Carol L. Delville
The University of Texas at Austin School of Nursing
1710 Red River, Austin, TX 78712
Phone: (512) 791-0817 Fax: (512) 471-3688 Email: firstname.lastname@example.org
The authors report no relevant financial relationships.
Diabetes represents one of the largest areas of health care spending in the United States. Severe hypoglycemic episodes (defined as blood glucose levels <70 mg/dL) require the assistance of a health care provider to treat. Hypoglycemic events can have catastrophic outcomes, including seizure, coma, long-term disability, and, if left untreated, death. For decades, glucagon has been an effective rescue medication for severe hypoglycemic episodes. Nurses are educated to assess and intervene when hypoglycemia occurs. Standing orders for hypoglycemia treatment may prevent or delay the treatment of hypoglycemia. To address hypoglycemia in long-term care (LTC), a quality improvement team of Adult-Gerontology Clinical Nurse Specialist students utilized the Plan-Do-Study-Act cycle, creating a glucagon protocol to treat hypoglycemia in LTC. The intention of this project was to reduce hypoglycemia treatment delay, prevent unnecessary emergency medical services (EMS) transports/hospitalizations, and prevent hypoglycemia complications. In the 3-month baseline, 15 hypoglycemic episodes resulted in two EMS transports. In the 3-month post-protocol implementation, seven hypoglycemic episodes occurred with no EMS transports. The decrease in EMS transports was clinically significant and represents cost savings and a reduction in resident burden from hospital transfer
Key words: glucagon, hypoglycemia, long-term care, diabetes, evidence-based protocol, guidelines
Diabetes is one of the largest health threats to Americans and to the US health care system. Approximately $322 billion is spent annually on diabetes care, representing 1 of every 5 total health care dollars and 1 of every 3 Medicare dollars.1 The Centers for Disease Control and Prevention reports that more than 29 million people in the United States have diabetes and another 86 million have prediabetes.2
Glucose is the primary fuel source for the body and is critical for normal brain function.3 Hypoglycemia—a dangerous condition that manifests as a vicious progression of sympathetic nervous system activation, altered mental status, seizure, coma, and, if left untreated, brain damage and death3-5—is generally defined as a blood glucose level below 70 mg/dL.6 Bree et al7 define severe hypoglycemia as a “low blood sugar event that requires the assistance of another person” to reverse the progression toward death. According to Pasala et al,8 the signs and symptoms of hypoglycemia first present in patients when their blood glucose levels reach 60 mg/dL and increase in severity as their levels fall to 50 mg/dL, with the most dangerous effects occurring at blood glucose levels below 40 mg/dL. Patients with diabetes who experience repeated hypoglycemic episodes over their lifetime lose the ability to perceive these symptoms, which places them at a higher risk for subsequent potentially devastating hypoglycemic events.9
Between 2004 and 2008, the average cost of being treated and discharged from an emergency department for hypoglycemia was $1386.80, with the average cost of an inpatient stay reported as being $17,564.10 By 2009, these costs increased almost 300% to an average of $46,000 per patient, 66% to 77% of which was paid for by Medicare.11 Most patients who require emergency services for hypoglycemia live in urban areas in southern United States and are publicly funded.12 Additional factors that place a patient at an especially high risk for severe hypoglycemia include advanced age, recent hospitalization, and polypharmacy, all of which are common characteristics of the long-term care (LTC) population.13
As far back as 2009, the National Quality Forum has specifically recommended that health care facilities undertake “actions to improve glycemic control by implementing evidence-based intervention practices that prevent hypoglycemia and optimize the care of patients with hyperglycemia and diabetes.”14 Similarly, the European Diabetes Working Party for Older People advocates for the need for well-structured shared protocols for diabetes management.15 Multiple guidelines for the treatment of hypoglycemia exist, but an evidenced-based algorithm for nurses in LTC to support a standardized order set was not identified in the literature.
