The Bypassing the Blues Trial: Telephone-Delivered Collaborative Care for Treating Post-CABG Depression www.bypassingtheblues.pitt.edu Bruce L. Rollman, MD, MPH Professor of Medicine, Psychiatry, and Clinical and Translational Science Center for Research on Health Care University of Pittsburgh School of Medicine
Where is Pittsburgh?
JAMA November 18, 2009 Telephone treatment of post-cabg depression can speed recovery and may reduce rehospitalizations
11 Years Effort 3/98: First thoughts of depression and CVD 7/98: Submitted proposal to American Heart Assoc. 9/98: AHA rejects application; start raising pilot $ 1999-2001: Conduct CABS pilot work 6/01: R01 submitted to NHLBI; 10/01 unscored 7/02: R01 resubmitted; 7/03 funded 3/04: Commence recruitment 6/08: Complete 8-month f/u; open study blind 3/09: First presentation (American Psychosomatic Society) 11/09: JAMA publication
So it began, one day.... March 1998
Depression and Cardiac Disease Depression: Affects up to 50% of cardiac patients Doubles mortality risk Reduces health-related quality of life Often unrecognized and untreated
Does Depression Treatment Improve C-V Outcomes? M-HART Frasure-Smith N. Lancet 1997; 350:473 SADHART Glassman AH, et al. JAMA 2002; 288:701 ENRICHD Berkman LF, et al. JAMA 2003; 289:3106 CREATE Lesperance F, et al. JAMA 2008; 297:367 SADHART-CHF O Connor CM, et al. J Cardiac Fail 2008; 14:797 Post-CABG CBT/SSM Freedland KE, et al. Arch Gen Psych 2009; 66:387
Interventions Produced Small Impact on Mood Symptoms: Why? Single antidepressant agent Patients preferences not considered Inadequate adherence to treatment Patients physicians not included Poor adherence to interventions Brief follow-up Few clinical events Insufficient study power
Collaborative Care Population perspective Linked to primary care Evidence-based Proactive Team approach Considers patient preferences Information technology Coleman K. et al. Health Aff. 2009; 28:75
Wagner Chronic Care Model www.improvingchroniccare.org
CABG Surgery ~450,000 / Yr. performed in U.S. 20-25% Elevated mood symptoms Mood symptoms associated with: Delayed recovery Readmissions, C-V events, and death
Bypassing the Blues Specific Aims Can collaborative care for depression: Increase: HRQoL (SF-36 MCS - primary outcome) Physical functioning (SF-36 PCS, DASI) Decrease: Mood symptoms (HRS-D) Health care utilization (Rehospitalization) Health care costs ($$)
Bypassing the Blues Study Design Rollman BL, et al. Psychosomatic Med. 2009; 71:217
7 Pittsburgh- Area Hospitals Jefferson Regional Mercy Hospital UPMC-Passavant UPMC-Presbyterian UPMC-Shadyside Westmoreland 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? Kroenke K. Med Care 2003; 41:1284
Screening Summary 3/04-9/07 Approached Post-CABG 3,057 PHQ-2 Completed 2,485 (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%)
Sociodemographics Depressed N=302 Non-Dep N=151 P Age (SD) 64 (11) 66 (10).03 Male 59% 63%.38 Caucasian 91% 81%.01 Hypertension 84% 81%.43 Diabetes 42% 39%.50 CHF 20% 21%.38
Bypassing the Blues Patient Intervention Informed of randomization status NIMH brochure on depression and heart disease Care manager phoned at regular intervals X 8 mo. to: Provide basic education on depression; Assess treatment preferences; Offer self-management workbook; Promote adherence/adjust pharmacotherapy; Monitor treatment response; and Facilitate MH referral as appropriate. Rollman BL, et al. Psychosomatic Med. 2009; 71:217
Bypassing the Blues PCP Intervention Informed of randomization status Provided guidance re: pharmacotherapy Prescribed pharmacotherapy Provided feedback re: symptoms and progress Offered assistance referring to a MH specialist Informed of patient s status at study end Rollman BL, et al. Psychosomatic Med. 2009; 71:217
