The Bypassing the Blues Trial: Telephone-Delivered Collaborative Care for Treating Post-CABG Depression

Transcription

1 The Bypassing the Blues Trial: Telephone-Delivered Collaborative Care for Treating Post-CABG Depression 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

2 Where is Pittsburgh?

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4 JAMA November 18, 2009 Telephone treatment of post-cabg depression can speed recovery and may reduce rehospitalizations

5 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 $ : 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

6 So it began, one day.... March 1998

7 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

8 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

9 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

10 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

11 Wagner Chronic Care Model

12 CABG Surgery ~450,000 / Yr. performed in U.S % Elevated mood symptoms Mood symptoms associated with: Delayed recovery Readmissions, C-V events, and death

13 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 ($$)

14 Bypassing the Blues Study Design Rollman BL, et al. Psychosomatic Med. 2009; 71:217

15 7 Pittsburgh- Area Hospitals Jefferson Regional Mercy Hospital UPMC-Passavant UPMC-Presbyterian UPMC-Shadyside Westmoreland West Penn Hospital

16 Tablet PC

17 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

18 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 (31%) Randomized 302 (90%)

19 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

20 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

21 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

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28 Treating Post-CABG Depression Improves Health-Related Quality of Life (Primary Study Outcome) MOS SF-36 MCS Intervention (n=150) Usual Care (n=152) Nondepressed (n=151) MCS ES: 0.30 ( ; P=0.01) * * * Month Rollman BL, et al. JAMA. 2009; 302:2095

29 Reduces Mood Symptoms Hamilton Rating Scale - Depression * Intervention (n=150) Usual Care (n=152) Nondepressed (n=151) HRS-D ES: 0.30 ( ; P=0.009) * Month Rollman BL, et al. JAMA. 2009; 302:2095

30 Differential Impact by Gender SF-36 MCS HRS-D SF-36 PCS DASI Favors UC Effect Size Favors Intervention SF-36 MCS (1 Outcome) All: 0.30 ( ) P=0.01 Male: 0.53 ( ) P<0.001 Female: 0.08 ( ) P=0.68 HRS-D All: 0.30 ( ) P=0.009 Male: 0.39 ( ) P=0.01 Female: 0.23 ( ) P=0.20 SF-36 PCS All: 0.26 ( ) P=0.03 Male: 0.57 ( ) P<0.001 Female: ( ) P=0.82 DASI All: 0.32 ( ) P=0.006 Male: 0.55 ( ) P<0.001 Female: 0.10 ( ) P=0.58 Rollman BL, et al. JAMA. 2009; 302:2095

31 Cardiovascular Rehospitalizations for Men 13% Intervention vs. 23% Usual Care; p= Cumulative Incidence Intervention (n=81) Usual Care (n=96) Non-Depressed (n=95) Month Rollman BL, et al. JAMA. 2009; 302:2095

32 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

33 Pharmacotherapy Usage * * *

34 Impact on Post-CABG Pain Morone NE, et al. Psychosomatic Med 2010; 72:620

35 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

36 Effect Sizes on Mood Symptoms Collaborative Care (2006) - meta analysis 0.25 ( ), CC vs. Usual Care (UC) Bypassing the Blues (2009) - CABG 0.30 ( ), CC vs. UC SADHART (2002) - MI 0.14 ( ), Sertraline vs. Placebo ENRICHD (2003) - MI 0.22 ( ), CBT/Sertraline vs. UC CREATE (2007) - Coronary Artery Disease 0.33 ( ), Citalopram vs. Placebo ( ), IPT vs. Clinical Management Post-CABG CBT/SSM (2009) - CABG 0.73 ( ), CBT vs. UC COPES (2010) - Acute coronary syndrome) 0.59 ( ), PST vs. UC

37 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

38 What is Next?

39 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

40 PHQ-2 is Predictive of Death. 0.3 All Cause Mortality PHQ-2 (+) (n=371) PHQ-2 (-) (n=100) Proportion Mortality Months: 20% vs. 8%; P= Month Rollman BL, et al. J. Cardiac Fail (in press)

41 .12- Month All-Cause Mortality HR (95% CI) P PHQ-2, (+) vs. (-) 3.0 ( ) Age, 65 vs. < ( ) 0.01 NYHA Class, III-IV vs. II 1.5 ( ) 0.12 ACE or ARB use 0.6 ( ) 0.02 Renal insufficiency (Cr >1.7) 1.9 ( ) Adjusted for: Sex, EF, DM, COPD, Anxiety, SBP, DBP, Hgb, and Na + Rollman BL, et al. J. Cardiac Fail (in press)

42 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 Months: 20% vs. 8%; P= Month

43 Our Research Team

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