Organizations such as the American Association of Clinical Endocrinologists (AACE) with the American College of Endocrinology (ACE), the American Diabetes Association (ADA), the Canadian Diabetes Association (CDA), The Endocrine Society (TES), and the National Health Service (NHS) have published guidelines recommending the use of intravenous (IV) glucose or intramuscular (IM)/subcutaneous (SC) glucagon to treat severe hypoglycemia.6,16-19 Glucagon injections are recognized as a rescue agent for patients with severe hypoglycemia and are efficacious by converting glycogen in the liver into usable glucose.20-22 This provides a transient boost in glucose levels, improving mental and functional ability so that the patient and caregiver can further stabilize the imbalance by eating or feeding. The time from injection of glucagon to action is approximately 10 to 15 minutes. Side effects such as nausea and vomiting are rare; such side effects may also occur with hypoglycemia.23 In an unresponsive patient or one who is unable to take oral glucose supplements, glucagon has been identified as the best option for severe hypoglycemia in nonhospital environments.21
By definition, standing orders with supporting protocols are written documents that direct nonphysician health care personnel to provide safe and efficacious medical care within predefined parameters without the physician being immediately present and available.24 The Joint Commission recognizes the value of nurse-driven standing orders in promoting patient outcomes.25 Areas in which standing orders for nurses have shown improved outcomes include vaccination rates,26-29 HIV testing,30 treatment of skin infection and allergic anaphylaxis,31-33 and expediting life-saving care such as emergency department triage.34 Researchers have published extensive support for standing orders in diabetes management.35-37
At an urban rehabilitation/skilled nursing LTC facility in Central Texas, approximately 39% of residents were diagnosed with diabetes. According to Thomas McDowell, PhD, chief administrative officer of the skilled-nursing facility (personal communication, August 2016), between June 1, 2016 and August 31, 2016, 15 of these residents reported hypoglycemic episodes, 2 of which resulted in emergency medical services (EMS) transport. When hypoglycemia was noted prior to this quality improvement (QI) project, the nursing staff was required to contact the residents’ health care providers (physician or advanced practice nurse) to directly authorize interventions that would correct the hypoglycemia or to activate EMS. If the providers did not immediately respond, the facility contacted EMS to transport the resident to an emergency department for evaluation and treatment. This process incurred potentially unnecessary costs to the facility, residents, and insurance payors. Activation of EMS and hospitalizations for the treatment of hypoglycemia have been associated with higher risks of complications, longer and costlier hospital stays, and increased mortality and morbidity.38-40
The purpose of this QI project was to determine whether a protocol with a standing order for injectable glucagon and appropriate aftercare to treat severe hypoglycemia in residents at this central Texas LTC facility could reduce the utilization of external health care resources over a 3-month period compared with a 3-month baseline. Benefits to standing glucagon orders for hypoglycemia include reduced treatment delay, improved patient outcomes, and facility staff empowerment by directly providing life-saving care. According to Kedia, “The risks associated with glucagon use are lower than those associated with severe hypoglycemia, plus glucagon can lead to a faster recovery than calling for paramedics and waiting for them to start an IV line to give dextrose.”21 It was hypothesized that, by providing the facility nurses with the means to treat hypoglycemic episodes with glucagon, the overall rates of hypoglycemia-related 911 calls, EMS transports, and hospitalizations would decrease and financial and patient outcomes would improve.
To inform this QI project, supportive literature specific to either glucagon use or glycemic management in the LTC population with relevant findings and information was examined. A search was conducted on Medline and PubMed for full-text, peer-reviewed studies published within the last 5 years (2012-2017) using the search terms “hypoglycemia,” “protocol,” and “nurse.” No studies were identified when including the terms “long-term care” or “nursing home and hypoglycemia,” and “protocol and nurse.”
The search returned 33 articles. Articles were excluded for the following reasons: no mention of glucagon (8), intensive care setting (6), computer technology focused (4), infants (2), interdisciplinary collaboration team (not treatment; 2), hypoglycemia monitoring tool (1), review (1), and a virtual trial (1). No article was specific to the use of glucagon or the management of hypoglycemia in an LTC setting. The articles included demonstrated the use of a glycemic protocol and/or resulted in improved nurse knowledge/resources for the treatment of hypoglycemia, improved glycemic control, and/or reduced hypoglycemic episodes.
Use of a Glycemic Protocol
Bansal and associates41 evaluated a nurse-led insulin infusion protocol’s effectiveness on glycemic control in 1675 post-cardiac surgery intensive care unit (ICU) patients. This team reported, “Despite the simplicity in implementing the protocol, the glycemic control improved significantly without increase in hypoglycemic episodes.” Dodson et al42 studied the effectiveness of a nurse-driven ICU hyperglycemia protocol on glycemic control. The sample consisted of 42 medical ICU patients. Investigators reported a need for future research, but that “the use of this protocol may reduce hypoglycemia rates as well as maintaining overall good glycemic control within this setting.” Hargraves43 evaluated the safety and efficacy of an evidenced-based insulin infusion protocol. In a sample of 76 post-cardiac surgery patients, the author reports that the incidence of hypoglycemia was significantly reduced after implementation of the protocol. Sabouhi et al44 studied the impact of an insulin infusion protocol on blood glucose level and outcomes in 64 patients with diabetes with acute coronary syndrome. They reported increased glycemic control, but no statistically significant difference in the number of hypoglycemic episodes.
These studies suggest that nurse-driven protocols are effective in improving glycemic control and/or reducing hypoglycemia in their respective study populations. It is likely that a nurse-driven protocol would also be effective in reducing hypoglycemia in other populations, such as LTC.
