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9

Clinical Decision Support

James M. Walker and Stephen T. Tingley

67 A man is driving home on a rainy night. He notices a small amber light has appeared on the dashboard in the shape of a gas pump. At the next exit, he pulls over, finds a gas station, and fills the tank.

This scenario is so familiar that it is almost invisible to us, but it provides an example of effective decision support. In this case, several things did and did not happen. What did not happen? The signal did not stop the car from running until gas was added. It did not try to teach the driver something new, nor did it try to convince the driver to do something with which he disagreed.

What did happen? The light provided a non-intrusive alert that helped the driver avoid an unpleasant outcome. The car was programmed to turn on the amber light (whose color was chosen carefully for its visibility) when the fuel tank neared empty.

The driver recognized the signal as a prompt to buy gas—without having to refer to his owner’s manual. The light came on while there was still time to find gas.

This chapter discusses how to design your EHR build to provide clinical decision support (CDS) as effectively as your car does. We assume that most CDOs will soon conclude that accreditation, care-quality, and reimbursement all require them to implement effective CDS in an EHR. This assumption is based on a research literature that provides good evidence of the efficacy of small numbers of CDS interventions in research settings using non-commercial EHRs. (See Bates, et al. for a recent review (1).) The assumption is also based on the anecdotal experience of thousands of EHR users, who find the prospect of practicing without CDS—for instance, allergy and drug-drug interaction checking—simply frightening. Finally, the assumption is based on the concerted movement of payers and regulators to require, and perhaps even pay for, provider and hospital performance that is not feasible without EHR-based CDS.

Definition

For the purposes of this book, we define CDS as any EHR-related process that gives a clinician patient-related healthcare information with the intent of making the clini- cian’s decision-making more efficient and better informed. While giving patients clin- ical decision support is vital, it is largely beyond the scope of current EHRs. (See

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Chapter 19 for a discussion of our first steps toward the use of the EHR to provide CDS to patients.)

The Need for CDS

Why do we need CDS? Are not clinicians intelligent, committed, and efficient users of information? Certainly, this is true. It is also true that we are human, performing complex intellectual tasks under stringent time constraints and with frequent inter- ruptions. For these reasons, we fall prey to many of the causes of human error, partic- ularly to the limitations of working memory. A recent report documenting pervasive error in American healthcare can be found in McGlynn et al. (2).

Consider this typical example: A 52 year-old woman with diabetes and a history of heart attack two years ago comes to her doctor’s office. The patient reports that she would like a routine check-up, but also notes a week of ankle pain. In the 15 to 20 minutes the physician has with this patient, the physician must consider many ques- tions: Has the patient had a recent Pap test, mammogram, and colorectal cancer screen- ing? When was her latest hemoglobin A1C and what was the result? Is it flu season and, if so, does she need vaccination? Does the practice have any more doses of vaccine available? What is her pneumococcal vaccine status? Has she had eye and foot exams within the last year? What is the patient’s cholesterol status and blood pressure control? What are appropriate targets for this patient and her actual risk if she doesn’t meet them? Is the patient taking appropriate medicines to protect her heart and kidneys? Has she had her urine checked for protein in the last year? Has she had any symptoms of low blood sugar? What is her risk of having osteoporosis? Is she taking calcium and Vitamin D in appropriate doses to prevent it? Has she been tested? Has she had any recent symptoms that might indicate worsening heart disease? Oh, and by the way, what’s causing that ankle pain?

Most of the questions raised in this example are fairly straightforward. Providers would generally agree with their clinical importance. The difficulty is in remembering all of the questions, finding the information needed (both patient-specific and general) to answer each one, and negotiating a plan for each one with the patient—along with diagnosing and treating the ankle pain.Yarnall, et al, estimate that it would take a physi- cian seven hours each working day to implement the United States Preventive Services Task Force disease-prevention guidelines (3). If the EHR can be programmed to help clinicians and patients identify and answer these questions efficiently, it will produce remarkable improvements in care quality and patient outcomes.

