Targeting Glycemic Control in Non-Critically Ill Patients at a Tertiary Teaching Hospital. Brian Gilbert, Pharm.D. PGY-1 Pharmacy Resident

Transcription

1 Targeting Glycemic Control in Non-Critically Ill Patients at a Tertiary Teaching Hospital Brian Gilbert, Pharm.D. PGY-1 Pharmacy Resident

2 Objectives Discuss rationale for the development of a glycemic control protocol for non-critically ill patients at Jackson Memorial Hospital Describe the glycemic control protocol and study methodology Assess results of the protocol on patient care based on the composite numbers of hyperglycemic and hypoglycemic events

3 Glucose Dysregulation Glucose variability is associated with increased mortality and length of stay (LOS) in the inpatient setting The likelihood of experiencing a hyperglycemic episode during an inpatient admission has been reported to be as high as 46% in non-critically ill patients Strict glucose control has been associated with increased morbidity and mortality due to increased hypoglycemic events Many factors can contribute to a patient s dysregulation in blood glucose during a hospital admission Jt Comm J Qual Patient Saf. 2015;41(7): J Diabetes Complications Jul-Aug;28(4):427-9.

4 Jackson Memorial Hospital (JMH) JMH participates in Hospital Engagement Network to reduce hypoglycemic events in patients receiving insulin or other hypoglycemic agents According to Centers for Medicare and Medicaid Services (CMS) the rate of hypoglycemia and hyperglycemia must be reported Protocol development mandated by JMH Hypoglycemia Taskforce Members of taskforce active within protocol development

5 Objective To investigate if implementation of a glycemic control protocol will result in less episodes of dysglycemia

6 Definitions Basal insulin: glargine ; NPH Prandial insulin: lispro; regular insulin Correctional insulin: lispro; regular insulin Hyperglycemia: Fasting plasma glucose (FPG)/ pre-meal > 140 mg/dl Random/ 2 hours post prandial > 200 mg/dl Average daily blood glucose > 200 mg/dl Hypoglycemia : any glucose value < 70 mg/dl WNL: within normal limits POC: point of care BG: blood glucose

7 Protocol Development Consultation with endocrinologist Evaluation of current practice Literature evaluation RABBIT Studies 2007 Medical patients 2011 Medical surgical patients Diabetes Care Sep;30(9): Diabetes Care Feb;34(2):

8 Study Design Prospective quasi experimental pre- and postintervention study Primary endpoint: composite of both hypo/hyperglycemic episodes

9 Secondary Endpoints Number of hyperglycemic episodes Number of hypoglycemic episodes Average daily blood glucose Infectious complications Length of stay Daily insulin requirements Discharge diabetic regimens Number of hypoglycemia rescue medications administered Number of patients re-admitted Safety analysis

10 Inclusion Criteria Internal Medicine patients 18 years or older At least 3 hyperglycemic events in a 48-hour period or an average daily BG greater than 200 mg/dl Patients who have at least 1 hypoglycemic event

11 Exclusion Criteria DKA on admission Type 1 diabetes Patients on hemodialysis/ CVVHD Patients being treated with U 500 insulin Patients expected to require ICU level care Patients expected to require surgery during admission

12 Statistics Primary endpoint: Composite difference of dysglycemic episodes pre and post intervention Wilcoxon s signed-rank test Secondary endpoints: Wilcoxon s signed-rank test and student t- test Baseline demographics: Student s t-test Power= 80% ; α= 0.05 Sample size: 500 total dysglycemic events Difference to detect= x σ

13 Demographics *10 pre-protocol study participants no A1c ordered during admission **9 study participants ordered A1c during admission at suggestion of intervening pharmacist

14 Dysglycemic Events p= Pre-Protocol Protocol Group

15 Hyperglycemic Events Pre-Protocol Group 217 Protocol Group p=0.52

16 Hypoglycemic Events Pre-Protocol Group 5 p=0.89 Protocol Group

17 Secondary Endpoints

18 Study Limitations Unblinded/non-randomized Disease state variability Point of care optimization Seasonal variations in patients being admitted Assumption that patients are strictly abiding to food preparations provided by staff

19 Conclusions The use of a glycemic control protocol was not statistically significant in reducing the composite number of dysglycemic events Average daily blood glucose values and average AM blood glucose values were lower in the protocol group The utilization of long acting insulin glargine was statistically higher in the protocol group There were positive trends in number of hypo/hyperglycemic events and number of patients re-admitted within 30 days in favor of the protocol group

20 Action Plan Operationalize the glycemic control protocol at JMH Perform a DUE on protocol utility after 3 months Implement protocol in patient care units with the highest dysglycemia rates Educate patients and health care providers on protocol utility and purpose

