Glucometrics: Where Are We Now?

PURPOSE OF REVIEW: Inpatient glucose data analysis, or glucometrics, has developed alongside the growing emphasis on glycemic control in the hospital. Shortcomings in the initial capabilities for glucometrics have pushed advancements in defining meaningful units of measurement and methods for capturing glucose data. This review addresses the growth in glucometrics and ends with its promising new state. RECENT FINDINGS: Standardization, allowing for benchmarking and purposeful comparison, has been a goal of the field. The National Quality Foundation glycemic measures and recently enacted Center for Medicare and Medicaid Services (CMS) electronic quality measures for hypo- and hyperglycemia have allowed for improved integration and consistency. Prior systems have culminated in an upcoming measure from the Center for Disease Control and Prevention's National Healthcare Safety Network. It is poised to create a new gold standard for glucometrics by expanding and refining the CMS metrics, which should empower both local improvement and benchmarking as the program matures.

Management of Individuals With Diabetes at High Risk for Hypoglycemia: An Endocrine Society Clinical Practice Guideline.

CONTEXT: Hypoglycemia in people with diabetes is common, especially in those taking medications such as insulin and sulfonylureas (SU) that place them at higher risk. Hypoglycemia is associated with distress in those with diabetes and their families, medication nonadherence, and disruption of life and work, and it leads to costly emergency department visits and hospitalizations, morbidity, and mortality. OBJECTIVE: To review and update the diabetes-specific parts of the 2009 Evaluation and Management of Adult Hypoglycemic Disorders: Endocrine Society Clinical Practice Guideline and to address developing issues surrounding hypoglycemia in both adults and children living with diabetes. The overriding objectives are to reduce and prevent hypoglycemia. METHODS: A multidisciplinary panel of clinician experts, together with a patient representative, and methodologists with expertise in evidence synthesis and guideline development, identified and prioritized 10 clinical questions related to hypoglycemia in people living with diabetes. Systematic reviews were conducted to address all the questions. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations. RESULTS: The panel agreed on 10 questions specific to hypoglycemia risk and prevention in people with diabetes for which 10 recommendations were made. The guideline includes conditional recommendations for use of real-time continuous glucose monitoring (CGM) and algorithm-driven insulin pumps in people with type 1 diabetes (T1D), use of CGM for outpatients with type 2 diabetes at high risk for hypoglycemia, use of long-acting and rapid-acting insulin analogs, and initiation of and continuation of CGM for select inpatient populations at high risk for hypoglycemia. Strong recommendations were made for structured diabetes education programs for those at high risk for hypoglycemia, use of glucagon preparations that do not require reconstitution vs those that do for managing severe outpatient hypoglycemia for adults and children, use of real-time CGM for individuals with T1D receiving multiple daily injections, and the use of inpatient glycemic management programs leveraging electronic health record data to reduce the risk of hypoglycemia. CONCLUSION: The recommendations are based on the consideration of critical outcomes as well as implementation factors such as feasibility and values and preferences of people with diabetes. These recommendations can be used to inform clinical practice and health care system improvement for this important complication for people living with diabetes.

Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

BACKGROUND: Hospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown. OBJECTIVES: The purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge. METHODS: MARINER (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE). Medically ill patients with a baseline creatinine clearance ≥50 ml/min were randomized in a double-blind fashion to rivaroxaban 10 mg or placebo daily at hospital discharge for 45 days. Exploratory efficacy analyses were performed with the intent-to-treat population including all data through day 45. Time-to-event curves were calculated using the Kaplan-Meier method. A blinded independent committee adjudicated all clinical events. RESULTS: In total, 4,909 patients were assigned to rivaroxaban and 4,913 patients to placebo. The mean age was 67.8 years, 55.5% were men, mean baseline creatinine clearance was 87.8 ml/min, and mean duration of hospitalization was 6.7 days. The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). CONCLUSIONS: Extended-duration rivaroxaban in hospitalized medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding. (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients [MARINER]; NCT02111564).

Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness.

