.6% 93.1%

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)

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%.

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

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

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)

About 1/3 of patients hospitalized with ACS have Cognitive Impairment, i.e. TICS≤ 30 (N=1,730). Correlates are: Characteristic Odds Ratio (95% CI)Age 1.02 (1.01, 1.03)Education, > HS 0.6 (0.5, 0.8)Race, White 0.7 (0.5, 0.9)Anxiety 1.1 (0.8, 1.4)Depression 0.9 (0.7, 1.2)Stress 1.0 (0.9, 1.1)Vision Impairment 1.0 (0.9, 1.1)Hearing Impairment 1.1 (0.9, 1.4)Caregiving Support 1.3 (0.9, 1.8)SF-36 Mental Domain 0.98 (0.97, 0.99)SF-36 Physical Domain 0.97 (0.96, 0.98)

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

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

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

QUESTIONS ?????

p-value = 0.001

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

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