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.

Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness.

Background Venous thromboembolism (VTE) often occurs after hospitalization in medically ill patients, but the population benefit-risk of extended thromboprophylaxis remains uncertain. Methods and Results The MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) study (NCT02111564) was a randomized double-blind trial that compared thromboprophylaxis with rivaroxaban 10 mg daily versus placebo for 45 days after hospital discharge in medically ill patients with a creatinine clearance ≥50 mL/min. The benefit-risk balance in this population was quantified by calculating the between-treatment rate differences in efficacy and safety end points per 10 000 patients treated. Clinical characteristics of the study population were consistent with a hospitalized medical population at risk for VTE. Treating 10 000 patients with rivaroxaban resulted in 32.5 fewer symptomatic VTE and VTE-related deaths but was associated with 8 additional major bleeding events. The treatment benefit was driven by the prevention of nonfatal symptomatic VTE (26 fewer events). There was no between-treatment difference in the composite of critical site or fatal bleeding. Conclusions Extending thromboprophylaxis with rivaroxaban for 45 days after hospitalization provides a positive benefit-risk balance in medically ill patients at risk for VTE who are not at high risk for bleeding. Registration URL: https://clinicaltrials.gov/; Unique identifier: NCT02111564.

Rivaroxaban Plus Aspirin for Extended Thromboprophylaxis in Acutely Ill Medical Patients: Insights from the MARINER Trial.

Background The MARINER trial evaluated whether postdischarge thromboprophylaxis with rivaroxaban could reduce the primary outcome of symptomatic venous thromboembolism (VTE) or VTE-related death in acutely ill medical patients at risk for VTE. Although aspirin use was not randomized, approximately half of the enrolled patients were receiving aspirin at baseline. We hypothesized that thromboprophylaxis with once-daily rivaroxaban (10 mg or, if creatinine clearance was 30-49 mL/min, 7.5 mg) plus aspirin (R/A) would be superior to placebo without aspirin (no thromboprophylaxis [no TP]). Methods We compared the primary and major secondary outcomes in the intention-to-treat population in four subgroups defined at baseline: (1) R/A ( N = 3,159); (2) rivaroxaban alone ( N = 2,848); (3) aspirin alone ( N = 3,046); and (4) no TP ( N = 2,966). Major bleeding (MB) and nonmajor clinically relevant (NMCR) bleeding were assessed in the safety population on treatment plus 2 days. Results Patients on R/A had reduced symptomatic VTE and VTE-related death compared with no TP (0.76 vs 1.28%, p = 0.042), and experienced less symptomatic VTE and all-cause mortality ( p = 0.005) and all-cause mortality alone ( p = 0.01) compared with no TP. Event incidences for rivaroxaban alone (0.91%) or aspirin alone (0.92%) were similar. MB was low in all groups but lowest in the no TP group. NMCR bleeding was increased with R/A compared with no TP ( p = 0.009). Limitations Aspirin use was not randomized. Conclusion Extended postdischarge thromboprophylaxis with R/A was associated with less symptomatic VTE and VTE-related death compared with no TP in previously hospitalized medical patients at risk for VTE. NMCR bleeding was increased with R/A compared with no TP. These post hoc findings need confirmation in a prospective trial.

Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials.

BACKGROUND: Extended thromboprophylaxis has not been widely implemented in acutely ill medical patients because of bleeding concerns. The MAGELLAN (Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin) and MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) trials evaluated whether rivaroxaban compared with enoxaparin or placebo could prevent venous thromboembolism without increased bleeding. We hypothesized that patients with major bleeding but not those with nonmajor clinically relevant bleeding would be at an increased risk of all-cause mortality (ACM). METHODS: We evaluated all bleeding events in patients taking at least 1 dose of study drug and their association with ACM in 4 mutually exclusive groups: (1) no bleeding, or first event was (2) nonmajor clinically relevant bleeding, (3) major bleeding, or (4) trivial bleeding. Using a Cox proportional hazards model adjusted for differences in baseline characteristics associated with ACM, we assessed the risk of ACM after such events. RESULTS: Compared with patients with no bleeding, the risk of ACM for patients with nonmajor clinically relevant bleeding was not increased in MARINER (hazard ratio, 0.43; P=0.235) but was increased in MAGELLAN (hazard ratio, 1.74; P=0.021). Major bleeding was associated with a higher incidence of ACM in both studies, whereas trivial bleeding was not associated with ACM in either study. CONCLUSIONS: Patients with major bleeding had an increased risk of ACM, whereas nonmajor clinically relevant bleeding was not consistently associated with an increased risk of death. These results inform the risk-benefit calculus of extended thromboprophylaxis in medically ill patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: MAGELLAN, NCT00571649. URL: https://www. CLINICALTRIALS: gov; Unique identifier: MARINER, NCT02111564.

