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Rethinking Treatment

Hospital taps into Six Sigma to change one way it treats people with high blood sugar
by Diane Muzenjak, Clark Carboneau and Robert Galagan, M.D.

In 50 Words Or Less

When adopting best practices, an organization must understand existing processes and performance levels before attempting to change. Six Sigma guided a New Mexico hospital looking to change how it treated patients with hyperglycemia. The change in treatment improved care, reduced lengths of stay and saved the hospital thousands of dollars.

Changing and improving complex processes in healthcare settings arent easy tasks. They require a systems approach using a variety of quality improvement methods and tools. One team at a New Mexico hospital tapped into Six Sigma to improve the way it managed patient glycemia, which in turn improved care and saved thousands of dollars. Glycemia is the presence of glucose circulating in bloodstreams. Hyperglycemia is the excessive amount of glucose and one of the symptoms of diabetes. For those with diabetes, high blood sugar levels can be dangerous and even life-threatening. The traditional way to treat this condition in hospitals and acute-care settings is through sliding-scale insulin managementa retrospective rather than prospective approach. Sliding-scale methods may correct hyperglycemia, but usually they dont prevent its recurrence.1 The regimen consists of short-acting insulineither regular insulin or rapid-acting insulin analogs given four to six times daily based on capillary blood glucose measurements. Basal-bolus insulin therapy, on the other hand, is one of the most advanced insulin replacement therapies.2 It is more flexible than sliding scales and provides physicians more options when matching treatment to patients. Basal-bolus regimen (basal, nutritional and correctional) insulin treatment uses a longacting basal insulin analog (glargine or detemir), combined with a mealtime rapid-acting insulin analog (aspart, glulisine or lispro) and a correction dose of the same rapid-acting insulin analog.

Basal-bolus regimen is more physiologic than sliding-scale insulin, providing full insulin coverage, and also supplements increased basal insulin requirements necessary for sick hospital patients. This affords insulin coverage for meal carbohydrate calories (blood sugar levels increase as carbohydrates are broken down), and it also gives correction insulin for the occurrence of hyperglycemia. Recent clinical trials have shown a comprehensive insulin treatment strategy to be superior to traditional sliding-scale insulin regimens for the treatment of inpatient diabetes.3 The American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) also recommend basal-bolus insulin therapy.4 Another benefit is that this therapy eases the transition to the outpatient practice of basal insulin with oral agents or basal-bolus insulin therapy.

Choosing to change
Presbyterian Hospital in Albuquerque, NM, is an acute- care, 453-bed facility. Three years ago, an inpatient glucose team used Six Sigma to convert the standard insulin practice from sliding scale to basal-bolus insulin. Table 1 lists the Six Sigma quality tools the team used to identify and implement its solutions.

The teams goal was to increase the percentage of patients within the ADA and AACE glycemic goal range of 80 to 180 milligrams per deciliter (mg/dl).5 In addition, the team was tasked with decreasing patients length of stay (LOS) by 0.5 days.

Presbyterian Hospital monitors hospitalwide glucose control levels with a monthly glucometric report. The glucometric report monitors high-level key aspects of glucose management within the hospitalfor example, the percentage of patients managed within the target glucose range.

Choosing the Six Sigma path

To assist with adopting best clinical practices, an organization should understand its existing processes and performance levels before attempting to change the status quo. Presbyterian Hospitals inpatient glucose team used the define, measure, analyze, improve and control (DMAIC) method to structure its work.6 Anticipated resistance to change, known complexity and a previous failed attempt at improvement were some of the reasons the team decided to try Six Sigma on this project. Along with the knowledge from the previous failed attempt, the team decided to use Six Sigma because the method uses statistics and various tools to gain process knowledge and enable process improvement. Six Sigma would give Presbyterian Hospital:

A clear focus on achieving measurable and quantifiable financial returns from this and future Six Sigma projects. An increased emphasis on strong and passionate management leadership and support. A clear commitment to making decisions on the basis of verifiable data, rather than assumptions and guesswork.