Types of CDS

Although CDS interventions are often divided into active alerts and passive reminders, the situation is not so simple. As Table 9.1 illustrates, CDS interventions can be char- acterized in at least two dimensions. On one axis reminders range from intrusive reminders that obscure the screen to non-intrusive reminders that make information available but do not interrupt the user’s work. In the second dimension, reminders range from optional through “soft-stopped” (requiring at least a simple override) to

“hard-stopped”(requiring a specific type of action before anything else can be done).

We know very little about which type of reminder is most effective for what sort of clinical situation. This is partly because so many factors influence reminder effective-

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ness. For an intrusive reminder to be effective, it will need to fire at the right moment.

This moment will be after the physician has had a chance to review the information needed to respond to the reminder—unless the reminder contains within itself all the information that will be needed. On the other hand, the reminder will need to be trig- gered before ordering is complete. Similarly, a non-intrusive reminder can range from hard-to-see (a few small letters turning from black to red) to highly visible (a one-inch button flashing optic yellow and Internet blue). (See Chapter 7.) Linking reminders to order sets with the recommended interventions defaulted is likely to make both types more effective. Reminders that reflect local physician consensus, that are clearly stated, that do not require a change in practice, and that are evidence-based are also more likely to be accepted (4).

Beyond the characteristics of the reminder itself, the presence or absence of effec- tive performance audits and financial incentives largely determines whether reminders are seen as an aid to improved performance or new, unreimbursed work to be avoided.

CDS Performance Standards

We believe that optimal reminders are

• Non-intrusive and highly visible

• Soft stopped

• Fast

• Simple

• Presented just in time

• Actionable (with order sets included in them or linked to them)

• Supported by best evidence, local consensus, payer incentives, and rapid-cycle feed- back to individual physicians and their leaders

If you are choosing an EHR, assess carefully how it will enable you to meet these standards.

Fast

Physicians are time pressured. Genuinely effective tools make doing the right thing easier and faster. Order sets and single orders with the (usually) appropriate selection TABLE9.1. Examples of CDS Reminder Types.

Intrusive Non-intrusive

Optional n/a Links to clinical guidelines

Soft stopped A reminder of a potential drug-drug A button changes color, indicating that interaction obscures the screen, but preventive care is due soon. An can be overridden with a single intrusive, soft-stopped reminder fires if

mouse click. the after-visit summary is printed

before the reminder is acted on.

Hard-stopped A reminder that a medicine cannot be A field turns yellow, indicating that a ordered without an associated drug order needs refill information. An diagnosis obscures the screen until an intrusive, hard-stopped reminder fires if acceptable diagnosis is entered. the user tries to sign the orders before

filling in the field.

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defaulted are particularly effective. So are note templates with the most frequently appropriate response defaulted. CDS messages should be short and clear. Overhage, et al., recommend against complete sentences and correct grammar in favor of mes- sages such as “treat with ACE inhibitor because of diabetes and HTN” (5)—but note that “Consider ACE inhibitor for diabetes and HTN.” may actually read faster because the capital “C” and the period cue the eye to the beginning and end of the message.

Simple

Very few providers will use complex tools, whether order sets or note templates. This is true even of well-made tools (5, 6). It is true even of tools they create themselves.

Just in Time

Intrusive reminders, particularly, must be delivered precisely when they are needed. If a reminder can only be presented at the beginning of a patient visit, the provider—

having not yet reviewed the problem list and medication list—will not be prepared to respond. Over time, many providers train themselves to ignore such alerts. If the reminder can only be presented after the physician has decided on a course of action and recommended it to the patient, it is likely to be ignored (See Box).

