Dissemination and Adoption of Comparative Effectiveness Research Findings When Findings Challenge Current Practices. Conclusions

01/01/2013

Uptake of the COMPANION study results has been uneven. Recent estimates indicate that there is both significant underuse of CRT among potentially eligible HF patients and fairly frequent CRT-D use in patients who lack an indication based on current CER evidence, including the COMPANION finding of a marginal benefit of CRT-D over CRT alone for only one secondary outcome.

In contrast to the other CER case studies, COMPANION engendered relatively few controversies in the generation and interpretation phases. The results were fairly readily accepted, the main disputes being over the degree to which they could be generalized to HF patients who did not meet the original inclusion criteria. Formalization of the COMPANION results was relatively rapid; specialty-society guidelines were updated promptly, which promoted their uptake, at least among proceduralists and HF-management specialists. No primary-care specialty-society guidelines were issued, and in addition, the specialty-society guidelines left open the appropriateness of CRT-D for patients who did not meet inclusion criteria. This and other factors contributed to an ineffective dissemination phase.

This case study illustrates several potential strategies for improving the CER dissemination phase. Essentially all the COMPANION dissemination activities targeted interventional cardiologists and HF specialists rather than referring physicians. Specialty societies, industry, and other CME producers (such as registries) also directed their educational efforts toward those groups. Most primary-care providers (who manage many HF patients) are still unaware of the COMPANION results. In addition, those primary-care providers and general cardiologists who took an interest were confronted by conflicting and ambiguous guidelines. This generated considerable confusion and a reported reluctance to refer patients for CRT. Future CER dissemination should focus significant effort on providers further upstream in the decision pathway and should deliver clear, unambiguous referral criteria. However, the COMPANION case is not merely a cautionary tale. HF registries have had a significant positive impact by publishing high-profile studies illustrating inappropriate ICD use. Similarly, recent limited experience shows that clinical decision support tools can be very effective at prompting appropriate referrals and discouraging inappropriate procedures, but only if they are integrated smoothly into providers’ routine workflow.

In the implementation phase, imprecise guidelines and evidence-neutral reimbursement policies may contribute to the use of CRT-D for inappropriate indications. Reimbursement policies, particularly Medicare’s, significantly favor CRT-D implantation over CRT alone, despite evidence that adding the ICD has a very high marginal cost relative to the benefits it confers. As shown in other studies as well, referral to an interventionist is also tantamount to ordering a procedure. This tendency is compounded by open guidelines that allow CER results to be cited as justifying use in patients who would not meet study inclusion criteria. While primary-care physicians and some general cardiologists fail to refer many potentially eligible patients, dedicated HF clinics have been achieving appropriate referrals and avoiding inappropriate ones. Such clinics may serve as a model for implementing CER results. Currently, patients are not generally equipped to participate as fully informed partners in clinical decisions, and decision aids are not readily available, but it is likely that such decision aids could significantly improve implementation if physicians were given appropriate incentives to use them.

Key findings from the COMPANION case study are given in Table 5.2.

 

Table 5.2

Key Findings from the COMPANION Case Study

Phase

Key Findings

Generation

• There were very few methodological issues with this CER study.

Interpretation

• Arguments about generalizability—i.e., which patients would benefit—muddled the main result: that CRT-D worked.

• Multiple professional societies involved allowed different interpretations to persist.

Formalization

• Rapid integration of the CER into guidelines promoted uptake.

• Professional-society guidelines leave open the appropriateness of CRT-D for patients who do not fit the study inclusion criteria.

Dissemination

• Specialty guidelines came only from cardiology societies and were not disseminated effectively to referring primary-care physicians.

• Conflicting messages about the generalizability of the CER results left interested primary-care physicians confused and reluctant to refer patients.

• Both CME and industry dissemination efforts focused only on interventionists, not the more-influential upstream referring physicians.

• Clinical decision support tools appear to improve appropriate use but must be integrated into physicians’ regular workflow to be accepted.

• Registries have dramatically illuminated both significant underuse and high levels of premature and inappropriate ICD use.

• Registries were also effective in disseminating appropriateness guidelines and other educational materials to participants.

Implementation

• Reimbursement significantly favors ICD (hence CRT-D) implantation, despite its high marginal cost benefit relative to CRT alone.

• Referral to an interventionist is taken as an endorsement and very frequently results in the procedure.

• CER results are often cited as a rationale for device implantation even in off-label, noncomparable patients.

• CER adoption was best in dedicated clinics/units (here, HF clinics).

• Lack of mandatory certification programs has allowed an increase in procedures done by less-skilled operators, resulting in more complications.

• Implementing patient decision aids for HF treatments may improve outcomes, but both referring physicians and interventionalists need more incentives to use them.

• The development of ACOs and similar incentive concepts is likely to reduce inappropriate use by aligning practice with evidence.

 

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