21 Learning Assessment True/False: Hyperglycemia is associated with poor patient outcomes True/False: CMS monitors the rates of hyperglycemia and hypoglycemia True/False: Many factors contribute to dysglycemia

22 References Armor BL, Britton ML, Dennis VC, Letassy NA. A review of pharmacist contributions to diabetes care in the United States. J Pharm Pract Jun;23(3): Flory JH, Aleman JO, Furst J, Seley JJ. Basal Insulin Use in the Non-Critical Care Setting: Is Fasting Hypoglycemia Inevitable or Preventable? J Diabetes Sci Technol Jan 21;8(2): Hermayer KL, Loftley AS, Reddy S, Narla SN, Epps NA, Zhu Y. Challenges of inpatient blood glucose monitoring: standards, methods, and devices to measure blood glucose. Curr Diab Rep Mar;15(3):10. Nkansah NT, Brewer JM, Connors R, Shermock KM. Clinical outcomes of patients with diabetes mellitus receiving medication management by pharmacists in an urban private physician practice. Am J Health Syst Pharm Jan 15;65(2): Rochester CD, Leon N, Dombrowski R, Haines ST. Collaborative drug therapy management for initiating and adjusting insulin therapy in patients with type 2 diabetes mellitus. Am J Health Syst Pharm Jan 1;67(1):42-8. Mathioudakis N, Golden SH. A comparison of inpatient glucose management guidelines: implications for patient safety and quality. Curr Diab Rep Mar;15(3):13. Rajendran R, Kerry C, Round RM, Barker S, Scott A, Rayman G. Impact of the Diabetes Inpatient Care and Education (DICE) project and the DICE Care Pathway on patient outcomes and trainee doctor's knowledge and confidence. Diabet Med Jul;32(7): Kerry C, Mitchell S, Sharma S, Scott A, Rayman G. Diurnal temporal patterns of hypoglycaemia in hospitalized people with diabetes may reveal potentially correctable factors. Diabet Med Dec;30(12): Kelly JL. Ensuring optimal insulin utilization in the hospital setting: role of the pharmacist. Am J Health Syst Pharm Aug;67(16 Suppl 8):S9-16. doi: /ajhp Erratum in: Am J Health Syst Pharm Nov 1;67(21):1794. Deal EN, Liu A, Wise LL, Honick KA, Tobin GS. Inpatient insulin orders: are patients getting what is prescribed? J Hosp Med Nov;6(9):526-9.

23 References Newton CA, Young S. Financial implications of glycemic control: results of an inpatient diabetes management program. Endocr Pract Jul-Aug;12 Suppl 3:43-8. Murad MH, Coburn JA, Coto-Yglesias F, Dzyubak S, Hazem A, Lane MA, Prokop LJ, Montori VM. Glycemic control in noncritically ill hospitalized patients: a systematic review and meta-analysis. J Clin Endocrinol Metab Jan;97(1): Pasala S, Dendy JA, Chockalingam V, Meadows RY. An inpatient hypoglycemia committee: development, successful implementation, and impact on patient safety. Ochsner J Fall;13(3): Mathioudakis N, Pronovost PJ, Cosgrove SE, Hager D, Golden SH. Modeling Inpatient Glucose Management Programs on Hospital Infection Control Programs: An Infrastructural Model of Excellence. Jt Comm J Qual Patient Saf. 2015;41(7): Kilpatrick CR, Elliott MB, Pratt E, Schafers SJ, Blackburn MC, Heard K, McGill JB, Thoelke M, Tobin GS. Prevention of inpatient hypoglycemia with a real-time informatics alert. J Hosp Med Oct;9(10): Umpierrez GE, Kosiborod M. Inpatient dysglycemia and clinical outcomes: association or causation? J Diabetes Complications Jul-Aug;28(4): Kilpatrick CR, Elliott MB, Pratt E, Schafers SJ, Blackburn MC, Heard K, McGill JB, Thoelke M, Tobin GS. Prevention of inpatient hypoglycemia with a real-time informatics alert. J Hosp Med Oct;9(10): Braithwaite SS. Process Performance Measures for Inpatient Glucose Management Programs. Jt Comm J Qual Patient Saf. 2015;41(7): Beliard R, Muzykovsky K, Vincent W 3rd, Shah B, Davanos E. Perceptions, Barriers, and Knowledge of Inpatient Glycemic Control: A Survey of Health Care Workers. J Pharm Pract Jan 20. Gilden JL, Gupta A. Non-ICU hospital care of diabetes mellitus in the elderly population. Curr Diab Rep May;15(5):26 Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care Sep;30(9): Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care Feb;34(2):

24 Targeting Glycemic Control in Non-Critically Ill Patients at a Tertiary Teaching Hospital Brian Gilbert, Pharm.D. PGY-1 Pharmacy Resident