Way Too Late

For approximately one year, we provided intrusive, soft-stopped reminders of primary-care tests and treatments that should precede referrals (for example, osteoarthritis of the knee). Physicians found the content of the reminders clini- cally appropriate but disliked the reminders so much that we removed them from the EHR. This was because the only available trigger for firing the reminder was ordering the referral. Since the physician has often discussed the referral with the patient before entering the order, following the reminder’s advice means that the physician would have to explain that the computer had just informed her that a referral was not yet appropriate because potentially useful primary-care tests and/or treatments should be tried first. Understand- ably, physicians found being “corrected by the computer” in this very visible way intolerable.

Actionable

In the case of diabetes and HTN, the reminder should include a form for ordering the ACE inhibitor that best fits the patient’s formulary—in the dose appropriate to the patient’s renal function. (As a first step, there should be a link to an order form pre- filled with the starting dose of the ACE inhibitor that is most frequently prescribed in the practice.)

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Managing CDS

In most CDOs, CDS topics have been developed ad hoc, driven by the early require- ments of payers and regulators and the concerns of local stakeholders. Even in the most advanced organizations, such as the Regenstrief Institute and Kaiser, scheduled review of existing CDS rules is the exception (7). The need to implement and maintain increas- ing numbers of CDS rules to meet quality and efficiency goals means that all CDOs will need a more organized approach to planning, developing, and maintaining their CDS tools. The Decision Support Implementers’ Workbook (8) is a succinct, practical, and thorough guide to this process. It offers step-by-step guidance and useful tools for identifying CDS stakeholders and goals; selecting CDS interventions; developing, testing and launching the interventions; and monitoring and enhancing their effects.

This chapter will not duplicate the Workbook’s contents. Instead, we will highlight some specific lessons we have learned.

Multidisciplinary Oversight Team

Even a high-performance EHR will have many idiosyncrasies that complicate the development of CDS. For instance, an intrusive reminder might be able to include an order set within it, while a non-intrusive reminder might not support even a link to an order set. Including members of the EHR technical team (who understand these idio- syncrasies) on the CDS oversight team improves the team’s efficiency at selecting CDS interventions that are both clinically valuable and technically feasible. The other members of the team will develop considerable expertise at feasibility assessment over time, but normal turnover and the continuing evolution of the EHR’s capabilities make ongoing technical team participation necessary.

Clinical Domain Experts

As the outpatient implementation progressed, we came to recognize a constellation of factors that regularly limit the effectiveness of CDS efforts:

• Lack of user awareness of CDS tools (such as note templates and order sets)

• Tools that fit the workflows of one or a few users rather than supporting practice- wide (or organization-wide) needs

• Tools that were built before we learned to make them optimally efficient and flexible

• Tools too large and complex for even the author to use

We concluded that the most efficient way to create and maintain the scores of EHR tools that each practice needs for optimal performance was to enlist a clinical Domain Expert (DE) to lead each practice’s CDS tool building. We invite each practice’s clin- ical leader to name a DE for the practice, based on the criteria in the box. We ask the leader to enable the DE to attend an all-day workshop six times a year and to support the DE’s work by making activities 1, 2, 3, and 5 a regular part of practice meetings and work expectations for the practice. (Although they are not paid for this work, DEs, most of whom are physicians, receive 6 hours of CME credit for each workshop.)

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Clinical-Domain Expert Responsibilities

1. Identify the practice workflow most in need of standardization and automation (working with all stakeholders).

2. Define a standardized workflow, including information content (working with all stakeholders and explicitly including the best available evidence).

3. Identify goals and objectives, measures, and the report format for assessing the new process and EMR tools (calling on the informatician mentor for support as needed).

4. Build EHR tools to support the standardized workflow (calling on the informati- cian mentor for support as needed).

5. Facilitate stakeholder review of proposed tools (working with the practice leader) 6. Report on the effects of the new EHR tools to practice leaders and to the Chief

Medical Information Officer (CMIO).

7. Identify the next clinical workflow most in need of standardization and automation.

(Without completion of tasks 3 and 6, the practice will not learn valuable lessons about the effect of their EMR-related improvement efforts, creating the risk of substantial resource waste. On the other hand, resource constraints may make completion of tasks 3 and 6 difficult. For these reasons, measurement and reporting should be as focused and automated as possible, e.g., automated reports on how many times each tool is used will be provided by the EHR technical team.)

