Clinicaltranslational research in the new era: the LUCHAR project

1
Clinical-translational research in the new era
the LUCHAR project

• John Steiner, MD, MPH (UCD)
• Edward Havranek, MD
• (Denver Health)
• Supported by NHLBI 1 U01 HL079208

2
Latinos Using Cardio Health Actions to Reduce
Risk (LUCHAR)

• Funded as 5-year cooperative agreement between
  Colorado Health Outcomes Program (COHO), DH
  through NHLBI RFA in October, 2004 (3.9 million
  direct costs)
• RFA intended to establish partnerships between
  academic and minority-serving institutions to
  reduce CVD health disparities
• 6 sites nationally ours the only site focused
  on Latinos

3
LUCHAR Investigators(partial list)

• UCDHSC/COHO
• John Steiner, MD, MPH (health services research)
• Sheana Bull, PhD (behavioral science, health
  disparities)
• Miriam Dickinson, PhD (biostatistics)
• Patrick Sullivan, PhD (health economics)
• Doug Fernald, MA (qualitative methods)
• DH
• Ed Havranek MD, Fred Masoudi MD, Mori Krantz, MD
  (cardiology)
• Carlin Long, MD, PhD (cardiology, inflammatory
  markers)
• Ray Estacio, MD (clinical trials)
• Rick Padilla, MD, Becky Hanratty, MD, Tom
  MacKenzie, MD, MSPH, Laura Hurley, MD (primary
  care)
• Art Davidson, MD, MSPH (informatics)

4
LUCHAR Specific Aims -1

• PPG of R21-sized pilot studies
• Aim 1 Develop/test interactive, computer-based
  CVD risk assessment and behavioral goal-setting
  program for Hispanics in the community
• Aim 2 Develop a hypertension registry to assess
  biomedical and behavioral risk factors for
  uncontrolled hypertension, and test an
  intervention to improve BP control

5
LUCHAR Specific Aims - 2

• Aim 3 Assess relationship between traditional
  CVD risk factors and pre-clinical CVD markers in
  bi-ethnic patient sample
• Aim 4 Assess additional contribution of
  pro-inflammatory markers to traditional CVD risk
  factors in prediction of pre-clinical CVD

6
LUCHAR Specific Aims - 3

• Aim 5 Develop a curriculum in culturally
  proficient research
• Aim 6 Maintain an interdisciplinary career
  development program in CVD prevention and health
  disparities at DH
• Aim 7 Develop a registry of individuals with
  impaired renal function at DH
• Aim 8 Evaluate system-wide QI strategies for
  hypertension within DH

7
Clinical-translational vision of LUCHAR

• Interdisciplinary and inter-institutional
  research team
• Combination of discovery translation (bench to
  bedside Aims 3,4), community translation
  (bedside to community Aims 1,2) research, and
  education in clinical-translational research
  (Aims 5,6)
• Embedded in live delivery system emphasis on
  practical and sustainable interventions for a
  defined population

8
Community Aim 1
Mechanisms Aims 3,4
Delivery system Aim 2
Training, Cultural Issues Aims 5,6
9
Natural Resources at DH

• Integrated delivery system (public health,
  primary care, specialty care)
• Well-developed IT infrastructure
• Registration data
• Encounter data (site, type, ICD-9 codes)
• Complete pharmacy data (on large subset)
• Lab data
• Some clinical data (BMI, BP) for last 2 yrs.
• Multi-racial/ethnic population
• Organizational culture of quality improvement

10
Aim 1 Develop a bilingual, interactive, behavior
assessment/goal-setting tool for community use
11
(No Transcript)
12
(No Transcript)
13
(No Transcript)
14
(No Transcript)
15
Aim 1 Design

• Focus groups to assist in development of program,
  extensive user testing
• Recruitment of 200 Latino community members, half
  English-speaking, half Spanish-speaking, from 5
  community sites in Denver (churches, community
  centers, restaurant)
• Computerized assessment of CVD risk, behavioral
  goals for physical activity/nutrition/smoking at
  baseline
• 2-month follow-up by telephone interactive voice
  response (IVR) to assess adherence to behavioral
  goals (81 retention)

16
Recruitment

• 285 invited to do survey
• 284 screened
• 230 eligible
• 130 scheduled an appointment to do the survey
• 200 completed the survey

17
Participant Characteristics
18
Findings Goal setting

• Nutrition (63)
• Managing snack foods
• Portion control
• Physical Activity (31)
• 82 chose a moderate activity such as walking
• Smoking (7)
• Cut down cigarettes
• Prepare to quit
• Set quit date