BACKGROUND: Patients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, but the role of extended thromboprophylaxis in the treatment of such patients is a subject of controversy. METHODS: In this randomized, double-blind trial, medically ill patients who were at increased risk for venous thromboembolism on the basis of a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (scores range from 0 to 10, with higher scores indicating a higher risk of venous thromboembolism) or a score of 2 or 3 plus a plasma d-dimer level of more than twice the upper limit of the normal range (defined according to local laboratory criteria) were assigned at hospital discharge to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days. The primary efficacy outcome was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism. The principal safety outcome was major bleeding. RESULTS: Of the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis. The primary efficacy outcome occurred in 50 of 6007 patients (0.83%) who were given rivaroxaban and in 66 of 6012 patients (1.10%) who were given placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P=0.14). The prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients in the rivaroxaban group and 0.42% of patients in the placebo group (hazard ratio, 0.44; 95% CI, 0.22 to 0.89). Major bleeding occurred in 17 of 5982 patients (0.28%) in the rivaroxaban group and in 9 of 5980 patients (0.15%) in the placebo group (hazard ratio, 1.88; 95% CI, 0.84 to 4.23). CONCLUSIONS: Rivaroxaban, given to medical patients for 45 days after hospital discharge, was not associated with a significantly lower risk of symptomatic venous thromboembolism and death due to venous thromboembolism than placebo. The incidence of major bleeding was low. (Funded by Janssen Research and Development; MARINER ClinicalTrials.gov number, NCT02111564 .).

I-PASS Mentored Implementation Handoff Curriculum: Implementation Guide and Resources.

Introduction: Communication failures during shift-to-shift handoffs of patient care have been identified as a leading cause of adverse events in health care institutions. The I-PASS Handoff Program is a comprehensive handoff program that has been shown to decrease rates of medical errors and adverse events. As part of the spread and adaptation of this program, a comprehensive implementation guide was created to assist individuals in the implementation process. Methods: The I-PASS Mentored Implementation Guide grew out of materials created for the original I-PASS Study, Society of Hospital Medicine (SHM) mentored implementation programs, and the experience of members of the I-PASS Study Group. The guide provides a comprehensive framework of all elements required to implement the large-scale I-PASS Handoff Program and contains detailed information on generating institutional support, training activities, a campaign, measuring impact, and sustaining the program. Results: Thirty-two sites across North America utilized the guide as part of the SHM program. The guide served as a main reference for 477 hours of mentoring phone calls between site leads and their mentors. Postprogram surveys from wave 2 sites revealed that 85% (N = 34) of respondents felt the quality of the guide was very good/excellent. Site leads noted that they referenced the guide most often during the early part of the program and that they referenced the sections on the curriculum and handoff observations most often. Discussion: The I-PASS Mentored Implementation Guide is an essential resource for those looking to implement the large-scale I-PASS Handoff Program at their institution.

Improving Glycemic Control Safely in Non-Critical Care Patients: A Collaborative Systems Approach in Nine Hospitals.

BACKGROUND: Practice variations in insulin management and glycemic adverse events led nine Dignity Health hospitals to initiate a collaborative effort to improve hypoglycemia, uncontrolled hyperglycemia, and glycemic control. METHODS: Non-critical care adult inpatients with ≥4 point-of-care blood glucose (BG) readings in a ≥2-day period were included. Balanced glucometric goals for each hospital were individualized to improve performance by 10%-20% from baseline or achieve top performance derived from Society of Hospital Medicine (SHM) benchmarking studies. Baseline measures (2011) were compared to mature results (postintervention, 2014). Protocols for insulin management and hypoglycemia prevention were piloted at one facility and were then spread to the cohort. Interventions included standardized order sets, education, mentoring from physician experts, feedback of metrics, and measure-vention (coupling measurement of patients "off protocol" with concurrent intervention to correct lapses in care). RESULTS: The day-weighted mean BG for the cohort improved by 11.4 mg/dL (95% confidence interval [CI]: 11.0-11.8]; all nine sites improved. Eight of the sites reduced severe hyperglycemic days, and the percentage of patient-days with any BG > 299 mg/dL for the total cohort improved from 11.6% to 8.8% (relative risk, 0.76 [95% CI: 0.74-0.78]). The percentage of patient-days with any BG < 70 mg/dL remained unchanged at 3.6%. Eight of the sites either reduced hypoglycemia by 20% or achieved SHM best-quartile rates. CONCLUSION: Multihospital improvements in glycemic control and severe hyperglycemia without significant increases in hypoglycemia are feasible using portable low-cost toolkits and metrics.

IMPROVING GLYCEMIC CONTROL SAFELY IN CRITICAL CARE PATIENTS: A COLLABORATIVE SYSTEMS APPROACH IN NINE HOSPITALS.