The team for the inpatient glucose process excellence project included physicians and administrators, and staff from the areas of nursing, dietary, pharmacy, point of care, information systems and process excellence. The team began its improvement efforts by documenting the high-level process flow and identifying the process customers and stakeholders. The team ranked the stakeholders and conducted more than 90 voice of the customer (VOC) interviews, asking each stakeholder:

What is important to you regarding managing adult inpatient blood glucose in the optimal glycemic range? What are the barriers to managing adult inpatient blood glucose in the optimal glycemic range?

The interviews resulted in 175 VOC comments, which were grouped into common themes and translated into critical to quality (CTQ) attributes by using an affinity diagram. Each CTQ was rated for its overall impact on the percentage of patients managed in the optimal glycemic range. Table 2 lists the nine CTQs identified.

Multiple process issues

Managing insulin in a hospital setting affects many departments and processes. The team identified several process issues during the VOC review and expanded the list by using a

cause and effect diagram. Figure 1 shows the four major categories: patient noncompliance, process issues, sliding scale and protocols, and communication.

The inpatient glucose team proved five root causes using statistical analysis, observation and comparison with best practices. The team implemented 22 solutions to address the root causes. The improvement map in Figure 2 summarizes the root causes and the implemented solutions.

The five root causes were: 1. Insulin management is not standardized or a current best practice. The pharmacy department conducted a 41-point comparison between the existing insulin order sets and the current best practice. Only 24% of the existing order set elements matched the best practice.7 There were clinical and technological barriers in developing the new order set. The electronic order set (I-Form) was developed by the informatics department using the McKesson clinical application. Stakeholder input and dialogue determined the safest transition to basal-bolus regimen was to include two options on the order set. The intent of the options approach was to safely equip providers with insulin choices appropriate for the hyperglycemic patients. For example, patients with stress hyperglycemia that is expected to resolve rapidly might need only correction insulin dosing, whereas patients with preexisting diabetes will require more comprehensive coverage with basal-bolus insulin treatment. Providers also may start with correction dosing and switch to basal-bolus insulin treatment as they learn their patients insulin requirements. Having only two options reduces variation and standardizes care among providers and nursing staff. Option one allows the provider to order correctional insulin with or without long-acting insulin. Option two is deemed the best practice by using basal, nutritional and correctional insulin.

An electronic insulin dosage calculator was developed and linked to option two. Furthermore, the 35 existing insulin order sets were linked to the I-Form, thereby standardizing the entire process. Online Figure 1 is an example of the I-Form, which relays the providers orders across the hospital. The form also allows users to order medications from the pharmacy and tests from the laboratory, acknowledges the patients dietary status and alerts the nurse to the required insulin dosage on his or her handheld medication scanners.

2. Staff knowledge of insulin management is less than 90% of target. An assessment tool using patient scenarios to evaluate staff knowledge was developed. The tool included

three categories: insulin types, dietary requirements and current insulin management practice. A 90% competency requirement was set, but the actual rate was 58%. Presbyterian Hospitals competency rate was similar to that of other facilities.8 Common themes emerged from the staff assessment:

Basal insulin withheld on NPO (nil per os, the Latin translation for "nothing by mouth") patients for fear of hypoglycemia. Lack of understanding of the normal glycemic range. Unclear understanding of cardiac insulin management protocol and medical insulin management protocol. Knowledge deficit regarding the onset and duration of various insulin types. More fear of hypoglycemia than hyperglycemia.

Educational programs were designed to develop critical thinking skills using a variety of media and resources. For nurse training, a computer-based education course was developed with input from all disciplines using videos, interactive learning and patient scenarios. In addition, "insulin road shows" were conducted for all inpatient nursing units. Content included insulin types, diet, standardized order sets, hypoglycemia protocol and the practice of changing insulin administration to scheduled doses in the medication handheld scanners. Hospitalists received individual and group education. A computer-based training course was developed and placed on the hospitals intranet system. 3. Coordination of blood glucose testing with meal delivery is greater than 60 minutes. Observation and convenient sampling were used to determine the cycle time between glucose meter testing and meal delivery. The Presbyterian Hospital standard for capillary glucose testing is 60 minutes prior to nutritional intake. Fifty-two meal deliveries were observed. Breakfast did not meet the standard with a median time of 124.5 minutes, as shown in Figure 3. Lunch and dinner met the standard with median times of 45 and 40 minutes, respectively.

