Closing the Gap Between Guidelines for Bipolar Disorder Treatment and Clinical Practice

The article by Mark Bauer et al. in this issue (1) presents important findings about improving bipolar disorder treatment and outcomes. The study, part of a larger, multisite Department of Veterans Affairs Cooperative Study Program, demonstrated that collaborative care achieved higher rates of guideline-concordant care, i.e., adherence to a criterion for prescription of an antimanic medication regimen, than treatment as usual.

Investigations of this type are crucial if we are to close the gap between evidence-based treatments developed in research settings and adoption in clinical practice. Fortunately, the scientific evidence to support specific treatments for many mental disorders is abundant and growing. Practice guidelines and algorithms based on this evidence continue to proliferate, are promoted through physician education activities, and are endorsed by health care systems, insurance plans, and regulatory bodies. Unfortunately, however, the current state of knowledge regarding how to actually implement them in clinical practice is much weaker. Uptake of evidence-based treatments at the clinical implementation level has therefore lagged (2) . Moreover, there is relatively scant evidence to support specific strategies to change practice and to increase adherence to guidelines. Also, although the steps within most guidelines are based on scientific evidence, it does not necessarily follow that implementation of guidelines in naturalistic clinical practice settings will be effective in achieving better outcomes on a population level. The work by Bauer and colleagues addresses some of these important gaps: despite solid evidence establishing the efficacy of medications for bipolar disorder, there is relatively little known about effective strategies for getting patients to take appropriate doses of the right medications over time.

The relevance of the study by Bauer et al. is further strengthened by its use of a real-world clinical population similar to those served in many hospital systems and community mental health centers. There were minimal exclusion criteria, and comorbidities were common. Perhaps more important, the cohort was heterogeneous in terms of psychosocial situations and level of functioning. The latter is significant because it suggests that collaborative care may be applicable to a fairly wide range of patients, not just those with specific attributes, such as high motivation, an involved family, or more education.

The intervention that was studied included three components: physician education using simplified practice guidelines, patient psychoeducation and self-care training, and practice-based care management. The model incorporated a patient-centered philosophy based on chronic care models and, while manual-based, was inherently flexible. That flexibility may have critical elements, difficult to tease apart and study individually, that together have a significant impact. The question may arise as to which specific aspects of the multicomponent intervention were critical in contributing to outcomes. Attempting to answer that question scientifically, by isolating specific components, is tempting but may or may not be useful. The multicomponent approach and patient-centered flexibility may themselves be the key elements and lose meaning when further reduced.

Limitations of the study include its patient population: predominantly male, diagnosed with bipolar I disorder, severely ill, hospitalized for mania, and having high levels of psychosis, suicidality, and substance use. This population is at high risk for adverse outcomes and thus represents a high priority for developing new outpatient treatment strategies. Also, this group may be most likely to have clearly observable clinical and utilization outcomes from adherence to antimanic medication regimens. However, patients with less severe bipolar disorder, those with more depression as opposed to manic episodes, and patients with bipolar II disorder may not be expected to demonstrate the same degree of benefit.

Another cautionary tale emerges from the study and will not surprise those in clinical practice: concordance rates were low overall and decreased over time. Even in the intervention group, concordance rates peaked at 60% at 24 weeks and were under 50% for most of the second and third years of the study. Concordance with guidelines reflects both the psychiatrist’s prescription of the correct medication and dosage and the patient’s adherence in taking the medication as prescribed. Care management is a multifaceted intervention that targets both the physician and the patient and family. The physician may be prompted to increase medication into evidence-based dose ranges or therapeutic serum levels when it is tempting to leave patients at subtherapeutic doses. Similarly, care management helps patients adhere to medication regimens by means of a number of strategies, such as managing uncomfortable side effects and encouraging patients to communicate concerns to their physicians. Medication adherence was enhanced for the intervention group in this study, but there is much work yet to be done to improve medication adherence for chronic illnesses, especially mental disorders (3) .

To advance care and improve outcomes for our patients, we need to continue to develop increasingly sophisticated biological and psychosocial interventions. Perhaps equally important, or even more important, we need to innovate and study new processes to deliver these interventions in clinical practice. The latter is of necessity messier, may be viewed by some as less scientific and by others as interfering in physicians’ autonomy, requires research to be conducted in practices rather than research settings, and involves innovations, such as care management, that may be at odds with the current reimbursement structures in the health care system. Much of the recent discussion about health care reform acknowledges the need to change the processes by which care is delivered, make practices patient-centered, and align financial incentives with quality and outcomes (4) . Merely developing new, evidence-based treatments without a similar investment in knowledge and evidence about how to achieve better outcomes in real practice settings is likely to yield only modest gains for our patients.