OBJECTIVE: Safely improve glycemic control in the critical care units of nine hospitals. METHODS: Critical care adult inpatients from nine hospitals with ≥4 point-of-care blood glucose (BG) readings over ≥2 days were targeted by collaborative improvement efforts to reduce hyper- and hypoglycemia. Balanced glucometric goals for each hospital were set targeting improvement from baseline or goals deemed desirable from Society of Hospital Medicine (SHM) benchmarking data. Collaborative interventions included standardized insulin infusion protocols, hypoglycemia prevention bundles, audit and feedback, education, and measure-vention (coupling measurement of patients "off protocol" with concurrent interventions to correct suboptimal care). RESULTS: All sites improved glycemic control. Six reached prespecified levels of improvement of the day-weighted mean BG. The day-weighted mean BG for the cohort decreased by 7.7 mg/dL (95% confidence interval [CI], 7.0 mg/dL to 8.4 mg/dL) to 151.3 mg/dL. Six of nine sites showed improvement in the percent intensive care unit (ICU) days with severe hyperglycemia (any BG >299 mg/dL). ICU severe hyperglycemic days declined from 8.6 to 7.2% for the cohort (relative risk, 0.84; 95% CI, 0.80 to 0.88). Patient days with any BG <70 mg/dL were reduced by 0.4% (95% CI, 0.06% to 0.6%), from 4.5 to 4.1%, for a small but statistically significant reduction in hypoglycemia. Seven of nine sites showed improvement. CONCLUSION: Multihospital improvements in ICU glycemic control, severe hyperglycemia, and hypoglycemia are feasible. Balanced goals for glycemic control and hypoglycemia in the ICU using SHM benchmarks and metrics enhanced successful improvement efforts with good staff acceptance and sustainability. ABBREVIATIONS: BG = blood glucose CMI = case-mix index CY = calendar year DKA = diabetic ketoacidosis EMR = electronic medical record GBMF = Gordon and Betty Moore Foundation ICU = intensive care unit IIP = insulin infusion protocol SHM = Society of z Hospital Medicine.

Reducing the incidence of hospital-associated venous thromboembolism within a network of academic hospitals: Findings from five University of California medical centers.

BACKGROUND: Almost 700 patients suffered from hospital-associated venous thromboembolism (HA-VTE) across 5 University of California hospitals in calendar year 2011. OBJECTIVE: Optimize venous thromboembolism (VTE) prophylaxis (VTEP) in adult medical/surgical inpatients and reduce HA-VTE by at least 20% within 3 years. DESIGN: Prospective, unblinded, open-intervention study with historical controls. SETTING: Five independent but cooperating academic hospitals. PATIENTS: All adult medical and surgical inpatients with stays ≥3 days. The baseline year was 2011, 2012 to 2014 were intervention years, and year 2014 was the mature comparison period. VTEP adequacy was assessed with structured chart review of 45 patients per month at each site via random selection beginning partway through the study. HA-VTE was identified by discharge coding, capturing patients readmitted within 30 days of prior VTE-free admit and VTE occurring during index admission. Cases were stratified medical versus surgical and cancer or noncancer. INTERVENTIONS: Interventions included structured order sets with "3-bucket" risk-assessment, measure-vention, techniques to improve reliable administration of VTEP, and education. RESULTS: Adequate prophylaxis reached 89% by early 2014. The rate of HA-VTE fell from 0.90% in 2011 to 0.69% in 2014 (24% relative risk [RR] reduction; RR: 0.76, 95% confidence interval: 0.68-0.852), equivalent to averting 81 pulmonary emboli and 89 deep venous thrombi. VTE rates were highest in cancer and surgical patients. CONCLUSIONS: Hospital systems can reduce HA-VTE by implementing a bundle of active interventions including structured VTEP orders with embedded risk assessment and measure-vention. Journal of Hospital Medicine 2016;11:S22-S28. © 2016 Society of Hospital Medicine.

The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications.

Hospital-associated venous thromboembolism (VTE) is a leading cause of premature death and disability worldwide. Evidence-based guidelines recommend that anticoagulant thromboprophylaxis be given to hospitalised medical patients at risk of VTE, but suggest against routine use of thromboprophylaxis beyond the hospital stay. The MARINER study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of thromboprophylaxis using rivaroxaban, begun at hospital discharge and continued for 45 days, for preventing symptomatic VTE in high-risk medical patients. Eligible patients are identified using the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE VTE) risk score, combined with a laboratory test, D-dimer. The rivaroxaban regimen is 10 mg once daily for patients with CrCl ≥ 50 ml/min, or 7.5 mg once daily for patients with CrCl ≥ 30 ml/min and < 50 ml/min. The primary efficacy outcome is the composite of symptomatic VTE (lower extremity deep-vein thrombosis and non-fatal pulmonary embolism) and VTE-related death. The principal safety outcome is major bleeding. A blinded clinical events committee adjudicates all suspected outcome events. The sample size is event-driven with an estimated total of 8,000 patients to acquire 161 primary outcome events. Study design features that distinguish MARINER from previous and ongoing thromboprophylaxis trials in medically ill patients are: (i) use of a validated risk assessment model (IMPROVE VTE) and D-dimer determination for identifying eligible patients at high risk of VTE, (ii) randomisation at the time of hospital discharge, (iii) a 45-day treatment period and (iv) restriction of the primary efficacy outcome to symptomatic VTE events.