Rivaroxaban for extended thromboprophylaxis in acutely ill medical patients 75 years of age or older.

BACKGROUND: Although older patients are at increased risk for venous thromboembolism (VTE), thromboprophylaxis is underused because of bleeding concerns. The MARINER trial evaluated whether rivaroxaban reduced symptomatic postdischarge VTE in acutely ill medical patients. OBJECTIVES: We hypothesized that rivaroxaban would have a favorable benefit/risk profile in patients ≥75 years of age. METHODS: Patients were randomized in a double-blind manner at hospital discharge to rivaroxaban (10 mg/day for creatinine clearance ≥50 ml/min; 7.5 mg/day for ≥30-<50 ml/min) or placebo for 45 days. Using a Cox proportional hazard model including treatment as a covariate, we compared the risk of the primary efficacy outcome (symptomatic VTE plus VTE-related death in the intention-to-treat population) and safety outcome (International Society on Thrombosis and Haemostasis major bleeding in the safety population) in the prespecified subgroups of patients ≥ and <75 years of age. RESULTS: The primary event rate in patients ≥75 years of age was 2-fold higher than that in those <75 years. The incidence of the primary efficacy outcomes in both age groups was numerically lower with rivaroxaban than with placebo (≥75: 1.2% and 1.6%, HR 0.73, 95% CI 0.43-1.22; <75 0.6% and 0.8%, HR 0.78, 95% CI 0.46-1.32; interaction p-value for age group = .85). The incidence of major bleeding was low and similar in the two age and treatment groups (interaction p value for age group = .35). CONCLUSION: Symptomatic VTE and VTE-related death occur frequently in older patients with acute medical illness. The benefit/risk profile of rivaroxaban in patients ≥75 years of age appears consistent with that observed in the general population.

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 .).

Impact of a Multicenter, Mentored Quality Collaborative on Hospital-Associated Venous Thromboembolism.

BACKGROUND: Reliable prophylaxis of hospitalassociated venous thromboembolism (HA-VTE) is not achieved in many hospitals. Efforts to improve prophylaxis have had uneven results. OBJECTIVE: To reduce HA-VTE with a scalable quality improvement collaborative. DESIGN: A prospective, unblinded, open-intervention study with historical controls. PARTICIPANTS AND SETTING: All adult inpatients at 35 community hospitals in California, Arizona, and Nevada. INTERVENTIONS: A centrally supported collaborative implementing standardized VTE risk assessment and prophylaxis. Protocols were developed with 9 "pilot" sites, which received individualized mentoring. Finished protocols were disseminated to 26 "spread" sites, which received improvement webinars without mentoring. Active surveillance for real-time correction of suboptimal prophylaxis was funded in pilot sites and encouraged in spread sites. Planning and minimal improvement work began in 2011; most implementation occurred in 2012 and 2013. MEASUREMENTS: Rates of per-protocol prophylaxis (at pilot sites), and compliance with The Joint Commission VTE measures (all sites), were monitored starting in January 2012. The International Classification of Diseases, 9th Edition-Clinical Modification codes were used to determine the rates of HA-VTE within 30 days of discharge, heparininduced thrombocytopenia, and anticoagulation adverse events; preimplementation (2011) rates were compared with postimplementation (2014) rates. RESULTS: Protocol-appropriate prophylaxis rates and The Joint Commission measure compliance both reached 97% in 2014, up from 70% to 89% in 2012 and 2013. Five thousand three hundred and seventy HA-VTEs occurred during 1.16 million admissions. Four hundred twenty-eight fewer HA-VTEs occurred in 2014 than in 2011 (relative risk 0.78; 95% confidence interval, 0.73-0.85). HA-VTEs fell more in pilot sites than spread sites (26% vs 20%). The rates of adverse events were reduced or unchanged. CONCLUSIONS: Collaborative efforts were associated with improved prophylaxis rates and fewer HA-VTEs.

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.

The physician mentored implementation model: a promising quality improvement framework for health care change.

