Bypassing the Blues:A Study to Improve the Quality of Life

Following Cardiac Bypass Surgery

Bruce L. Rollman, M.D., M.P.H.Associate Professor of Medicine and Psychiatry

Charles F. Reynolds, M.D.Professor of Geriatric Psychiatry and Neuroscience

Bea Herbeck Belnap, Dr. Biol. Hum.Senior Research Associate

University of Pittsburgh School of Medicine

All work supported by R01 HL70000

Depression

• Affects 16-35% of patients with CVD

• Mortality associated with post-MI depression

greater than any medical predictor of risk

• Seldom diagnosed and treated in cardiac patients

• Failure to recognize is a failure to provide the best

care for our patients

Rumsfeld JS. Circulation 2005; 111:250-253

Will Treatment for Depression Improve

CAD Outcomes?

Montreal Heart Attack Readjustment Trial (M-HART)Frasure-Smith N. Lancet 1997; 350:473

ENRICHDJAMA 2003; 289:3106-16

SADHARTGlassman AH, et al. JAMA 2002; 288:701-709

CREATELesperance F, et al. JAMA 2008; 297:367-379

Prior Treatment Trials

Issues with Prior Trials• Single antidepressant agent

• Inadequate treatment adherence

• Treatment preference(s) not accounted for

• PCP not included as a partner

• Generalizability of screening

• Short follow-up

• Impact of depression treatment on HRQoL,

health services utilization, employment, and

economic outcomes not assessed

• Study power

Wagner Chronic Care Model

www.improvingchroniccare.org

Meta-Analysis of Collaborative Care on 6-Month

Depression Outcomes by Source

Gilbody S. Arch Intern Med 2006;166:2314-2321

To examine if treating post-CABG depression will

improve HRQoL and functional status, decrease

cardiovascular morbidity and health care costs

To study the effect of depression and our

intervention on subgroups defined by age, gender,

race, and co-morbid illness

To identify predictors for post-CABG depression

Bypassing the BluesObjectives

Bypassing the BluesStudy Design

Blinded Assessments

Assessment Instruments:

Month:

0

inpatient

0.5 2 4 8 12 Every 6

Months

Sociodemographic Characteristics

Health-Related Quality of Life

1) MOS SF-36 (MCS/PCS)

2) Duke Activity Status Index (DASI)

Psychiatric Symptoms

1) Patient Health Questionnaire (PHQ)

2) Depression Interview and Structured Hamilton (DISH)

3) PRIME-MD PQ-Anxiety Module/HRS-A

Medical Co-Morbidity/Biologic/Physiologic Variables

1) Medical/Surgical History

2) Biologic/Physiologic measures

3) Cardiovascular morbidity

Recovery Modifiers

1) Perceived Social Support Scale (PSSS)

2) MOS Specific Adherence Scale for Cardiac Patients

3) LOT Optimism

4) WHO Work Survey

5) Insurance status

Health Care Costs

1) Health Care Utilization

8 Pittsburgh-Area

Study Hospitals

Jefferson Regional

Mercy Hospital

UPMC-Passavant

UPMC-Presbyterian

UPMC-Shadyside

VA Medical Center

Westmoreland Regional

West Penn Hospital

Tablet PC

Patient Health Questionnaire

(PHQ-2)

In the past two weeks, have you had:

• Little interest or pleasure doing things?

• Feeling down, depressed, or hopeless?

PHQ-2Major Depression

Sensitivity Specificity

Primary care patientsPast 2 weeks,

≥1 vs. 0

Kroenke K. Med Care 2003; 41:1284

98% 59%

Cardiac patientsPast month,

≥1 vs. 0

McManus D. Am J Cardiol 2005; 9:1076

90% 69%

PHQ-9

Kroenke K. J Gen Intern Med 2001; 16:606-13

PHQ-9Major Depression

Sensitivity Specificity

Primary care patients

Past 2 weeks, ≥10 vs. <10

Kroenke K. J Gen Intern Med 2001;16:606

88% 88%

Cardiac patients

Past 2 weeks, ≥10 vs. <10

McManus D. Am J Cardiol 2005; 9:1076

54% 90%

Screening Summary

Approached Post-CABG 3,058

PHQ-2 Completed 2,486 (81%)

PHQ-2 (+) Screen 1,387 (56%)

Protocol-Elig./Consented 1,268 (91%)

PHQ-9 Completed (2-wk f/u) 1,100 (87%)

PHQ-9≥10 337 (31%)

Randomized 302 (90%)

Screening by Gender

Overall Male Female

PHQ-2 (+) 56% 53% 62%

PHQ-9 ≥10 31% 27% 38%

Baseline SociodemographicsDepressed

N=302Non-DepN=151

P

Age, mean 64 66 .04

Male 59% 63% .38

Caucasian 90% 80% .002

Marital statusSingleMarriedSep/Div/Widowed

7%

68%

25%

7%

69%

24%

.97

Working 38% 42% .45

Clinical Characteristics

DepressedN=302

Non-DepN=151

P

Hypertension 81% 78% .41

Diabetes 42% 38% .38

Smoked, past year 28% 14% .002

Hyperlipidemia 78% 71% .09

MI, prior 43% 42% .84

CHF 19% 18% .73

COPD 20% 9% .003

EF, mean 51% 50% .84

Baseline Mental Health

DepressedN=302

Non-DepN=151

P

PHQ-9 (SD) 13.5 (3.4) 1.9 (1.4) <.001

DISH (SD) 16.2 (7.0) 3.5 (2.8) <.001

SF-36 MCS (SD) 43.1 (11.4) 61.6 (6.1) <.001

SF-36 PCS (SD) 30.3 (6.8) 37.2 (7.5) <.001

Hx of Depression 40% 5% <.001

On SSRI/SNRI 22% 0% <.001

Bypassing the Blues

Implementing the

Chronic Care Model

Wagner Chronic Care Model

www.improvingchroniccare.org

Bypassing the BluesPatient Intervention

• Informed of randomization/control status

• Given brochure on depression and heart disease

• Care manager phones at regular intervals X 8 mo. to:

– Provide basic psychoeducation

– Assess treatment preferences • Coach with self-management workbook

• Promote adherence/adjust pharmacotherapy

• Facilitate MHS referral when appropriate

– Monitor treatment response

Bypassing the BluesPCP Intervention

• Informed of patient’s randomization status

• Provided guidance re: pharmacotherapy

• Can initiate, adjust, or discontinue meds as

indicated

• Provided feedback re: pt.’s symptoms and progress

• Offered assistance referring patient to a MHS

• Informed of patient’s status at end of intervention

Quality ControlDigital Audiotape Monitoring

Bypassing the Blues

Case Review Registry