Deep vein thrombosis (DVT) and pulmonary embolism (PE): awareness and prophylaxis practices reported by patients with cancer.

Patients with cancer are at increased risk for venous thromboembolism (VTE). An online survey to measure PE/DVT terminology awareness and understanding of VTE risks revealed 24% and 15% of the 500 cancer patients surveyed had heard of term DVT/PE; 19% and 17% could name signs/ symptoms of DVT/PE; 3% recognized cancer treatments as risk factors for DVT/PE. Only 25% of the patients received prevention education from providers; <50% received VTE prophylaxis. Cancer patient awareness of VTE terminology and cancer and/or its treatment as risk for VTE is low. More effective patient/physician dialogue about VTE risk and thromboprophylaxis is needed.

Using a triggered endocrinology service consultation to improve the evaluation, management, and follow-up of osteoporosis in hip-fracture patients.

BACKGROUND: Nearly 2 million osteoporosis-related fractures occur yearly in the United States, with more than 400,000 requiring hospital admissions. Fewer than 30% receive proper evaluation and care for osteoporosis, representing a large opportunity to enhance secondary prevention of fractures. Methods to improve identification and triage of hospitalized fragility-fracture patients are desirable. METHODS: A multidisciplinary team was created, and definitions were established for an evidence-based best-practice protocol to assess, treat, and document an osteoporosis diagnosis and triage patients with hip-fragility fractures on the basis of the best-practice recommendations from The Joint Commission and the National Osteoporosis Foundation. The team initiated a preauthorized osteoporosis consultation from the endocrinology service for hip-fracture patients, "triggered" via a brief query in admission orders or by the orthopedic service nurse practitioner. Osteoporosis consultations used a consultation template reflecting the protocol. RESULTS: Data were analyzed for 71 baseline patients and 61 intervention patients. The groups possessed similar age, gender, race, and body mass index characteristics. The baseline (on-demand consultation) group suffered from poor performance, with only 3%-21% of patients receiving the desired evaluation, documentation, treatment, or outpatient follow-up. Intervention (triggered-consultation) patients improved markedly postintervention, With performance increasing by 52%-76% on all parameters except outpatient follow-up, which changed insignificantly (6%-15%). CONCLUSION: Although triggered consultation was effective, multimodal layered interventions may achieve even better results and address several identified barriers.

Glycemic control mentored implementation: creating a national network of shared information.

BACKGROUND: The Society of Hospital Medicine's (SHM's) Glycemic Control Mentored Implementation (GCMI) program, which, like all MI programs, is conducted as an improvement collaborative, is intended to help hospitals improve inpatient glycemic control in diabetic and nondiabetic patients by educating and mentoring quality teams. METHODS: Hospital quality improvement (QI) teams applied for participation in GCMI from 2009 through 2012. Accepted sites were assigned either a hospitalist or endocrinologist mentor to work through the life cycle of a QI project. SHM's Implementation Guide, online resources, measurement strategies, Web-based Glycemic Control Data Center for Performance Tracking, webinars, interactive list-serve, and other tools help mentors guide these teams through the program. Mentors in GCMI bring expertise in both inpatient glycemic control and QI. RESULTS: One hundred fourteen hospital QI teams were enrolled into the GCMI program in the course of 2.5 years. Of these 114 sites, 90 completed the program, with 63 of them uploading data to the Data Center. Feedback from the sites was consistently positive, with the listserve, Data Center, and mentorship reported as the top three most effective components of the program. Ninety-five percent of respondents stated that they would recommend participation in an SHM-mentored implementation program to a colleague. Participants reported improved leadership skills and increased institutional support for glycemic control. CONCLUSIONS: Hospital quality teams participating in the GCMI program gained support to overcome barriers, focus on improving glycemic control, network with peers and expert mentor physicians, collect and analyze data, and build quality leaders. The features and structure of this program can be used in other multisite QI goals and projects.

