ADVERTISEMENT

The Bypassing the Blues trial: Collaborative care for post-CABG depression and implications for future research

Author and Disclosure Information

ABSTRACTDepressive symptoms are reported by up to one-half of patients following coronary artery bypass graft (CABG) surgery, and are associated with numerous adverse outcomes, including poorer health-related quality of life, worse functional status, and delayed recovery. Strategies to detect and then manage depression in CABG patients and in cardiac populations are of great interest given the potential for depression treatment to reduce cardiovascular morbidity. Yet, many tested interventions have had little or no effect on mood symptoms in cardiac patients. “Collaborative care” is a safe and proven-effective strategy for treating depression in concert with patients’ primary care physicians; however, it had not been tested previously in patients with cardiac disease. This article presents the design and main outcome findings from the National Institutes of Health–funded Bypassing the Blues study, the first trial to examine the impact of a collaborative care strategy for treating depression among patients with cardiac disease, and our efforts to improve upon and expand the model for testing in other cardiac conditions.

PROMOTING MEDICATION ADHERENCE

To promote adherence with our treatment recommendations, our nurse care managers offered to call in antidepressant prescriptions to patients’ pharmacies under their PCP’s verbal orders, and then forwarded an order sheet for the PCP to sign and return to document it.

Some patients agreed to a trial of antidepressant pharmacotherapy but then declined or quickly discontinued it because of cost, side effects, or concerns about dependence, safety, or stigma. In these instances, particularly if the patient remained symptomatic, care managers attempted to overcome the patient’s reluctance using various motivational interviewing approaches. Care managers also provided educational materials, including the workbook,51 to mitigate any concerns, and emphasized they would monitor the patient’s clinical status closely and report back to the clinical team and the patient’s PCP for ongoing guidance. The care manager also informed the PCP of the patient’s reason(s) for nonadherence, raising the possibility that the clinician could help overcome the patient’s resistance.

OUTCOMES

Self-reported measures

Figure 4. Main study outcomes.45 DASI = Duke Activity Status Index; HRS-D: Hamilton Rating Scale for Depression (17-item); SF-36 MCS: Medical Outcomes Study 36-item Short Form Mental Component Summary; SF-36 PCS: Medical Outcomes Study 36-item Short Form Physical Component Summary
BtB enrolled 453 post-CABG patients (101% target goal) who lived across western Pennsylvania, eastern Ohio, and West Virginia and met all protocol eligibility criteria. At the 8-month followup, depressed intervention patients reported significant improvements in mental and physical HRQoL, functional status, and mood symptoms versus those randomized to usual care (Figure 4). Furthermore, intervention patients were more likely to achieve a 50% or greater decline from their baseline level of mood symptoms, as measured by the HRS-D, than patients randomized to usual care (50% vs 30%), or an effect size (ES) improvement of 0.42 (P < .001)45; and they reported lower levels of pain.52 As observed in other trials of depression treatment among patients with cardiac disease,53–55 the intervention tended to be more effective in men than in women (Figure 4).

PROCESSES OF CARE

Of the 150 patients randomized to our collaborative care intervention, 146 (97%) had one or more telephone care manager contacts and 83% had three or more contacts by the 4-month followup. At the 8-month conclusion of our intervention, the median number of care manager contacts per patient was 10 (range: 1–28). The proportion of intervention patients using antidepressants also increased from 15% at baseline to 44% by 8 months, and 4% reported a visit to a mental health specialist. In comparison, 31% (P = .05) and 6% (NS) of usual-care patients, respectively, were using an antidepressant or saw a mental health specialist during this period.45

HEALTH SERVICES UTILIZATION

Depressed patients reported a similar 8-month incidence of all-cause (33% intervention vs 32% usual care) and cardiovascular-cause (15% vs 18%) rehospitalizations by randomization status. However, male intervention subjects tended to have a lower incidence of cardiovascular-cause rehospitalizations than men randomized to usual care (13% vs 23%; P = .07) and one that was similar to that of nondepressed BtB male post-CABG patients (13%). Notably, we did not observe a similar pattern among female patients enrolled in BtB. To better examine the “business case” for treating post-CABG depression, we are presently analyzing claims data from Medicare and from two large western Pennsylvania insurance providers and hope to report these analyses shortly.

DISCUSSION

BtB was the first trial to examine the impact of a real-world collaborative care strategy for treating depression in post-CABG patients or in any other cardiac population. The generalizability of our treatment strategy is enhanced by multiple design features including: (1) use of a brief, validated, two-stage PHQ depression screening procedure that was endorsed by the AHA and can be routinely implemented by nonresearch clinical personnel; (2) a centralized telephone-delivered intervention; (3) reliance on a variety of safe, effective, simple-to-dose and increasingly generic pharmacotherapy options, a commercially available workbook, and community mental health specialists to deliver step-up care; (4) consideration of patients’ prior treatment experiences, current care preferences, and insurance coverage when recommending care; (5) use of trained nurses as care coordinators across treatment delivery settings and providers across state lines; and (6) an informatics infrastructure designed to document and promote delivery of evidence-based depression treatment, care coordination, and efficient internal operations.

The ES improvement in HRS-D we observed in the BtB trial was at the upper end of a meta-analysis of 37 collaborative care trials for depression involving 12,355 primary care patients (ES: 0.25; 0.18–0.32).27 It compared favorably with the improvements reported by the ENRICHD (Enhancing Recovery in Coronary Heart Disease Patients) randomized trial (ES: 0.22; 0.11–0.33),10 the SADHART (Sertraline Antidepressant Heart Attack Randomized Trial) (ES: 0.14; −0.06–0.35),9 and the citalopram arm of the CREATE (Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy) trial (ES: 0.29; 0.05–0.52).13 However, our ES improvement was smaller than those generated by the more laborintensive and face-to-face interventions provided by Freedland et al’s trial of cognitive behavioral therapy (CBT) for post-CABG depression (ES: 0.73; 0.29–1.20; N = 123),15 the COPES (Coronary Psychosocial Evaluation Studies) trial of problem-solving therapy (ES: 0.59; 0.18–1.00) that was the first to report a significant reduction in major adverse cardiac events from treating depression,15,56 or a recent meta-analysis of psychologic treatments in patients with medical disorders (ES: 1.00; 0.57–1.44).57

Although the BtB intervention focused on depressed post-CABG patients, it is also generalizable to patients with other cardiovascular conditions. Moreover, the model can be readily adapted into practices at a variety of integrated health care delivery systems.58 Therefore, we believe collaborative care interventions such as ours will become more widespread as elements of the 2010 Affordable Care Act are phased in.