Improved Nurse Knowledge/Resources for Treatment of Hypoglycemia
Engvall et al45 sought to evaluate the effectiveness of education of 113 medical surgical unit nurses in diabetes management. They noted baseline gaps in knowledge of diabetes, leading to the development and implementation of a hypoglycemia management protocol. Ninety percent of nurses reported improved hypoglycemia treatment in their patients.45 Segal et al46 compared the efficacy and safety of a nurse-guided protocol and physician-guided treatment for glycemic control in 53 noncritically ill adults with type 2 diabetes admitted to an internal medicine ward. Their findings demonstrated that a nurse-guided protocol is noninferior to physician-guided treatment in efficacy and safety parameters. Both studies demonstrate that nurse-driven protocols are effective in maintaining glycemic control and/or in reducing hypoglycemic events.
Improved Glycemic Control
Osman et al47 found limited available evidence specific to diabetes management in LTC. This team studied the current glycemic management practices of frail elderly patients with diabetes in LTC facilities using survey responses from 30 medical directors and 9 attending physicians. They concluded that further research is needed to “assess the distinct needs and considerations of this unique population and health care setting.”47 Feldman et al48 used the same method to examine diabetes management in 13 LTC facilities in 6 states. They concluded that “the development of protocols and tools embracing the latest strategies and treatment algorithms for the management of DM [diabetes mellitus] in the geriatric resident are necessary.”48
Reduced Hypoglycemic Episodes
Kedia21 identified glucagon as a safe and efficacious first-line treatment for severe hypoglycemia, noting that glucagon is the only treatment for severe hypoglycemic events that can be used in nonhospital settings.” Glucagon does not have to be administered by a qualified health care professional, does not require an IV, and can be administered via IM or SC injection, which can reduce the number of severe hypoglycemia-related hospital admissions and health care resources.21
This literature strongly supports the development and testing of a protocol in LTC, specifically the use of glucagon as part of the protocol intervention for severe hypoglycemia in LTC residents unable to take oral glucose supplements.
Creation and Approval of Protocol
The institute for Healthcare Improvement’s Plan-Do-Study-Act cycle quality improvement process was implemented by a team of Adult-Gerontology Clinical Nurse Specialist students (AGCN-S) to address hypoglycemia in LTC. The Plan-Do-Study-Act worksheet was designed to develop a plan to test change (Plan), implement the plan (Do), examine the results of the intervention (Study) and determine if further modification should be made (ACT).49
An evidence-based protocol/algorithm (Figure 1) was created through the synthesis of diabetes guidelines published by the AACE/ACE, ADA, NHS, CDA, and TES, with local input from nursing, pharmacy, and administration (Table 1).6,16-19 The algorithm and supporting literature were presented by the AGCN-S team to the LTC facility’s QI team, including the chief medical officer, facility director, director of nursing, pharmacist, social worker, 2 collaborating physicians, 2 advanced practice nurses, and consulting psychiatry team. The QI team reviewed the literature and met 2 weeks later, approving the algorithm for the management of hypoglycemic episodes throughout the facility. A standing order was created (ie, “resident has diabetes mellites, for blood glucose <70 mg/dL implement hypoglycemia protocol”) and the algorithm was attached to the standing order and was signed by the health care provider. This generated the addition of the algorithm into the resident’s medication records and a pharmacy order. Glucagon was stored on the emergency cart and in the locked drawer of medication carts.
A hypoglycemia protocol containing the algorithm was created with the stipulation that there would be a monthly review of all hypoglycemic episodes in the quality and safety meeting, an annual review of the algorithm by the QI team, and annual training reinforcement for the nursing staff. Copies of the protocol were posted on each medication cart, the medication room, and the nursing station. Incidences of hypoglycemia were added to the daily director of nursing report for review of adherence to protocol and outcome of the algorithm’s implementation, and were included in monthly QI meetings.
This protocol (Figure 1) allowed the nursing staff to administer glucagon without the need to call the resident’s health care provider prior to administration. A 30-minute training session on signs, symptoms, and treatment of hypoglycemia was provided to the nursing staff that included information on how to use the hypoglycemic algorithm and glucagon. This was followed by 2 evolving case studies (one in a resident that could take oral glucose and one who could not) that required the nursing staff to use the algorithm to address a hypoglycemic episode. All nursing staff (registered nurses=4, licensed vocational nurses=21) correctly completed the case studies addressing hypoglycemia. The case studies are used as part of the annual competency checklist for the hypoglycemia protocol.
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The QI project design was quasi-experimental due to fluctuations in resident and staff populations. The primary measurements collected from facility reports were admissions, discharges, hypoglycemic events, and EMS transfers. Individual patient data included demographics, diagnoses, and glucose logs collected from the patient record system.