EHR Team Support

The EHR team provides the following services to DEs:

1. Introductory and ongoing tool-building education for Clinical-Domain Experts (at bimonthly workshops).

Anything But a Geek

The ideal Domain Expert possesses the following attitudes, abilities, and skills:

• A deep and broad understanding of the thought processes, common language, workflows, and information needs of a practice

• The respect of the work group—as a practitioner and group member

• A keen understanding of the need for usability, that is, of the most users’

limited interest in EHRs for their own sake

• The ability to enlist the aid of fellow-workers in developing and critiquing EHR tools

• The ability to motivate fellow workers to use the EHR effectively

• An understanding of the difference between what is possible with EHRs and what is feasible in the present project—and a willingness to work on achiev- ing the feasible

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2. An informatician mentor to be consulted as needed.

3. Technical support for tool implementation in the EHR.

Results

We have more than 30 DEs, with 20 to 25 attending each workshop. Each workshop runs from 9 A.M. to 4 P.M.—although many DEs work considerably later—and con- sists of four 15-minute teaching sessions punctuating long periods for tool building. By the second workshop, the DEs are teaching each other novel solutions to tool build- ing needs, so much so that we have made the sharing of these solutions a standard part of the teaching sessions. Individual DEs routinely build six or more tools during a single workshop. We are not yet able to monitor the use of the tools, but practices report finding the DE’s tools very useful.

Our next challenge is to integrate the work of DEs more effectively with practice performance-improvement initiatives. This will require many practices to adopt more formal quality-improvement methodologies as a first step.

Standardization and Freedom

Many organizations (including ours) encourage physicians to develop their own note templates and order sets as a way of increasing physician acceptance of the EHR. We are not aware of even anecdotal evidence that this freedom is important to any but a handful of physicians. The pervasiveness of this strategy is probably due to the fact that clinician members of implementation teams and feedback groups tend to have a strong personal interest in developing software tools. At some point in the implementation, our clinical and administrative leaders and the implementation team become aware that, without standardization, the EHR’s support of improved efficiency and quality will be hobbled. For example, if users can edit an evidence-based admission order set, DVT prophylaxis might disappear. In addition, clinicians will lose the efficiencies that come with being able to anticipate standard patterns of care, for example, for uncom- plicated open-heart surgery. Finally, the chance of error increases as process variabil- ity increases (9).

Identifying three categories of CDS content makes the balancing of standardization and freedom more manageable:

• Organizational standards: These standards represent the organization’s understand- ing of evidence-based best practices, combined with external standards (legal, regu- latory, and reimbursement). If one of these standards is not met, the reason must be documented.

• Organizational Conventions: These are conventions the organization has created for the sake of consistency and efficiency. Documenting reasons for non-adherence aids in reviewing and refining the conventions.

• Departmental Conventions: These are similar to organizational conventions, but are relevant only to the work of a single work group.

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Error as a Source for CDS

Participation of the CDS team in your organization’s error-reduction efforts can produce several benefits. One is to sensitize the CDS team to the different types and sources of errors that your organization is addressing. Harnessing the EHR to help prevent these errors (as in the Cortisporin example in Chapter 7 and the methotrex- ate example below) will provide some of the short-term wins that help to maintain the organization’s commitment to the EHR and to CDS. Informatician participation in formal root-cause analyses of errors is particularly productive. (See Glossary.)