The dietary department standardized all diabetic meals to 60 grams of carbohydrates, including clear and full liquids.9 A diabetic nutrition training video was developed for staff. 4. Glucose meter testing process has significant variations in test results. A measurement system analysis (MSA) was conducted on the glucose meters to distinguish device variation and the process of obtaining the patients capillary blood glucose level. The study was conducted with four patients scheduled to have a capillary and a venous blood draw. The capillary blood glucose result from a tool used to test glucose levels was compared to the laboratory venous blood result from the tester. The difference in results was attributed to the capillary testing process on the nursing units. A standardized process should include: hand hygiene, appropriate finger selection, finger cleaning with alcohol, removing the test strip from the container immediately prior to use, discarding the first drop of blood and completely covering the test strip. Random observations and video recordings of nurse technicians performing glucose meter testing demonstrated multiple process variations. Standardized work, an audit tool and education tools were developed to reduce the process variation.

In particular, nurse technicians were trained on the proper bedside capillary glucose test procedure, which in theory would reduce variation. A video was produced demonstrating the proper testing process. Nurse technicians were required to pass an exam on the procedure with a passing score of 80%. 5. Insulin administered by nurses is 50% less than daily insulin ordered by providers. A sample of 485 provider insulin orders was reviewed, and 54% of the insulin ordered was administered. There were no reasons documented for the 46% insulin not given. The majority of insulin ordered was designated PRN (pro re nata, the Latin translation of "administer as necessary"), therefore no documentation was required. All insulin is now designated as "scheduled" in the nurses medication scanners. This action requires documenting the reasons if not given. A hypoglycemia protocol or standing order was hospital-approved and included in the insulin order set, and automatically populates on the nurses medication scanners as a PRN medication. Insulin guideline pocket cards were developed and distributed to nursing staff for a quick insulin reference.

Change for the better

Implementing the multiple solutions increased the percentage of patients managed in the goal range from 67% to 81%, shown in Figure 4. This reduced the average LOS for patients with diabetes by 0.32 patient days, saving $170,000 in 2010.

Changing the insulin designation from PRN to scheduled doses in the medication scanners reduced the rate of insulin not administered and undocumented from 46% to 6.1%. The dietary services now provide 100% standardized 60-gram carbohydrates per meal, including all clear liquid and full-liquid diets. Presbyterian Hospital has 100% insulin management standardization by linking the 35 existing sliding scales to the new I-Form order set. Ongoing process monitoring includes:

Percentage of patients managed in the optimum glycemic range. Long and short-term insulin usage. Option two usage rate. Percentage of new nursing staff receiving glucose education. Glycemic testing process compliance. Percentage of insulin ordered to administered rate.

Using Six Sigma has allowed the inpatient glucose team to improve multiple processes, resulting in significant blood glucose control. The team increased the percentage of patients in the optimal glycemic range from 67% to 81%. In addition to achieving tighter glycemic control in a larger percentage of patients, the team also lowered the risk for hypoglycemia.

Adapting Six Sigma to an inpatient glucose quality improvement project proved successful because it provided a framework to examine and understand the entire insulin management system within the hospital. The process changes of this project affected all providers, as well as staff in nursing, dietary, laboratory, pharmacy and informatics areas. After six months of use, providers chose option two on the I-Form (strictly basal-bolus insulin treatment) less than 10% of the time; however, total basal insulin usage increased to 40% of all insulin ordered. Going forward, more improvements are planned:
1. Mandate a diabetes training program for all providers who order insulin, focusing on basal-bolus versus sliding-scale therapy. 2. Electronically alert providers to transition patients with pre-existing diabetes and patients with A1C hemoglobin levels >7% from option one (sliding scale) to option two (basal bolus) by the second day of hospitalization. A1C test measures average blood glucose control. 3. Hire a certified nurse practitioner/certified diabetes educator to work with the hospitalist and directly manage patients with blood glucose levels that exceed 300 mg/dl and dip below 60 mg/dl.