Documentation of these measures were completed by facility staff via the following redundant methods: nurses are required to complete a transfer form, which was filed in the resident’s medical record when a resident was discharged via EMS; discharges via EMS were recorded in the director of nursing’s daily report; and EMS discharges were reviewed by the monthly Minimum Data Set staff. Data were collected 3 months prior to intervention (June 1, 2016 through August 31, 2016) and 3 months post-intervention (January 1, 2017 through March 31, 2017). At the end of the intervention period, data were analyzed by the AGCN-S team with faculty supervision for final review and evaluation using IBM SPSS Statistics version 24.
Data Analysis and Results
All data were recorded in Microsoft Excel and presented as percentages and means. Data were collected on 71 residents throughout the course of the project. Although there was monthly fluctuation in the sample population (ie, 6 residents were discharged/lost to follow-up vs 13 admissions), the frequency of residents with diabetes per overall population remained stable (33%), with a mean monthly resident population of 65 ± 3.37. The sample of residents consisted of 53 individuals without diabetes, with a mean age of 72.87 (standard deviation [SD], 15.53) and 26 invidivuals with diabetes (mean age, 69.15; SD, 14.49).
Primary data analysis compared the number of facility transfers/discharges for hypoglycemia over 3 months after implementation of the protocol with baseline. In the 26 residents with diabetes at baseline, 15 reported hypoglycemic episodes resulted in 2 EMS transports. In the 3 months post-protocol implementation, 7 reported episodes of hypoglycemia were recorded, none resulting in EMS transports. A paired t test (IBM SPSS Statistics, version 24) was conducted to compare the rates of EMS transport, with no significant change in the rate of EMS-related transfers at baseline (M=0.08; SD=0.277) and post-protocol (M=0.00; SD=0.00); t(1.445), P=.16. This analysis is not statistically significant due to the limitations of the sample size and the short data collection time frame.
In the seminal work Crossing the Quality Chasm: A New Health System for the 21st Century, the Institute of Medicine encourages the development of innovative approaches to facilitate the goals of providing safe, effective, patient-centered, timely, efficient, and equitable care.50 This QI project sought to examine how authorizing nurses to provide the timely treatment of severe hypoglycemic episodes with the implementation of a provider-approved standing order protocol could impact the utilization of external health care resources and control overall costs.
In summary, between the June 1, 2016 and August 31, 2016 baseline period, 15 hypoglycemic episodes resulted in 2 EMS transports. Between the January 2017 to March 2017 post-protocol implementation, 7 hypoglycemic episodes occurred with no EMS transports. The decrease in EMS transports was clinically significant and represents cost savings and a reduction in resident burden from hospital transfer. Although the study did not achieve statistical significance, there was strong clinical significance based on the reduction of resident transfer from the LTC facility by EMS for the treatment of severe hypoglycemia observed after the implementation of the standardized glucagon protocol. Baseline data revealed 2 discharges to the hospital prior to this QI intervention and no discharges after protocol implementation. Confounding factors such as increased vigilance may have influenced this data; however, this only lends support that a standardized hypoglycemia protocol promotes improved outcomes.
Severe hypoglycemia in the LTC population can result in unnecessary health care costs and risks for negative outcomes related to hypoglycemic episodes.11,13,38-40 An easy-to-use rescue method for severe hypoglycemia includes IM/SC injection of glucagon to raise glucose levels.21 This newly developed protocol for hypoglycemia management provides facility nurses with the authorization to administer glucagon to residents with hypoglycemia and then follow up with the health care provider. Use of this protocol can potentially reduce costs, decrease delays in care, and improve outcomes for residents.
While there is substantial evidence in the literature indicating that nurse-driven protocols provide improved outcomes in various patient populations,41-44 there is a paucity of evidence related to nurse-driven hypoglycemia protocols in LTC settings. It is strongly recommended that more robust trials and projects be implemented to further explore the efficacy of this nurse-driven protocol and its impact on patient safety and outcomes.
Internal validity of project measures were influenced by the level of education and experience of staff nurses related to the identification of and treatment for hypoglycemia; differences among the brands, models, and calibration settings of glucometers; and appropriate documentation of hypoglycemic events and the interventions performed. External validity was limited by population and setting, as this LTC facility had a varied population of adult residents. Therefore, these results may not be applicable to certain populations, such as pediatrics or other geographic groups.
The aim of this project was to determine whether a protocol with a standing order for injectable glucagon and appropriate aftercare to treat severe hypoglycemia in residents could reduce the utilization of external health care resources. There was a clinical significant decrease in EMS transports that represented cost savings and a reduction in resident burden from hospital transfer. This study lends support that a standardized hypoglycemia protocol promotes improved outcomes.
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