2011 John M. Eisenberg Patient Safety and Quality Awards. Mentored implementation: building leaders and achieving results through a collaborative improvement model. Innovation in patient safety and quality at the national level.

BACKGROUND: The Society of Hospital Medicine (SHM) created "Mentored Implementation" (MI) programs with the dual aims of educating and mentoring hospitalists and their quality improvement (QI) teams and accelerating improvement in the inpatient setting in three signature programs: Venous Thromboembolism (VTE) Prevention, Glycemic Control, and Project BOOST (Better Outcomes for Older adults through Safe Transitions). METHODS: More than 300 hospital improvement teams were enrolled in SHM MI programs in a series of cohorts. Hospitalist mentors worked with individual hospitals/health systems to guide local teams through the life cycle of a QI project. Implementation Guides and comprehensive Web-based "Resource Rooms," as well as the mentor's own experience, provided best-practice definitions, practical implementation tips, measurement strategies, and other tools. E-mail interactions and mentoring were augmented by regularly scheduled teleconferences; group webinars; and, in some instances, a site visit. Performance was tracked in a centralized data tracking center. RESULTS: Preliminary data on all three MI programs show significant improvement in patient outcomes, as well as enhancements of communication and leadership skills of the hospitalists and their QI teams. CONCLUSIONS: Although objective data on outcomes and process measures for the MI program's efficacy remain preliminary at this time, the maturing data tracking system, multiple awards, and early results indicate that the MI programs are successful in providing QI training and accelerating improvement efforts.

Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline.

OBJECTIVE: The aim was to formulate practice guidelines on the management of hyperglycemia in hospitalized patients in the non-critical care setting. PARTICIPANTS: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, six additional experts, and a methodologist. EVIDENCE: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. CONSENSUS PROCESS: One group meeting, several conference calls, and e-mail communications enabled consensus. Endocrine Society members, American Diabetes Association, American Heart Association, American Association of Diabetes Educators, European Society of Endocrinology, and the Society of Hospital Medicine reviewed and commented on preliminary drafts of this guideline. CONCLUSIONS: Hyperglycemia is a common, serious, and costly health care problem in hospitalized patients. Observational and randomized controlled studies indicate that improvement in glycemic control results in lower rates of hospital complications in general medicine and surgery patients. Implementing a standardized sc insulin order set promoting the use of scheduled basal and nutritional insulin therapy is a key intervention in the inpatient management of diabetes. We provide recommendations for practical, achievable, and safe glycemic targets and describe protocols, procedures, and system improvements required to facilitate the achievement of glycemic goals in patients with hyperglycemia and diabetes admitted in non-critical care settings.

Optimizing prevention of hospital-acquired venous thromboembolism (VTE): prospective validation of a VTE risk assessment model.

BACKGROUND: Hospital-acquired (HA) venous thromboembolism (VTE) is a common source of morbidity/mortality. Prophylactic measures are underutilized. Available risk assessment models/protocols are not prospectively validated. OBJECTIVES: Improve VTE prophylaxis, reduce HA VTE, and prospectively validate a VTE risk-assessment model. DESIGN: Observational design. SETTING: Academic medical center. PATIENTS: Adult inpatients on medical/surgical services. INTERVENTIONS: A simple VTE risk assessment linked to a menu of preferred VTE prophylaxis methods, embedded in order sets. Education, audit/feedback, and concurrent identification of nonadherence. MEASUREMENTS: Randomly sampled inpatient audits determined the percent of patients with "adequate" VTE prevention. HA VTE cases were identified concurrently via digital imaging system. Interobserver agreement for VTE risk level and judgment of adequate prophylaxis were calculated from 150 random audits. RESULTS: Interobserver agreement with 5 observers was high (kappa score for VTE risk level = 0.81, and for judgment of "adequate" prophylaxis = 0.90). The percent of patients on adequate prophylaxis improved each of the 3 years (58%, 78%, and 93%; P < 0.001) and reached 98% in the last 6 months of 2007; 361 cases of HA VTE occurred over 3 years. Significant reductions for the risk of HA VTE (risk ratio [RR] = 0.69; 95% confidence interval [CI] = 0.47-0.79) and preventable HA VTE (RR = 0.14; 95% CI = 0.06-0.31) occurred. We detected no increase in heparin-induced thrombocytopenia (HIT) or prophylaxis-related bleeding using administrative data/chart review. CONCLUSIONS: We prospectively validated a VTE risk-assessment/prevention protocol by demonstrating ease of use, good interobserver agreement, and effectiveness. Improved VTE prophylaxis resulted in a substantial reduction in HA VTE.