7 critical steps to implementing clinical guidelines.

Guidelines are developed to fill the gaps between current knowledge and evidence as published in the medical literature, the Cochrane Database and actual physician practice.

Many physicians and physician executives believe that guidelines can effectively decrease clinical practice variation, improve clinical performance and favorably influence patient outcomes.

Evidence-based guidelines are decision support tools that facilitate the introduction of new knowledge into clinical practice. Standardizing them is absolutely essential. Guidelines do not implement themselves and they are often not used after dissemination. Implementation activities frequently produce only moderate acceptance.

Discussions about clinical guidelines should include:

* Physician attitudes about guidelines and strategies to promote their adoption

* Physician adherence to guidelines

* Standardized reporting

* Diffusion of information

* The role of guidelines in promoting quality medical care

Theoretically, practice guidelines come from sound clinical research. The guidelines are promulgated within health care systems and they, in turn, are used to generate quality indicators, performance measures in particular microenvironments, and outcomes data. (1)

One guideline, for example, recommends that all eligible patients receive a beta blocker after acute myocardial infarction. This recommendation translates into the quality indicator "prescription for beta blocker at discharge after MI."

The performance measure is the "percent of patients given a beta blocker after MI," and the outcome linked to this measure is the cardiovascular risk reduction in that group of patients compared to a control population.

Many variables

Despite the enormous work and energy invested in guideline authoring, the quality of individual guidelines varies considerably. That's why The Conference on Guideline Standardization issued a proposal in 2003 that presents a checklist for reporting guidelines. (2)

The checklist includes a description of the methods used to search the scientific literature, the criteria used to rate the quality of evidence (Figure 1), a description of the clinical condition and intervention that the guideline addresses, recommendations and rationale, and algorithm. Standardization of guidelines is critical to their acceptance and is necessary prior to the dissemination of such information.

Clinical guidelines may be successfully implemented in one location and not another. Dissemination of information is slow and acceptance suboptimal. The failure to use available scientific information is costly and potentially harmful. This promotes the continued overuse of unhelpful care and the underuse of effective care.

Donald Berwick states that several perceptions of an innovation determine its rate of spread. The perceived benefit of the change is the most powerful perception that leads to adoption. Second, the innovation must be compatible with the values and beliefs of the individual. The third factor affecting the rate of diffusion is the complexity of the proposed innovation.

Detailed and complex guidelines are less likely to be disseminated than simple ones. Trialability is another factor. That is, can the adopter find a way to test the change on a small scale without implementing it everywhere at first. Finally, operability is the last factor and it refers to the ease with which potential adopters can watch others try the change first. (3)

Barriers to change include:

* Lack of awareness or familiarity with the guidelines

* Inertia from previous practice patterns

* Inability to reconcile patient preferences with guideline recommendations

* Lack of adequate resources to permit adherence to the guidelines such as insufficient staff and increased practice costs (5)

These barriers are significant hurdles to overcome but with time, dedication, and a team approach the successful implementation of guidelines is achievable.

7 steps

In my roles as medical director in a health plan and my experience as a change agent for different medical staffs over the last several years, I identified seven key factors for the successful implementation of clinical care guidelines.

Execution of these steps requires true collaboration between the health plan and hospitals within its network. The combination of these factors has proven synergy and what emerges, in the long run, are aligned incentives between all parties.

1. Engineer physician leadership support for the project

The first order of business is to enlist the support of physician champions for the guidelines. Change occurs from within the health care system. The imposition of clinical guidelines by a managed care organization (MCO) never works. Rather, the medical director needs the support, expertise and momentum that physical leaders provide. These physicians are well-respected colleagues and they can ``tweak'' the guidelines to ensure that they are deliverable given local hospital and outpatient resources and physician practice patterns.

2. Align internal and external delivery incentives

Microsystems such as a critical care unit are part of the internal delivery system of care. Processes of care are based on clinical pathways, for example, in congestive failure. These pathways use guidelines as their foundation. Managed care organizations on the other hand, are on the external delivery side of the system. These organizations have disease management programs whose structure is also based on practice guidelines. The MCO never delivers the care. The next generation MCO is a proponent of population health management. Part of that mission is to match appropriate health care resources with the patient's needs, and to facilitate patient flow through the delivery system. The MCO embeds the clinical care guidelines into its disease management and population health management programs. That's the key: the guidelines are embedded within and outside the delivery system, part of the overall structure of the programs and also of the processes of care in the hospital.

3. Budget resources for an educational campaign

I cannot overemphasize the importance of an educational campaign that targets the primary care network of physicians. Physician leaders, who make major contributions at the inception of the project in terms of their willingness to adopt and modify the guidelines, advocate for their use at educational meetings of physicians in their respective communities. The quality improvement staff at the health plan, in collaboration with the medical director, sponsor these meetings and are also responsible for general mailings that explain the disease management programs that includes an abbreviated version of the guidelines along with flow charts of pertinent algorithms.

