Dissemination and Adoption of Comparative Effectiveness Research Findings When Findings Challenge Current Practices. Key Enablers of Clinical-Practice Change

01/01/2013

Practice-Change Interventions

Interventions such as computerized clinical decision support and academic detailing based on CER results are often effective in changing prescribing practices, but their impact on implementation of CATIE’s findings is unclear. Our case-study results suggest that these interventions may have limits. For example, one initiative undertaken in the VA health system required physicians to fill out a computerized form before prescribing a second-generation antipsychotic—a minor administrative hurdle designed to cause them to consider the rationale behind their choice (Rosenheck and Sernyak, 2009). Not only did it fail to change practice, it drew the attention of the pharmaceutical industry and actually resulted in new policies in the VA that forbade such administrative barriers. One prominent integrated delivery system did not even attempt a strategy of academic detailing following CATIE, because existing prescribing patterns were considered too well established for it to succeed. Despite these early setbacks, discussants representing several public and private payers reported achieving physician buy-in and a successful practice change to step therapy. In all of these efforts, prescribers were presented with data on their actual prescribing patterns, as compared with best practice. The data often demonstrated that their prescribing was much further from ideal practice than they believed. One discussant described this as applying “gentle but unyielding pressure,” because the process of gaining physician participation often took years.

Potential for Harm

In CATIE, olanzapine was associated with greater weight gain and increases in glycosylated hemoglobin, total cholesterol, and triglycerides. Despite having superior efficacy, olanzapine’s adverse-event rate combined with the elevated cardiovascular mortality risk of patients with schizophrenia (patients have a 26-year-shorter life expectancy on average) may have contributed to discussants’ perceived decrease in olanzapine use over time. While metabolic parameters can be monitored to ensure that they remain controlled, many physicians may have concluded that the metabolic side effects should be avoided at all costs (Carpenter and Buchanan, 2008). Psychiatrists might also view the decision to continue use of second-generation antipsychotics as the result of a calculation of risk tradeoffs—tardive dyskinesia from first-generation medications versus metabolic side effects from the newer medications—and not about efficacy differences at all. Many psychiatrists might favor the preservation of patients’ quality of life (controlling tardive dyskinesia) over preserving life expectancy (avoiding diabetes and cardiovascular disease). In support of this argument, some experts claim that the determinants of lower life expectancy in patients with schizophrenia are still unclear, implying that it might be related to reasons other than cardiovascular disease.

Coordination Between Government Agencies

SAMHSA is dedicated to translating evidence and disseminating best practices in the treatment of mental health and substance abuse. NIMH and SAMHSA engaged in a series of discussions following the CATIE trial, and SAMHSA’s messaging focused on enhancing patient engagement with regard to antipsychotic prescribing, because of the observed heterogeneity in benefits and harms. SAMHSA also helps to disseminate CER evidence on mental health programs through the National Registry of Evidence-Based Programs and Practices. This customizable database includes information on study design, populations studied, and outcomes (including costs) and provides references to studies that have replicated the results. Users can identify evidence that pertains to specific populations of interest. The database does not contain any information on pharmacologic interventions but theoretically provides a model for doing so in the future.

Medicaid Spending Cuts

Experts predict that anticipated cuts in state Medicaid spending may accelerate the switch to generic antipsychotics, and because all first-generation medications are available in generic form, this may effectively accelerate the adoption of step therapy. It is possible that formulary policies that were unpalatable several years ago might be tolerable during times of shrinking public budgets.

Adverse-Event Surveillance

The CATIE trial was criticized because its time frame was not long enough to assess the rate of adverse events—particularly the incidence of tardive dyskinesia—with first-generation medi-cations or the incidence of diabetes or metabolic syndrome with second-generation anti-psychotics. Adverse-event surveillance programs may help to resolve questions about the long-term safety of antipsychotics. Current initiatives, such as the FDA’s Sentinel Initiative to develop the ability to use distributed-data networks to track adverse events from drugs and devices, may therefore be an enabler of practice change in the near future.

Timely CER

CATIE took more than five years to complete. Timely CER is critical, because the treatments being compared are likely to have been in use for years, and practice patterns can become fixed, as they did in antipsychotic prescribing. Experts have proposed trial designs, including adaptive designs, that allow new treatments to be integrated into studies as they progress. This could greatly improve the efficiency of these trials and protect against the criticism that their findings are outdated because of the use of treatments that do not reflect current practices. CATIE used an adaptive design by allowing patients to be randomized to ziprasidone after it became FDA approved. More timely CER using these new trial designs may represent a future enabler of clinical-practice change.

State and Local Regulatory Policy Restricting Pharmaceutical-Industry Influence
on Prescribers

A number of states and medical centers have adopted policies to limit the influence of the pharmaceutical industry. Several states have passed laws barring physicians from accepting gifts, and as of December 2009, nine states (California, Florida, Maine, Massachusetts, Minnesota, New Hampshire, South Carolina, Vermont, West Virginia) and the District of Columbia had laws or resolutions governing pharmaceutical marketing practices (National Conference of State Legislatures, 2010). Many academic medical centers have implemented similar policies, and others that are even more far-reaching bar detailers altogether. The effectiveness of these policies and the prospects for their continued diffusion are not known.

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