Treating Post-CABG Depression Improves Health-Related Quality of Life (Primary Study Outcome) 65 60 MOS SF-36 MCS Intervention (n=150) Usual Care (n=152) Nondepressed (n=151) MCS 55 50 ES: 0.30 (0.17-0.52; P=0.01) * * * 45 40 0 2 4 6 8 Month Rollman BL, et al. JAMA. 2009; 302:2095
Reduces Mood Symptoms 18 16 14 Hamilton Rating Scale - Depression * Intervention (n=150) Usual Care (n=152) Nondepressed (n=151) HRS-D 12 10 8 ES: 0.30 (0.08-0.53; P=0.009) * 6 4 2 0 2 4 6 8 Month Rollman BL, et al. JAMA. 2009; 302:2095
Differential Impact by Gender SF-36 MCS HRS-D SF-36 PCS DASI -0.6-0.4-0.2 0.0 0.2 0.4 0.6 0.8 1.0 Favors UC Effect Size Favors Intervention SF-36 MCS (1 Outcome) All: 0.30 (0.17-0.52) P=0.01 Male: 0.53 (0.23-0.84) P<0.001 Female: 0.08 (-0.28-0.43) P=0.68 HRS-D All: 0.30 (0.08-0.53) P=0.009 Male: 0.39 (0.09-0.69) P=0.01 Female: 0.23 (-0.13-0.59) P=0.20 SF-36 PCS All: 0.26 (0.03-0.48) P=0.03 Male: 0.57 (0.26-0.87) P<0.001 Female: -0.04 (-0.40-0.31) P=0.82 DASI All: 0.32 (0.09-0.54) P=0.006 Male: 0.55 (0.24-0.85) P<0.001 Female: 0.10 (-0.25-0.46) P=0.58 Rollman BL, et al. JAMA. 2009; 302:2095
Cardiovascular Rehospitalizations for Men 13% Intervention vs. 23% Usual Care; p=0.07 0.25 0.20 Cumulative Incidence 0.15 0.10 0.05 0.00 Intervention (n=81) Usual Care (n=96) Non-Depressed (n=95) 0 2 4 6 8 Month Rollman BL, et al. JAMA. 2009; 302:2095
Care Manager Contacts Intervention Time Median (Range) All N=150 Men N=81 Women N=69 3 Months 5 (0-11) 5 (0-11) 5 (0-11) 6 Months 8 (0-17) 8 (0-17) 7 (0-16) 8 Months 10 (0-28) 10 (0-28) 10 (0-23) 3+ Calls at 6 Months 85% 91% 78%* * P=0.02
Pharmacotherapy Usage * * *
Impact on Post-CABG Pain Morone NE, et al. Psychosomatic Med 2010; 72:620
12-Month Total Costs (Preliminary)* Study Arm Median (SD) Intervention (n=62) $5,287 (19,767) Usual Care (n=70) $6,542 (19,605) Non-Depressed (n=78) $3,026 (25,008) *Medicare and Highmark BC/BS enrollees 12-Month continuous plan enrollment from date of randomization
Effect Sizes on Mood Symptoms Collaborative Care (2006) - meta analysis 0.25 (0.18-0.32), CC vs. Usual Care (UC) Bypassing the Blues (2009) - CABG 0.30 (0.08-0.54), CC vs. UC SADHART (2002) - MI 0.14 (-0.06-0.35), Sertraline vs. Placebo ENRICHD (2003) - MI 0.22 (0.11-0.33), CBT/Sertraline vs. UC CREATE (2007) - Coronary Artery Disease 0.33 (0.10-0.56), Citalopram vs. Placebo -0.23 (-0.46-0.00), IPT vs. Clinical Management Post-CABG CBT/SSM (2009) - CABG 0.73 (0.29-1.20), CBT vs. UC COPES (2010) - Acute coronary syndrome) 0.59 (0.18-1.00), PST vs. UC
Conclusions Compared to usual care for post-cabg depression, telephone-delivered collaborative care is cost-effective and improves: Mental HRQoL Physical functioning Mood symptoms Pain
What is Next?
Heart Failure 5,700,000 in U.S. are affected Annually: 660,000 newly diagnosed cases 1,100,000 hospital discharges 277,000 deaths 2011 AHA Heart and Stroke Statistical Update
PHQ-2 is Predictive of Death. 0.3 All Cause Mortality PHQ-2 (+) (n=371) PHQ-2 (-) (n=100) Proportion Mortality 0.2 0.1 12-Months: 20% vs. 8%; P=0.007 0.0 0 2 4 6 8 10 12 Month Rollman BL, et al. J. Cardiac Fail (in press)
.12- Month All-Cause Mortality HR (95% CI) P PHQ-2, (+) vs. (-) 3.0 (1.4-6.4) 0.004 Age, 65 vs. <65 1.9 (1.2-3.1) 0.01 NYHA Class, III-IV vs. II 1.5 (0.9-2.6) 0.12 ACE or ARB use 0.6 (0.4-0.9) 0.02 Renal insufficiency (Cr >1.7) 1.9 (1.2-3.0) 0.009 Adjusted for: Sex, EF, DM, COPD, Anxiety, SBP, DBP, Hgb, and Na + Rollman BL, et al. J. Cardiac Fail (in press)
What if we Apply Collaborative Care for Depression to Heart Failure? 0.3 All Cause Mortality PHQ-2 (+) (n=371) PHQ-2 (-) (n=100) + Proportion Mortality 0.2 0.1 12-Months: 20% vs. 8%; P=0.007 0.0 0 2 4 6 8 10 12 Month
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