4. Leverage information technology

Study any industry today and you will get a real sense for the power of information technology. The same applies in the health care industry. Clinical guidelines are incorporated as decision-support tools in the computerized physician order entry (CPOE) systems in hospitals. Multiple studies in the literature prove the efficacy of CPOE to promote cost-effective care. The MCO incorporates the guidelines into clinical messaging services. These clinical messages are given to physicians on a monthly or quarterly basis and provide them with good data on how well they perform on quality indicators. The messages gleaned from pharmaceutical and claims data alert physicians on patient noncompliance with medications, diabetics who need eye examinations, congestive failure patients who are not taking an ACE inhibitor or ARB, asthmatics who are abusing beta agonist inhalers and other quality issues. The improvement in health plan HEDIS measures, in part, is directly attributable to the success of a well-established clinical messaging program.

5. Measure process-based and outcomes-based performance

Process-based and outcomes-based metrics are necessary to assess the success of implementation. Metrics are part of the quality cycle that presupposes the dissemination of guidelines into the practice of medicine after tried-and-true research. MCOs also analyze utilization metrics in order to get a handle on savings-to-cost ratios, resource allocation and cost effectiveness.

6. Roll out a quality incentive program

The best way to align incentives between the physicians and MCOs is to reward quality. Health plans should award cost-effective care. That means one combines the utilization and quality metrics into a fair pay-for-performance program. No one is reinventing the wheel here. Organizations across multiple industries reward employees who demonstrate economic value-added performance. Why should the health care industry be any different? There are many iterations of these programs. Suffice it to say that a successful program uses peer-to-peer comparisons as well as national or regional benchmarks. The incentive program is a powerful way to ensure the delivery of quality care.

7. Obtain physician and patient feedback

Physician and patient feedback is the last critical success factor that is an essential ingredient in the dissemination of clinical guidelines. Generally, physician satisfaction reflects patient satisfaction. We all know the value of patient satisfaction and, in fact, it is a general measure used in quality incentive programs. However, you must go one step further. What about physicians? We should be measuring their satisfaction as they perform their difficult job. I find that physician surveys are invaluable in many ways. Surveys allow the medical director to assess the services provided by the MCO. That is, one gets a better fix on how well the disease management and clinical messaging programs work. How do they feel about the data provided? Are the care management nurses doing a good job for their patients? On the hospital side, the vice president of medical affairs also measures physician satisfaction. Are radiologic and laboratory data presented in a timely fashion? Are the nurses knowledgeable about their patients? Simple surveys provide lots of information.

It is interesting to see how MCOs are reinventing themselves. The days of an adversarial relationship between the managed care organization and the providers of care are ending. Everyone strives for the delivery of cost-effective health care.

One means to achieving that end is in the implementation of evidence-based guidelines and the dissemination of good data to physicians. The MCO provides an essential role since, ultimately, it is a repository of data and information. Guidelines work best when embedded in systems of care and the incentives of all interested parties are aligned.

Figure 1 Levels of Evidence for Treatment Recommendations

Level I. Independent, blind comparison with a gold standard of anatomy,
physiology, diagnosis or prognosis among a large number of consecutive
patients suspected of having the target condition
Level II. Independent, blind comparison with a gold standard among a
small number of consecutive patients suspected of having the target
condition
Level III. Independent, blind comparison with a gold standard among
non-consecutive patients suspected of having the target condition
Level IV. All other studies that do not meet criteria for at least level
III evidence.

Strength of evidence (quality of evidence)
Grade A. Multiple, well-designed randomized clinical trials in
representative populations that directly assess effects on health
outcomes
Grade B. Strength of the evidence is limited by the number, quality or
consistency of the individual studies but the evidence is sufficient to
determine effects on health outcomes
Grade C. Evidence is insufficient to determine the effects on health
outcomes because of limited number or power of studies, flaws in the
design or conduct of the studies, gaps in the chain of evidence or lack
of information on important health outcomes

References

1. Califf R, Peterson E, Gibbons R, and others. "Integrating quality into the cycle of therapeutic development." J Am Coll Cardiology Dec 4, 2002, 40:1895-1901.

2. Shiffman R, Shekelle P, Overhage M, and others. "Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization." Ann Intern Med Sept. 16, 2003, 139:493-498.

3. Berwick D. "Disseminating innovations in health care." JAMA April 16, 2003, 289:1969-1975.

4. Cabana M, Rand C, Poew N, and others. "Why don't physicians follow clinical practice guidelines? A framework for improvement." JAMA Oct. 20, 1999, 282:1458-1465.

RELATED ARTICLE: IN THIS ARTICLE ...

Finding physician champions, launching an educational campaign and obtaining feedback are three of the seven keys to successfully implementing clinical guidelines.

By Thomas J. Biuso, MD, MBA 

Thomas J. Biuso, MD, MBA, is senior medical director at MVP Health Care in Schenectady, N.Y. He can be reached at 518-388-22921 or [e-mail].

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