Reliable Interventions - Beyond Protocols: Layering Reliability

Greg Maynard and Jason Stein

Consider the following hierarchy of reliability in implementing programs to enhance glycemic control and reduce hypoglycemia with physiologic subcutaneous insulin prescribing, intravenous insulin infusion regimens, and safe-use practices. Keep in mind that you are creating several linked protocols and order sets and that these levels pertain to each protocol and order set and to the transitions you build into them to go from one protocol to the next. Focusing on only one aspect (such as IV insulin infusion protocols) will result in suboptimal care, as patients flow from one setting to the next.

Level 1 State of nature (sometimes chaos)

The institution has no standardized order sets or protocols. Reliance on individual expertise and experience is the only strategy to achieve quality care. Expect:

• More than 30% of your patients in non-critical care areas to have a mean glucose > 200 mg/dL.
• Only 30% of subcutaneous insulin regimens have a basal insulin component.
• Uneven training/knowledge by providers.
• High rates of preventable hypoglycemia.
• Dissatisfaction of patients with the care they receive for their diabetes/hyperglycemia.
• Poor coordination of tray delivery/glucose testing/insulin administration.

Level 2 Average: incomplete order sets/protocols

• Standardized order sets with basal, nutrition, and correction dose terminology and/or standardized orders for insulin infusion may exist, but guidance for managing the myriad challenges of inpatient glycemic control at the point of care is incomplete and suboptimal; or
• Detailed guidance is available in stand-alone protocols, but these protocols are not well integrated into the order sets or work flow.

Level 3 Integrated order sets/protocols

Level 3 is the entry point for most serious QI efforts; some would term this method "indication-based order sets," meaning each order set is for a specific purpose (order subcutaneous insulin or administer intravenous insulin, for example), and some guidance for proper ordering, administration, and monitoring is integrated into it. Both elements in level 2 are combined into a paper order set or CPOE that also has instructions endorsing the preferred options for different situations. This visual link enables providers to "back into" appropriate treatment choices. Aids for decision making, created by the multidisciplinary team, are available to support decision making at the point of care or in the order sets.

Remember that providers should always retain the freedom to deviate from the protocol specifically to meet the needs of a given patient. Eventually, with successive refinements, the protocol should drive management choices for the great majority of patients.

Level 4

All three level 3 conditions are in place, but the general order sets and protocols are supported by more detailed, comprehensive, institution-specific algorithms and protocols that promote a standardized approach, and additional performance-improvement strategies are used.

Of all the acceptable options listed by Clement et al in their technical review, one subcutaneous insulin regimen is the institutional favorite for each of these patients/situations:

• Patient who is eating;
• Patient who is NPO;
• Patient who is receiving enteral nutrition, continuous or intermittent bolus;
• Patient who is receiving TPN;
• Patient who is perioperative (brief or longer duration of expected NPO status);
• Patient who is on steroids;
• Patient who needs insulin infusion;
• Patient who is transitioning from infusion insulin to subcutaneous insulin; and
• Patient who is being transitioned from the hospital regimen to a home regimen.

Guidance from your local algorithms and protocols are reinforced at the point of care whenever possible. Remember, some tradeoffs are inherent to this more guided and algorithmic methodology. As you integrate more and more of your preferred algorithm and regimens into your order set, you reduce not only variability in ordering but also the choices available to your prescribers and patients. For example, if your team decides all hyperglycemic patients who are eating should be on insulin glargine as a basal insulin and a rapid-acting analogue insulin as a nutritional insulin, you can eliminate the other choices from your order set for that type of patient. So, what is the downside? The loss of choice may irritate both physicians and patients, and extra efforts must be taken to ensure the patient is informed about why these changes are being made. Extra care must be taken to ensure the diabetes regimen the patient receives on discharge is appropriate to that patient's level of understanding, motivation, finances, insurance plan, and other considerations. Also, education must continue, as always, because health care providers must understand the rationale for the protocol in order to know when to wisely deviate from it.

The table on the next page outlines several quality improvement strategies to consider. Most of these other strategies leverage that you now have glycemic control and insulin protocols in the work flow. Providers, nurses, pharmacists, even patients can refer back to the glycemic control protocols for clarity, confidence, or advocacy. With any additional layer(s) to the overall glycemic control effort, include at least one high-reliability mechanism in the design.

Level 5 Oversights "identified-and-mitigated"

Level 5 represents a profound leap in quality. At this level you will improve care by a whole order of magnitude, a rare achievement in health care. All the conditions of level 4 exist, plus there is now a strategy to identify and address the management oversights that inevitably occur. At level 4, 70% - 80% of your patients on subcutaneous insulin will have a scheduled basal insulin in their regimen. Will your team be satisfied with that considerable gain? It depends on whether you are merely pursuing excellence (relative to "industry standards" ) or whether you are actually pursuing perfection. There will always be instances when the optimal insulin strategy is not used or an HbA1c is not ordered or a patient suffers from a preventable hypoglycemic episode. Strategies that "identify-and-mitigate" these oversights are critical for achieving breakthrough improvement. Level 5 may be impractical or unsustainable without an electronic-reporting mechanism and proper metrics, which we reviewed in Track Performance.

Nolan T, Resar R, Haraaden C, Griffin F. White Paper: Improving the reliability of health care. Institute for Healthcare Improvement. Innovation Series 2004. http://www.ihi.org/IHI/Results/WhitePapers/ImprovingtheReliabilityofHealthCare.htm. Accessed December 1, 2006.

Amamentarium of QI Strategies

Level 6 Achieving true excellence

As in level 5, almost all patients receive insulin orders and other testing/therapy per protocol and every patient not addressed by the protocol is channeled through the "identify-and-mitigate" strategy. In level 6 the efficacy of mitigation itself is immediately judged, and its own failures are immediately remedied. Most important, the failure modes of mitigation are systematically analyzed and eliminated. If your team achieves this level of reliability, you will be pioneers. If your solutions can be adopted readily by other institutions, you will utterly transform hospital care.