Implicit CDS

The EHR provides many opportunities to provide decision support in ways that are minimally intrusive. For example, simply defaulting the new preferred administration rate of a medicine can change prescribing patterns rapidly and dramatically. (6) Chang- ing the order-entry name of a medication (e.g. from “CORTISPORIN OT” to “COR- TISPORIN OTIC SUSP (FOR PERFORATION)” can help even specialists prescribe more appropriately (see Chapter 7). Creating pre-populated administration fields for a drug like methotrexate (e.g. “Methotrexate 2.5 mg; four pills together each week”) can help avoid prescriptions such as “Methotrexate 2.5 mg; as directed”—and the tragedies that can result from the resulting patient confusion (10). Inserting generic drugs into listings of brand name drugs can aid providers who want to order generic drugs but have trouble remembering their names. For example, if a provider types

“lasix”, the following list appears:

Flexible Standardization

Healthcare’s understanding of process standardization is powerfully conditioned by its continuing dependence on paper records. Since it is rarely feasible to create paper note templates or order sets that support both standardization and flexi- bility in usably compact form, we are prone to assume that we must choose between standardization and flexibility.

One of the yet-to-be implemented potentials of the EHR is to inform users clearly which elements of a note template or order set represent organizational performance standards (e.g., by highlighting them in yellow) and which are acceptable options. The EHR can also enable the user to document the con- traindication to standards they do not perform and the indication for options selected. This ability means that 100% performance, defined as guidance imple- mented+ guidance contraindication documented + patient deferral documented, will become the achievable goal for validated quality measures.

Finally, because patients really are unique, free-text entry should be available in every section of every tool, allowing physicians to adapt their documentation and treatment to the patient’s unique needs.

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Lasix (Furosemide 20 mg) Lasix (Furosemide 40 mg) Lasix (Furosemide 80 mg) Lasix 20 mg

Lasix 40 mg Lasix 80 mg

Transparency and Feedback

It is important to publish in advance (to all users who will be affected), every signifi- cant new CDS intervention. This can be done via E-mail with a link to a Web page.

Despite our initial concerns about opening the oversight team to personal attacks, this process produces feedback that has saved us from several implementation errors and increased physician acceptance of CDS. (As physician acceptance of CDS grows, this publication needs to become increasingly selective to avoid irritating physicians with what they have come to regard as routine information.)

Summary

Providing high-quality clinical decision support is difficult but has enormous potential to improve healthcare efficiency and quality. It begins with an EHR designed to support it. It requires agreement regarding CDS opportunities. It demands a steady focus on simple, usable tools that meet the felt needs of physicians and that can be built in the current version of the EHR. It needs ongoing feedback from users regarding what actu- ally supports and what subverts their clinical decision-making.

References

1. Bates DW, Gawande AA. Improving safety with information technology. New Engl J Med 2003;348:2526–2534.

2. McGlynn EA, Asch SM, Adams J. The quality of health care delivered to adults in the United States. New Engl J Med 2003;348:2635–2645.

3. Yarnall K, Pollak K, Ostbye T. Primary care: is there enough time for prevention? Am J Public Health 2003;93(4):635–641.

4. Grol R. Attributes of clinical guidelines that influence use of guidelines in general practice:

observational study. Br Med J 1998;317:858–861.

5. Overhage J, Tierney W, McDonald C. Clinical decision support: tools, trials, and tribulations.

J Healthcare Inform Manag 1999;13(2):67.

6. Bates DW, Kuperman GJ, Wang S, Middleton B. Ten commandments for effective clinical decision support: making the practice of evidence-based medicine a reality. JAMIA 2003;

10:523–530.

7. Overhage J, Sittig D. CDS rules management. Personal communication; 2003.

8. Content Matrix in the The Decision Support Implementers’ Workbook. In:

www.himss.org/asp/cds_workbook.asp.

9. Reason J. Human Error. Cambridge: Cambridge Univ Press; 1990.

10. Mayor S. UK introduces measures to reduce errors with methotrexate. Br Med J 2003;327:70.

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Additional Reading

Osheroff J, Sittig D., et al. (2003). Decision-Support Implementer’s Workbook. www.himss.org/

ASP/cds_workbook.asp

A succinct, practical, thorough guide to getting CDS into practice.

Reason J. (1990). Human Error. Cambridge: Cambridge University Press.

The seminal work on the types and causes of error. Must reading for understanding error prevention.

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