Quality improvement (QI) efforts hold great promise for improving care delivery. However, hospitals often struggle with QI implementation and fail to sustain improvement in either process changes or patient outcomes. Physician mentored implementation (PMI) is a novel approach that promotes the success and sustainability of QI initiatives at hospitals. It leverages the expertise of external physician mentors who coach QI teams to implement interventions at their local hospitals. The PMI model includes five core components: (1) a hospital self-assessment tool, (2) a face-to-face training session including direct interaction with a physician mentor, (3) a guided continuous quality improvement and systems approach, (4) yearlong individual physician mentoring, and (5) a learning community supported by a resource center, listserv, and webinars. Mentors provide content and process expertise, rather than offering "one-size-fits-all" technical assistance that might not be sustained after the mentoring year ends. Mentors support and motivate QI teams throughout the planning and implementation phases of their interventions, help to engage hospital leadership, garner local physician buy-in, and address institutional barriers. Mentors also guide hospitals to identify opportunities for the adaptation and customization of original evidence-based models of care while ensuring the fidelity of those models. More than 350 hospitals have used the PMI model to implement successful national and statewide QI initiatives. Academic medical centers are charged with improving the health of patients and reengineering care delivery; thus, they serve as the ideal source for physician mentors and can act as leaders in implementing QI projects using the PMI model.

Improved coding of postoperative deep vein thrombosis and pulmonary embolism in administrative data (AHRQ Patient Safety Indicator 12) after introduction of new ICD-9-CM diagnosis codes.

BACKGROUND: Symptomatic venous thromboembolism is a common postoperative complication. The Agency for Healthcare Research and Quality (AHRQ) has developed a Patient Safety Indicator 12 to assist hospitals, payers, and other stakeholders to identify patients who experienced this complication. OBJECTIVES: To determine whether newly created and recently redefined ICD-9-CM codes improved the criterion validity of Patient Safety Indicator 12, based on new samples of records dated after October 2009. RESEARCH DESIGN, SUBJECTS, MEASURES: Two sources of data were used: (1) UHC retrospective case-control study of risk factors for acute symptomatic venous thromboembolism occurring within 90 days after total knee arthroplasty in teaching hospitals; (2) chart abstraction data by volunteer hospitals participating in the Validation Pilot Project of the AHRQ. RESULTS: In the UHC sample, the positive predictive value (PPV) was 99% (125/126) and the negative predictive value was 99.4% (460/463). In the AHRQ sample, the overall PPV was 81% (126/156). CONCLUSIONS: The PPV based on both samples shows substantial improvement compared with the previously reported PPVs of 43%-48%, suggesting that changes in ICD-9-CM code architecture and better coding guidance can improve the usefulness of coded data.

Predictive value of the present-on-admission indicator for hospital-acquired venous thromboembolism.

BACKGROUND: Hospital-acquired venous thromboembolic (HA-VTE) events are an important, preventable cause of morbidity and death, but accurately identifying HA-VTE events requires labor-intensive chart review. Administrative diagnosis codes and their associated "present-on-admission" (POA) indicator might allow automated identification of HA-VTE events, but only if VTE codes are accurately flagged "not present-on-admission" (POA=N). New codes were introduced in 2009 to improve accuracy. METHODS: We identified all medical patients with at least 1 VTE "other" discharge diagnosis code from 5 academic medical centers over a 24-month period. We then sampled, within each center, patients with VTE codes flagged POA=N or POA=U (insufficient documentation) and POA=Y or POA=W (timing clinically uncertain) and abstracted each chart to clarify VTE timing. All events that were not clearly POA were classified as HA-VTE. We then calculated predictive values of the POA=N/U flags for HA-VTE and the POA=Y/W flags for non-HA-VTE. RESULTS: Among 2070 cases with at least 1 "other" VTE code, we found 339 codes flagged POA=N/U and 1941 flagged POA=Y/W. Among 275 POA=N/U abstracted codes, 75.6% (95% CI, 70.1%-80.6%) were HA-VTE; among 291 POA=Y/W abstracted events, 73.5% (95% CI, 68.0%-78.5%) were non-HA-VTE. Extrapolating from this sample, we estimated that 59% of actual HA-VTE codes were incorrectly flagged POA=Y/W. POA indicator predictive values did not improve after new codes were introduced in 2009. CONCLUSIONS: The predictive value of VTE events flagged POA=N/U for HA-VTE was 75%. However, sole reliance on this flag may substantially underestimate the incidence of HA-VTE.

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.