19
Outcomes Nutrition

• How many servings of fruit or vegetables do you
  eat each day?
• Significant increase in 5 or more servings/day
  to 25 from 14
• Significant decrease in 2 or less servings/day
  to 46 from 56
• p.03

20
Outcomes Perception of Meeting Recommended
Guidelines for PA

• About what is recommended increased to 49 from
  34
• Less than recommended significantly decreased
  to 40 from 52
• p.04

21
Aim 1 next steps

• Community-based recruitment and retention of a
  bilingual sample are feasible
• Digital divide can be overcome with assistance
  from project staff
• Refine program and administer to 100 Latino
  patients at DH outpatient clinics (higher CVD
  risk)
• R18 for RCT (community or clinic-based)
  planned submission 1/08

22
Aim 2 Identification of HTN and comorbid
conditions

• Medical record review of 1169 patients at DH to
  assess accuracy of ICD-9 codes for hypertension,
  CVD and risk factors, and important comorbidities
  (e.g. substance use, mental health diagnoses)
• Building registry using best ICD-9 based
  algorithm to identify hypertensives
• Focus groups to identify barriers to BP control
  among white, Latino, and African-American
  hypertensives at DH
• Conducting small RCT at East Side clinic of a
  navigator to improve care for uncontrolled
  hypertensives

23
Comparison of electronic data to chart review for
presence of HTN
24
Electronic case-finding for other conditions
(compared to chart review)
25
Chart review findings - 3
26
DH Hypertension Registry

• N 35,561 patients (2000-2006)
• 23 AA, 44 Latino, 28 white
• 46 have BP values (since 2005 only)
• Last SBP/DBP 137/80
• Mean BMI 31.1
• Examples of analyses
• Predictors of adherence (visits, med)
• Impact of race, ethnicity and acculturation on BP
  control
• Relationship between mental health, substance
  use, and BP control.

27
Aims 3-4

• Recruitment of 100 white, 100 Latino
  hypertensives without clinical CVD
• Baseline measurement of traditional CVD risk
  factors (BP, lipids, A1C, insulin, smoking)
• Baseline measurement of pre-clinical markers
  (EKG/LVH, echo/LVH, BAR, CIMT)
• Baseline measurement of inflammatory markers
  (hs-CRP, LP-PLA2, adiponectin, Somologics panel)
• 1-year follow-up

28
Aims 3-4 - Goals

• Compare traditional, pre-clinical, inflammatory
  markers between white/Latino subjects
• Assess ethnic differences in changes in
  traditional risk factors and novel risk factors
  over 1 year
• Begin to assess Hispanic paradox of lower CVD
  rate despite higher risk factors

29
Aims 3-4 Recruitment (N first 92 of 200)

• 89 Latino, 40 Spanish-speaking
• Hyperlipidemia (25), diabetes (44),
  current/former smoker (59)
• BMI 32.5 5.9
• Mean BP 142/81, total cholesterol 177, LDL 91
• 16/17 eligible for 1-year follow-up have been
  re-studied

30
Collateral benefits of LUCHAR

• Career development awards Pam Peterson (AHA),
  Ro Pereira (K08)
• Implementation grants CDPHE grants to Chris
  Urbina/Ray Estacio, Pam Peterson/Fred Masoudi
• New grant applications
• R01 (Irene Blair, Boulder) on relationship of
  physician implicit stereotypes to quality of HTN
  care for minorities
• R21 (Ed Havranek) to pilot test self-empowerment
  intervention to help minorities overcome
  communication problems leading to disparities
• New curriculum in cultural proficiency in
  research
• 7 submitted/published papers to date

31
Clinical-Translational Science Institute (CTSI)

• NIH traditionally supported clinical research
  infrastructure through GCRCs
• CTSA initiative arose in response to perception
  that massive investment in biomedical research
  has not led to expected improvements in public
  health
• GCRCs to be replaced by CTSI

32
Changes in clinical research infrastructure
through CTSI

• Preserving the endangered species of C-T
  researchers
• Focus on interdisciplinary research teams
• New emphasis on step 2 translational research
• Tighter linkage of education, career development
  to research infrastructure
• New institutional programs for predoctoral
  students (T32) and career development (K12)

33
Implications of LUCHAR for CTSI

• Interdisciplinary research teams can work
• Education/training can be incorporated into
  community-based research
• Research initiative can include step 1 and
  step 2 translational studies
• Community-based research is feasible and
  efficient, given adequate institutional buy-in
  and IT infrastructure