Standard operation
The inpatient glucose team at Presbyterian Hospital encountered many obstacles in transitioning from sliding scale to basal-bolus insulin management. Six Sigma principles helped identify the cultural, clinical and technological barriers, and provided the necessary solutions for improvement. With the standardized systems now in place, Presbyterian Hospital will continue to increase the percentage of patients managed within the glycemic goal range.

References and Notes

1. Irl B. Hirsch, "Sliding Scale InsulinTime to Stop Sliding," Journal of the American Medical Association, Jan. 14, 2009, Vol. 301, No. 2, pp. 213-214. 2. E.S. Moghissi and I.B. Hirsch, "Hospital Management of Diabetes," Endocrinology and Metabolism Clinics of North America, March 2005, Vol. 34, No. 1, pp. 99-116. 3. Guillermo E. Umpierrez, M.D., Dawn Smiley, M.D., Ariel Zisman, M.D., Luz M. Prieto, M.D., Andres Palacio, M.D., Miguel Ceron, M.D., Alvaro Puig, M.D., and Roberto Mejia, "Randomized Study of Basal-bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes (RABBIT 2 Trial)," Diabetes Care, Vol. 30, 2007, pp. 2,1812,186. 4. Etie S. Moghissi, M.D., Mary T. Korytkowski, M.D., Monica DiNardo, Daniel Einhorn, M.D., Richard Hellman, M.D., Irl B. Hirsch, M.D., Silvio E. Inzucchi, M.D., Faramarz Ismail-

5. 6. 7.



Beigi, M.D., M. Sue Kirkman, M.D., and Guillermo E. Umpierrez, M.D., "Consensus Statement: Inpatient Hyperglycemia," Endocrine Practice, Vol. 15, No. 4, 2009. Bradley Flansbaum, "Management of Hyperglycemia," Journal of Hospital Medicine, November-December 2006, Vol. 1, No. 6, pp. 382-385. www.isixsigma.com, "What is Six Sigma?" www.isixsigma.com/new-to-sixsigma/getting-started/what-six-sigma. Greg Maynard, M.D., David H. Wesorick, M.D., Cheryl OMalley, M.D., and Silvio E. Inzucchi, M.D., "Subcutaneous Insulin Order Sets and Protocols: Effective Design and Implementation Strategies," Society of Hospital Medicine, Wiley InterScience, 2007 http://deepblue.lib.umich.edu/bitstream/2027.42/61216/1/ 354_ftp.pdf. Daniel J. Rubin, Joan Moshang and Serge A. Jabbour, "Diabetes Knowledge: Are Resident Physicians and Nurses Adequately Prepared to Manage Diabetes?" Endocrine Practice, 2007, Vol. 13, No. 1, pp. 17-21. Michelle Curll, Monica DiNardo, Michelle Noschese and Mary T. Korytkowski, "Menu Selection, Glycemic Control and Satisfaction With Standard and Patient-Controlled Consistent Carbohydrate Meal Plans in Hospitalized Patients With Diabetes," BMJ Quality & Safety, 2009, Vol. 19, pp. 355-359.

Diane Muzenjak is a clinical nurse specialist at Presbyterian Healthcare Services in Albuquerque, NM. She holds a masters degree in nursing, adult health and adult critical care from Florida International University in Miami. She also is a certified nurse practitioner, a certified clinical nurse specialist and a Juran Institute-certified Green Belt. Clark Carboneau is a lean Six Sigma Black Belt at Presbyterian Healthcare Services. He earned a Deming Scholar MBA from Fordham University in New York. Carboneau is a senior member of ASQ and a certified manager of quality/organizational excellence. Robert Galagan, M.D., is an endocrinologist at Presbyterian Healthcare Services. He earned his medical degree from St. Louis University.